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Sponsored by: |
Memorial Sloan-Kettering Cancer Center |
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Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00582413 |
The purpose of this study is to learn more about the quality of life and emotional changes that patients experience during their treatment for cancer of the mouth. We want to learn more about the emotional and quality of life problems that occur during and after treatment. This will help us better understand these complex issues and improve treatment.
Condition | Intervention |
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Cancer of the Oral Cavity |
Behavioral: questionnaires |
Study Type: | Observational |
Study Design: | Case-Crossover, Prospective |
Official Title: | Prospective Evaluation of Quality of Life and Development of Measures in Patients With Cancer of the Oral Cavity |
Estimated Enrollment: | 133 |
Study Start Date: | December 2004 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1
Patients who have been diagnosed with Carcinoma of the oral cavity
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Behavioral: questionnaires
Patient will fill out questionnaires, initial clinic visit, first post-surgery clinic evaluation and 3, 6, 12, 18 and 24 months following completion of all therapy.
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The objectives of this project are to prospectively assess quality of life (QOL) and psychosocial adaptation in patients undergoing treatment for carcinoma of the oral cavity, including squamous cell carcinoma of the oral cavity (SCCOC) and to validate new instruments (shame & stigma, demoralization) that will guide quality of life assessment of patients with cancer of the oral cavity. We will utilize modifications of previously described and validated questionnaires that will be administered to eligible patients before the start of their therapy and at several predefined time points during the post-therapy period. This prospective longitudinal assessment will allow us to study the impact of patient demographic, tumor, treatment and lifestyle related variables on the quality of life of patients treated for oral cavity cancer.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients seen on the Head and Neck Surgery Service, Radiation Oncology Service, Medical Oncology Service and Dental Service.
Inclusion Criteria:
PATIENT INCLUSION CRITERIA FOR THE LONDITUDINAL STUDY:
Exclusion Criteria:
EXCLUSION FOR THE LONDITUDINAL STUDY:
PATIENT INCLUSION CRITERIA FOR THE CROSS-SECTIONAL STUDY:
EXCLUSION CRITERIA FOR THE CROSS-SECTIONAL STUDY:
Contact: David Kissane, MD | 646-888-0019 | kissaned@mskcc.org |
Contact: Bhuvanesh Singh, MD | 212-639-2024 | singhb@mskcc.org |
United States, New York | |
Memorial Sloan Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
Contact: David Kissane, MD 646-888-0019 kissaned@mskcc.org | |
Contact: Bhuvanesh Singh, MD 212-639-2024 singhb@mskcc.org | |
Principal Investigator: David Kissane, MD |
Principal Investigator: | David Kissane, MD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( David Kissane, MD ) |
Study ID Numbers: | 04-137 |
Study First Received: | December 21, 2007 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00582413 |
Health Authority: | United States: Institutional Review Board |
Head and Neck Cancer |
Head and Neck Neoplasms Quality of Life |