The PRISM-Social Needs (PRISM-SN) Intervention for Adolescents and Young Adults With Cancer

Part of paid clinical trials in Seattle, Washington.

Sponsor
Seattle Children's Hospital
Study ID
NCT06242964
Status
Recruiting
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Conditions

  • Cancer
  • Coping Skills
  • Psychosocial Functioning
  • Social Functioning

Eligibility Criteria

Sex
ALL
Age
12 Years - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Promoting Resilience in Stress Management - Social Needs (PRISM-SN) — BEHAVIORAL
    The Promoting Resilience in Stress Management - Social Needs (PRISM-SN) intervention is a brief, skill-based psychosocial program. Five core sessions are delivered one-on-one, 1-2 weeks apart, in-person or via videoconference. Sessions teach evidence-based behavioral skills for managing stress, setting goals, reframing negative thoughts, meaning-making, and connecting with others. Each session lasts \<60 minutes and is supported by paper-and-pencil or mobile app-based worksheet(s) for learning and practice. A final review session may be completed individually or with a family member, caregiver, or significant other.

Study Details

The goal of this study is to establish feasibility, acceptability, and proof-of-concept of an psychosocial intervention adapted to address social health needs of adolescents and young adults (AYAs) newly diagnosed with cancer. The aims of this study are to: 1. Determine if the Promoting Resilience in Stress Management - Social Needs (PRISM-SN) adapted intervention is feasible and acceptable, defined via program uptake and retention and patient-reported feedback. 2. Explore whether PRISM-SN improves social outcomes at 12-week follow-up compared to usual care. Participants will be randomized to receive usual psychosocial care or the PRISM-SN program. Participants on both arms will complete patient-reported outcome surveys at enrollment and 12-weeks later. Researchers will compare participants who received the PRISM-SN program to those who received usual care to see if the program improves psychosocial outcomes.

Key Dates

Start date
May 15, 2024
Status verified
Jun 2024
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: PRISM-SN Intervention
    Skill-based psychosocial program
  • No Intervention: Usual Care
    Standard psychosocial care

Primary Outcome Measure

Cancer Behavior Inventory - Social Relationship Coping Efficacy (CBI-SCRE) Measure [ Time Frame: 12-weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Seattle Children'sSeattleWashington98105
Kaitlyn Fladeboe, PhD

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By research site
Seattle Children's· Seattle, WA

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