Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-29 @ 8:21 PM
Study NCT ID:
NCT04337203
Status:
COMPLETED
Last Update Posted:
2023-06-28
First Post:
2020-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Shared Healthcare Actions and Reflections Electronic Systems in Survivorship
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'c.kittel@wakehealth.edu', 'phone': '336-399-3832', 'title': 'Carol Kittel', 'organization': 'Wake Forest Baptist Comprehensive Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 30 days after the final intervention session.', 'eventGroups': [{'id': 'EG000', 'title': 'Overall', 'description': 'Single Arm - Intervention', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients Enrolled Out of Those Electronically Referred', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SHARE-S Intervention', 'description': 'Enrolled in intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '50'}]}]}], 'analyses': [{'pValue': '0.54', 'groupIds': ['OG000'], 'statisticalMethod': 'Independent samples proportions test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Feasibility study and calculated confidence interval.'}], 'paramType': 'NUMBER', 'timeFrame': '1 year, 8 months', 'description': 'Using a 95% confidence interval (CI) to determine the range of estimates that are consistent with our data. Investigators will track the number of new patients seen in the Survivorship Clinic, and the percent who agree to be referred to SHARE-S.', 'unitOfMeasure': 'number of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Total number reflects the total number of participants who were electronically referred in SHARE-S intervention.'}, {'type': 'SECONDARY', 'title': 'Adoption - Number of Electronically Referred Patients - Those Possible [Based on Chart Review]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '409', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SHARE-S - Intervention', 'description': 'Participants given a care plan'}], 'classes': [{'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year, 8 months', 'description': 'Using a 95% confidence interval to determine the range of estimates that are consistent with our data. Investigators will track the number of new patients seen in the Survivorship Clinic, and the percent who agree to enroll in SHARE-S', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Total number given a care plan'}, {'type': 'SECONDARY', 'title': 'Acceptability of Intervention Measure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SHARE-S Intervention', 'description': 'Initial cohort less 6 lost to follow-up at time of subsequent survey administration'}], 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'spread': '.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 30 days after the final intervention session.', 'description': 'This measure will be used along with qualitative feedback among participants using a mixed-methods to assess acceptability of intervention with different cancer types. Acceptability ranges from 1-5 with higher scores indicating more acceptability.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Initial cohort less 6 lost to follow-up at time of subsequent survey administration'}, {'type': 'SECONDARY', 'title': 'Appropriateness of Intervention Measure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SHARE-S Intervention', 'description': 'Initial cohort less 6 lost to follow-up at time of subsequent survey administration'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'spread': '0.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 30 days after the final intervention session.', 'description': 'This measure will be used along with qualitative feedback among participants using a mixed-methods to assess appropriateness of intervention with different cancer types. Appropriateness ranges from 1-5 with higher scores meaning more appropriateness.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Initial cohort less 6 lost to follow-up at time of subsequent survey administration'}, {'type': 'SECONDARY', 'title': 'Number of Participants Enrolled Per Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SHARE-S Intervention', 'description': 'SHARE-S Intervention Enrolled Participants'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '7'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year, 8 months', 'description': 'This will be defined as the average number of participants that enroll per month that the study is open to enrollment.', 'unitOfMeasure': 'participants/month', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Number enrolled per month.'}, {'type': 'SECONDARY', 'title': 'Feasibility of Intervention Measure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SHARE-S Intervention', 'description': 'Initial cohort less 6 lost to follow-up at time of subsequent survey administration'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'spread': '.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 30 days after the final intervention session.', 'description': 'This measure will be used along with qualitative feedback among participants using a mixed-methods to assess feasibility of intervention with different cancer types. Feasibility ranges from 1-5 with higher scores indicating more feasibility.