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

Last updated: November 5, 2024
Sponsor: Dana-Farber Cancer Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stress

Treatment

PRISM Program Text Coach

mPRISM Program App

PRISM Program Video Coach

Clinical Study ID

NCT06038318
22-652
R01CA269574-01
  • Ages 12-25
  • All Genders
  • Accepts Healthy Volunteers

Study 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)

Eligibility Criteria

Inclusion

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 Design

Total Participants: 325
Treatment Group(s): 3
Primary Treatment: PRISM Program Text Coach
Phase:
Study Start date:
October 16, 2023
Estimated Completion Date:
September 30, 2026

Study 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.

Connect with a study center

  • Boston Children's Hospital

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

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