Coping Together: Couple-based Interventions for Cancer

Advanced Cancer Clinical Trial

— CCST2  

Official title:

Couple Communication Skills Training for Advanced Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04590885
• Other study ID #: Pro00103232
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: Duke University
• Contact: Laura Porter, PhD
• Phone: 919-416-3436
• Email: Laura.Porter[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 460
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms

Intervention

Behavioral:
• Couple Communication Skills Training
Participants attend six 60-minute sessions consisting of education and skills training to enhance cancer-related communication.
• Healthy Lifestyle Information
Participants attend attend six 60-minute sessions consisting of information and support across a range of cancer-related topics.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in patient relationship functioning	Change in patient relationship satisfaction measured by the Couples Satisfaction Inventory (higher scores indicate higher satisfaction)	Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Primary	Changes in partner relationship functioning	Change in partner relationship satisfaction measured by the Couples Satisfaction Inventory (higher scores indicate higher satisfaction)	Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Primary	Changes in patient relationship functioning	Change in patient intimacy as measured by the Miller Social Intimacy Scale (higher scores indicate higher intimacy)	Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Primary	Changes in partner relationship functioning	Change in partner intimacy as measured by the Miller Social Intimacy Scale (higher scores indicate higher intimacy)	Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Secondary	Changes in patient psychological functioning	Change in patient psychological distress measured by the Hospital Anxiety and Depression Scale (higher scores indicate higher distress)	Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Secondary	Changes in partner psychological functioning	Change in partner psychological distress measured by the Hospital Anxiety and Depression Scale (higher scores indicate higher distress)	Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Secondary	Changes in patient psychological functioning	Change in patient mood as measured by the Positive and Negative Mood Scale (higher scores on the positive and negative mood subscales indicate higher negative and positive mood, respectively)	Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Secondary	Changes in partner psychological functioning	Change in partner mood as measured by the Positive and Negative Mood Scale (higher scores on the positive and negative mood subscales indicate higher negative and positive mood, respectively)	Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Secondary	Changes in patient psychological functioning	Change in patient life completion measured by the Life Completion scale of the QUAL-E (higher scores indicate higher completion)	Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Secondary	Changes in partner psychological functioning	Change in partner life completion measured by the Life Completion scale of the QUAL-E Family (higher scores indicate higher completion)	Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Secondary	Changes in patient psychological functioning	Change in patient physical well being as measured by the Physical Well Being subscale of the Functional Assessment of Cancer Therapy scale (higher scores indicate higher physical well being)	Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Secondary	Changes in patient and partner psychological functioning	Change in symptom distress as measured by the Condensed Memorial Symptom Assessment Scale (higher scores indicate higher symptom distress)	Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Secondary	Changes in patient psychological functioning	Change in patient advance care planning discussions (presence or absence, via patient self-report)	Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Secondary	Changes in patient psychological functioning	Change in patient completion of advanced directives (presence or absence, via patient self-report)	Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Secondary	Changes in patient psychological functioning	Change in patient hospitalizations (number of hospitalizations per patient self-report, validated by medical record review)	Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Secondary	Changes in patient psychological functioning	Change in patient emergency department visits (number of emergency department visits per patient self-report, validated by medical record review)	Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up