PRISM for Depression and Anxiety in Young Adults With Cancer

NCT ID: NCT06502483

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-06
• Study Completion Date: 2026-02-01

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

PRISM 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

Group Type: EXPERIMENTAL

Promoting Resilience in Stress Management Program

Intervention Type: 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.

Interventions

Promoting Resilience in Stress Management Program

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

PRISM Program

Eligibility Criteria

Inclusion Criteria

1. 18-39 years of age

2. Speak and comprehend English sufficiently to be able to complete study procedures and participate in the program in English*

3. Have been diagnosed with cancer or desmoid tumor at least 6 or more weeks ago

4. Currently receiving treatment or has completed treatment for cancer or desmoid tumor no more than 6 months ago

5. 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.

-≥ 18 years of age

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

Exclusion Criteria

1. Adults unable to consent, individuals who are not yet adults (age <18), pregnant women, and prisoners.

2. Individuals who score less than 10 on both PHQ-9 and GAD-7.

3. 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.

5) 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Samantha Bento

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Samantha Bento, PhD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Greta J Khanna, PhD, MA

Role: STUDY_DIRECTOR

Dana-Farber Cancer Institute

Locations

Dana-Farber Cancer Institute

Brighton, Massachusetts, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 30230531 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34817581 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10259963 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16717171 (View on PubMed)

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

Reference Type: BACKGROUND

Other Identifiers

24-147

Identifier Type: -

Identifier Source: org_study_id