Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Spousal Support in Head and Neck Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00824252
First received: January 15, 2009
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

Objectives:

Specific Aim 1. To examine the associations between emotional disclosure, social constraints/support and patient/spouse cognitive processing in Head and Neck Cancer (HNC) using self-report and observational methods.

Specific Aim 2. To examine the associations between emotional disclosure and social constraints/support at the initiation of radiation treatment (XRT) for HNC (baseline) and patient/spouse adjustment 4 and 12 months after XRT using self-report and observational methods.

Specific Aim 3. To examine the associations between patient/spouse reported emotional disclosure at baseline on patient distress and patient physical symptom reports/spouse caregiver burden 4 and 12 months after XRT.


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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 452
Study Start Date: December 2008
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Spousal Support
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00824252

Contacts
Contact: Ellen R. Gritz, PHD,BA 713-792-1890

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Ellen R. Gritz, PHD,BA         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Ellen R. Gritz, PHD,BA UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00824252     History of Changes
Other Study ID Numbers: 2008-0188
Study First Received: January 15, 2009
Last Updated: July 25, 2014
Health Authority: United States: Institutional Review Board

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
Neoplasms by Site

ClinicalTrials.gov processed this record on November 20, 2014