PRISM for Depression and Anxiety in Young Adults with Cancer

Dana-Farber Cancer Institute

Status: Enrolling

Conditions: Non-Metastatic Neoplasm; Cancer Diagnosis; Depression, Anxiety; Depression; Anxiety Disorders; Anxiety; Desmoid; Depressive Disorder

Treatments: Behavioral: Promoting Resilience in Stress Management Program

Study type: Interventional

Funder types: Other

Identifiers

NCT06502483

24-147

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Participants:

• 18-30 years of age
• Speak and comprehend English sufficiently to be able to complete study procedures and participate in the program in English
• Have been diagnosed with cancer or desmoid tumor at least 6 or more weeks ago
• Currently receiving treatment with curative intent or has completed treatment with curative intent for cancer or desmoid tumor no more than 6 months ago
• Score 10-14 on the PHQ-9 (Kroenke et al., 1999) or/and score 10-14 on the GAD-7 (Spitzer et al., 2006) during the initial screening assessment.

Participant 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

PRISM Program

Experimental group

Description:

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

Treatment:

Behavioral: Promoting Resilience in Stress Management Program