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Initial cohort less 6 lost to follow-up at time of subsequent survey administration'}, {'type': 'SECONDARY', 'title': 'Retention Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SHARE-S Intervention', 'description': 'SHARE-S Intervention enrolled participants'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 30 days after the final intervention session.', 'description': 'Retention is defined as participants that complete the follow up assessment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SHARE-S Intervention enrolled participants less 5 lost in follow-up.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Adhering to Text Responses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SHARE-S Intervention', 'description': 'Participants enrolled in the intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year, 8 months', 'description': 'Defined as participants that adhere to responding to text messages received during intervention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '40 enrolled'}, {'type': 'SECONDARY', 'title': 'Participant Adherence to Coaching Sessions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SHARE-S Intervention', 'description': 'Participants enrolled in the intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year, 8 months', 'description': 'Defined as adherence to completing coaching sessions during the intervention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '40 enrolled'}, {'type': 'SECONDARY', 'title': 'Length of Coaching Sessions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SHARE-S Intervention', 'description': 'Participants enrolled in the intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '69'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 30 days after the final intervention session.', 'description': 'Defined as how long each completed coaching sessions lasted during the intervention.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '40 enrolled (mean minutes over coach calls at 3 timepoints).'}, {'type': 'SECONDARY', 'title': 'Number of Coaching Sessions Completed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SHARE-S Intervention', 'description': 'Participants enrolled in the intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year, 8 months', 'description': 'Defined as an observational checklist completed for a subset of coaching sessions.', 'unitOfMeasure': 'sessions', 'reportingStatus': 'POSTED', 'populationDescription': '40 enrolled'}, {'type': 'SECONDARY', 'title': 'Total Number of Patients Enrolled', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SHARE-S Intervention', 'description': 'Participants enrolled in the intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year, 8 months', 'description': 'Number of patients enrolled will be defined as overall participants for the entirety of the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '40 participants enrolled'}, {'type': 'SECONDARY', 'title': 'Frequency of Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SHARE-S Intervention', 'description': 'Participants enrolled in the intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 30 days after the final intervention session.', 'description': 'Adverse events related to the intervention will be assessed in adverse event log.', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': '40 participants enrolled'}, {'type': 'SECONDARY', 'title': 'HEAL Patient-Provider Connection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SHARE-S Intervention', 'description': 'Initial cohort with 6 lost to follow-up at time of subsequent survey administration'}], 'classes': [{'categories': [{'measurements': [{'value': '32.3', 'spread': '4.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 30 days after the final intervention session.', 'description': 'Patient reported measure of patient-centered communication/relatedness completed only at follow-up. Range 0-35 with higher scores indicating better communication.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Initial cohort with 6 lost to follow-up at time of subsequent survey administration'}, {'type': 'SECONDARY', 'title': 'Patient-Reported Health Outcomes PROMIS Profile 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SHARE-S Intervention - Baseline', 'description': 'Entire sample of 40 participants responses at baseline survey'}, {'id': 'OG001', 'title': 'SHARE-S Intervention - Follow-Up', 'description': 'Same cohort with 5 lost to follow-up at time of subsequent survey administration'}], 'classes': [{'title': 'physical function (0-100)', 'categories': [{'measurements': [{'value': '48.4', 'spread': '8.2', 'groupId': 'OG000'}, {'value': '49.2', 'spread': '8.5', 'groupId': 'OG001'}]}]}, {'title': 'anxiety (0-100)', 'categories': [{'measurements': [{'value': '50.6', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '49.0', 'spread': '8.5', 'groupId': 'OG001'}]}]}, {'title': 'depression (0-100)', 'categories': [{'measurements': [{'value': '48.1', 'spread': '9.3', 'groupId': 'OG000'}, {'value': '45.9', 'spread': '7.7', 'groupId': 'OG001'}]}]}, {'title': 'fatigue (0-100)', 'categories': [{'measurements': [{'value': '51.3', 'spread': '10.9', 'groupId': 'OG000'}, {'value': '49.2', 'spread': '11.5', 'groupId': 'OG001'}]}]}, {'title': 'sleep disturbance (0-100)', 'categories': [{'measurements': [{'value': '49.6', 'spread': '7.4', 'groupId': 'OG000'}, {'value': '48.9', 'spread': '6.3', 'groupId': 'OG001'}]}]}, {'title': 'social roles (0-100)', 'categories': [{'measurements': [{'value': '51.2', 'spread': '9.4', 'groupId': 'OG000'}, {'value': '54.2', 'spread': '10.8', 'groupId': 'OG001'}]}]}, {'title': 'pain interference (0-100)', 'categories': [{'measurements': [{'value': '51.5', 'spread': '10.2', 'groupId': 'OG000'}, {'value': '50.3', 'spread': '9.3', 'groupId': 'OG001'}]}]}, {'title': 'pain intensity (0-10)', 'categories': [{'measurements': [{'value': '2.7', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and up to 30 days after the final intervention session.', 'description': 'Questionnaire to assess the social role (0-100), physical functioning (0-100), anxiety (0-100), depression (0-100), fatigue (0-100), sleep disturbance (0-100), pain interference (0-100), pain intensity (0-10). Lower scores indicate less of construct.