PRISM for Depression and Anxiety in Young Adults With Cancer

NCT06502483 | Completed

• 1 other identifier: 24-147
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Cancer Diagnosis; Non-Metastatic Neoplasm; Anxiety; Anxiety Disorders; Depression; Depression Disorder; Depression, Anxiety; Young adults with cancer; Desmoid tumor

Outcome Measures

Primary Outcomes (3)

• Rate of PRISM Intervention Completion

  Feasibility is defined as 70% of PRISM sessions are completed by participants who start the study.

  Up to 12 weeks

• Rate of Study Assessment Completion

  Study feasibility is defined as 70% of all study assessments are completed by participants who complete PRISM sessions.

  Up to 12 weeks

• Participant Satisfaction

  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.

  At final intervention session, up to 6 weeks

Secondary Outcomes (2)

• mPRISM Phone Application Usage

  Up to 12 weeks

• Questionnaires

  Up to 12 weeks

Study Arms (1)

PRISM Program

EXPERIMENTAL

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

Behavioral: Promoting Resilience in Stress Management Program

Interventions

Promoting Resilience in Stress Management Program BEHAVIORAL

Promoting Resilience in Stress Management (PRISM; Rosenberg et al., 2018; Rosenberg et al., 2021) is is an evidence-based skills-based resilience intervention. In the current study, PRISM sessions with be facilitated by a trained mental health provider to equip participants with skills for coping with anxiety, low mood, and adjustment to cancer diagnosis and to target four resilience resources (i.e., stress management, goal setting, cognitive reframing, and meaning-making). Sessions will be conducted by phone or Zoom, a HIPAA-compliant telemedicine platform. The optional mPRISM phone application includes 6 modules to practice PRISM skills and is available for iOS/Android.

Also known as: PRISM Program

PRISM Program

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 or has completed treatment for cancer or desmoid tumor no more than 6 months ago
• Score 10-24 (with question #9 not endorsed, or 0) on the PHQ-9 (Kroenke et al., 1999) or/and score 10-21 on the GAD-7 (Spitzer et al., 2006) during the initial screening assessment.

You may not qualify if:

• Adults unable to consent, individuals who are not yet adults (age \<18), pregnant women, and prisoners.
• Individuals who score less than 10 on both PHQ-9 and GAD-7.
• Individuals 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) on PHQ-9 screen (i.e., endorse anything more than 0 for question #9) 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 (see section 14.1 for more details on the procedure).
• ≥ 18 years of age
• A friend or family member invited by the study participant to join the 6th PRISM session

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (1)

Dana-Farber Cancer Institute

Brighton, Massachusetts, 02135, United States

Location

Related Publications (5)

• Rosenberg AR, Bradford MC, McCauley E, Curtis JR, Wolfe J, Baker KS, Yi-Frazier JP. Promoting resilience in adolescents and young adults with cancer: Results from the PRISM randomized controlled trial. Cancer. 2018 Oct 1;124(19):3909-3917. doi: 10.1002/cncr.31666. Epub 2018 Sep 19.

  PMID: 30230531 BACKGROUND

• Rosenberg AR, Zhou C, Bradford MC, Salsman JM, Sexton K, O'Daffer A, Yi-Frazier JP. Assessment of the Promoting Resilience in Stress Management Intervention for Adolescent and Young Adult Survivors of Cancer at 2 Years: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2021 Nov 1;4(11):e2136039. doi: 10.1001/jamanetworkopen.2021.36039.

  PMID: 34817581 BACKGROUND

• Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233-7. doi: 10.1016/0149-7189(82)90074-x.

  PMID: 10259963 BACKGROUND

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  PMID: 16717171 BACKGROUND

• Kroenke, K., Spitzer, R. L., & Williams, J. B. W. (1999). Patient Health Questionnaire-9 (PHQ-9) [Database record]. APA PsycTests. https://doi.org/10.1037/t06165-000

  BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depression; Depressive Disorder; Desmoid Tumors

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Mood Disorders; Fibroma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Samantha Bento, PhD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

• Greta J Khanna, PhD, MA

  Dana-Farber Cancer Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 16, 2024
• Study Start: September 6, 2024
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: April 21, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (1)