Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2025-12-24 @ 4:49 PM
Study NCT ID:
NCT05905250
Status:
COMPLETED
Last Update Posted:
2025-12-24
First Post:
2023-05-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
mHealth for Young Adult Cancer Survivors
Sponsor:
Organization:
Raw JSON
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Its 8-week design was informed by cognitive behavioral therapy and positive psychology intervention literature.', 'otherNumAtRisk': 78, 'deathsNumAtRisk': 78, 'otherNumAffected': 0, 'seriousNumAtRisk': 78, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Attention Control', 'description': 'Health education regarding maintaining a healthy weight, physical activity, and nutrition, based on American Cancer Society and NCI guidelines/recommendations.', 'otherNumAtRisk': 77, 'deathsNumAtRisk': 77, 'otherNumAffected': 0, 'seriousNumAtRisk': 77, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Retention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'The intervention utilizes an empirically supported protocol, further refined with evidence-based strategies targeting the needs of young adult (YA) survivors. 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Its 8-week design was informed by cognitive behavioral therapy and positive psychology intervention literature.'}, {'id': 'OG001', 'title': 'Attention Control', 'description': 'Health education regarding maintaining a healthy weight, physical activity, and nutrition, based on American Cancer Society and NCI guidelines/recommendations.'}], 'classes': [{'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000', 'lowerLimit': '70', 'upperLimit': '78'}, {'value': '72', 'groupId': 'OG001', 'lowerLimit': '68', 'upperLimit': '76'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 months (end-of-treatment; EOT)', 'description': 'Number of Participants with Retention at End of Treatment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Retention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'The intervention utilizes an empirically supported protocol, further refined with evidence-based strategies targeting the needs of young adult (YA) survivors. 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Its 8-week design was informed by cognitive behavioral therapy and positive psychology intervention literature.'}, {'id': 'OG001', 'title': 'Attention Control', 'description': 'Health education regarding maintaining a healthy weight, physical activity, and nutrition, based on American Cancer Society and NCI guidelines/recommendations.'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 months (follow-up; FU)', 'description': 'Number of Participants with Retention at End of Study', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'The intervention utilizes an empirically supported protocol, further refined with evidence-based strategies targeting the needs of young adult (YA) survivors. 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Its 8-week design was informed by cognitive behavioral therapy and positive psychology intervention literature.'}, {'id': 'OG001', 'title': 'Attention Control', 'description': 'Health education regarding maintaining a healthy weight, physical activity, and nutrition, based on American Cancer Society and NCI guidelines/recommendations.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.15', 'spread': '7.94', 'groupId': 'OG000'}, {'value': '51.11', 'spread': '8.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 months (follow-up; FU)', 'description': "Hope, per Snyder's Adult Hope Scale - a 12-item measure, each scored on a 1-8 scale; 8 items assess hope-related factors (4 are distractor/filler items), for a total score range of 8-64. 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The intervention follows 8 weekly curricula, reinforced through psychoeducation and skill-building, homework/practical application, and self-monitoring. Its 8-week design was informed by cognitive behavioral therapy and positive psychology intervention literature.'}, {'id': 'OG001', 'title': 'Attention Control', 'description': 'Health education regarding maintaining a healthy weight, physical activity, and nutrition, based on American Cancer Society and NCI guidelines/recommendations.'}], 'classes': [{'categories': [{'measurements': [{'value': '51.72', 'spread': '3.75', 'groupId': 'OG000'}, {'value': '51.38', 'spread': '3.40', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 months (end-of-treatment; EOT)', 'description': 'Higher scores indicate higher Quality of Life (QOL; scale 0-100) (PMCID: PMC2724630); mean scores across QOL dimensions (physical functioning, social functioning, pain interference, fatigue, sleep disturbance, anxiety, depression)', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed among participants who completed the 2-month survey'}, {'type': 'SECONDARY', 'title': 'Quality of Life - Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'The intervention utilizes an empirically supported protocol, further refined with evidence-based strategies targeting the needs of young adult (YA) survivors. 