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Spousal Support in Head and Neck Cancer
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, January 2009
Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00824252
  Purpose

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)

  • When patients/spouses report fewer social constraints/more support from their partners, they will report more disclosure/less holding back and, in turn, fewer intrusive and avoidant thoughts.
  • When patients/spouses report more social constraints/less support from their partners, they will report less disclosure/more holding back and, in turn, more intrusive and avoidant thoughts.

Hypothesis 1B (observation)

  • When spouses respond positively to patient disclosures, patients and spouses will have better cognitive processing (a smaller absolute difference in reaction times to cancer-related words on a cancer Stroop task).
  • When spouses respond negatively (criticize, stonewall), patients and spouses will have less adaptive cognitive processing (a larger absolute difference in reaction times to cancer-related words on a cancer Stroop task).

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)

  • When patients/spouses report fewer baseline social constraints/more support from their partners, they will report more disclosure/less holding back and, in turn, better psychological functioning, relationship quality, and QOL 4 and 12 months after XRT.
  • When patients/spouses report more baseline social constraints/less social support from their partners, they will report less disclosure/more holding back and, in turn, worse psychological functioning, relationship quality, and QOL 4 and 12 months after XRT.

Hypothesis 2B (observation)

  • When spouses respond positively to patients' baseline disclosures, patients/spouses will report better psychological functioning, relationship quality, and QOL 4 and 12 months after XRT.
  • When spouses respond negatively to patients' baseline disclosures, patients/spouses will report worse psychological functioning, relationship quality, and QOL 4 and 12 months after XRT.

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
Head and Neck Cancer
Behavioral: Questionnaires & Study Visit

MedlinePlus related topics: Cancer Head and Neck Cancer
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Spousal Support, Emotional Disclosure, and Adjustment to Head and Neck Cancer

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

Primary Outcome Measures:
  • To study the social and relationship factors that may affect the quality of life of patients with head and neck cancer and their spouses. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

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
1
Head and Neck Cancer Patients + Spouses
Behavioral: Questionnaires & Study Visit
Individual Questionnaires (1 hour) and videotaped discussion during Study Visit (1 1/4 hours)

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

Contacts
Contact: Hoda Badr, PHD 713-792-5922

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

Additional Information:
No publications provided

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

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

Study placed in the following topic categories:
Head and Neck Neoplasms
Quality of Life

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on February 12, 2009