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '40 enrolled at baseline; 35 available at follow-up'}, {'type': 'SECONDARY', 'title': '36-Item Short Form Survey (SF-36)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SHARE-S Intervention - Baseline', 'description': 'Entire sample of 40 participants responses at baseline survey'}, {'id': 'OG001', 'title': 'SHARE-S Intervention - Follow-Up', 'description': 'Same cohort with 5 lost to follow-up at time of subsequent survey administration'}], 'classes': [{'categories': [{'measurements': [{'value': '3.15', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '3.15', 'spread': '0.89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and up to 30 days after the final intervention session.', 'description': 'Participants will only answer the single item question that provides an indication of perceived change in health. Score range: 1 - excellent health, 2 - very good health, 3 - good health, 4 - fair health and 5 - poor health.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '40 enrolled at baseline; 35 answered follow-up questionnaire'}, {'type': 'SECONDARY', 'title': 'Cancer-specific Quality of Life in Adult Cancer Survivors (QLACS) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SHARE-S Intervention - Baseline', 'description': 'Entire sample of 40 participants responses at baseline survey'}, {'id': 'OG001', 'title': 'SHARE-S Intervention - Follow-Up', 'description': 'Same cohort with 5 lost to follow-up at time of subsequent survey administration'}], 'classes': [{'title': 'Cancer-Specific Quality of Life', 'categories': [{'measurements': [{'value': '47', 'spread': '20.5', 'groupId': 'OG000'}, {'value': '40.9', 'spread': '19.1', 'groupId': 'OG001'}]}]}, {'title': 'Benefits of Having Cancer', 'categories': [{'measurements': [{'value': '13.9', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '12.2', 'spread': '5.7', 'groupId': 'OG001'}]}]}, {'title': 'Positive Feelings', 'categories': [{'measurements': [{'value': '10.6', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '9.5', 'spread': '4.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and up to 30 days after the final intervention session.', 'description': 'Investigators will only assess the quality of life of adult cancer survivors measuring domains of cancer survivorship that are cancer-specific. Cancer-Specific Quality of Life (range 15-105) - higher score indicates more quality of life; Benefits of Having Cancer (range 4-28) - higher score indicates more benefits; Positive Feelings (range 4-28) - lower score indicates more positive feelings.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '40 participants at baseline; 35 participants answered follow-up questionnaire'}, {'type': 'SECONDARY', 'title': 'Index of Autonomous Functioning - Self Congruence Subscale Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SHARE-S Intervention - Baseline', 'description': 'Entire sample of 40 participants responses at baseline survey.'}, {'id': 'OG001', 'title': 'SHARE-S Intervention - Follow-Up', 'description': 'Same cohort with 5 lost to follow-up at time of subsequent survey administration'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'spread': '.5', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and up to 30 days after the final intervention session.', 'description': 'The Index of Autonomous Functioning - self congruence subscale only. 5 Items were paired with a Likert-type scale with 1 = "not at all true", 2 = "a bit true", 3 = "somewhat true", 4 = "mostly true", and 5 = "completely true." Mean score is average of 5 items. Higher mean score indicate a higher level of self congruence functioning.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '40 participants at baseline; 35 participants answered follow-up questionnaire'}, {'type': 'SECONDARY', 'title': 'Self-Efficacy to Manage Chronic Disease Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SHARE-S Intervention - Baseline', 'description': 'Entire sample of 40 participants responses at baseline survey'}, {'id': 'OG001', 'title': 'SHARE-S Intervention - Follow-Up', 'description': 'Same cohort with 5 lost to follow-up at time of subsequent survey administration'}], 'classes': [{'categories': [{'measurements': [{'value': '7.7', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '7.8', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and up to 30 days after the final intervention session.', 'description': 'A questionnaire made up of 6-items on a visual analog scale, ranging from 1 (not at all confident) to 10 (totally confident). Higher the mean score indicates higher self-efficacy.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '40 participants at baseline; 35 participants answered follow-up questionnaire'}, {'type': 'SECONDARY', 'title': 'Engagement With the Survivorship Care Plan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SHARE-S Intervention - Follow-up', 'description': 'Initial baseline cohort with 6 lost to follow-up at time of subsequent survey administration'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year, 8 months', 'description': 'Self-reported use of the care plan since enrolled on the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '34 participants available at follow-up'}, {'type': 'SECONDARY', 'title': 'Satisfaction of Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SHARE-S Intervention - Follow-Up', 'description': 'Initial baseline cohort with 5 lost to follow-up at time of subsequent survey administration'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'spread': '.