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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01785576
Recruitment Status : Completed
First Posted : February 7, 2013
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Rachel Pulido, NorthShore University HealthSystem

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Behavioral: Couple-Based CBT Intervention Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Couple-Based Intervention for Patients With Head and Neck Cancer and Their Partners
Study Start Date : March 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Couple-Based CBT Intervention
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
Patients and partners will receive 4 sessions of a couple-based cognitive behavioral intervention focusing on communication and spousal support.

No Intervention: Treatment as Usual
The treatment as usual group will complete all assessements and will not receive the psychosocial couple based intervention.



Primary Outcome Measures :
  1. Quality of Life [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Spousal Support [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • 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

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): NCT01785576


Locations
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United States, Illinois
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
Sponsors and Collaborators
NorthShore University HealthSystem
Investigators
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Principal Investigator: Tina Gremore, PhD NorthShore University HealthSystem

Additional Information:
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Responsible Party: Rachel Pulido, Asst Director, Research Compliance, NorthShore University HealthSystem
ClinicalTrials.gov Identifier: NCT01785576    
Other Study ID Numbers: EH12-140
First Posted: February 7, 2013    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rachel Pulido, NorthShore University HealthSystem:
couples
head and neck cancer
oncology
spousal support
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms