Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2025-12-29 @ 4:22 PM
Study NCT ID:
NCT03032250
Status:
COMPLETED
Last Update Posted:
2023-01-09
First Post:
2017-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prepare to Care, A Supported Self-Management Intervention for Head and Neck Cancer CaregiversHead and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'C562489', 'term': 'Lymphoid Interstitial Pneumonia'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}, {'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cnightin@wakehealth.edu', 'phone': '336-713-1432', 'title': 'Principal Investigator', 'organization': 'Wake Forest Baptist Comprehensive Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Group I Supportive Care (Prepare to Care Kit)', 'description': 'Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.\n\nCommunication Intervention: Attend interventionist sessions\n\nWatch video: Watch video on a DVD\n\nModule completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit\n\nQuality-of-Life Assessment: Ancillary studies\n\nSurvey Administration: Ancillary studies\n\nSalivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group II Control Group', 'description': 'Caregivers received standard of care throughout course of intervention, with option to receive study intervention at end of study.\n\nWatch video: Watch video on a DVD\n\nModule completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit\n\nQuality-of-Life Assessment: Ancillary studies\n\nSurvey Administration: Ancillary studies\n\nSalivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I Supportive Care (Prepare to Care Kit)', 'description': 'Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.\n\nCommunication Intervention: Attend interventionist sessions\n\nWatch video: Watch video on a DVD\n\nModule completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit\n\nQuality-of-Life Assessment: Ancillary studies\n\nSurvey Administration: Ancillary studies\n\nSalivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.'}], 'classes': [{'title': 'Introductory DVD', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Meetings with study interventionist', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Relaxation CD', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Weekly text reminders', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Weekly email reminders', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Study website', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Clinic iPads', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Cancer Education workbook', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Utilizing Resources workbook', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Managing Time workbook', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Seeking/Accepting Support workbook', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Communicating with Others workbook', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Healthy Behaviors workbook', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Positive Coping workbook', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Muscle Relaxation workbook', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Six weeks post radiation therapy', 'description': '10-item quantitative survey will be developed for study to assess how much caregivers liked different aspects of the intervention. Acceptability will be summarized quantitatively and qualitatively. These acceptability questions were asked only of caregivers in the intervention group - Group 1 Supportive Care (Prepare to Care Kit). All data is based on participants answering the acceptability questions as "Quite a Bit/Very Much Helpful" for the intervention materials. Not all participants answered this part of the outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Accrual Assessed by Number of Caregivers Who Agreed to Participate Divided by the Number of Months of Recruitment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.\n\nCommunication Intervention: Attend interventionist sessions\n\nWatch video: Watch video on a DVD\n\nModule completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit\n\nQuality-of-Life Assessment: Ancillary studies\n\nSurvey Administration: Ancillary studies\n\nSalivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 1 year', 'description': '38 patient/caregiver dyads agreed to participate, 22 months of recruitment, for accrual rate of 1.7 (caregiver) participants per month', 'unitOfMeasure': 'participants/months', 'reportingStatus': 'POSTED', 'populationDescription': '38 patient/caregiver dyads agreed to participate, 22 months of recruitment, for accrual rate of 1.7 (caregiver) participants per month'}, {'type': 'PRIMARY', 'title': 'Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I Supportive Care (Prepare to Care Kit)', 'description': 'Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.