An Observational Study to Determine the Effects of Human Papillomavirus Diagnosis on Relationships of Head and Neck Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change Patients' and partners' perceived relationship intimacy levels
研究概览
简要总结
This trial studies the effects of human papillomavirus diagnosis on the relationships of patients with head and neck cancer. Determining the effects of human papillomavirus diagnosis on relationships may determine whether human papillomavirus-positive patients and their partners are more likely to experience decline in relationship intimacy after diagnosis than human papillomavirus-negative patients and their partners. This may help researchers provide valuable insight into the degree to which a diagnosis of human papillomavirus affects patient relationships over and above the effects of a cancer diagnosis and address the need for additional patient counseling or education following diagnosis.
详细描述
PRIMARY OBJECTIVES:
I. To explore the agreement between patients' perceived intimacy level and their partners' perceived intimacy level at different time points in the course of their head and neck cancer (HNC) treatment.
II. To compare any changes in the patients' perceived intimacy scores between human papillomavirus (HPV)-positive and HPV-negative HNC patients at different time points in the course of their HNC treatment.
EXPLORATORY OBJECTIVE:
I. Identify areas of concern or misinformation among patients and partners where further patient counseling or education may be indicated.
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
- •Capable of giving informed consent
- •Diagnosis of head and neck cancer (previously untreated, any stage) or in a partnered relationship with an individual diagnosed with head and neck cancer
- •Tumors positive for HPV
- •Tumors negative for HPV
- •Treatment plan is intent to cure
- •In a partnered relationship
- •Willing to answer brief survey prior to treatment and again after completion of treatment
- •English Speaking
排除标准
- •Prior treatment (surgery, chemotherapy, radiation therapy [XRT], or chemoradiotherapy [CRT]) for head and neck cancer
- •Partners of eligible patients undergoing active cancer treatment
- •Not in a partnered relationship
- •Non-English speaking
结局指标
主要结局
Change Patients' and partners' perceived relationship intimacy levels
时间窗: within 30 weeks post treatment
Categorized from the corresponding intimacy scores in the manner of loss of intimacy (0-48), stable relationships (49-71) and improvement (72-120).
Change in patients' and partners' perceived intimacy scores at baseline
时间窗: Before treatment
Defined as total scores of the primary questions in patient survey and partner survey
Change in patients' and partners' perceived intimacy scores post treatment
时间窗: within 30 weeks after treatment
Defined as total scores of the primary questions in patient survey and partner survey
次要结局
未报告次要终点