Spousal Support in Head and Neck Cancer
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 15, 2009 | ||||
| Last Updated Date | January 23, 2013 | ||||
| Start Date ICMJE | December 2008 | ||||
| Estimated Primary Completion Date | December 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Social + Relationship Factors Affecting QOL of HNC Patients & Spouses [ Time Frame: 12 Months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
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 ] | ||||
| Change History | Complete list of historical versions of study NCT00824252 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Spousal Support in Head and Neck Cancer | ||||
| Official Title ICMJE | Spousal Support, Emotional Disclosure, and Adjustment to Head and Neck Cancer | ||||
| Brief Summary | 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. |
||||
| Detailed Description | 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:
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. Up to 452 participants (226 patients and 226 spouses) will take part in this study. All will be enrolled at MD Anderson. |
||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Head and neck cancer patients who will be starting radiation therapy and their spouses. |
||||
| Condition ICMJE | Head And Neck Cancer | ||||
| Intervention ICMJE | Behavioral: Questionnaires & Study Visit
Individual Questionnaires (1 hour) and videotaped discussion during Study Visit (1 1/4 hours)
Other Name: Survey |
||||
| Study Group/Cohort (s) | Spousal Support
Head and Neck Cancer Patients + Spouses
Intervention: Behavioral: Questionnaires & Study Visit |
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 452 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | December 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: 1) None |
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
|
||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00824252 | ||||
| Other Study ID Numbers ICMJE | 2008-0188 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | M.D. Anderson Cancer Center | ||||
| Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | M.D. Anderson Cancer Center | ||||
| Verification Date | January 2013 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||