\n\nCommunication Intervention: Attend interventionist sessions\n\nWatch video: Watch video on a DVD\n\nModule completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit\n\nQuality-of-Life Assessment: Ancillary studies\n\nSurvey Administration: Ancillary studies\n\nSalivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.'}, {'id': 'OG001', 'title': 'Group II No Interventionist Sessions', 'description': 'Caregivers receive educational intervention as in Group I but do not attend interventionist sessions\n\nWatch video: Watch video on a DVD\n\nModule completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit\n\nQuality-of-Life Assessment: Ancillary studies\n\nSurvey Administration: Ancillary studies\n\nSalivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.'}], 'classes': [{'title': 'Esteem at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.98', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '25.88', 'spread': '3.8', 'groupId': 'OG001'}]}]}, {'title': 'Lack of family support at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.29', 'spread': '2.69', 'groupId': 'OG000'}, {'value': '11.25', 'spread': '2.67', 'groupId': 'OG001'}]}]}, {'title': 'Impact on finances at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.29', 'spread': '2.28', 'groupId': 'OG000'}, {'value': '8.89', 'spread': '1.78', 'groupId': 'OG001'}]}]}, {'title': 'Impact on schedule at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.35', 'spread': '3.31', 'groupId': 'OG000'}, {'value': '16.78', 'spread': '4.1', 'groupId': 'OG001'}]}]}, {'title': 'Impact on health at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.94', 'spread': '1.48', 'groupId': 'OG000'}, {'value': '13.67', 'spread': '1.65', 'groupId': 'OG001'}]}]}, {'title': 'Esteem after radiotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.75', 'spread': '3.31', 'groupId': 'OG000'}, {'value': '25.30', 'spread': '4.19', 'groupId': 'OG001'}]}]}, {'title': 'Lack of family support after radiotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.58', 'spread': '2.23', 'groupId': 'OG000'}, {'value': '11.19', 'spread': '3.23', 'groupId': 'OG001'}]}]}, {'title': 'Impact on finances after radiotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.42', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '8.25', 'spread': '1.24', 'groupId': 'OG001'}]}]}, {'title': 'Impact on schedule after radiotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.33', 'spread': '2.74', 'groupId': 'OG000'}, {'value': '16.56', 'spread': '4.43', 'groupId': 'OG001'}]}]}, {'title': 'Impact on health after radiotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.33', 'spread': '1.61', 'groupId': 'OG000'}, {'value': '14.38', 'spread': '1.59', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and following radiotherapy, assessed up to 1 year', 'description': '21-item instrument assessing positive and negative aspects of caregiving (esteem, lack of family support, finances, schedule, and health). The CRA has been tested in cancer caregivers; demonstrated validity and reliability. Minimum and maximum scoring scale: BASELINE: Scores for esteem 15-31; lack of family support 5-15, impact of finances 3-12, impact of schedule 12-23, impact of health 11-16). AFTER RADIOTHERAPY: Scores for esteem 20-31; lack of family support 9-17, impact of finances 7-11, impact of schedule 14-22, impact of health 12-17). The higher the score the more the item being assessed impacted the participant.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all participants submitted information after completion of radiotherapy.'}, {'type': 'PRIMARY', 'title': 'Change in Psychological Distress - Center for Epidemiological Studies Depression (CESD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I Supportive Care (Prepare to Care Kit)', 'description': 'Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.\n\nCommunication Intervention: Attend interventionist sessions\n\nWatch video: Watch video on a DVD\n\nModule completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit\n\nQuality-of-Life Assessment: Ancillary studies\n\nSurvey Administration: Ancillary studies\n\nSalivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.'}, {'id': 'OG001', 'title': 'Group II No Interventionist Sessions', 'description': 'Caregivers receive educational intervention as in Group I but do not attend interventionist sessions\n\nWatch video: Watch video on a DVD\n\nModule completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit\n\nQuality-of-Life Assessment: Ancillary studies\n\nSurvey Administration: Ancillary studies\n\nSalivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.'