Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
440 participants
INTERVENTIONAL
2020-10-20
2025-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Couple Communication and Support
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.
Couple Communication Skills Training
Participants attend six 60-minute sessions consisting of education and skills training to enhance cancer-related communication.
Healthy Lifestyle Informaion
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.
Healthy Lifestyle Information
Participants attend attend six 60-minute sessions consisting of information and support across a range of cancer-related topics.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Duke University
OTHER
Responsible Party
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Principal Investigators
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Laura Porter, PhD
Role: PRINCIPAL_INVESTIGATOR
Duke
Locations
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Duke University Medical Center
Durham, North Carolina, United States
Countries
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References
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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.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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Pro00103232
Identifier Type: -
Identifier Source: org_study_id