Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-27 @ 4:16 AM
Study NCT ID:
NCT04659993
Status:
TERMINATED
Last Update Posted:
2025-10-16
First Post:
2020-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cancer Within a Pandemic: A Telemental Health Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012657', 'term': 'Self-Help Groups'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D009938', 'term': 'Organizations'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Katie.Duckworth@advocatehealth.org', 'phone': '3367135440', 'title': 'Principal Investigator', 'organization': 'Wake Forest Baptist Comprehensive Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Deaths and adverse events were not collected.', 'description': 'Due to the nature and scope of this study, investigators did not anticipate any adverse events would be reported by participants.', 'eventGroups': [{'id': 'EG000', 'title': 'TeleHealth Group', 'description': 'The virtual group will be conducted within a secure platform such as Microsoft WebEx. Assessments (pre-, post-, mid-way) will be distributed through REDCap, a secure virtual platform, as will session handouts and forms.\n\nTelemental Health Sessions, Support Groups and Questionnaires: Participants will complete initial online questionnaires lasting about 25-30 minutes as well as attend weekly support group meetings online. After 4 weeks, participants will complete seven online follow-up questionnaires that should take no longer than 30 minutes and again at the end of the study.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Self-Efficacy in Pandemic Conditions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TeleHealth Group', 'description': 'The virtual group will be conducted within a secure platform such as Microsoft WebEx. Assessments (pre-, post-, mid-way) will be distributed through REDCap, a secure virtual platform, as will session handouts and forms.\n\nTelemental Health Sessions, Support Groups and Questionnaires: Participants will complete initial online questionnaires lasting about 25-30 minutes as well as attend weekly support group meetings online. After 4 weeks, participants will complete seven online follow-up questionnaires that should take no longer than 30 minutes and again at the end of the study.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '86.7', 'groupId': 'OG000', 'lowerLimit': '75.2', 'upperLimit': '98.3'}]}]}, {'title': '4 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '87.0', 'groupId': 'OG000', 'lowerLimit': '66.1', 'upperLimit': '107.9'}]}]}, {'title': '8 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '87.8', 'groupId': 'OG000', 'lowerLimit': '68.5', 'upperLimit': '107.2'}]}]}], 'analyses': [{'pValue': '0.8036', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-7.3', 'ciUpperLimit': '9.0', 'pValueComment': 'All statistical tests were performed with a significance level of 0.05.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '7.8', 'groupDescription': 'To test the change over the 8 weeks, a paired t-test (using the baseline and Visit 8 scores within the same patient) will be used; the expected difference in the CBI-B between the two scores would be no change. All statistical test used an alpha of 0.05.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'To test the change over the 8 weeks, a paired t-test (using the baseline and Visit 8 scores within the same patient) will be used; the expected difference in the CBI-B between the two scores would be no change. All statistical test used an alpha of 0.05.'}], 'paramType': 'MEAN', 'timeFrame': 'At baseline up to 8 weeks', 'description': 'The improvement of self-efficacy for young adult cancer survivors navigating pandemic conditions will be assessed by comparing the change in the Cancer Behaviour Inventory-Brief (CBI-B) version (a 12-item validated questionnaire used widely as a measure of self-efficacy for coping with cancer) from baseline to Visit 8. To test the change over the 8 weeks, a paired t-test (using the baseline and Visit 8 scores within the same patient) will be used; the expected difference in the CBI-B between the two scores would be no change. Score range is 1 (not at all confident) to 9 (totally confident) (minimum score of 12, maximum score of 108). Sum the scores for the 12 items with higher scores indicating greater coping efficacy.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Seven participants completed instruments at Baseline, 6 at 4 weeks and 8 weeks.'}, {'type': 'SECONDARY', 'title': 'Changes in Depression and Anxiety Levels (CAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TeleHealth Group', 'description': 'The virtual group will be conducted within a secure platform such as Microsoft WebEx. Assessments (pre-, post-, mid-way) will be distributed through REDCap, a secure virtual platform, as will session handouts and forms.\n\nTelemental Health Sessions, Support Groups and Questionnaires: Participants will complete initial online questionnaires lasting about 25-30 minutes as well as attend weekly support group meetings online. After 4 weeks, participants will complete seven online follow-up questionnaires that should take no longer than 30 minutes and again at the end of the study.