}], 'classes': [{'title': 'Score at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.71', 'spread': '13.05', 'groupId': 'OG000'}, {'value': '19.28', 'spread': '12.97', 'groupId': 'OG001'}]}]}, {'title': 'Score after radiotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.00', 'spread': '15.66', 'groupId': 'OG000'}, {'value': '13.58', 'spread': '8.65', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before and after radiotherapy, assessed up to 1 year', 'description': 'The score is the sum of the 20 questions. Possible scoring range is 0-60. A score of 16 points or more is considered depressed.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all participants completed this intervention after radiotherapy timeframe indicated for this outcome measure'}, {'type': 'PRIMARY', 'title': 'Change in Quality of Life Assessed by Caregiver Quality of Life Index-Cancer (CqoL-Canc)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I Supportive Care (Prepare to Care Kit)', 'description': 'Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.\n\nCommunication Intervention: Attend interventionist sessions\n\nWatch video: Watch video on a DVD\n\nModule completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit\n\nQuality-of-Life Assessment: Ancillary studies\n\nSurvey Administration: Ancillary studies\n\nSalivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.'}, {'id': 'OG001', 'title': 'Group II No Interventionist Sessions', 'description': 'Caregivers receive educational intervention as in Group I but do not attend interventionist sessions\n\nWatch video: Watch video on a DVD\n\nModule completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit\n\nQuality-of-Life Assessment: Ancillary studies\n\nSurvey Administration: Ancillary studies\n\nSalivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.'}], 'classes': [{'title': 'At baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '87.63', 'spread': '25.95', 'groupId': 'OG000'}, {'value': '87.26', 'spread': '20.32', 'groupId': 'OG001'}]}]}, {'title': 'After radiotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '92.55', 'spread': '22.09', 'groupId': 'OG000'}, {'value': '89.86', 'spread': '18.78', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before and after radiotherapy, assessed up to 1 year', 'description': '35-item instrument assessing dimensions of caregiver quality of life (burden, disruptiveness, positive adaptation, financial concerns). The Cqol-Canc has demonstrated validity and reliability. Minimum and maximum score at baseline is a range of 9-78 and after radiotherapy a range of 2-73. The higher the score the greater the level of change in the quality of life for participants.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all participants completed this intervention after radiotherapy as indicated for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Frequency of Intervention Modules Utilized Assessed by Caregiver Logs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I Supportive Care (Prepare to Care Kit)', 'description': 'Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.\n\nCommunication Intervention: Attend interventionist sessions\n\nWatch video: Watch video on a DVD\n\nModule completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit\n\nQuality-of-Life Assessment: Ancillary studies\n\nSurvey Administration: Ancillary studies\n\nSalivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.'}], 'classes': [{'title': 'Cancer Education', 'categories': [{'measurements': [{'value': '22.3', 'spread': '10.2', 'groupId': 'OG000'}]}]}, {'title': 'Utilizing Resources', 'categories': [{'measurements': [{'value': '38.7', 'spread': '20.1', 'groupId': 'OG000'}]}]}, {'title': 'Seeking/ Accepting Support', 'categories': [{'measurements': [{'value': '55.2', 'spread': '27.8', 'groupId': 'OG000'}]}]}, {'title': 'Communicating with others', 'categories': [{'measurements': [{'value': '40.3', 'spread': '12.7', 'groupId': 'OG000'}]}]}, {'title': 'Managing Time', 'categories': [{'measurements': [{'value': '40.8', 'spread': '26.9', 'groupId': 'OG000'}]}]}, {'title': 'Coping', 'categories': [{'measurements': [{'value': '66.7', 'spread': '51.1', 'groupId': 'OG000'}]}]}, {'title': 'Practicing Healthy Behaviors', 'categories': [{'measurements': [{'value': '48', 'spread': '15.6', 'groupId': 'OG000'}]}]}, {'title': 'Relaxation CD', 'categories': [{'measurements': [{'value': '58', 'spread': '18.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 1 year', 'description': 'Data on intervention resources used and time spent using them based on caregivers in intervention group', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants in Agreement to Perform Interventions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination of Intervention and Control Groups to Assess Participation', 'description': 'Participation assessed by proportion of eligible participants who agreed to participate'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 1 year', 'description': 'Participation assessed by number of eligible participants who agreed to participate and complete study interventions.