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 30 days after the final intervention session.', 'description': 'Participants will evaluate their overall satisfaction with their care after the study intervention. Mean of Likert scale. 1=very poor, 5=very good.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Follow-up only'}, {'type': 'SECONDARY', 'title': 'Health Behaviors Questionnaire - Tobacco Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SHARE-S Intervention - Baseline', 'description': 'Entire sample of 40 participants responses at baseline survey'}, {'id': 'OG001', 'title': 'SHARE-S Intervention - Follow-Up', 'description': 'Same cohort with 6 lost to follow-up at time of subsequent survey administration'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At baseline and up to 30 days after the final intervention session.', 'description': 'Participants will be asked about their tobacco use within the last seven days. Tobacco use is scored 1=yes, 0=no. Higher values represent more participants were tobacco users.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '40 participants at baseline; 34 participants answered follow-up questionnaire'}, {'type': 'SECONDARY', 'title': 'Health Behaviors Questionnaire - Alcohol Use Disorder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SHARE-S Intervention - Baseline', 'description': 'Entire sample of 40 participants responses at baseline survey'}, {'id': 'OG001', 'title': 'SHARE-S Intervention - Follow-Up', 'description': 'Same cohort with 6 lost to follow-up at time of subsequent survey administration'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and up to 30 days after the final intervention session.', 'description': 'Participants will be asked individual questions about their alcohol use. Alcohol use disorder is on a scale of 0-12 with higher scores indicating more hazardous; men ≥ 4, women ≥ 3 is considered hazardous.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Entire cohort at baseline; 34 participants at follow-up.'}, {'type': 'SECONDARY', 'title': 'Health Behaviors Questionnaire - Physical Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SHARE-S Intervention - Baseline', 'description': 'Entire sample of 40 participants responses at baseline survey'}, {'id': 'OG001', 'title': 'SHARE-S Intervention - Follow-Up', 'description': 'Same cohort with 6 lost to follow-up at time of subsequent survey administration'}], 'classes': [{'categories': [{'measurements': [{'value': '124.5', 'spread': '140', 'groupId': 'OG000'}, {'value': '162.4', 'spread': '157.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and up to 30 days after the final intervention session.', 'description': 'Participants will be asked individual questions about their physical activity. Physical activity is minutes/week with \\<90 minutes considered insufficient.', 'unitOfMeasure': 'minutes/week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Entire cohort at baseline; 34 participants at follow-up.'}, {'type': 'SECONDARY', 'title': 'Health Behaviors Questionnaire - Fruit and Vegetable Intake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SHARE-S Intervention - Baseline', 'description': 'Entire sample of 40 participants responses at baseline survey'}, {'id': 'OG001', 'title': 'SHARE-S Intervention - Follow-Up', 'description': 'Same cohort with 6 lost to follow-up at time of subsequent survey administration'}], 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and up to 30 days after the final intervention session.', 'description': 'Participants will be asked individual questions about their fruit and vegetable intake. Mean for the responses were calculated in cups so ½ to 1 cup = 0.75 cups, at least 2-3 cups for both considered sufficient.', 'unitOfMeasure': 'cups/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Entire cohort at baseline; 34 participants at follow-up.'}, {'type': 'SECONDARY', 'title': 'Health Behaviors Questionnaire - Mindfulness Practice', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SHARE-S Intervention - Baseline', 'description': 'Entire sample of 40 participants responses at baseline survey'}, {'id': 'OG001', 'title': 'SHARE-S Intervention - Follow-Up', 'description': 'Same cohort with 6 lost to follow-up at time of subsequent survey administration'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and up to 30 days after the final intervention session.', 'description': 'Participants will be asked individual questions how many days/week they practice mindfulness.', 'unitOfMeasure': 'days/week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Entire cohort at baseline; 34 participants at follow-up.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SHARE-S Intervention', 'description': 'SHARE-S Intervention'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Single Arm', 'description': 'Intervention'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.4', 'spread': '15.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.2', 'spread': '6.