Brief Pain Coping Skills Training for Older Women With Breast Cancer and Pain: An Efficacy-Effectiveness Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Pain severity as measured by the Brief Pain Inventory (BPI)
研究概览
简要总结
This randomized controlled trial examines a 1-session, telehealth pain coping skills training (PCST) protocol with five 15-minute maintenance calls (Brief PCST-Community) adapted for women with breast cancer in medically underserved areas. Pain, health-related quality of life, and self-efficacy for pain management will be assessed at baseline and 10 and 15 weeks later.
详细描述
Pain continues to be persistent, interfering, and distressing for women with breast cancer. Behavioral cancer pain interventions continue to be poorly implemented with pronounced disparities for older breast cancer patients receiving oncology care in medically underserved areas. Within this context, this randomized controlled trial examines a 1-session, telehealth pain coping skills training (PCST) protocol with five 15-minute maintenance calls (Brief PCST-Community) adapted for women with breast cancer in medically underserved areas. Pain, health-related quality of life, and self-efficacy for pain management will be assessed at baseline and 10 and 15 weeks later.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Receiving cancer care at a Duke Cancer Network (DCN) clinic
- •Stage I-IV breast cancer
- •Self-reported pain on at least 10 days in the last month and pain rating of worst pain of 4 or greater on a 0-10 scale in the last week
- •Biologically female
- •Greater than or equal to 55 years old
- •Ability to speak and read English
- •Hearing and vision that allows for successful completion of videoconferencing and phone session
排除标准
- •Participation in the last 6 months in a pain coping skills training program
研究组 & 干预措施
Pain Coping Skills Training
Participants in this group will complete a 50-minute telehealth session with a trained study nurse. During this session, they will be taught how to use several coping strategies for managing pain. This will be followed by 5 weekly, 15-minute supportive phone calls, where the study nurse will reinforce the learned coping skills. They will be asked to complete 2 follow-up surveys (10 weeks and 15 weeks after the first survey).
干预措施: Pain Coping Skills Training (PCST) (Behavioral)
Usual Care
Participants in this group will not complete the new program. They will be asked to complete 2 follow-up surveys (10 and 15 weeks after the first survey).
结局指标
主要结局
Pain severity as measured by the Brief Pain Inventory (BPI)
时间窗: Baseline, 10-week assessment, 15-week assessment
BPI Pain Severity (worst, least, average, current pain on 0-10 scale) scores are averaged for a total score range of 0 to 10, with higher scores indicating greater pain severity.
Pain interference as measured by the Brief Pain Inventory (BPI)
时间窗: Baseline, 10-week assessment, 15-week assessment
BPI Pain Interference (7 daily life areas such as mood, sleep, activity rated 0-10) scores are averaged for a total score range of 0 to 10, with higher scores indicating greater pain interference.
Health Related Quality of Life (HR-QOL) as measured by the Patient Reported Outcomes Measurement Information System (PROMIS-29) - Physical Function
时间窗: Baseline, 10-week assessment, 15-week assessment
A PROMIS Physical Function T-score is a standardized number (mean 50, SD 10) from the Patient-Reported Outcomes Measurement Information System (PROMIS) that reflects self-reported physical ability with higher scores indicating better function.
Health Related Quality of Life (HR-QOL) as measured by the Patient Reported Outcomes Measurement Information System (PROMIS-29) - Mental Health
时间窗: Baseline, 10-week assessment, 15-week assessment
A PROMIS Mental Health T-score is a standardized number (mean 50, SD 10) from the Patient-Reported Outcomes Measurement Information System (PROMIS) that reflects self-reported mental health with higher scores indicating worse mental health.
次要结局
- Self-Efficacy for Pain Management(Baseline, 10-week assessment, 15-week assessment)