Recruiting

Observational Study

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT06038318

Conditions

Stress

Anxiety

Eligibility Criteria

Sex: All

Age: 12 - 25

Healthy Volunteers: Accepted

Interventions

PRISM Program Video Coach

PRISM Program Text Coach

mPRISM Program App

Study Details

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)

Conditions

Stress

Anxiety

Study ID

NCT06038318

Start date

Oct 16, 2023

Status verified date

Dec, 2025

Completion date

May 1, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 25

Healthy Volunteers: Accepted

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

Enrollment

325 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: PRISM Program Mobile App

Participants 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.

active comparator: PRISM Program Video Coach

Participants 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.

active comparator: PRISM Program Text Coach

Participants 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

PRISM 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.

PRISM 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.

mPRISM 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.

Primary outcome measure

  • Connor Davidson Resilience Scale (CDRISC-10) Score [ Time Frame: At 6 months ]

Central Contacts and Locations

Central contacts

Abby Rosenberg, MD

206-987-6892AbbyR_Rosenberg@DFCI.HARVARD.EDU

Locations

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Abby Rosenberg, MD

206-987-6892abbyr_rosenberg@dfci.harvard.edu

Principal Investigator:

Abby Rosenberg, MD

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Dec 29, 2025

Last verified

Dec, 2025

Keywords

  • Stress Management

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2025-12-29.