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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01785576
Acronym
CoupleCare
Enrollment
20
Registered
2013-02-07
Start date
2013-03-31
Completion date
2015-10-31
Last updated
2019-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

Keywords

couples, head and neck cancer, oncology, spousal support

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.

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.

Interventions

BEHAVIORALCouple-Based CBT Intervention

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

Sponsors

Endeavor Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Quality of Life6 months

Secondary

MeasureTime frame
Spousal Support6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026