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Coping Together: Couple-based Interventions for Cancer (CCST2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04590885
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : September 23, 2021
Sponsor:
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Advanced Cancer Behavioral: Couple Communication Skills Training Behavioral: Healthy Lifestyle Information Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 460 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Couple Communication Skills Training for Advanced Cancer
Actual Study Start Date : October 16, 2020
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Healthy Living

Arm Intervention/treatment
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.
Behavioral: Couple Communication Skills Training
Participants attend six 60-minute sessions consisting of education and skills training to enhance cancer-related communication.
Other Name: CCST

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.
Behavioral: Healthy Lifestyle Information
Participants attend attend six 60-minute sessions consisting of information and support across a range of cancer-related topics.
Other Name: HLI




Primary Outcome Measures :
  1. Changes in patient relationship functioning [ Time Frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up ]
    Change in patient relationship satisfaction measured by the Couples Satisfaction Inventory (higher scores indicate higher satisfaction)

  2. Changes in partner relationship functioning [ Time Frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up ]
    Change in partner relationship satisfaction measured by the Couples Satisfaction Inventory (higher scores indicate higher satisfaction)

  3. Changes in patient relationship functioning [ Time Frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up ]
    Change in patient intimacy as measured by the Miller Social Intimacy Scale (higher scores indicate higher intimacy)

  4. Changes in partner relationship functioning [ Time Frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up ]
    Change in partner intimacy as measured by the Miller Social Intimacy Scale (higher scores indicate higher intimacy)


Secondary Outcome Measures :
  1. Changes in patient psychological functioning [ Time Frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up ]
    Change in patient psychological distress measured by the Hospital Anxiety and Depression Scale (higher scores indicate higher distress)

  2. Changes in partner psychological functioning [ Time Frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up ]
    Change in partner psychological distress measured by the Hospital Anxiety and Depression Scale (higher scores indicate higher distress)

  3. Changes in patient psychological functioning [ Time Frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up ]
    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)

  4. Changes in partner psychological functioning [ Time Frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up ]
    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)

  5. Changes in patient psychological functioning [ Time Frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up ]
    Change in patient life completion measured by the Life Completion scale of the QUAL-E (higher scores indicate higher completion)

  6. Changes in partner psychological functioning [ Time Frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up ]
    Change in partner life completion measured by the Life Completion scale of the QUAL-E Family (higher scores indicate higher completion)

  7. Changes in patient psychological functioning [ Time Frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up ]
    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)

  8. Changes in patient and partner psychological functioning [ Time Frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up ]
    Change in symptom distress as measured by the Condensed Memorial Symptom Assessment Scale (higher scores indicate higher symptom distress)

  9. Changes in patient psychological functioning [ Time Frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up ]
    Change in patient advance care planning discussions (presence or absence, via patient self-report)

  10. Changes in patient psychological functioning [ Time Frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up ]
    Change in patient completion of advanced directives (presence or absence, via patient self-report)

  11. Changes in patient psychological functioning [ Time Frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up ]
    Change in patient hospitalizations (number of hospitalizations per patient self-report, validated by medical record review)

  12. Changes in patient psychological functioning [ Time Frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up ]
    Change in patient emergency department visits (number of emergency department visits per patient self-report, validated by medical record review)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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, or Stage IV breast cancer.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04590885


Contacts
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Contact: Laura Porter, PhD 919-416-3436 Laura.Porter@duke.edu

Locations
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United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Laura Porter, Ph.D    919-416-3436    porte008@mc.duke.edu   
Principal Investigator: Laura Porter, Ph.D         
Principal Investigator: Francis Keefe, Ph.D         
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Laura Porter, PhD Duke
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04590885    
Other Study ID Numbers: Pro00103232
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: September 23, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms