Couple-Based Intervention for Patients With Head and Neck Cancer and Their Partners

Study Overview
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Brief Summary
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The purpose of this study is to determine whether a brief couple-based supportive intervention effectively assists patients and their partners coping with the challenges of head and neck cancer.

Detailed Description
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This intervention will adapt a well-validated cognitive-behavioral therapeutic approach in a four-session intervention to teach patients and partners specific couple-based cancer-focused support skills. In addition, in order to gather information on outcome variables, couples will complete three assessments during the course of treatment (pre-treatment, following treatment, and six month follow-up). These assessments will include questionnaire measures as well as couple communication whereby couples will participate in two videotaped conversations whereby one partner of the couple discusses a concern and the other member of the couple provides support. We also will implement a daily diary assessment whereby day-to-day psychological and physical symptoms experienced by the patient and partner will be assessed and daily effects of the intervention can be analyzed. Patients and partners will participate in the daily diary portion of the study following the post-assessment. They will be emailed an electronic link to a brief questionnaire daily for 7 days. The items in this daily assessment will comprise questions that are part of the general assessment measures such as dyadic coping, spousal support, and relationship satisfaction. The patient will also complete questions about pain and fatigue.

Official Title
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Couple-Based Intervention for Patients With Head and Neck Cancer and Their Partners

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Behavioral: Couple-Based CBT Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Recently diagnosed with Head and Neck Cancer receiving chemotherapy and/or radiation therapy No history of cancer within past 3 years (other than basal cell) Living with partner in a committed relationship at least 6 months Patient and partner speak and read English Exclusion Criteria: Serious cognitive or emotional issues that preclude full participation in study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Couple-Based CBT Intervention<br>Patients and partners will receive 4 sessions of a couple-based cognitive behavioral intervention focusing on communication and spousal support. | Behavioral: Couple-Based CBT Intervention<br>* Patients and partners will receive 4 sessions of a couple-based cognitive behavioral intervention focusing on communication and spousal support.<br>|
| No Intervention: Treatment as Usual<br>The treatment as usual group will complete all assessements and will not receive the psychosocial couple based intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spousal Support |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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couples, head and neck cancer, oncology, spousal support