Clinical trial NCT06502483: PRISM for Depression and Anxiety in Young Adults With Cancer
Official title: Treatment Development Study of the Promoting Resilience in Stress Management (PRISM) Intervention for Depression and Anxiety in Young Adults With Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Rate of PRISM Intervention Completion
timeFrame: Up to 12 weeks
measure: Rate of Study Assessment Completion
timeFrame: Up to 12 weeks
measure: Participant Satisfaction
timeFrame: At final intervention session, up to 6 weeks
Secondary outcomes:
measure: mPRISM Phone Application Usage
timeFrame: Up to 12 weeks
measure: Questionnaires
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Brighton
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Samantha Bento, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dana-Farber Cancer Institute
name: Greta Jankauskaite, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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