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Spousal Support in Head and Neck Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00824252
First Posted: January 16, 2009
Last Update Posted: July 11, 2017
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose
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.

Condition Intervention
Head And Neck Cancer Behavioral: Questionnaires & Study Visit

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Spousal Support, Emotional Disclosure, and Adjustment to Head and Neck Cancer

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Social + Relationship Factors Affecting QOL of HNC Patients & Spouses [ Time Frame: 12 Months ]

Enrollment: 361
Actual Study Start Date: December 8, 2008
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Spousal Support
Questionnaire for Head and Neck Cancer Patients + Spouses
Behavioral: Questionnaires & Study Visit
Individual Questionnaires (1 hour) and videotaped discussion during Study Visit (1 1/4 hours)
Other Name: Survey

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Head and neck cancer patients who will be starting radiation therapy and their spouses.
Criteria

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

  Contacts and Locations
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): NCT00824252


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Kathrin Milbury, PHD, MA M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00824252     History of Changes
Other Study ID Numbers: 2008-0188
K07CA124668 ( U.S. NIH Grant/Contract )
First Submitted: January 15, 2009
First Posted: January 16, 2009
Last Update Posted: July 11, 2017
Last Verified: July 2017

Keywords provided by M.D. Anderson Cancer Center:
Head And Neck Cancer
HNC
Radiation Therapy
Spousal Support
Emotional Disclosure
Observational
Social Constraints
Questionnaires
Videotaped Interview
Quality of Life

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms