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

NCT ID: NCT06242964

Last Updated: 2024-06-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-15
• Study Completion Date: 2026-07-31

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.

Detailed Description

In this randomized controlled trial, AYAs newly diagnosed with cancer will be recruited from two sites and randomly assigned to receive usual care alone or usual care with the Promoting Resilience in Stress Management - Social Needs (PRISM-SN) adapted program. PRISM-SN is a skill-based behavioral program that includes 4 core modules plus a newly developed social health module. Participants on both arms with complete a standardized patient-reported outcome survey assessing aspects of social and psychological functioning at enrollment and 12-week follow-up.

Conditions

Cancer; Social Functioning; Psychosocial Functioning; Coping Skills

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

PRISM-SN Intervention

Skill-based psychosocial program

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Usual Care

Standard psychosocial care

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh Medical Center

OTHER

Sponsor Role: collaborator

Seattle Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kaitlyn M Fladeboe, PhD

Role: PRINCIPAL_INVESTIGATOR

Seattle Children's Hospital

Locations

Seattle Children's

Seattle, Washington, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kaitlyn M Fladeboe, PhD

Role: CONTACT

katy.fladeboe@seattlechildrens.org

2068844140

Facility Contacts

Kaitlyn Fladeboe, PhD

Role: primary

Other Identifiers

STUDY00004509

Identifier Type: -

Identifier Source: org_study_id