Effects of a Lay-led Anxiety and Depression Self-management Program for Cancer Patients (NCT04537195) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effects of a Lay-led Anxiety and Depression Self-management Program for Cancer Patients
Denmark234 participantsStarted 2020-03-06
Plain-language summary
The investigators aim to evaluate a peer-to-peer patient self-management program targeting symptoms of anxiety and depression in a randomized trial. A total of 234 cancer patients recently having completed primary treatment with curative intent in central Region Denmark will be included. The intervention is a lay-led, group-based transdiagnostic patient education program consisting of seven 2 ½ hour weekly sessions focusing on increasing patient self-efficacy in symptom management of anxiety and depression. The intervention is highly structured and manualized.
Who can participate
Age range
18 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:
* Treated in Central Region Denmark
* Recently completed (\< 1 yr.) primary treatment for cancer with curative intent
* BDI-II score \>=14 and/or STAI-state score \>=40
Exclusion Criteria:
* Not sufficient Danish language skills to fill Questionnaires and participate in a group based intervention
* Psychosis
* Aggressive behavior
* Imminent suicidal risk
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.
1This trial is led by laypeople rather than mental health professionals — given my specific situation, does my doctor think a peer-led self-management program would be enough support for my anxiety and depression, or would I also need professional clinical care alongside it?
2The trial is no longer actively recruiting, so how would my doctor suggest I find similar group-based or peer-led mental health programs for cancer patients that might still be available to me?
3Since this study is measuring changes in depression and anxiety symptoms specifically, how does my doctor recommend we track whether my own mental health is improving, and what would signal that I need a different kind of support?
4This program appears to focus on self-management strategies taught in a group setting — would my doctor be able to review whether my current anxiety or depression is at a level where a self-management approach is appropriate, or whether I might need medication or individual therapy first?
5Because this is a Phase N/A study focused on a behavioral program rather than a drug, what does my doctor know about the evidence so far for peer-led cancer mental health programs, and are there any risks to trying this kind of approach for someone in my position?
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
Change in Depressive Symptoms
Timeframe: Baseline and 3 months post-intervention
2
Change in Anxiety Symptoms
Timeframe: Baseline and 3 months post-intervention