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Spousal Support, Emotional Disclosure, and Adjustment to Head and Neck Cancer


N/A
18 Years
N/A
Open (Enrolling)
Both
Head And Neck Cancer

Thank you

Trial Information

Spousal Support, Emotional Disclosure, and Adjustment to Head and Neck Cancer


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.

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


Inclusion Criteria:



1. Part 2. Patient is initiating radiation therapy for newly diagnosed head and neck
cancer

2. Part 2. Patient has an Eastern Cooperative Oncology Group performance status score of
2 or less

3. Part 2. Patient has a spouse or significant other with whom he/she resides

4. Part 2. Patient is able to vocalize well enough to complete the spousal interaction
task

5. Parts 1 and 2. Patient and spouse are able to read and speak English

6. Parts 1 and 2. Patient and spouse are able to provide informed consent

7. Parts 1 and 2. Patient and spouse are at least 18 years of age

8. Part 1. Individual is a patient who was diagnosed with head and neck cancer or the
spouse or partner of an patient who was diagnosed with head and neck cancer and
resides with the patient.

Exclusion Criteria:

1) None

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Social + Relationship Factors Affecting QOL of HNC Patients & Spouses

Outcome Time Frame:

12 Months

Safety Issue:

No

Principal Investigator

Ellen R. Gritz, PHD,BA

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2008-0188

NCT ID:

NCT00824252

Start Date:

December 2008

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • Head And Neck Cancer
  • HNC
  • Radiation Therapy
  • Spousal Support
  • Emotional Disclosure
  • Observational
  • Social Constraints
  • Questionnaires
  • Videotaped Interview
  • Quality of Life
  • Head and Neck Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030