Coping Together: Couple-based Interventions for Cancer

NCT04590885 | Completed

• 1 other identifier: Pro00103232
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (12)

• Changes in patient psychological functioning

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

• Changes in partner psychological functioning

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

• Changes in patient psychological functioning

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

• Changes in partner psychological functioning

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

• Changes in patient psychological functioning

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

Study Arms (2)

Couple Communication and Support

OTHER

CCST includes components to assist couples in communicating effectively, decreasing avoidance of important cancer-related issues, and providing each other with support. It includes training in skills for sharing one's thoughts and feelings and listening to one's partner and responding in a supportive manner, and joint problem solving. Participants will be asked to participate inactivities at home between sessions to strengthen skills acquisition.

Behavioral: Couple Communication Skills Training

Healthy Lifestyle Informaion

OTHER

Healthy Lifestyle Information provides couples with health information relevant to cancer in a supportive environment. Sessions focus on the following topics: fatigue, sleep disturbance, nutrition, physical activity, survivorship care plans, and palliative care. Patients and partners are invited to discuss their experiences around the session topics with the therapist and ask questions about the information presented.

Behavioral: Healthy Lifestyle Information

Interventions

Couple Communication Skills Training BEHAVIORAL

Participants attend six 60-minute sessions consisting of education and skills training to enhance cancer-related communication.

Also known as: CCST

Couple Communication and Support

Healthy Lifestyle Information BEHAVIORAL

Participants attend attend six 60-minute sessions consisting of information and support across a range of cancer-related topics.

Also known as: HLI

Healthy Lifestyle Informaion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

• 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.

  PMID: 36028908 DERIVED

Study Officials

• Laura Porter, PhD

  Duke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 19, 2020
• Study Start: October 20, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 20, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)