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '-0.8', 'upperLimit': '2.8'}]}]}, {'title': '4 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '-0.8', 'upperLimit': '2.5'}]}]}, {'title': '8 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '-0.3', 'upperLimit': '0.6'}]}]}], 'analyses': [{'pValue': '0.3632', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.3', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.4', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Paired t-test for Coronavirus Anxiety Scale. Statistical significance using alpha of 0.05.'}], 'paramType': 'MEAN', 'timeFrame': 'At baseline up to 8 weeks', 'description': 'Three instruments will provide information on baseline, Visit 8, and change over time.\n\n1\\) The Coronavirus Anxiety Scale (CAS) - 5-item mental health screener of dysfunctional anxiety associated with the coronavirus. Scoring is on a 5-point scale of 0 (not at all) to 4 (nearly every day). Minimum score (0): A score of 0 indicates that a person has not experienced any dysfunctional anxiety symptoms related to the coronavirus within the past two weeks. Maximum score (20): A score of 20 indicates the highest level of coronavirus-related anxiety, with the individual experiencing all five symptoms "nearly every day" over the past two weeks.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Seven participants completed instruments at Baseline, 6 at 4 weeks and 8 weeks.'}, {'type': 'SECONDARY', 'title': 'Changes in Depression and Anxiety Levels (PIL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TeleHealth Group', 'description': 'The virtual group will be conducted within a secure platform such as Microsoft WebEx. Assessments (pre-, post-, mid-way) will be distributed through REDCap, a secure virtual platform, as will session handouts and forms.\n\nTelemental Health Sessions, Support Groups and Questionnaires: Participants will complete initial online questionnaires lasting about 25-30 minutes as well as attend weekly support group meetings online. After 4 weeks, participants will complete seven online follow-up questionnaires that should take no longer than 30 minutes and again at the end of the study.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '76.4', 'groupId': 'OG000', 'lowerLimit': '71.2', 'upperLimit': '81.6'}]}]}, {'title': '4 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '79.3', 'groupId': 'OG000', 'lowerLimit': '67.9', 'upperLimit': '90.7'}]}]}, {'title': '8 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '76.3', 'groupId': 'OG000', 'lowerLimit': '61.1', 'upperLimit': '91.5'}]}]}], 'analyses': [{'pValue': '0.7918', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-11.3', 'ciUpperLimit': '9.1', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '9.7', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Paired t-test of Purpose in life test. Statistical significance determine with alpha of 0.05.'}], 'paramType': 'MEAN', 'timeFrame': 'At baseline up to 8 weeks', 'description': 'Three instruments will provide information on baseline, Visit 8, and change over time.\n\n2\\) The Purpose in Life Test (PIL) - 20-item, 7-point Likert scale designed to measure the extent to which a respondent perceives a general sense of meaning and purpose in life using varying scale labels, scores are aggregated with a minimum score of 20 (lowest purpose) and a maximum score of 140 (highest purpose).', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Seven participants completed instruments at Baseline, 6 at 4 weeks and 8 weeks.'}, {'type': 'SECONDARY', 'title': 'Changes in Depression and Anxiety Levels (MAC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TeleHealth Group', 'description': 'The virtual group will be conducted within a secure platform such as Microsoft WebEx. Assessments (pre-, post-, mid-way) will be distributed through REDCap, a secure virtual platform, as will session handouts and forms.\n\nTelemental Health Sessions, Support Groups and Questionnaires: Participants will complete initial online questionnaires lasting about 25-30 minutes as well as attend weekly support group meetings online. After 4 weeks, participants will complete seven online follow-up questionnaires that should take no longer than 30 minutes and again at the end of the study.'