Promoting Resilience in Early Survivorship Among Adolescents and Young Adults With Cancer
2 other identifiers
interventional
325
1 country
2
Brief Summary
The goal of this study is to find the best way to help participants and families manage the stress of facing a serious illness and be better able to "bounce back" or be resilient after a difficult situation. Participants will take part in the "Promoting Resilience in Stress Management" PRISM program, which is designed to provide skills to change or improve the impact of stress in everyday life. The name of the intervention used in this research study is:
- PRISM (a mobile app program comprised of 6 sessions of skills-based, manualized resilience education)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2023
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2023
CompletedFirst Posted
Study publicly available on registry
September 14, 2023
CompletedStudy Start
First participant enrolled
October 16, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
December 29, 2025
December 1, 2025
3.2 years
September 8, 2023
December 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Connor Davidson Resilience Scale (CDRISC-10) Score
Assessed by the CDRISC-10, a 10-item measures consisting of a 5-point Likert scale with answers ranging from 0 (not true at all) to 4 (true nearly all the time) for a total of 40 points. Higher scores reflect greater resilience. Evaluation will be based on the scores of the video and text cohorts vs. the self-guided cohort.
At 6 months
Secondary Outcomes (8)
CDRISC-10 Score for App-Only Cohort Responders
3 months
CDRISC-10 Score for Text Coach Cohort Responders
3 months
Change in HOPE Scale Score
At Baseline, 3 months, and 6 months
Change in Adolescent Participant Quality of Life Total Score
At Baseline, 3 months, and 6 months
Change in Young Adult Participant Quality of Life Total Score
At Baseline, 3 months, and 6 months
- +3 more secondary outcomes
Study Arms (3)
PRISM Program Mobile App
EXPERIMENTALParticipants will be randomized to "app-only" group and will complete: * Baseline questionnaire. * mPRISM App self guided modules * 3 month questionnaire. * mPRISM App self guided modules until final survey at 6 months and end of participation.
PRISM Program Video Coach
ACTIVE COMPARATORParticipants will be randomized to "video" group and will complete: * Baseline questionnaire. * PRISM sessions. * 3 month questionnaire with re-randomization to either "app-only" or "text" groups or referral to specialty psychosocial support. * After re-randomization, participants will complete PRISM sessions until final survey at 6 months and end of participation.
PRISM Program Text Coach
ACTIVE COMPARATORParticipants will be randomized to "text" group and will complete: * Baseline questionnaire. * PRISM sessions. * 3 month questionnaire with re-randomization to "app-only," "text," or "video" groups. * After re-randomization, participants will complete PRISM sessions until final survey at 6 months and end of participation.
Interventions
A 6-session, skills-based, manualized resilience education program delivered via video coaching by trained English or Spanish speaking PRISM coaches. Participants will have complete access to the PRISM Program mobile app. Sessions will be delivered by a HIPAA compliant videoconferencing platform, Zoom, approximately every 1-2 weeks based on participant preference. For participants who do not have smartphones, temporary equipment will be provided.
A 6-session, skills-based, manualized, resilience education program delivered via text coaching by trained English or Spanish speaking PRISM coaches. Participants will have complete access to the PRISM Program mobile app. Sessions will be delivered by HIPAA compliant SMS text-messaging service, Zoom, approximately every other week. For participants who do not have smartphones, temporary equipment will be provided.
6 static modules to practice skills-based, manualized, resilience education program delivered via PRISM Program mobile app. For participants who do not have smartphones, temporary equipment will be provided.
Eligibility Criteria
You may qualify if:
- All genders ≥ 12 and ≤ 25 years of age at baseline
- Participant is able to speak English or Spanish language (for PRISM sessions)
- Participant is able to read English or Spanish language (for completion of surveys)
- Participant is cognitively able to participate in PRISM sessions and complete written questionnaires and surveys, as judged by the site investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Cancer Institute (NCI)collaborator
- Dana-Farber Cancer Institutelead
Study Sites (2)
Boston Children's Hospital
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Abby Rosenberg, MD
Dana-Farber Cancer Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 8, 2023
First Posted
September 14, 2023
Study Start
October 16, 2023
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
May 1, 2027
Last Updated
December 29, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.