Clinical trial NCT04590885: Coping Together: Couple-based Interventions for Cancer
Official title: Couple Communication Skills Training for Advanced Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Advanced Cancer
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: For patients and their intimate partners, advanced cancer poses significant challenges that can negatively impact both individuals and the couple's collective well-being. Couples' ability to communicate openly and effectively with each other about cancer-related concerns can improve their psychological adjustment and quality of their relationship. Open and effective communication may also lead to better symptom management and goal-concordant care. However, many couples report difficulties communicating about cancer, even in the context of overall satisfying relationships. This can have a number of deleterious consequences, including deficits in emotional support, decreases in intimacy and relationship quality, and increased psychological distress. Thus, interventions designed to facilitate effective communication between cancer patients and their partners are likely to have beneficial effects on both individual and relationship functioning.

Prior research, including studies conducted by our team, has found that couple-based interventions that target communication lead to positive outcomes for cancer patients and their partners. However, most prior studies have been limited by reliance on an in-person treatment delivery format which keeps many couples from participating. In addition, prior studies have not targeted interventions to couples who are most likely to benefit. There is increasing evidence that psychosocial interventions for cancer, including couple-based interventions, should be targeted to those at risk of poor outcomes. Our prior research indicates that couples who report communication difficulties (e.g., high levels of holding back from discussing cancer-related concerns) have increased psychological distress and poorer relationship functioning and are most likely to benefit from a couple communication intervention specifically designed to addressed their communication problems.

The specific aims of this study are (1)To determine whether CCST significantly improves patients' and partners' individual psychological adjustment (i.e., psychological distress, life completion) and patient health and health care outcomes (physical well-being, symptom distress, advance care planning discussions and completion of advance directives, hospitalizations, and emergency department visits) compared to an education condition. (2) To determine whether, for couples receiving the CCST intervention, improvements in psychological adjustment, relationship functioning, and patient health are mediated by improvements in their communication, including objective measures of communication quality and communal coping (e.g., "we-talk") derived from couple conversations and self-reported protective buffering. (3) To examine differences in response to the CCST intervention for patients versus partners, for male versus female participants, and for patients with different cancer diagnoses (breast, lung, GI, GU). (4) To conduct an implementation-related process evaluation of the intervention.

Eligibility criteria: Inclusion Criteria:

1. Married or in a committed intimate relationship
2. 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.
3. Both members of the couple must speak and read English.
4. Patient and/or partner scores \>=1.0 on the Holding Back screen.

Exclusion Criteria:

1. Patient lacks capacity for interview (documented diagnosis of active psychosis or dementia) or is unable to provide informed consent as assessed by research staff.
2. Patient has a life expectancy \< 6 months as estimated by his/her treating oncologist.
3. Patient or partner is physically impaired in such a way that precludes the use of a computer or videoconferencing.
4. Patient or partner is too sick to participate, as judged by the oncologist or research staff.

Primary outcomes:
measure: Changes in patient relationship functioning
timeFrame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
measure: Changes in partner relationship functioning
timeFrame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
measure: Changes in patient relationship functioning
timeFrame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
measure: Changes in partner relationship functioning
timeFrame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Secondary outcomes:
measure: Changes in patient psychological functioning
timeFrame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
measure: Changes in partner psychological functioning
timeFrame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
measure: Changes in patient psychological functioning
timeFrame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
measure: Changes in partner psychological functioning
timeFrame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
measure: Changes in patient psychological functioning
timeFrame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
measure: Changes in partner psychological functioning
timeFrame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
measure: Changes in patient psychological functioning
timeFrame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
measure: Changes in patient and partner psychological functioning
timeFrame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
measure: Changes in patient psychological functioning
timeFrame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
measure: Changes in patient psychological functioning
timeFrame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
measure: Changes in patient psychological functioning
timeFrame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
measure: Changes in patient psychological functioning
timeFrame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke
name: Laura Porter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Porter LS, Ramos K, Baucom DH, Steinhauser K, Erkanli A, Strauman TJ, Zafar SY, Check DK, Leo K, Liu E, Keefe FJ. Evaluating a couple communication skills training (CCST) intervention for advanced cancer: study protocol for a randomized controlled trial. Trials. 2022 Aug 26;23(1):712. doi: 10.1186/s13063-022-06656-4.