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '90 eligible patient/caregiver dyads, 38 agreed to participate'}, {'type': 'PRIMARY', 'title': 'Retention Assessed by Number of Participants Who Completed the End of Radiotherapy Visit Divided by the Number Who Agreed to Participate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I Supportive Care (Prepare to Care Kit)', 'description': 'Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.\n\nCommunication Intervention: Attend interventionist sessions\n\nWatch video: Watch video on a DVD\n\nModule completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit\n\nQuality-of-Life Assessment: Ancillary studies\n\nSurvey Administration: Ancillary studies\n\nSalivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.'}, {'id': 'OG001', 'title': 'Group II No Interventionist Sessions', 'description': 'Caregivers receive educational intervention as in Group I but do not attend interventionist sessions\n\nWatch video: Watch video on a DVD\n\nModule completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit\n\nQuality-of-Life Assessment: Ancillary studies\n\nSurvey Administration: Ancillary studies\n\nSalivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 1 year', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '38 agreed to participate (19 in caregiver intervention group, 19 in caregiver control group)'}, {'type': 'PRIMARY', 'title': 'Self-efficacy in Abbreviated Progressive Muscle Relaxation (APMR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I Supportive Care (Prepare to Care Kit)', 'description': 'Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.\n\nCommunication Intervention: Attend interventionist sessions\n\nWatch video: Watch video on a DVD\n\nModule completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit\n\nQuality-of-Life Assessment: Ancillary studies\n\nSurvey Administration: Ancillary studies\n\nSalivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.'}, {'id': 'OG001', 'title': 'Group II No Interventionist Sessions', 'description': 'Caregivers receive educational intervention as in Group I but do not attend interventionist sessions\n\nWatch video: Watch video on a DVD\n\nModule completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit\n\nQuality-of-Life Assessment: Ancillary studies\n\nSurvey Administration: Ancillary studies\n\nSalivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.'}], 'classes': [{'title': 'At baseline', 'categories': [{'measurements': [{'value': '11.88', 'spread': '6.53', 'groupId': 'OG000'}, {'value': '13.33', 'spread': '5.36', 'groupId': 'OG001'}]}]}, {'title': 'After radiotherapy', 'categories': [{'measurements': [{'value': '16.08', 'spread': '2.68', 'groupId': 'OG000'}, {'value': '12.19', 'spread': '5.59', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and up to the end of radiotherapy, assessed up to 1 year', 'description': 'A 3-item instrument developed for study to evaluate self-efficacy in APMR. Minimum to maximum scores range from 3-27. Higher scores demonstrate higher self efficacy in participants.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Self-efficacy in Coping With Cancer Caregiver Inventory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I Supportive Care (Prepare to Care Kit)', 'description': 'Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.\n\nCommunication Intervention: Attend interventionist sessions\n\nWatch video: Watch video on a DVD\n\nModule completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit\n\nQuality-of-Life Assessment: Ancillary studies\n\nSurvey Administration: Ancillary studies\n\nSalivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.'}, {'id': 'OG001', 'title': 'Group II No Interventionist Sessions', 'description': 'Caregivers receive educational intervention as in Group I but do not attend interventionist sessions\n\nWatch video: Watch video on a DVD\n\nModule completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit\n\nQuality-of-Life Assessment: Ancillary studies\n\nSurvey Administration: Ancillary studies\n\nSalivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.'