Survivors of Head and Neck Cancer: Optimizing Pain Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 4
- 主要终点
- Depression
研究概览
简要总结
This clinical trial improves an existing pain management program and tests its effect on head and neck cancer survivors. This trial aims to find a better program to improve pain-related physical functioning, mood, and quality of life in a sample of individuals who have undergone treatment for head and neck cancer.
详细描述
PRIMARY OBJECTIVES:
I. Adapt an existing telehealth pain management intervention to target improvement of pain-related physical functioning, mood, substance use, and quality of life in a local sample of veteran head and neck cancer (HNC) survivors.
II. Conduct a pilot of the adapted intervention to examine the feasibility (accrual, adherence, attrition) and acceptability (participant satisfaction) that will form the basis of a well-powered, randomized clinical trial submitted for funding to the National Institutes of Health (NIH), American Cancer Society (ACS), or Veterans Affairs (VA).
OUTLINE:
Patients attend 5 sessions of Mobile Pain Coping Skills Training for 45 minutes each over 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Clinically confirmed diagnosis of HNC for which the participants have completed curative cancer treatment at the VA hospital or Oregon Health & Science University (OHSU) within the 3-12 months following treatment
- •Self-reported current pain of 4 or higher, using the 0-10 Numeric Pain Rating (NRS) (0="no pain" to 10="the worst pain imaginable")
- •Self-report of pain 4 or higher on two occasions, more than three weeks apart, since the completion of curative treatment
排除标准
- •Enrolled in hospice
- •Have substantial hearing or visual difficulties that would impair ability to participate
- •Have inadequate cognitive functioning as indicated by medical record review and/or interactions with clinical staff. If needed the investigators can follow up with the St. Louis University Mental State Examination (score of < 22/30) (SLUMS); or
- •Have untreated severe psychiatric illness that would impact the ability to consent and participate in the intervention
- •Had only surgical treatment for their HNC
结局指标
主要结局
Depression
时间窗: Up to 2 months
Will be assessed by the Patient Health Questionnaire. Scores of 5, 10, 15, and 20 represent point scale for mild, moderate, moderately severe and severe depression, respectively.
Pain-interference
时间窗: Up to 2 months
Will be assessed by Brief Pain Inventory. Will be assessed as 1-4=mild pain; 5-6 moderate pain; 7-10 severe pain.
Pain coping self-efficacy
时间窗: Up to 2 months
Will be assessed by the Chronic Pain Self-Efficacy Scale.
次要结局
- Head and neck cancer related quality of life(Up to 2 months)
- Substance use(Up to 2 months)
研究者
Shannon Madore, Ph.D.
Principal Investigator
OHSU Knight Cancer Institute