Patient Preferences in Head and Neck Cancer Treatment Decisions - a Pilot Study of the Durability of Patient Priorities
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Stability of HNPS ranking between pre- and post-treatment assessments
研究概览
简要总结
This pilot research trial studies patient preferences in making treatment decisions in patients with stage I-IVA oropharyngeal cancer. Questionnaires that measure patient priorities before and after treatment may improve the ability to plan for better quality of life in patients with oropharyngeal cancer.
详细描述
PRIMARY OBJECTIVES:
I. Determine the stability of Head and Neck Priorities Scale (HNPS) ranking between pre- and post-treatment assessments.
SECONDARY OBJECTIVES:
I. Use patient-interviews to refine and modify the HNPS for use in a larger scale trial.
II. Pilot the Head and Neck Patient Outcomes Survey (HNPOS) as a potential tool to identify priorities most important to quality-of-life outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treatment naïve American Joint Committee on Cancer (AJCC) stage I-IVa squamous cell carcinoma of the head and neck with no definitive evidence of metastatic disease
- •Sufficient vision, writing, and communication ability to complete the interviews and assessment tool
- •Signed informed consent
排除标准
- •Patients who are enrolled in other head and neck cancer treatment protocols are permitted to participate in this study if a) the other protocol permits this and b) the other protocol does not utilize the HNPS
- •Patients who have previously undergone cancer treatment or are presently undergoing additional cancer treatments
- •Patients who have already undergone unsuccessful curative-intent surgery on their head and neck cancer
- •Patients, who have had a major surgery (defined as requiring general anesthesia but not including tonsillectomy, neck dissection, or panendoscopy [triple endoscopy or examination under general anesthesia]), or significant traumatic injury within 4 weeks of the study; patients who have not recovered from the side effects of any of the above surgeries
- •Patients unwilling to or unable to comply with the protocol
- •Patients unable to communicate with the interviewer
结局指标
主要结局
Stability of HNPS ranking between pre- and post-treatment assessments
时间窗: Up to 12 months
Proportion of patients for whom the domain was considered stable calculated. Exact binomial tests will be used to test whether each proportion is greater than 50%.
次要结局
- Validity of HNPOS(Up to 12 months)
- Reliability of HNPPQ scale, in terms of test-retest and internal consistency(Up to 12 months)