Coping Together: Couple-based Interventions for Cancer (NCT04590885) | Clinical Trial Compass
CompletedNot Applicable
Coping Together: Couple-based Interventions for Cancer
United States440 participantsStarted 2020-10-20
Plain-language summary
The objective of the proposed study is to evaluate the Couple Communication Skills Training (CCST) intervention in 250 patients with advanced cancer and their spouses/intimate partners. Couples will be randomized 1:1 to receive either the CCST or to an attention control condition (Healthy Living Information; HLI). We will evaluate CCST effects on a range of patient and partner relationship and psychological outcomes.
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
. Married or in a committed intimate relationship
. Diagnosis of one the following advanced cancers: Stage IIIB or IV non-small cell lung cancer or extensive stage small cell lung cancer, Stage III pancreatic cancer or Stage IV GI cancer, Stage IV GU cancer, Stage IV breast cancer and GYN cancer Stage III-IV ovarian, IV uterine, IV cervical.
. Both members of the couple must speak and read English.
. Patient and/or partner scores \>=1.0 on the Holding Back screen.
Exclusion criteria
. Patient lacks capacity for interview (documented diagnosis of active psychosis or dementia) or is unable to provide informed consent as assessed by research staff.
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
Changes in patient relationship functioning
Timeframe: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
2
Changes in partner relationship functioning
Timeframe: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
3
Changes in patient relationship functioning
Timeframe: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
4
Changes in partner relationship functioning
Timeframe: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up