}], 'classes': [{'title': 'Baseline-Anxious preoccupation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21.6', 'groupId': 'OG000', 'lowerLimit': '15.2', 'upperLimit': '28.0'}]}]}, {'title': 'Baseline- Cognitive avoidance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000', 'lowerLimit': '6.3', 'upperLimit': '14.0'}]}]}, {'title': 'Baseline-Fatalism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.6', 'groupId': 'OG000', 'lowerLimit': '12.4', 'upperLimit': '18.7'}]}]}, {'title': 'Baseline- Fighting spirit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.4', 'groupId': 'OG000', 'lowerLimit': '11.4', 'upperLimit': '15.4'}]}]}, {'title': 'Baseline- Helplessness/hopelessness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.0', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '16.6'}]}]}, {'title': '4 weeks - Anxious preoccupation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.2', 'groupId': 'OG000', 'lowerLimit': '10.4', 'upperLimit': '28.0'}]}]}, {'title': '4 weeks - Cognitive avoidance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': '8.5'}]}]}, {'title': '4 weeks - Fatalism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.7', 'groupId': 'OG000', 'lowerLimit': '12.8', 'upperLimit': '18.5'}]}]}, {'title': '4 weeks -Fighting spirit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.8', 'groupId': 'OG000', 'lowerLimit': '11.8', 'upperLimit': '15.9'}]}]}, {'title': '4 weeks -Helplessness/hopelessness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000', 'lowerLimit': '5.8', 'upperLimit': '17.2'}]}]}, {'title': '8 weeks- Anxious preoccupation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.2', 'groupId': 'OG000', 'lowerLimit': '6.4', 'upperLimit': '17.9'}]}]}, {'title': '8 weeks- Cognitive avoidance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '12.5'}]}]}, {'title': '8 weeks- Fatalism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.8', 'groupId': 'OG000', 'lowerLimit': '13.1', 'upperLimit': '18.6'}]}]}, {'title': '8 weeks- Fighting spirit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.0', 'groupId': 'OG000', 'lowerLimit': '6.6', 'upperLimit': '15.4'}]}]}, {'title': '8 weeks- Helplessness/hopelessness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000', 'lowerLimit': '7.1', 'upperLimit': '12.6'}]}]}], 'analyses': [{'pValue': '0.7711', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-6.2', 'ciUpperLimit': '4.9', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '5.3', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Paired t-test of The Mini-Mental Adjustment to Cancer Anxious preoccupation Subscale. Statistical significance determine with alpha of 0.05.'}, {'pValue': '0.0772', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.3', 'ciLowerLimit': '-11.5', 'ciUpperLimit': '0.8', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '5.9', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Paired t-test of The Mini-Mental Adjustment to Cancer Cognitive avoidance Subscale. Statistical significance determine with alpha of 0.05.'}, {'pValue': '0.2452', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.0', 'ciLowerLimit': '-2.9', 'ciUpperLimit': '8.9', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '5.6', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Paired t-test of The Mini-Mental Adjustment to Cancer Fatalism Subscale. Statistical significance determine with alpha of 0.05.'}, {'pValue': '0.6099', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.8', 'ciLowerLimit': '-10.5', 'ciUpperLimit': '6.8', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '8.3', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Paired t-test of The Mini-Mental Adjustment to Cancer Fighting spirit Subscale. Statistical significance determine with alpha of 0.05.'}, {'pValue': '0.0913', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.0', 'ciLowerLimit': '-6.7', 'ciUpperLimit': '0.7', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '3.5', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Paired t-test of The Mini-Mental Adjustment to Cancer Helplessness/hopelessness Subscale. Statistical significance determine with alpha of 0.05.'}], 'paramType': 'MEAN', 'timeFrame': 'At baseline up to 8 weeks', 'description': 'Three instruments will provide information on baseline, Visit 8, and change over time.\n\n3\\) Mini-Mental Adjustments to Cancer - 29-item, 4-point Likert scale (maximum possible score of 116 and minimum possible score of 29) for rapid assessment of present coping style from 1 (Definitely Does Not Apply to Me) to 4 (Definitely Apply to Me), higher score represents higher endorsement of the adjustment response. (4). Five subscales include: Helpless-Hopeless (score range 8-32), Anxious Preoccupation (score range 8-32), Cognitive Avoidance (score range 4-16), Fighting Spirit (score range 4-16) and Fatalism (score range 5-20).', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Seven participants completed instruments at Baseline, 6 at 4 weeks and 8 weeks.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TeleHealth Group', 'description': 'The virtual group will be conducted within a secure platform such as Microsoft WebEx. Assessments (pre-, post-, mid-way) will be distributed through REDCap, a secure virtual platform, as will session handouts and forms.