}], 'classes': [{'title': 'Managing medical information at baseline', 'categories': [{'measurements': [{'value': '22.35', 'spread': '3.26', 'groupId': 'OG000'}, {'value': '22.00', 'spread': '3.29', 'groupId': 'OG001'}]}]}, {'title': 'Caring for care recipient at baseline', 'categories': [{'measurements': [{'value': '52.94', 'spread': '9.65', 'groupId': 'OG000'}, {'value': '55.11', 'spread': '6.11', 'groupId': 'OG001'}]}]}, {'title': 'Caring for oneself at baseline', 'categories': [{'measurements': [{'value': '25.71', 'spread': '10.44', 'groupId': 'OG000'}, {'value': '28.06', 'spread': '7.83', 'groupId': 'OG001'}]}]}, {'title': 'Managing difficult interactions/emotions at baseline', 'categories': [{'measurements': [{'value': '34.52', 'spread': '10.96', 'groupId': 'OG000'}, {'value': '39.13', 'spread': '7.95', 'groupId': 'OG001'}]}]}, {'title': 'Managing medical information after radiotherapy', 'categories': [{'measurements': [{'value': '23.08', 'spread': '2.54', 'groupId': 'OG000'}, {'value': '22.43', 'spread': '4.80', 'groupId': 'OG001'}]}]}, {'title': 'Caring for care recipient after radiotherapy', 'categories': [{'measurements': [{'value': '54.42', 'spread': '5.62', 'groupId': 'OG000'}, {'value': '54.98', 'spread': '6.82', 'groupId': 'OG001'}]}]}, {'title': 'Caring for oneself after radiotherapy', 'categories': [{'measurements': [{'value': '25.75', 'spread': '9.40', 'groupId': 'OG000'}, {'value': '31.30', 'spread': '8.26', 'groupId': 'OG001'}]}]}, {'title': 'Managing difficult interactions/emotions after radiotherapy', 'categories': [{'measurements': [{'value': '37.92', 'spread': '10.03', 'groupId': 'OG000'}, {'value': '39.68', 'spread': '7.86', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and up to the end of radiotherapy, assessed up to 1 year', 'description': "21-item instrument assessing caregivers' perceived self-efficacy for coping with cancer (managing medical information, caring for care recipient, caring for oneself, managing difficult interactions/emotions); demonstrated validity and reliability. Minimum and maximum scores range from 10-63. Higher scores indicate higher self-efficacy in coping with cancer from the participants.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Salivary Cortisol Collection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I Supportive Care (Prepare to Care Kit)', 'description': 'Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.\n\nCommunication Intervention: Attend interventionist sessions\n\nWatch video: Watch video on a DVD\n\nModule completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit\n\nQuality-of-Life Assessment: Ancillary studies\n\nSurvey Administration: Ancillary studies\n\nSalivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.'}, {'id': 'OG001', 'title': 'Group II Control Group', 'description': 'Caregivers received standard of care throughout course of intervention, with option to receive study intervention at end of study\n\nWatch video: Watch video on a DVD\n\nModule completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit\n\nQuality-of-Life Assessment: Ancillary studies\n\nSurvey Administration: Ancillary studies\n\nSalivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.'}], 'timeFrame': 'Up to 1 year', 'description': 'For eligible caregivers only - collected three times a day (at awakening, 30 minutes post-awakening, and bedtime) for two consecutive days following T1 (start of radiation), T2 (end of radiation), and T3 (6 weeks post radiation). To obtain preliminary data on caregiver cortisol response (cortisol slope, cortisol awakening response, area under the curve, and intra-individual cortisol variability). Investigators will use a mixed model to evaluate differences between the groups in these parameters at times T1 and T2 and T3', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis of this outcome measure is currently incomplete and cannot be reported as this time as the information is not available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group I Supportive Care (Prepare to Care Kit)', 'description': 'Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.\n\nCommunication Intervention: Attend interventionist sessions\n\nWatch video: Watch video on a DVD\n\nModule completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit\n\nQuality-of-Life Assessment: Ancillary studies\n\nSurvey Administration: Ancillary studies\n\nSalivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.'}, {'id': 'FG001', 'title': 'Group II Control Group', 'description': 'Caregivers received standard of care throughout course of intervention, with option to receive study intervention at end of study.\n\nWatch video: Watch video on a DVD\n\nModule completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit\n\nQuality-of-Life Assessment: Ancillary studies\n\nSurvey Administration: Ancillary studies\n\nSalivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group I Supportive Care (Prepare to Care Kit)', 'description': 'Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.\n\nCommunication Intervention: Attend interventionist sessions\n\nWatch video: Watch video on a DVD\n\nModule completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit\n\nQuality-of-Life Assessment: Ancillary studies\n\nSurvey Administration: Ancillary studies\n\nSalivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.'}, {'id': 'BG001', 'title': 'Group II Control Group', 'description': 'Caregivers received standard of care throughout course of intervention, with option to receive study intervention at end of study."