Prospective Evaluation of Quality of Life and Development of Measures in Patients With Cancer of the Oral Cavity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PATIENT INCLUSION CRITERIA FOR THE LONDITUDINAL STUDY:
- •Carcinoma of the oral cavity including one or more of the following anatomic sub-sites: Anterior 2/3rds of the tongue, the floor of the mouth, the upper and lower gums, buccal mucosa, retromolar trigone, hard palate and minor salivary glands.
- •Surgically resectable disease in the oral cavity and the neck.
- •Patients with prior cancers other than Head and Neck cancers who are currently in remission, have no evidence of disease and are not undergoing any active chemotherapy or radiation therapy.
排除标准
- •EXCLUSION FOR THE LONDITUDINAL STUDY:
- •Primary tumor of the lips (these are skin cancers).
- •Surgical treatment excluding diagnostic biopsy of the primary site or biopsy of neck node/s prior to referral to MSKCC.
- •Surgically unresectable disease in the neck; including carotid encasement, massive dermal infiltration, and other clinical and radiographic findings which would preclude surgically resectable nodal disease in the neck, prior to initiation of treatment.
- •Evidence of distant metastases by clinical or radiographic examination.
- •Patients with more than one simultaneous primary tumor.
- •Patient unable to read or comprehend the content of the questionnaires due to language barriers or psychiatric disorders.
- •PATIENT INCLUSION CRITERIA FOR THE CROSS-SECTIONAL STUDY:
- •Upper aerodigestive squamous cell carcinoma, including the oropharynx, hypopharynx and larynx - newly diagnosed or recurrent cancers.
- •Newly diagnosed and recurrent carcinoma of the oral cavity including one or more of the following anatomic sub-sites: Anterior 2/3rds of the tongue, the floor of the mouth, the upper and lower gums, buccal mucosa, retromolar trigone, hard palate and minor salivary glands.
- •EXCLUSION CRITERIA FOR THE CROSS-SECTIONAL STUDY:
- •Primary tumor of the lips (these are skin cancers).
- •Patient unable to read or comprehend the content of the questionnaires due to language barriers or psychiatric disorders.
结局指标
主要结局
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.
时间窗: conclusion of study
次要结局
- Assess patterns of tobacco and/or alcohol use in cancer of the oral cavity survivors.(conclusion of the study)
- Assess the impact of lifestyle and socio-economic issues on post-therapy quality of life.(conclusion of the study)
- 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(conclusion of study)