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Spousal Support in Head and Neck Cancer
Spousal Support, Emotional Disclosure, and Adjustment to Head and Neck Cancer
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
-
-
Texas
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Houston, Texas, Verenigde Staten, 77030
- University of Texas MD Anderson Cancer Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- Part 2. Patient is initiating radiation therapy for newly diagnosed head and neck cancer
- Part 2. Patient has an Eastern Cooperative Oncology Group performance status score of 2 or less
- Part 2. Patient has a spouse or significant other with whom he/she resides
- Part 2. Patient is able to vocalize well enough to complete the spousal interaction task
- Parts 1 and 2. Patient and spouse are able to read and speak English
- Parts 1 and 2. Patient and spouse are able to provide informed consent
- Parts 1 and 2. Patient and spouse are at least 18 years of age
- 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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Cohort
- Tijdsperspectieven: Prospectief
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
---|---|
Spousal Support
Questionnaire for Head and Neck Cancer Patients + Spouses
|
Individual Questionnaires (1 hour) and videotaped discussion during Study Visit (1 1/4 hours)
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Social + Relationship Factors Affecting QOL of HNC Patients & Spouses
Tijdsspanne: 12 Months
|
12 Months
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2008-0188
- K07CA124668 (Subsidie/contract van de Amerikaanse NIH)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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