\n\nWatch video: Watch video on a DVD\n\nModule completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit\n\nQuality-of-Life Assessment: Ancillary studies\n\nSurvey Administration: Ancillary studies\n\nSalivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.3', 'spread': '15.5', 'groupId': 'BG000'}, {'value': '57.4', 'spread': '11.8', 'groupId': 'BG001'}, {'value': '56.4', 'spread': '13.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-04', 'size': 499128, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-04-19T14:59', 'hasProtocol': True}, {'date': '2018-03-19', 'size': 215872, 'label': 'Informed Consent Form: Caregiver Informed Consent', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-04-19T15:08', 'hasProtocol': False}, {'date': '2018-03-19', 'size': 144973, 'label': 'Informed Consent Form: Patient Informed Consent', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-04-19T15:13', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2020-04-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-14', 'studyFirstSubmitDate': '2017-01-17', 'resultsFirstSubmitDate': '2021-04-23', 'studyFirstSubmitQcDate': '2017-01-23', 'lastUpdatePostDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-09', 'studyFirstPostDateStruct': {'date': '2017-01-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Salivary Cortisol Collection', 'timeFrame': 'Up to 1 year', 'description': 'For eligible caregivers only - collected three times a day (at awakening, 30 minutes post-awakening, and bedtime) for two consecutive days following T1 (start of radiation), T2 (end of radiation), and T3 (6 weeks post radiation). To obtain preliminary data on caregiver cortisol response (cortisol slope, cortisol awakening response, area under the curve, and intra-individual cortisol variability). Investigators will use a mixed model to evaluate differences between the groups in these parameters at times T1 and T2 and T3'}], 'primaryOutcomes': [{'measure': 'Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions', 'timeFrame': 'Six weeks post radiation therapy', 'description': '10-item quantitative survey will be developed for study to assess how much caregivers liked different aspects of the intervention. Acceptability will be summarized quantitatively and qualitatively. These acceptability questions were asked only of caregivers in the intervention group - Group 1 Supportive Care (Prepare to Care Kit). All data is based on participants answering the acceptability questions as "Quite a Bit/Very Much Helpful" for the intervention materials. Not all participants answered this part of the outcome measure.'}, {'measure': 'Accrual Assessed by Number of Caregivers Who Agreed to Participate Divided by the Number of Months of Recruitment', 'timeFrame': 'Up to 1 year', 'description': '38 patient/caregiver dyads agreed to participate, 22 months of recruitment, for accrual rate of 1.7 (caregiver) participants per month'}, {'measure': 'Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA)', 'timeFrame': 'Baseline and following radiotherapy, assessed up to 1 year', 'description': '21-item instrument assessing positive and negative aspects of caregiving (esteem, lack of family support, finances, schedule, and health). The CRA has been tested in cancer caregivers; demonstrated validity and reliability. Minimum and maximum scoring scale: BASELINE: Scores for esteem 15-31; lack of family support 5-15, impact of finances 3-12, impact of schedule 12-23, impact of health 11-16). AFTER RADIOTHERAPY: Scores for esteem 20-31; lack of family support 9-17, impact of finances 7-11, impact of schedule 14-22, impact of health 12-17). The higher the score the more the item being assessed impacted the participant.'}, {'measure': 'Change in Psychological Distress - Center for Epidemiological Studies Depression (CESD)', 'timeFrame': 'Before and after radiotherapy, assessed up to 1 year', 'description': 'The score is the sum of the 20 questions. Possible scoring range is 0-60. A score of 16 points or more is considered depressed.'}, {'measure': 'Change in Quality of Life Assessed by Caregiver Quality of Life Index-Cancer (CqoL-Canc)', 'timeFrame': 'Before and after radiotherapy, assessed up to 1 year', 'description': '35-item instrument assessing dimensions of caregiver quality of life (burden, disruptiveness, positive adaptation, financial concerns). The Cqol-Canc has demonstrated validity and reliability. Minimum and maximum score at baseline is a range of 9-78 and after radiotherapy a range of 2-73. The higher the score the greater the level of change in the quality of life for participants.'}, {'measure': 'Frequency of Intervention Modules Utilized Assessed by Caregiver Logs', 'timeFrame': 'Up to 1 year', 'description': 'Data on intervention resources used and time spent using them based on caregivers in intervention group'}, {'measure': 'Number of Participants in Agreement to Perform Interventions', 'timeFrame': 'Up to 1 year', 'description': 'Participation assessed by number of eligible participants who agreed to participate and complete study interventions.'}, {'measure': 'Retention Assessed by Number of Participants Who Completed the End of Radiotherapy Visit Divided by the Number Who Agreed to Participate', 'timeFrame': 'Up to 1 year'}, {'measure': 'Self-efficacy in Abbreviated Progressive Muscle Relaxation (APMR)', 'timeFrame': 'At baseline and up to the end of radiotherapy, assessed up to 1 year', 'description': 'A 3-item instrument developed for study to evaluate self-efficacy in APMR. Minimum to maximum scores range from 3-27. Higher scores demonstrate higher self efficacy in participants.'}, {'measure': 'Self-efficacy in Coping With Cancer Caregiver Inventory', 'timeFrame': 'At baseline and up to the end of radiotherapy, assessed up to 1 year', 'description': "21-item instrument assessing caregivers' perceived self-efficacy for coping with cancer (managing medical information, caring for care recipient, caring for oneself, managing difficult interactions/emotions); demonstrated validity and reliability. Minimum and maximum scores range from 10-63. Higher scores indicate higher self-efficacy in coping with cancer from the participants."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Caregiver', 'Malignant Head and Neck Neoplasm', 'Paranasal Sinus Squamous Cell Carcinoma', 'Salivary Gland Squamous Cell Carcinoma', 'Stage I Hypopharyngeal Squamous Cell Carcinoma', 'Stage I Laryngeal Squamous Cell Carcinoma', 'Stage I Lip and Oral Cavity Squamous Cell Carcinoma', 'Stage I Oropharyngeal Squamous Cell Carcinoma', 'Stage II Hypopharyngeal Squamous Cell Carcinoma', 'Stage II Laryngeal Squamous Cell Carcinoma', 'Stage II Lip and Oral Cavity Squamous Cell Carcinoma', 'Stage II Oropharyngeal Squamous Cell Carcinoma', 'Stage III Hypopharyngeal Squamous Cell Carcinoma', 'Stage III Laryngeal Squamous Cell Carcinoma', 'Stage III Lip and Oral Cavity Squamous Cell Carcinoma', 'Stage III Oropharyngeal Squamous Cell Carcinoma', 'Stage IV Hypopharyngeal Squamous Cell Carcinoma', 'Stage IV Laryngeal Squamous Cell Carcinoma', 'Stage IV Lip and Oral Cavity Squamous Cell Carcinoma', 'Stage IV Oropharyngeal Squamous Cell Carcinoma', 'Stage IVA Hypopharyngeal Squamous Cell Carcinoma', 'Stage IVA Laryngeal Squamous Cell Carcinoma', 'Stage IVA Lip and Oral Cavity Squamous Cell Carcinoma', 'Stage IVA Oropharyngeal Squamous Cell Carcinoma', 'Stage IVB Hypopharyngeal Squamous Cell Carcinoma', 'Stage IVB Laryngeal Squamous Cell Carcinoma', 'Stage IVB Lip and Oral Cavity Squamous Cell Carcinoma', 'Stage IVB Oropharyngeal Squamous Cell Carcinoma', 'Stage IVC Hypopharyngeal Squamous Cell Carcinoma', 'Stage IVC Laryngeal Squamous Cell Carcinoma', 'Stage IVC Lip and Oral Cavity Squamous Cell Carcinoma', 'Stage IVC Oropharyngeal Squamous Cell Carcinoma', 'Recurrent Head and Neck Squamous Cell Carcinoma', 'Recurrent Hypopharyngeal Squamous Cell Carcinoma', 'Recurrent Laryngeal Squamous Cell Carcinoma', 'Recurrent Lip and Oral Cavity Squamous Cell Carcinoma', 'Recurrent Oropharyngeal SCC', 'Recurrent Paranasal Sinus Squamous Cell Carcinoma']}, 'referencesModule': {'references': [{'pmid': '35575280', 'type': 'DERIVED', 'citation': 'Nightingale C, Sterba KR, Levine B, Tooze JA, Greven K, Frizzell B, Hughes RT, Snavely A, Lesser GJ, Norona S, Pleasant K, Weaver KE. Feasibility and Acceptability of a Multi-Modality Self-Management Intervention for Head and Neck Cancer Caregivers: A Pilot Randomized Trial. Integr Cancer Ther. 2022 Jan-Dec;21:15347354221098984. doi: 10.1177/15347354221098984.'}]}, 'descriptionModule': {'briefSummary': 'This pilot clinical trial studies how well Prepare to Care kit works in improving caregiver support in patients with stage I-IV head and neck cancer that is new or has come back. Prepare to Care kit may increase knowledge about head and neck cancer and enhance stress-management skills.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To assess feasibility (accrual, participation, and retention) and acceptability of a supported self-management intervention for psycho-education and stress management skills building designed for informal caregivers (intervention group n=20; waitlist control group, n=20) of head and neck cancer (HNC) patients undergoing radiotherapy (RT).\n\nII. To obtain preliminary data on caregiver intermediate (self-efficacy for \\[a\\] coping with cancer and \\[b\\] abbreviated progressive muscle relaxation) and outcome variables (burden, psychological distress, quality of life) in intervention caregivers and waitlist control caregivers at the start of radiation (T1), end of radiation (T2), and 6-weeks post-radiation (T3).