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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00824252 |
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.
Hypothesis 1A (self-report)
Hypothesis 1B (observation)
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.
Hypothesis 2A (self-report)
Hypothesis 2B (observation)
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.
Hypothesis 3A (patients)
-When patients hold back less/disclose more at baseline, they will report better psychological functioning, which, in turn, will be associated with less severe physical symptom reports 4 and 12 months after XRT.
Hypothesis 3B (spouses)
-When spouses disclose more to HNC patients at baseline, patients will report better psychological functioning, which, in turn, will be associated with spouses reporting less caregiver burden 4 and 12 months after XRT.
Condition | Intervention |
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Head and Neck Cancer |
Behavioral: Questionnaires & Study Visit |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Spousal Support, Emotional Disclosure, and Adjustment to Head and Neck Cancer |
Estimated Enrollment: | 452 |
Study Start Date: | December 2008 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1
Head and Neck Cancer Patients + Spouses
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Behavioral: Questionnaires & Study Visit
Individual Questionnaires (1 hour) and videotaped discussion during Study Visit (1 1/4 hours)
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Head and neck cancer patients who will be starting radiation therapy and their spouses.
Inclusion Criteria:
Exclusion Criteria:
1) None
Contact: Hoda Badr, PHD | 713-792-5922 |
United States, Texas | |
UT MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Hoda Badr, PHD |
Principal Investigator: | Hoda Badr, PHD | UT MD Anderson Cancer Center |
Responsible Party: | UT MD Anderson Cancer Center ( Hoda Badr,PHD ) |
Study ID Numbers: | 2008-0188 |
Study First Received: | January 15, 2009 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00824252 |
Health Authority: | United States: Institutional Review Board |
Head And Neck Cancer HNC Radiation Therapy Spousal Support Emotional Disclosure |
Observational Social Constraints Questionnaires Videotaped Interview Quality of Life |
Head and Neck Neoplasms Quality of Life |
Neoplasms Neoplasms by Site |