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Marital Status, Categorical', 'classes': [{'categories': [{'title': 'Currently Married', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'Separated', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Divorced', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Widowed', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Single, never married', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Prefer not to answer', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Highest Grade, Categorical', 'classes': [{'categories': [{'title': '8th to 11th grade', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'High school or equivalent', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Vocation/technical school post HS', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': "Associate's degree/some college", 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': "Bachelor's degree", 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Graduate or professional school', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Primary Tumor Site, Categorical', 'classes': [{'categories': [{'title': 'Breast', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Colorectal', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Endometrial', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Non-Hodgkin Lymphoma', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Prostate', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History of Cancer-Related Surgical Procedure, Categorical', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History of Radiation Therapy, Categorical', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History of Chemotherapy, Categorical', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Time since last treatment/surgery (months)', 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000', 'lowerLimit': '2', 'upperLimit': '39'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'months', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Difficult to pay monthly bills, Categorical', 'classes': [{'categories': [{'title': 'Very difficult', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Somewhat difficult', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Not very difficult', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Not at all difficult', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Travel to clinic bills (minutes)', 'classes': [{'categories': [{'measurements': [{'value': '31.5', 'spread': '28.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'minutes', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Use internet or email at least occasionally, Categorical', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Confident filling out medical forms, Categorical', 'classes': [{'categories': [{'title': 'Extremely', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'Quite a bit', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Somewhat', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'A little bit', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not at all', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of times received income assistance, Categorical', 'classes': [{'categories': [{'title': 'Never', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': 'Once', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Twice', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Three times', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Four times', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than four times', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Rural residence, Categorical', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-15', 'size': 397841, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-02-09T15:07', 'hasProtocol': True}, {'date': '2021-11-17', 'size': 156163, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-06-30T14:41', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-05', 'studyFirstSubmitDate': '2020-04-01', 'resultsFirstSubmitDate': '2023-02-10', 'studyFirstSubmitQcDate': '2020-04-03', 'lastUpdatePostDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-06-05', 'studyFirstPostDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients Enrolled Out of Those Electronically Referred', 'timeFrame': '1 year, 8 months', 'description': 'Using a 95% confidence interval (CI) to determine the range of estimates that are consistent with our data. Investigators will track the number of new patients seen in the Survivorship Clinic, and the percent who agree to be referred to SHARE-S.'}], 'secondaryOutcomes': [{'measure': 'Adoption - Number of Electronically Referred Patients - Those Possible [Based on Chart Review]', 'timeFrame': '1 year, 8 months', 'description': 'Using a 95% confidence interval to determine the range of estimates that are consistent with our data. Investigators will track the number of new patients seen in the Survivorship Clinic, and the percent who agree to enroll in SHARE-S'}, {'measure': 'Acceptability of Intervention Measure', 'timeFrame': 'Up to 30 days after the final intervention session.', 'description': 'This measure will be used along with qualitative feedback among participants using a mixed-methods to assess acceptability of intervention with different cancer types. Acceptability ranges from 1-5 with higher scores indicating more acceptability.'}, {'measure': 'Appropriateness of Intervention Measure', 'timeFrame': 'Up to 30 days after the final intervention session.', 'description': 'This measure will be used along with qualitative feedback among participants using a mixed-methods to assess appropriateness of intervention with different cancer types. Appropriateness ranges from 1-5 with higher scores meaning more appropriateness.'