\n\nTelemental Health Sessions, Support Groups and Questionnaires: Participants will complete initial online questionnaires lasting about 25-30 minutes as well as attend weekly support group meetings online. After 4 weeks, participants will complete seven online follow-up questionnaires that should take no longer than 30 minutes and again at the end of the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Pre-intervention Assessment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Telehealth Intervention', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'Mid-point Evaluation', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Among the eligible recruitment pool, direct staff member referrals were most common. The final group was comprised primarily of referrals from existing databases.', 'preAssignmentDetails': 'The most common exclusion reasons were being from outside the health system, patients/missing information or deceased prior to medical record review and non-North Carolina resident status. 55 individuals met basic study criteria, 42% cited no specific reason for declining interest or participation. 14 individuals (25%) were both eligible and interested in participating. Two people consented but did not participate. Four individuals never formally consented.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'TeleHealth Group', 'description': 'The virtual group will be conducted within a secure platform such as Microsoft WebEx. Assessments (pre-, post-, mid-way) will be distributed through REDCap, a secure virtual platform, as will session handouts and forms.\n\nTelemental Health Sessions, Support Groups and Questionnaires: Participants will complete initial online questionnaires lasting about 25-30 minutes as well as attend weekly support group meetings online. After 4 weeks, participants will complete seven online follow-up questionnaires that should take no longer than 30 minutes and again at the end of the study.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '37'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Non-Hispanic White', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Non-Hispanic Black', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Hispanic', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Work/Study Location', 'classes': [{'categories': [{'title': 'Home', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Office or School', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Marital Status', 'classes': [{'categories': [{'title': 'Single', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Married', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Divorced', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Widowed', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-14', 'size': 924404, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-08-20T15:32', 'hasProtocol': True}, {'date': '2021-01-20', 'size': 164397, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-01-30T10:38', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'Low accruals', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2020-12-02', 'resultsFirstSubmitDate': '2025-08-20', 'studyFirstSubmitQcDate': '2020-12-02', 'lastUpdatePostDateStruct': {'date': '2025-10-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-30', 'studyFirstPostDateStruct': {'date': '2020-12-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Self-Efficacy in Pandemic Conditions', 'timeFrame': 'At baseline up to 8 weeks', 'description': 'The improvement of self-efficacy for young adult cancer survivors navigating pandemic conditions will be assessed by comparing the change in the Cancer Behaviour Inventory-Brief (CBI-B) version (a 12-item validated questionnaire used widely as a measure of self-efficacy for coping with cancer) from baseline to Visit 8. To test the change over the 8 weeks, a paired t-test (using the baseline and Visit 8 scores within the same patient) will be used; the expected difference in the CBI-B between the two scores would be no change. Score range is 1 (not at all confident) to 9 (totally confident) (minimum score of 12, maximum score of 108). Sum the scores for the 12 items with higher scores indicating greater coping efficacy.'}], 'secondaryOutcomes': [{'measure': 'Changes in Depression and Anxiety Levels (CAS)', 'timeFrame': 'At baseline up to 8 weeks', 'description': 'Three instruments will provide information on baseline, Visit 8, and change over time.\n\n1\\) The Coronavirus Anxiety Scale (CAS) - 5-item mental health screener of dysfunctional anxiety associated with the coronavirus. Scoring is on a 5-point scale of 0 (not at all) to 4 (nearly every day). Minimum score (0): A score of 0 indicates that a person has not experienced any dysfunctional anxiety symptoms related to the coronavirus within the past two weeks. Maximum score (20): A score of 20 indicates the highest level of coronavirus-related anxiety, with the individual experiencing all five symptoms "nearly every day" over the past two weeks.'}, {'measure': 'Changes in Depression and Anxiety Levels (PIL)', 'timeFrame': 'At baseline up to 8 weeks', 'description': 'Three instruments will provide information on baseline, Visit 8, and change over time.\n\n2\\) The Purpose in Life Test (PIL) - 20-item, 7-point Likert scale designed to measure the extent to which a respondent perceives a general sense of meaning and purpose in life using varying scale labels, scores are aggregated with a minimum score of 20 (lowest purpose) and a maximum score of 140 (highest purpose).'