Quality of Life and Development of Measures in Patients With Cancer of the Oral Cavity
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.
|Study Design:||Observational Model: Case-Crossover
Time Perspective: Prospective
|Official Title:||Prospective Evaluation of Quality of Life and Development of Measures in Patients With Cancer of the Oral Cavity|
- is to assess quality of life and psychosocial adaptation in patients undergoing treatment for cancer of the oral cavity so that we can develop empirically-informed interventions to improve the adaptation of these patients. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
- Validate two new measures of psychosocial adjustment in patients treated for cancer of the oral cavity and upper aerodigestive SCC: The Shame and Stigma in Head and Neck Cancer Scale and the Demoralization Scale [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
- Assess patterns of tobacco and/or alcohol use in cancer of the oral cavity survivors. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
- Assess the impact of lifestyle and socio-economic issues on post-therapy quality of life. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
|Study Start Date:||December 2004|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Patients who have been diagnosed with Carcinoma of the oral cavity
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00582413
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Snehal Patel, MD||Memorial Sloan-Kettering Cancer Center|