PRISM for Depression and Anxiety in Young Adults With Cancer (NCT06502483) | Clinical Trial Compass
CompletedNot Applicable
PRISM for Depression and Anxiety in Young Adults With Cancer
United States13 participantsStarted 2024-09-06
Plain-language 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
Who can participate
Age range
18 Years – 39 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of PRISM Intervention Completion
Timeframe: Up to 12 weeks
2
Rate of Study Assessment Completion
Timeframe: Up to 12 weeks
3
Participant Satisfaction
Timeframe: At final intervention session, up to 6 weeks
. 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.
≥ 18 years of age
A friend or family member invited by the study participant to join the 6th PRISM session