An interventional study of PRISM Program Video Coach and PRISM Program Text Coach in Stress and Anxiety, sponsored by Dana-Farber Cancer Institute. Recruiting at 2 sites in United States. Open to participants aged 12 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-29.
Sponsored by Dana-Farber Cancer Institute · Not applicable, Interventional, and Health services research
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)
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's planned enrollment of 325 is above the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Dana-Farber Cancer Institute is the lead sponsor of 813 studies on the registry; 124 are open to participants now.
Of its 113 completed or terminated interventional studies of FDA-regulated products, 77 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
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.
Behavioral: mPRISM Program App
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.
Behavioral: PRISM Program Video Coach · Behavioral: mPRISM Program App
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.
Behavioral: PRISM Program Text Coach · Behavioral: mPRISM Program App
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.
Also known as: Promoting Resilience in Stress Management
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.
Also known as: Promoting Resilience in Stress Management
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.
Also known as: Promoting Resilience in Stress Management
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
CDRISC-10 Score for App-Only Cohort Responders
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. Participant "responders" are defined as having sustained CDRISC scores \>29 after PRISM sessions or increased by \>2 points at the timepoints.
Time frame: 3 months
CDRISC-10 Score for Text Coach Cohort Responders
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. Participant "responders" are defined as having sustained CDRISC scores \>29 after PRISM sessions or increased by \>2 points at the timepoints.
Time frame: 3 months
Change in HOPE Scale Score
Assessed by the HOPE Scale, a 12-item measures scored on an 8-point Likert scale with answers ranging from 1 "Definitely False" to 8 "Definitely True" for a total score of 96. A higher score implies a greater level of hopeful thought patterns.
Time frame: At Baseline, 3 months, and 6 months
Change in Adolescent Participant Quality of Life Total Score
Assessed by the Pediatric Quality of Life (PedsQL) Generic Core Scales Short Form (SF15) (Teen or Child Report) and PedsQL Cancer Module (Child or Teen Report) scales, 42-items to evaluate health-related quality of life. Items are rated on a 5-point Likert scale with answers ranging from 0 "Never" to 4 "Almost Always" for a score range of 0 - 100. A higher score represents better health-related quality of life.
Time frame: At Baseline, 3 months, and 6 months
Change in Young Adult Participant Quality of Life Total Score
Assessed by the Pediatric Quality of Life (PedsQL) Generic Core Scales Short Form (SF15) Young Adult Report and PedsQL Cancer Module Young Adult Report scales, 42-items to evaluate health-related quality of life. Items are rated on a 5-point Likert scale with answers ranging from 0 "Never" to 4 "Almost Always" for a score range of 0 - 100. A higher score represents better health-related quality of life.
Time frame: At Baseline, 3 months, and 6 months
Change in Kessler-6 Psychological Distress Scale Score
Assessed by the Kessler-6, a 6-item measure for the level of psychological distress in the past month. Responses are scored on a 5-point Likert scare with answers ranging from 0 "None of the time" to 4 "All of the time," and with a total score range of 0 - 4. Scores \> or = 7 suggest "high" distressed and those \> or = 13 meet criteria for serious or debilitating psychological distress.
Time frame: At Baseline, 3 months, and 6 months
Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score
Assessed by the HADS-A subscale which is comprised of 7 items. Items are scored 0-3 with a subscale total score range of 0 - 21. A higher scores represents increasing abnormality (or caseness) for anxiety.
Time frame: At Baseline, 3 months, and 6 months
Change in HADS Depression Subscale Score
Assessed by the HADS-D subscale score which is comprised of 7 items. Items are scored 0-3 with a subscale total score range of 0 - 21. A higher score represents increasing abnormality (or caseness) for depression.
Time frame: At Baseline, 3 months, and 6 months
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap
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