PRISM for Depression and Anxiety in Young Adults With Cancer

Not Applicable

Recruiting

• Conditions: Cancer Diagnosis; Non-Metastatic Neoplasm; Anxiety; Anxiety Disorders; Depression; Depressive Disorder; Depression, Anxiety; Desmoid
• Interventions: Behavioral: Promoting Resilience in Stress Management Program

• Registration Number: NCT06502483
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

This research study is being done to test the feasibility of an existing supportive program (PRISM) to address psychological symptoms (i.e., depressive and anxiety symptoms) that young adult participants diagnosed with cancer or desmoid tumor may experience.

The name of the intervention used in this research study is:

-Promoting Resilience in Stress Management (PRISM) Program

Detailed Description

This research study is being done to test the initial feasibility and acceptability of a six-session, skills-based resilience coaching intervention, Promoting Resilience in Stress Management (PRISM; Rosenberg et al., 2018; Rosenberg et al., 2021), that targets four resilience resources (stress management, goal setting, cognitive reframing, and meaning-making) for young adult patients (18-30 years old) with cancer or desmoid tumor who are treated with curative intent and who report moderate depressive and/or anxiety symptoms.

The research study procedures include screening for eligibility, completing one diagnostic assessment of depressive and anxiety symptoms, pre-intervention and post-intervention questionnaires, completion of the six-session PRISM intervention, and a semi-structured exit interview about the experience with the PRISM intervention.

Participation in this research study is expected to last approximately 2 to 3 months.

It is expected that up to 15 young adults with cancer (i.e., participants) and up to a total of 15 support persons (i.e., friends or family members who participants will have an option to invite for the final session of the intervention) will take part in this research study.

The Hans and Mavis Lopater Foundation is funding this research study by providing philanthropic support.

Study Timeline

• Study First Submitted: 2024-07-09
• Study First Submitted QC: 2024-07-09
• Study First Posted: 2024-07-16
• Study Start: 2024-09-06
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-31
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

• Adults unable to consent, individuals who are not yet adults (age <18), pregnant women, and prisoners.
• Individuals who score <10 on both PHQ-9 and GAD-7.
• Patients who score >14 (indicating moderately severe or severe depressive and/or anxiety symptoms) on PHQ-9 and/or GAD-7 will be ineligible for the current study but will be offered a referral to an appropriate mental health provider for support, if desired.
• Individuals who are treated with palliative intent for their disease, those who are diagnosed with cancer less than 6 weeks at the time of screening (we will be able to approach them again after 6 weeks since diagnosis has passed), or those who completed treatment more than 6 months ago will also be ineligible for this study; they will be offered resources for support, if desired.
• Individuals who report any suicidality (ideation, plan, and/or intent) at the time of the eligibility screening will also be excluded from the current study, and the appropriate safety measures and/or referral to a mental health provider will be made.

Inclusion Criteria for Support Person:

-≥ 18 years of age

-A friend or family member invited by the study participant to join the 6th PRISM session

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PRISM Program	Promoting Resilience in Stress Management Program	Participants will be enrolled and will complete study procedures as follows: * Baseline visit with questionnaires. * 6 weekly or bi-weekly remote or in-clinic, psychotherapy sessions with psychologist. * Final questionnaires and post-study exit interview

Primary Outcome Measures

Name	Time	Method
Participant Satisfaction	At final intervention session, up to 6 weeks	Acceptability of the PRISM intervention will be determined by responses on semi-structured exit interviews using descriptive statistics and scores on the Client Satisfaction Questionnaire- (CSQ-8), an 8-item measuring a participant's opinions and assessment of the intervention. Total scores range from 8 to 32 with a higher number indicating greater satisfaction.
Rate of PRISM Intervention Completion	Up to 12 weeks	Feasibility is defined as 70% of PRISM sessions are completed by participants who start the study.
Rate of Study Assessment Completion	Up to 12 weeks	Study feasibility is defined as 70% of all study assessments are completed by participants who complete PRISM sessions.

Secondary Outcome Measures

Name	Time	Method
Questionnaires	Up to 12 weeks	The feasibility of using the assessment questionnaires in the current study (e.g., length, administration)
mPRISM Phone Application Usage	Up to 12 weeks	The feasibility of the mPRISM phone application as a tool to practice PRISM skills, as evidenced by the participant usage metrics.

Trial Locations

Locations (1)

Dana-Farber Cancer Institute; 🇺🇸 Brighton, Massachusetts, United States