}, {'measure': 'Changes in Depression and Anxiety Levels (MAC)', 'timeFrame': 'At baseline up to 8 weeks', 'description': 'Three instruments will provide information on baseline, Visit 8, and change over time.\n\n3\\) Mini-Mental Adjustments to Cancer - 29-item, 4-point Likert scale (maximum possible score of 116 and minimum possible score of 29) for rapid assessment of present coping style from 1 (Definitely Does Not Apply to Me) to 4 (Definitely Apply to Me), higher score represents higher endorsement of the adjustment response. (4). Five subscales include: Helpless-Hopeless (score range 8-32), Anxious Preoccupation (score range 8-32), Cognitive Avoidance (score range 4-16), Fighting Spirit (score range 4-16) and Fatalism (score range 5-20).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Telemental intervention'], 'conditions': ['Cancer', 'Survivorship', 'Depression, Anxiety']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to test an online support group designed to help young adults who have had cancer treatment to manage their mood during a pandemic. Investigators hope to learn more about what effects a support group may have upon the health and well-being of young adults who have undergone cancer treatment by offering an online support group that teaches healthy coping skills in a practical and acceptable way. Investigators would also like to know if certain parts of the online material is more effective in helping subjects manage their mood.', 'detailedDescription': 'Primary Objective: To improve self-efficacy for young adult cancer survivors navigating pandemic conditions.\n\nSecondary Objective: To reduce depression and anxiety levels through meaning-making.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented cancer diagnosis within the Wake Forest Baptist Medical Center medical record;\n* Outpatient Cancer Survivor (diagnosis, treatment, or post-treatment);\n* Aged 18-39\n* Must speak English\n* Must have computer with audio and visual capabilities.\n* Must live within North Carolina\n* Must have experienced health-related anxiety and/or distress in last 3 months.\n\nExclusion Criteria:\n\n* Exclusion criteria will be determined by pre-screening data and medical chart reviews\n* Active inpatient hospitalization\n* Major cognitive impairment, marked concerns with working memory, concentration, or word finding difficulties that significantly impairs daily functioning documented in most recent clinic note or self-reported\n* Recent suicide attempt(s), psychiatric hospitalization, or psychotic processing (last 3 years)\n* Bipolar disorder (I or II) diagnosis, as evidenced by an ICD-10 code within the past year or revealed during subject interview\n* Moderate to severe alcohol or drug abuse; as evidenced by an ICD-10 codes related to alcohol or illicit substance abuse in the medical record within the past year or revealed during subject interview.\n* Severe eating disorders; as evidenced by an ICD-10 code in the medical record such as anorexia nervosa or bulimia within the past year or revealed during patient interview\n* Repeated "acute" crises for example: repeated acute crises consisting of marked psychological distress that impairs function and warrants clinician intervention (e.g., occurring once a month or more frequently); this we be evaluated by the clinician screener.'}, 'identificationModule': {'nctId': 'NCT04659993', 'briefTitle': 'Cancer Within a Pandemic: A Telemental Health Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Cancer Within a Pandemic: A Telemental Health Intervention Designed to Augment Psychological Resilience Amidst Dual Health Threats', 'orgStudyIdInfo': {'id': 'IRB00070150'}, 'secondaryIdInfos': [{'id': 'WFBCCC01520', 'type': 'OTHER', 'domain': 'Wake Forest Baptist Comprehensive Cancer Center'}, {'id': 'P30CA012197', 'link': 'https://reporter.nih.gov/quickSearch/P30CA012197', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telemental Group', 'description': 'The virtual group will be conducted within a secure platform such as Microsoft WebEx. Assessments (pre-, post-, mid-way) will be distributed through REDCap, a secure virtual platform, as will session handouts and forms.', 'interventionNames': ['Behavioral: Telemental Health Sessions, Support Groups and Questionnaires']}], 'interventions': [{'name': 'Telemental Health Sessions, Support Groups and Questionnaires', 'type': 'BEHAVIORAL', 'description': 'Participants will complete initial online questionnaires lasting about 25-30 minutes as well as attend weekly support group meetings online. After 4 weeks, participants will complete seven online follow-up questionnaires that should take no longer than 30 minutes and again at the end of the study.', 'armGroupLabels': ['Telemental Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Baptist Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Katie Duckworth, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}