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 range18 Years

SexALL

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.
✕. Patient has a life expectancy \< 6 months as estimated by his/her treating oncologist.
✕. Patient or partner is physically impaired in such a way that precludes the use of a computer or videoconferencing.
✕. Patient or partner is too sick to participate, as judged by the oncologist or research staff.

What they're measuring

Changes in patient relationship functioning

Timeframe: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up

Changes in partner relationship functioning

Timeframe: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up

Changes in patient relationship functioning

Timeframe: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up

Changes in partner relationship functioning

Timeframe: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up

Trial details

NCT IDNCT04590885

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Advanced Cancer trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

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.
✕. Patient has a life expectancy \< 6 months as estimated by his/her treating oncologist.
✕. Patient or partner is physically impaired in such a way that precludes the use of a computer or videoconferencing.
✕. Patient or partner is too sick to participate, as judged by the oncologist or research staff.

What they're measuring

Changes in patient relationship functioning

Timeframe: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up

Changes in partner relationship functioning

Timeframe: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up

Changes in patient relationship functioning

Timeframe: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up

Changes in partner relationship functioning

Timeframe: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up