}, {'measure': 'Number of Participants Enrolled Per Month', 'timeFrame': '1 year, 8 months', 'description': 'This will be defined as the average number of participants that enroll per month that the study is open to enrollment.'}, {'measure': 'Feasibility of Intervention Measure', 'timeFrame': 'Up to 30 days after the final intervention session.', 'description': 'This measure will be used along with qualitative feedback among participants using a mixed-methods to assess feasibility of intervention with different cancer types. Feasibility ranges from 1-5 with higher scores indicating more feasibility.'}, {'measure': 'Retention Rates', 'timeFrame': 'Up to 30 days after the final intervention session.', 'description': 'Retention is defined as participants that complete the follow up assessment.'}, {'measure': 'Number of Participants Adhering to Text Responses', 'timeFrame': '1 year, 8 months', 'description': 'Defined as participants that adhere to responding to text messages received during intervention.'}, {'measure': 'Participant Adherence to Coaching Sessions', 'timeFrame': '1 year, 8 months', 'description': 'Defined as adherence to completing coaching sessions during the intervention.'}, {'measure': 'Length of Coaching Sessions', 'timeFrame': 'Up to 30 days after the final intervention session.', 'description': 'Defined as how long each completed coaching sessions lasted during the intervention.'}, {'measure': 'Number of Coaching Sessions Completed', 'timeFrame': '1 year, 8 months', 'description': 'Defined as an observational checklist completed for a subset of coaching sessions.'}, {'measure': 'Total Number of Patients Enrolled', 'timeFrame': '1 year, 8 months', 'description': 'Number of patients enrolled will be defined as overall participants for the entirety of the study.'}, {'measure': 'Frequency of Adverse Events', 'timeFrame': 'Up to 30 days after the final intervention session.', 'description': 'Adverse events related to the intervention will be assessed in adverse event log.'}, {'measure': 'HEAL Patient-Provider Connection', 'timeFrame': 'Up to 30 days after the final intervention session.', 'description': 'Patient reported measure of patient-centered communication/relatedness completed only at follow-up. Range 0-35 with higher scores indicating better communication.'}, {'measure': 'Patient-Reported Health Outcomes PROMIS Profile 29', 'timeFrame': 'At baseline and up to 30 days after the final intervention session.', 'description': 'Questionnaire to assess the social role (0-100), physical functioning (0-100), anxiety (0-100), depression (0-100), fatigue (0-100), sleep disturbance (0-100), pain interference (0-100), pain intensity (0-10). Lower scores indicate less of construct.'}, {'measure': '36-Item Short Form Survey (SF-36)', 'timeFrame': 'At baseline and up to 30 days after the final intervention session.', 'description': 'Participants will only answer the single item question that provides an indication of perceived change in health. Score range: 1 - excellent health, 2 - very good health, 3 - good health, 4 - fair health and 5 - poor health.'}, {'measure': 'Cancer-specific Quality of Life in Adult Cancer Survivors (QLACS) Questionnaire', 'timeFrame': 'At baseline and up to 30 days after the final intervention session.', 'description': 'Investigators will only assess the quality of life of adult cancer survivors measuring domains of cancer survivorship that are cancer-specific. Cancer-Specific Quality of Life (range 15-105) - higher score indicates more quality of life; Benefits of Having Cancer (range 4-28) - higher score indicates more benefits; Positive Feelings (range 4-28) - lower score indicates more positive feelings.'}, {'measure': 'Index of Autonomous Functioning - Self Congruence Subscale Only', 'timeFrame': 'At baseline and up to 30 days after the final intervention session.', 'description': 'The Index of Autonomous Functioning - self congruence subscale only. 5 Items were paired with a Likert-type scale with 1 = "not at all true", 2 = "a bit true", 3 = "somewhat true", 4 = "mostly true", and 5 = "completely true." Mean score is average of 5 items. Higher mean score indicate a higher level of self congruence functioning.'}, {'measure': 'Self-Efficacy to Manage Chronic Disease Questionnaire', 'timeFrame': 'At baseline and up to 30 days after the final intervention session.', 'description': 'A questionnaire made up of 6-items on a visual analog scale, ranging from 1 (not at all confident) to 10 (totally confident). Higher the mean score indicates higher self-efficacy.'}, {'measure': 'Engagement With the Survivorship Care Plan', 'timeFrame': '1 year, 8 months', 'description': 'Self-reported use of the care plan since enrolled on the study.'}, {'measure': 'Satisfaction of Care', 'timeFrame': 'Up to 30 days after the final intervention session.', 'description': 'Participants will evaluate their overall satisfaction with their care after the study intervention. Mean of Likert scale. 1=very poor, 5=very good.'}, {'measure': 'Health Behaviors Questionnaire - Tobacco Use', 'timeFrame': 'At baseline and up to 30 days after the final intervention session.', 'description': 'Participants will be asked about their tobacco use within the last seven days. Tobacco use is scored 1=yes, 0=no. Higher values represent more participants were tobacco users.'