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Completed

NCT Number: NCT01785576

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Couple-Based CBT Intervention

Behavioral

Patients and partners will receive 4 sessions of a couple-based cognitive behavioral intervention focusing on communication and spousal support.

Primary outcomes

  1. Quality of Life

    Time frame: 6 months

Secondary outcomes

  1. Spousal Support

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Endeavor Health

Other

Registry information

Acronym: CoupleCare

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Feb 7, 2013
Registry last updated
Jul 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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