Evaluating an Online Interprofessional Chronic Pain Management Group for Survivors of Breast Cancer: A Feasibility Study of a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Pain Interference.
研究概览
简要总结
The goal of this research study is to evaluate an online inter-professional pain management program for survivors of breast cancer.
The main questions it aims to answer:
- whether this treatment will help address the pain management concerns of patients,
- whether it is feasible to offer this treatment in the future as multi-centre randomized controlled trial (RCT).
Participants will be asked to attend a 6-week online pain management group sessions (1h/week). Participants will also be asked to fill out questionnaires before and after the program completion.
详细描述
Survivors of breast cancer often experience chronic pain that is undertreated and gets in the way of their functioning, relationships, mental health, and quality of life. There is little research on the best ways of treating chronic pain in cancer that make good use of all the expertise offered by different health care providers such as nurses, psychologists, and physiotherapists. In addition, little is known about how to offer such a service in an online format.
This study aims to pilot an online interprofessional pain management program for survivors of breast cancer. The investigators would like to know whether this treatment will help address the pain management concerns of patients, and whether it is feasible to offer this treatment in the future as multi-centre randomized controlled trial (RCT).
Participants in the study will attend a 6-week online pain management program (I-Can-Manage-Pain after cancer) that will cover the topics of understanding cancer pain, exercises to manage pain and psychological strategies to cope with pain. Questionnaires will be administered before and after the program to assess their satisfaction and changes in outcomes related to pain, quality of life, confidence to manage their pain, and use of health care services. The feasibility of implementing the study and the program will be pre-determined by an acceptability criteria for patient recruitment, completion of questionnaires, participation in the online sessions, and satisfaction with the pain management program.
It is hoped that study findings will help inform the development of treatment programs to improve post-treatment pain management and the quality of life of survivors of breast cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •diagnosis of Stage 1-3 breast cancer;
- •had surgical excision at least 3 months ago;
- •completed neoadjuvant/adjuvant chemotherapy and/or radiation treatment at least 4 months ago;
- •within 5 years post active cancer treatment;
- •persistent pain within the last 3 months that is bothersome;
- •medical clearance to participate in the intervention
- •over 18 years of age;
- •verbal fluency in English;
- •have access to internet and technology to participate in the online program. Patients currently receiving adjuvant endocrine therapy or molecularly targeted therapies or who have completed these therapies within the last 5 years are eligible to participate.
排除标准
- •Participants will be excluded from the study if they:
- •demonstrate significant cognitive impairment as determined by the clinical judgment of the provider;
- •have a pre-existing non-cancer pain condition,
- •have severe emotional distress that interferes with group participation as determined by scores above 15 on the Patient Health Questionnaire-9.
结局指标
主要结局
Pain Interference.
时间窗: 6 weeks
This construct will be measured using the 6-item Patient-Reported Outcome Measurement Information System (PROMIS) Pain Interference Scale. (PIS) The PIS uses a 5-point rating scale to determine the degree to which an individual perceives their pain symptoms to interfere with their physical, mental and social functioning. Sum of raw scores will be translated to a T-score using a conversion table. A T-score of 50 with a standard deviation of 10 is the average for the general population based on United States Data. The minimally important difference20 for the PIS scores among pain samples ranges from 2 to 3 T-score points.
次要结局
- Healthcare Utilization(6 weeks)
- Pain intensity.(6 weeks)
- Psychological Distress (depression, anxiety, stress)(6 weeks)
- Patient Satisfaction(6 weeks)
- Trial Feasibility (ability to recruit patients)(12 months)
- Self-Efficacy(6 weeks)
- Trial adherence and fidelity(12 months)
- Patients' satisfaction with the intervention.(12 months)
- Pain Catastrophizing;(6 weeks)
- Psychological Distress (Fear of Cancer recurrence)(6 weeks)
研究者
Karen Zhang
Clinical, Health and Rehabilitation Psychologist
Hamilton Health Sciences Corporation