Promoting Resilience in Early Survivorship Among Adolescents and Young Adults With Cancer
NCT ID: NCT06038318
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
325 participants
INTERVENTIONAL
2023-10-16
2027-05-01
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SEQUENTIAL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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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.
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.
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.
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.
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.
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
12 Years
25 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Dana-Farber Cancer Institute
OTHER
Responsible Party
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Abby Rosenberg
Principal Investigator
Principal Investigators
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Abby Rosenberg, MD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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Boston Children's Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Abby Rosenberg, MD
Role: primary
Abby Rosenberg, MD
Role: primary
Other Identifiers
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22-652
Identifier Type: -
Identifier Source: org_study_id