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Promoting Resilience in Early Survivorship Among Adolescents and Young Adults With Cancer

NCT ID: NCT06038318Sponsor: Dana-Farber Cancer InstituteLast updated: 2025-12-29

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)

Detailed description

In this sequential, multiple assignment, randomized trial participants will be randomly selected to participate in PRISM program sessions with a trained research coach either by text or by video sessions, or participants will use the PRISM mobile app program in a self-guided way. Randomization means the group participants are placed in will be decided by chance. All groups will continue to receive all the same care from primary medical, social work, and other care teams. In this two-stage study, participants will be randomly assigned to either the "app-only" (20% chance), "text" (40% chance) or "video" (40% chance) groups for the first stage. In the second stage, participants may be re-randomized again to the "app-only," or "text," groups, or will be referred to a specialty psychosocial support, social worker or counselor, based on responses to questionnaires. Participants randomized to the "app-only" group in the first stage will not be re-randomized. The research study procedures include screening for eligibility and completion of questionnaires. Participation in this research study is expected to last for up to 6 months. It is expected about 325 people will take part in this research study. The National Institute for Health (NIH) is funding this research study.

Arms & interventions

  • BehavioralPRISM Program Video Coach

    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.

  • BehavioralPRISM Program Text Coach

    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.

  • BehavioralmPRISM Program App

    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.

Outcome measures

Primary

  • 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.

    Time frame: At 6 months

Secondary

  • CDRISC-10 Score for App-Only Cohort Responders

    Time frame: 3 months

  • CDRISC-10 Score for Text Coach Cohort Responders

    Time frame: 3 months

  • Change in HOPE Scale Score

    Time frame: At Baseline, 3 months, and 6 months

  • Change in Adolescent Participant Quality of Life Total Score

    Time frame: At Baseline, 3 months, and 6 months

  • Change in Young Adult Participant Quality of Life Total Score

    Time frame: At Baseline, 3 months, and 6 months

  • Change in Kessler-6 Psychological Distress Scale Score

    Time frame: At Baseline, 3 months, and 6 months

  • Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score

    Time frame: At Baseline, 3 months, and 6 months

  • Change in HADS Depression Subscale Score

    Time frame: At Baseline, 3 months, and 6 months

Eligibility criteria

Sex: AllAge: 12 Years to 25 YearsHealthy volunteers: Yes
Participants that have completed their main cancer-directed therapy at one of the study sites affiliated centers who meet all the eligibility criteria will be eligible for participation in this study. Inclusion Criteria: * 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

Study locations (2)

Boston Children's Hospital

Boston, Massachusetts, 02215

Not Yet Recruiting
Abby Rosenberg, MD · Principal Investigator

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Recruiting
Abby Rosenberg, MD · Principal Investigator
Promoting Resilience in Early Survivorship Among Adolescents and Young Adults With Cancer | Cancerify