\n\nIII. To compare intermediate (self-efficacy for (a) coping with cancer and (b) abbreviated progressive muscle relaxation) and outcome variables (burden, psychological distress, quality of life) between intervention caregivers and waitlist control caregivers at T1, T2, and T3.\n\nIV. To obtain preliminary data on caregiver cortisol response (cortisol slope, cortisol awakening\n\nOUTLINE: Patients are randomized to 1 of 2 groups.\n\nGROUP I: Caregivers watch introduction video on a digital video disc (DVD) over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.\n\nGROUP II: Caregivers receive educational intervention as in Group I but do not attend interventionist sessions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCAREGIVERS:\n\n* Providing the majority of the informal (unpaid) care during radiation therapy for a patient meeting inclusion criteria and participating in study\n\nCARE-RECIPIENTS:\n\n* Has a new or recurrent American Joint Committee on Cancer (AJCC) stage I-IV squamous cell carcinoma of the upper aerodigestive tract (including lip/oral cavity, nasopharynx, salivary gland, oropharynx, hypopharynx, paranasal sinus, and larynx cancers)\n* Has planned external beam radiotherapy (+/- chemotherapy) for 6-7 weeks\n* Has an informal (unpaid) caregiver during radiation therapy who is participating in study\n\nExclusion Criteria:\n\n* CAREGIVERS: Has a current cancer diagnosis\n* CAREGIVERS: Cannot read/communicate in English\n* CAREGIVERS: Have an endocrine disorder (e.g., diabetes and thyroid disorders), or is currently taking a steroid based medication will not be eligible to participate in the saliva portion of the study\n* CARE-RECIPIENTS: Cannot read/communicate in English'}, 'identificationModule': {'nctId': 'NCT03032250', 'briefTitle': 'Prepare to Care, A Supported Self-Management Intervention for Head and Neck Cancer CaregiversHead and Neck Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Prepare to Care, A Supported Self-Management Intervention for Head and Neck Cancer Caregivers', 'orgStudyIdInfo': {'id': 'IRB00038084'}, 'secondaryIdInfos': [{'id': 'NCI-2016-02045', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'CCCWFU 99616', 'type': 'OTHER', 'domain': 'Comprehensive Cancer Center of Wake Forest University'}, {'id': 'P30CA012197', 'link': 'https://reporter.nih.gov/quickSearch/P30CA012197', 'type': 'NIH'}, {'id': 'R03CA208560', 'link': 'https://reporter.nih.gov/quickSearch/R03CA208560', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I Supportive Care (Prepare to Care kit)', 'description': 'Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.', 'interventionNames': ['Other: Communication Intervention', 'Other: Watch video', 'Other: Module completion of the Prepare to Care kit', 'Other: Quality-of-Life Assessment', 'Other: Survey Administration', 'Other: Salivary cortisol collection']}, {'type': 'EXPERIMENTAL', 'label': 'Group II Control Group', 'description': 'Caregivers received standard of care throughout course of intervention, with option to receive study intervention at end of study', 'interventionNames': ['Other: Watch video', 'Other: Module completion of the Prepare to Care kit', 'Other: Quality-of-Life Assessment', 'Other: Survey Administration', 'Other: Salivary cortisol collection']}], 'interventions': [{'name': 'Communication Intervention', 'type': 'OTHER', 'description': 'Attend interventionist sessions', 'armGroupLabels': ['Group I Supportive Care (Prepare to Care kit)']}, {'name': 'Watch video', 'type': 'OTHER', 'otherNames': ['Education for Intervention', 'Intervention by Education', 'Intervention through Education', 'Intervention, Educational'], 'description': 'Watch video on a DVD', 'armGroupLabels': ['Group I Supportive Care (Prepare to Care kit)', 'Group II Control Group']}, {'name': 'Module completion of the Prepare to Care kit', 'type': 'OTHER', 'otherNames': ['Education for Intervention', 'Intervention by Education', 'Intervention through Education', 'Intervention, Educational'], 'description': 'Complete modules of the Prepare to Care kit', 'armGroupLabels': ['Group I Supportive Care (Prepare to Care kit)', 'Group II Control Group']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Group I Supportive Care (Prepare to Care kit)', 'Group II Control Group']}, {'name': 'Survey Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Group I Supportive Care (Prepare to Care kit)', 'Group II Control Group']}, {'name': 'Salivary cortisol collection', 'type': 'OTHER', 'description': 'Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.', 'armGroupLabels': ['Group I Supportive Care (Prepare to Care kit)', 'Group II Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Comprehensive Cancer Center of Wake Forest University', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Chandylen Nightingale', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}