}, {'measure': 'Health Behaviors Questionnaire - Alcohol Use Disorder', 'timeFrame': 'At baseline and up to 30 days after the final intervention session.', 'description': 'Participants will be asked individual questions about their alcohol use. Alcohol use disorder is on a scale of 0-12 with higher scores indicating more hazardous; men ≥ 4, women ≥ 3 is considered hazardous.'}, {'measure': 'Health Behaviors Questionnaire - Physical Activity', 'timeFrame': 'At baseline and up to 30 days after the final intervention session.', 'description': 'Participants will be asked individual questions about their physical activity. Physical activity is minutes/week with \\<90 minutes considered insufficient.'}, {'measure': 'Health Behaviors Questionnaire - Fruit and Vegetable Intake', 'timeFrame': 'At baseline and up to 30 days after the final intervention session.', 'description': 'Participants will be asked individual questions about their fruit and vegetable intake. Mean for the responses were calculated in cups so ½ to 1 cup = 0.75 cups, at least 2-3 cups for both considered sufficient.'}, {'measure': 'Health Behaviors Questionnaire - Mindfulness Practice', 'timeFrame': 'At baseline and up to 30 days after the final intervention session.', 'description': 'Participants will be asked individual questions how many days/week they practice mindfulness.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer', 'Survivorship', 'Hematopoietic and Lymphoid Cell Neoplasm', 'Malignant Solid Neoplasm']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is conduct a pilot study testing the study protocols, implementation program, and mixed-methods data collection.', 'detailedDescription': 'Primary Objectives:\n\n• To evaluate how successfully SHARE-S can be implemented into clinical care as characterized by rates of enrollment. Investigators hypothesize \\>30% of patients e-referred to SHARE-S will enroll.\n\nSecondary Objectives:\n\n* To assess additional implementation outcomes that evaluate preliminary implementation success (i.e., further assessment of adoption, acceptability, appropriateness, further assessment of feasibility, and fidelity).\n* To describe service outcome variability to inform future studies. Investigators will assess service outcomes relevant to Commission on Cancer requirements by reporting annual estimates for: (1) the estimated number of patients impacted by SHARE-S; (2) the cancer sites impacted by SHARE-S; and the (3) resources/processes utilized to enhance each of the chosen services if barriers were encountered. We will also assess safety and perceived patient-centeredness of care.\n* To describe patient health outcome variability to inform future studies (i.e., social role, physical functioning, anxiety, depression, fatigue, sleep disturbance, pain, cancer-specific quality of life, health behaviors, patient autonomy, self-efficacy for managing cancer, engagement with the survivorship care plan document, and satisfaction with care).\n* To evaluate the Implementation Program we will assess key milestones and processes for this pilot study of the Implementation Stage measured at the clinic level.\n* To qualitatively assess implementation barriers and facilitators using semi-structured interviews that will be audio-recorded.\n* To examine how study results vary by cancer type.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults ≥18 years of age\n* Documented or planned cancer survivorship visit\n* Have a texting enabled telephone\n* Cognitively able to complete study procedures as judged by the study team\n* Able to understand, read and write English\n\nChildren under the age of 18 with cancer will be excluded due to the potentially different self-management support intervention needs of this population that will likely include parental involvement. Results from this research may inform future studies in children with cancer under 18 who should be researched separately.\n\nExclusion Criteria\n\n\\- Declined participation in the study'}, 'identificationModule': {'nctId': 'NCT04337203', 'briefTitle': 'Shared Healthcare Actions and Reflections Electronic Systems in Survivorship', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'SHARE-S Aim 3: Shared Healthcare Actions & Reflections Electronic Systems in Survivorship', 'orgStudyIdInfo': {'id': 'IRB00064683'}, 'secondaryIdInfos': [{'id': 'WFBCCC 99420', 'type': 'OTHER', 'domain': 'Wake Forest Baptist Comprehensive Cancer Center'}, {'id': '1P50CA244693-01', 'link': 'https://reporter.nih.gov/quickSearch/1P50CA244693-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHARE-S', 'description': 'Three components consisting of electronic referral, health coaching and tailored text/email messages for patients that have been referred to the cancer survivorship clinic.', 'interventionNames': ['Behavioral: SHARE-S Implementation Program']}], 'interventions': [{'name': 'SHARE-S Implementation Program', 'type': 'BEHAVIORAL', 'description': 'The program consists of three components: An electronic referral among clinical teams for potential participants, patient engagement with survivorship care planning guidelines through self-management/health coaching. One coaching call before a clinic visit (60 minutes) and two coaching calls after the clinic visit (30 minutes each). Participants will also receive automated, tailored text messages (daily for three weeks before and after a clinic visit for a total of six weeks).', 'armGroupLabels': ['SHARE-S']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Baptist Comprehensive Cancer Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Stephanie Sohl, 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'}}}}