PRISM for Depression and Anxiety in Young Adults with Cancer

Trial Title: PRISM for Depression and Anxiety in Young Adults with Cancer

NCT ID: NCT06502483

Condition: Cancer Diagnosis
Non-Metastatic Neoplasm
Anxiety
Anxiety Disorders
Depression
Depressive Disorder
Depression, Anxiety

Conditions: Official terms:
Depression
Depressive Disorder
Anxiety Disorders

Conditions: Keywords:
Cancer Diagnosis
Non-Metastatic Neoplasm
Anxiety
Anxiety Disorders
Depression
Depression Disorder
Depression, Anxiety
Young adults with cancer

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Promoting Resilience in Stress Management Program
Description: 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.
Arm group label: PRISM Program

Other name: PRISM Program

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 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 (18-25 years old) with nonmetastatic cancer 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.

Criteria for eligibility:
Criteria:
Inclusion Criteria for Participants: - 18-25 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 nonmetastatic cancer at least 6 or more weeks ago - Currently receiving treatment for their cancer or has completed treatment for cancer 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 diagnosed with a metastatic 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 cancer 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

Gender: All

Minimum age: 18 Years

Maximum age: 25 Years

Healthy volunteers: No

Locations:

Facility:
Name: Dana-Farber Cancer Institute

Address:
City: Brighton
Zip: 02135
Country: United States

Status: Recruiting

Contact:
Last name: Samantha Bento, PhD

Phone: 7325131002
Email: samanthap_bento@dfci.harvard.ed

Contact backup:
Last name: Greta Jankauskaite, PhD
Email: greta_jankauskaite@dfci.harvard.edu

Contact backup:
Last name: Samantha Bento, PhD

Contact backup:
Last name: Greta Jankauskaite, PhD

Start date: September 6, 2024

Completion date: July 1, 2025

Lead sponsor:
Agency: Dana-Farber Cancer Institute
Agency class: Other

Source: Dana-Farber Cancer Institute

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06502483