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Its 8-week design was informed by cognitive behavioral therapy and positive psychology intervention literature.'}, {'id': 'OG001', 'title': 'Attention Control', 'description': 'Health education regarding maintaining a healthy weight, physical activity, and nutrition, based on American Cancer Society and NCI guidelines/recommendations.'}], 'classes': [{'categories': [{'measurements': [{'value': '51.17', 'spread': '3.50', 'groupId': 'OG000'}, {'value': '51.56', 'spread': '3.10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 months (follow-up; FU)', 'description': 'Higher scores indicate higher Quality of Life (QOL; scale 0-100) (PMCID: PMC2724630); mean score across QOL dimensions (physical functioning, social functioning, pain interference, fatigue, sleep disturbance, anxiety, depression)', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed among participants who completed the 4-month survey'}, {'type': 'SECONDARY', 'title': 'Functional Assessment of Cancer Therapy - General (FACT-G)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'The intervention utilizes an empirically supported protocol, further refined with evidence-based strategies targeting the needs of young adult (YA) survivors. Its long-term goal is to promote hopeful thinking, and ultimately enhance other long-term markers of quality of life (QOL) (including mental health and health behaviors). The intervention follows 8 weekly curricula, reinforced through psychoeducation and skill-building, homework/practical application, and self-monitoring. Its 8-week design was informed by cognitive behavioral therapy and positive psychology intervention literature.'}, {'id': 'OG001', 'title': 'Attention Control', 'description': 'Health education regarding maintaining a healthy weight, physical activity, and nutrition, based on American Cancer Society and NCI guidelines/recommendations.'}], 'classes': [{'categories': [{'measurements': [{'value': '77.49', 'spread': '17.52', 'groupId': 'OG000'}, {'value': '80.17', 'spread': '15.87', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 months (end-of-treatment; EOT)', 'description': 'Higher scores indicate higher Quality of Life (QOL; scale: 0-108) (https://www.facit.org/measures/fact-g)', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed among participants who completed the 2-month survey'}, {'type': 'SECONDARY', 'title': 'Functional Assessment of Cancer Therapy - General (FACT-G)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'The intervention utilizes an empirically supported protocol, further refined with evidence-based strategies targeting the needs of young adult (YA) survivors. Its long-term goal is to promote hopeful thinking, and ultimately enhance other long-term markers of quality of life (QOL) (including mental health and health behaviors). The intervention follows 8 weekly curricula, reinforced through psychoeducation and skill-building, homework/practical application, and self-monitoring. Its 8-week design was informed by cognitive behavioral therapy and positive psychology intervention literature.'}, {'id': 'OG001', 'title': 'Attention Control', 'description': 'Health education regarding maintaining a healthy weight, physical activity, and nutrition, based on American Cancer Society and NCI guidelines/recommendations.'}], 'classes': [{'categories': [{'measurements': [{'value': '79.18', 'spread': '11.37', 'groupId': 'OG000'}, {'value': '79.15', 'spread': '10.41', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 months (follow-up; FU)', 'description': 'Higher scores indicate higher Quality of Life (QOL; scale: 0-108) (https://www.facit.org/measures/fact-g)', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed among participants who completed the 4-month survey'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': 'The intervention utilizes an empirically supported protocol, further refined with evidence-based strategies targeting the needs of young adult (YA) survivors. Its long-term goal is to promote hopeful thinking, and ultimately enhance other long-term markers of quality of life (QOL) (including mental health and health behaviors). The intervention follows 8 weekly curricula, reinforced through psychoeducation and skill-building, homework/practical application, and self-monitoring. Its 8-week design was informed by cognitive behavioral therapy and positive psychology intervention literature.'}, {'id': 'FG001', 'title': 'Attention Control', 'description': 'Health education regarding maintaining a healthy weight, physical activity, and nutrition, based on American Cancer Society and NCI guidelines/recommendations.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '77'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '77'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study focuses on young adult (YA) cancer survivors, targeting \\~150 participants total enrolled. Inclusion criteria included: 18-39 years old, within 3 years of completing primary treatment or on maintenance chemotherapy, English-speaking, US resident, and smartphone access.', 'preAssignmentDetails': 'Participants were recruited, screened for eligibility, consented, and asked to complete the baseline survey. Both AWARE and the AC involved an 8-week intervention and control for non-specific intervention components.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': 'The intervention utilizes an empirically supported protocol, further refined with evidence-based strategies targeting the needs of young adult (YA) survivors. Its long-term goal is to promote hopeful thinking, and ultimately enhance other long-term markers of quality of life (QOL) (including mental health and health behaviors). The intervention follows 8 weekly curricula, reinforced through psychoeducation and skill-building, homework/practical application, and self-monitoring. Its 8-week design was informed by cognitive behavioral therapy and positive psychology intervention literature.'}, {'id': 'BG001', 'title': 'Attention Control', 'description': 'Health education regarding maintaining a healthy weight, physical activity, and nutrition, based on American Cancer Society and NCI guidelines/recommendations.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.96', 'spread': '5.01', 'groupId': 'BG000'}, {'value': '32.82', 'spread': '4.79', 'groupId': 'BG001'}, {'value': '32.89', 'spread': '4.86', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Sex at birth: female or male', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', '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': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Race, based on NIH/clinicaltrials categories', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'US-based, recruited online', 'unitOfMeasure': 'Participants'}, {'title': 'Hope', 'classes': [{'categories': [{'measurements': [{'value': '48.74', 'spread': '9.03', 'groupId': 'BG000'}, {'value': '50.09', 'spread': '8.03', 'groupId': 'BG001'}, {'value': '49.41', 'spread': '8.55', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Hope, per Snyder's Adult Hope Scale - a 12-item measure, each scored on a 1-8 scale; 8 items assess hope-related factors (4 are distractor/filler items), for a total score range of 8-64. Higher scores indicate higher hope (better outcome).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-10-18', 'size': 2147783, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2025-10-19T06:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The investigative team will be masked except in the event interventionists or data collectors require input from the team that requires disclosure of identifying information. Participants will be randomized to the intervention or attention control.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Individual randomized control trial with 1:1 randomization'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 155}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2023-05-26', 'resultsFirstSubmitDate': '2025-10-31', 'studyFirstSubmitQcDate': '2023-06-14', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-12-08', 'studyFirstPostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retention', 'timeFrame': '2 months (end-of-treatment; EOT)', 'description': 'Number of Participants with Retention at End of Treatment'}, {'measure': 'Retention', 'timeFrame': '4 months (follow-up; FU)', 'description': 'Number of Participants with Retention at End of Study'}, {'measure': 'Adherence', 'timeFrame': '2 months (end-of-treatment; EOT)', 'description': 'Adherence to intervention (number of sessions completed out of 8)'}, {'measure': 'Acceptability', 'timeFrame': '2 months (end-of-treatment; EOT)', 'description': '\\>75% participants reporting high satisfaction (3 or 4 on scale of 0=not at all to 4=very)'}, {'measure': 'Acceptability', 'timeFrame': '2 months (end-of-treatment; EOT)', 'description': '\\>75% report yes to "would you recommend this program to your friends who are cancer survivors?"'}, {'measure': 'Hope', 'timeFrame': '4 months (follow-up; FU)', 'description': "Hope, per Snyder's Adult Hope Scale - a 12-item measure, each scored on a 1-8 scale; 8 items assess hope-related factors (4 are distractor/filler items), for a total score range of 8-64. Higher scores indicate higher hope (better outcome)."}], 'secondaryOutcomes': [{'measure': 'Hope', 'timeFrame': '2 months (end-of-treatment; EOT)', 'description': "Hope, per Snyder's Adult Hope Scale - a 12-item measure, each scored on a 1-8 scale; 8 items assess hope-related factors (4 are distractor/filler items), for a total score range of 8-64. Higher scores indicate higher hope (better outcome)."