Neoplasms

All Conditions

Head and Neck Neoplasms

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

The treatment as usual group will complete all assessements and will not receive the psychosocial couple based intervention.

Couple-Based CBT Intervention

Tina Gremore, PhD

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.

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.

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

NorthShore University HealthSystem

Asst Director, Research Compliance

Behaviors and Mental Disorders

Quality of Life

Questionnaire for Head and Neck Cancer Patients + Spouses

Individual Questionnaires (1 hour) and videotaped discussion during Study Visit (1 1/4 hours)

Questionnaires & Study Visit

Kathrin Milbury, PHD, MA

The goal of this research study is to look at social and relationship factors that may affect the quality of life of patients with head and neck cancer and their spouses.

If you agree to take part in this study, you first fill out a questionnaire, which will take about 1 hour. You will also have a study visit with your spouse, where you and your spouse will fill out several questionnaires, have a videotaped discussion, and complete tasks on the computer. This study visit will last about 75 minutes.

Health and Relationship Questionnaire:

On Day 1 you will be given a questionnaire about your health and your relationship with your spouse. This will be before you begin treatment. You may complete the questionnaire while waiting for your clinic appointment, or you may take it home, complete it, and return it by mail. It will take about 60 minutes to complete.

If you agree to take part in this study, your spouse will also be asked to take part. If your spouse does not wish to take part, your participation in this study will be over after you complete the questionnaire.

Study Visit:

During the first 2 weeks after you start treatment, you and your spouse will come to the clinic together for a study visit. The visit will take about 75 minutes. For all of the procedures at this visit, you and your spouse will be in the same room together. A study staff member will also be in the room, except for during the videotaped discussions. The following procedures will be performed at the study visit:

* You will complete a questionnaire that asks you to identify one instance where you felt supported by your spouse since the cancer diagnosis, and one issue that has caused conflict with your spouse since the cancer diagnosis. You will also complete a questionnaire about your mood. Your spouse will complete the same questionnaires. This will take about 10-15 minutes.
* You and your spouse will take part in a videotaped discussion. You will discuss the topic you identified as an instance where you felt supported by your spouse since the cancer diagnosis. Your spouse will also discuss the topic he/she identified as an instance where he/she felt supported by you since the cancer diagnosis. This will take about 10-15 minutes.
* After the discussion, you and your spouse will be asked to complete a cognitive (thinking) task, on separate computers. Words in different colors will appear on the computer screen. The goal of the task is to name the color of the words, as quickly as possible. It will take about 5 minutes to complete the task.
* After the cognitive task, you and your spouse will complete separate questionnaires that will ask questions about the discussion and how you feel about it. This will take about 5-10 minutes.
* You and your spouse will take part in another videotaped discussion. This time, you will discuss the topic you identified as causing conflict with your spouse since the cancer diagnosis. Your spouse will also discuss the topic he/she identified as causing conflict since the cancer diagnosis. It will take about 10-15 minutes.
* After the discussion, you and your spouse will repeat the same cognitive task. It will again be on separate computers and will take about 5 minutes.
* After the cognitive task, you and your spouse will complete separate questionnaires that will ask questions about the discussion and how you feel about it. This will take about 5-10 minutes.
* At the conclusion of the study visit, you will have the option to view the videotape of your discussion with your spouse. If, after viewing your videotape you decide for any reason that you do not want it to be used for research, the tape will be destroyed.

Follow-Up Questionnaire:

You will complete the Health and Relationship questionnaire 2 more times.

If possible, you will complete this questionnaire while you are at the clinic for your regularly scheduled follow-up visits that will occur 4 months and 12 months after you complete your radiation treatment. Otherwise, if your appointment is not on the same schedule as this study's questionnaire schedule, you will receive the questionnaire by mail and you should mail it back to the study staff.

Information Collection:

During the course of this study, a study staff member will review your medical records to collect medical information such as your diagnosis and health history.

Length of Study:

After you complete the last questionnaire (Month 12), your participation in this study will be over.

This is an investigational study. For any questionnaires that you are asked to return by mail, you will be provided stamped envelopes.

Up to 452 participants (226 patients and 226 spouses) will take part in this study. All will be enrolled at MD Anderson.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Couple-Based Intervention for Patients With Head and Neck Cancer and Their Partners	NCT01785576	Head and Neck C...	Couple-Based CB...	18 Years -	NorthShore University HealthSystem
Spousal Support in Head and Neck Cancer	NCT00824252	Head And Neck C...	Questionnaires ...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for spousal support