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

Seattle Children's Healthcare System

Status: Enrolling

Conditions: Coping Skills; Psychosocial Functioning; Social Functioning; Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06242964

STUDY00004509

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 12 to 25 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

PRISM-SN Intervention

Experimental group

Description:

Skill-based psychosocial program

Treatment:

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

Usual Care

No Intervention group

Description:

Standard psychosocial care