}, {'measure': 'Quality of Life - Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Scale', 'timeFrame': '2 months (end-of-treatment; EOT)', 'description': 'Higher scores indicate higher Quality of Life (QOL; scale 0-100) (PMCID: PMC2724630); mean scores across QOL dimensions (physical functioning, social functioning, pain interference, fatigue, sleep disturbance, anxiety, depression)'}, {'measure': 'Quality of Life - Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Scale', 'timeFrame': '4 months (follow-up; FU)', 'description': 'Higher scores indicate higher Quality of Life (QOL; scale 0-100) (PMCID: PMC2724630); mean score across QOL dimensions (physical functioning, social functioning, pain interference, fatigue, sleep disturbance, anxiety, depression)'}, {'measure': 'Functional Assessment of Cancer Therapy - General (FACT-G)', 'timeFrame': '2 months (end-of-treatment; EOT)', 'description': 'Higher scores indicate higher Quality of Life (QOL; scale: 0-108) (https://www.facit.org/measures/fact-g)'}, {'measure': 'Functional Assessment of Cancer Therapy - General (FACT-G)', 'timeFrame': '4 months (follow-up; FU)', 'description': 'Higher scores indicate higher Quality of Life (QOL; scale: 0-108) (https://www.facit.org/measures/fact-g)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Survivorship', 'Cancer', 'Psychological Well-Being']}, 'referencesModule': {'references': [{'pmid': '41170949', 'type': 'DERIVED', 'citation': 'Berg CJ, McCready DM, Hinds PS, Lyon ME, Dennis K, Howlader A, Bhanot P, Shajan S, Chalasani P, Chitalia A, Arem H. Outcomes of a Randomized Controlled Trial Testing the Feasibility, Acceptability and Preliminary Efficacy of a Digital, Coach-Assisted Intervention to Enhance Hope and Quality of Life Among Young Adult Cancer Survivors. Psychooncology. 2025 Nov;34(11):e70315. doi: 10.1002/pon.70315.'}, {'pmid': '40580382', 'type': 'DERIVED', 'citation': 'Berg CJ, Schubel LC, McCready DM, Shajan S, Bhanot P, Dopke C, Howlader A, Hinds PS, Levine J, Lyon ME, Chalasani P, Arem H. Profiles of quality of life among US young adult cancer survivors and their associations with potential psychosocial intervention targets of hope and psychological flexibility. Qual Life Res. 2025 Sep;34(9):2677-2688. doi: 10.1007/s11136-025-04010-0. Epub 2025 Jun 28.'}, {'pmid': '38657732', 'type': 'DERIVED', 'citation': 'McCready DM, Arem H, Duarte DA, Dennis K, Ball N, Cafferty LA, Hinds PS, Howlader A, Berg CJ. A digital, coach-assisted intervention to address the psychosocial needs of young adult cancer survivors: Randomized controlled trial protocol and intervention adaptation process. Contemp Clin Trials. 2024 Jun;141:107545. doi: 10.1016/j.cct.2024.107545. Epub 2024 Apr 23.'}]}, 'descriptionModule': {'briefSummary': "We aim to refine and pilot test an 8-week phone- and app-based intervention to promote hope, and thereby mitigate life disruption caused by cancer diagnosis and treatment, among young adults (YAs); our proposal involves (Aim 1) formative research among YA survivors and healthcare providers; and (Aim 2) an randomized controlled trial (RCT) of the intervention vs. attention control among 150 YA cancer survivors. The proposed research is innovative in its use of: 1) a novel intervention target - hope - as a mechanism for addressing goal-disruption and quality of life (QOL) among YA survivors; and 2) novel mHealth components and population-based recruitment strategy (via social media) that are particularly relevant to YA survivors and those with potentially limited access to healthcare. This proposal has potential high impact due to the number of YA cancer survivors for whom the intervention may be relevant, the intervention's potential utility in enhancing hope and QOL among YAs, and its reach/scalability.", 'detailedDescription': 'Young adulthood (YA) is a critical time in shaping life trajectories related to educational, financial, and family goals, among others. Unfortunately, cancer diagnosis/treatment and its psychosocial sequelae disrupt this critical period for some YAs. This life goal disturbance is related to poorer psychological outcomes, particularly among YAs; however, goal revision and reprioritization lead to more positive psychological outcomes. Thus, goal negotiation is a critical part of survivorship. Understanding psychosocial determinants of positive psychological and behavioral outcomes is critical for developing effective behavioral interventions. Within the rich positive psychology literature, the construct of hope is one particularly relevant factor for YA cancer survivors; hope has been defined as a positive cognitive state based on a sense of successful goal-directed determination and planning to meet these goals. In the general population and in cancer survivors, hope is related to better quality of life (QOL), mental health, health behaviors, and coping with illness/cancer. Our team pioneered an mHealth intervention (i.e., app-based with phone-based counseling) aimed at increasing hope among YA survivors, thereby re-engaging them in long-term life goals across domains (e.g., vocational, familial) and ultimately increasing QOL. In an 8-week pilot randomized controlled trial (RCT) of 56 YAs recruited from 2 cancer centers, the intervention demonstrated feasibility (95% retention), acceptability (e.g., high satisfaction), and promising trends in changes in hope, QOL, depressive symptoms, and health behaviors (e.g., substance use) in YA survivors. This study builds on our prior work to update the intervention (e.g., its technology), enhance its reach, and increase our ability to examine its effects. Our specific aims are to: 1) conduct formative research examining YA cancer survivor preferences on phone-based counseling with app support to enhance the intervention; and 2) test the feasibility, acceptability, and preliminary efficacy of the intervention vs. attention control (AC) via an 8-week RCT of 150 YA cancer survivors. The proposed research is innovative in its use of a novel intervention target - hope - as a mechanism for addressing goal-disruption and QOL among YA survivors, and its use of novel mHealth components and population-based recruitment strategy (via social media) that are particularly relevant to YA survivors and those with potentially limited access to healthcare.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of stage I-IV cancer from age 18-39\n* Completion of curative treatment (surgery, chemotherapy and/or radiation) within three years of study enrollment\n* No significant psychological disabilities\n* Able to complete forms and understand instructions in English\n* Smartphone access\n* Aim 2: Able to commit to 8-week remotely delivered study\n\nExclusion Criteria:\n\n* Completion of curative treatment (surgery, chemotherapy and/or radiation) over three years ago or currently in treatment\n* Significant psychological disabilities'}, 'identificationModule': {'nctId': 'NCT05905250', 'acronym': 'mHealthAYA', 'briefTitle': 'mHealth for Young Adult Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'George Washington University'}, 'officialTitle': 'An mHealth Positive Psychology Intervention to Reduce Cancer Burden in Young Adult Cancer Survivors', 'orgStudyIdInfo': {'id': 'NCR224269'}, 'secondaryIdInfos': [{'id': 'R21CA261884', 'link': 'https://reporter.nih.gov/quickSearch/R21CA261884', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'The intervention utilizes an empirically supported protocol, further refined with evidence-based strategies targeting the needs of young adult (YA) survivors. Its long-term goal is to promote hopeful thinking, and ultimately enhance other long-term markers of quality of life (QOL) (including mental health and health behaviors). The intervention follows 8 weekly curricula, reinforced through psychoeducation and skill-building, homework/practical application, and self-monitoring. Its 8-week design was informed by cognitive behavioral therapy and positive psychology intervention literature.', 'interventionNames': ['Behavioral: an empirically supported protocol, further refined with evidence-based strategies']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Attention Control', 'description': 'Health education regarding maintaining a healthy weight, physical activity, and nutrition, based on American Cancer Society and NCI guidelines/recommendations.', 'interventionNames': ['Behavioral: Health education']}], 'interventions': [{'name': 'an empirically supported protocol, further refined with evidence-based strategies', 'type': 'BEHAVIORAL', 'description': 'The intervention utilizes an empirically supported protocol, further refined with evidence-based strategies targeting the needs of young adult (YA) survivors. Its long-term goal is to promote hopeful thinking, and ultimately enhance other long-term markers of quality of life (QOL) (including mental health and health behaviors). The intervention follows 8 weekly curricula, reinforced through psychoeducation and skill-building, homework/practical application, and self-monitoring. Its 8-week design was informed by cognitive behavioral therapy and positive psychology intervention literature.', 'armGroupLabels': ['Intervention']}, {'name': 'Health education', 'type': 'BEHAVIORAL', 'description': 'Health education regarding maintaining a healthy weight, physical activity, and nutrition, based on American Cancer Society and NCI guidelines/recommendations.', 'armGroupLabels': ['Attention Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20052', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'George Washington University', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'overallOfficials': [{'name': 'Carla J Berg, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'George Washington University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'George Washington University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Prevention and Community Health', 'investigatorFullName': 'Carla Berg', 'investigatorAffiliation': 'George Washington University'}}}}