Recruiting

PRISM-SN

Sponsor:

Seattle Children's Hospital

Code:

NCT06242964

Conditions

Cancer

Social Functioning

Psychosocial Functioning

Coping Skills

Eligibility Criteria

Sex: All

Age: 12 - 25

Healthy Volunteers: Not accepted

Interventions

Promoting Resilience in Stress Management - Social Needs (PRISM-SN)

Study Details

Brief summary:

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.

Conditions

Cancer

Social Functioning

Psychosocial Functioning

Coping Skills

Study ID

NCT06242964

Start date

May 15, 2024

Status verified date

Jun, 2024

Completion date

Jul 31, 2026

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 25

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Aged 12-25 years
  • Diagnosed with new malignancy treated with chemotherapy and/or radiation <6-months
  • Able to speak in the English language
  • Able to read in the English language
  • Cognitively able to participate in intervention sessions and complete surveys

Exclusion Criteria:

  • Aged <12 or >25 years
  • Diagnosed with recurrent malignancy
  • Diagnosed with new malignancy >6 months
  • Not receiving chemotherapy and/or radiation
  • Not able to speak in the English language
  • Not able to read in the English language
  • Not cognitively able to participate in intervention session or complete surveys

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: PRISM-SN Intervention

Skill-based psychosocial program

no intervention: Usual Care

Standard psychosocial care

Interventions

Promoting Resilience in Stress Management - Social Needs (PRISM-SN)

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Kaitlyn M Fladeboe, PhD

2068844140katy.fladeboe@seattlechildrens.org

Locations

Seattle Children's

Recruiting

Seattle, Washington, United States, 98105

More Information

Sponsor

Seattle Children's Hospital

Last update posted

Jun 25, 2024

Last verified

Jun, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Seattle Children's Hospital on 2024-06-25.