Skip to main content
OpenTrials
Completed

NCT Number: NCT06502483

PRISM for Depression and Anxiety in Young Adults With Cancer

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana-Farber Cancer Institute

Brighton, Massachusetts, 02135, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for Participants:

  • 18-39 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.

Participant Exclusion Criteria:

  • 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).

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

Treatment and study plan

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.

Other names: PRISM Program

Primary outcomes

  1. Rate of PRISM Intervention Completion

    Time frame: Up to 12 weeks

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

  2. Rate of Study Assessment Completion

    Time frame: Up to 12 weeks

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

  3. Participant Satisfaction

    Time frame: 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.

Secondary outcomes

  1. mPRISM Phone Application Usage

    Time frame: 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.

  2. Questionnaires

    Time frame: Up to 12 weeks

    The feasibility of using the assessment questionnaires in the current study (e.g., length, administration)

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Official study title

Treatment Development Study of the Promoting Resilience in Stress Management (PRISM) Intervention for Depression and Anxiety in Young Adults With Cancer

Acronym: PRISM

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 16, 2024
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.