Clinical trial · Interventional
PRISM for Depression and Anxiety in Young Adults With Cancer
Treatment Development Study of the Promoting Resilience in Stress Management (PRISM) Intervention for Depression and Anxiety in Young Adults With Cancer
NCT06502483CI-TRIAL-00108862PRISMcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
| Anxiety Disorders | — | UNRESOLVED | — |
| Cancer Diagnosis | — | UNRESOLVED | — |
| Depression | — | UNRESOLVED | — |
| Depression, Anxiety | — | UNRESOLVED | — |
| Depressive Disorder | — | UNRESOLVED | — |
| Desmoid | — | UNRESOLVED | — |
| Non-Metastatic Neoplasm | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Promoting Resilience in Stress Management Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PRISM Program
- description
- 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
- interventionNames
- Behavioral: Promoting Resilience in Stress Management Program
Primary outcomes (3)
- measure
- Rate of PRISM Intervention Completion
- timeFrame
- Up to 12 weeks
- description
- Feasibility is defined as 70% of PRISM sessions are completed by participants who start the study.
- measure
- Rate of Study Assessment Completion
- timeFrame
- Up to 12 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 39 Years
Show eligibility criteria text
Inclusion Criteria for Participants: 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. Participant 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). 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
References
Publications (5)
- BACKGROUNDRosenberg 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
- BACKGROUNDRosenberg 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
- BACKGROUNDAttkisson 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
- BACKGROUNDSpitzer 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
- BACKGROUNDKroenke, 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