Effectiveness of an eHealth Self-management Support Program for Persistent Pain After Breast Cancer Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 270
- 试验地点
- 2
- 主要终点
- Pain-related disability
研究概览
简要总结
The scientific goals of the project are:
- The primary scientific objective of the study is to determine the effectiveness of an eHealth self-management support program for persistent pain after breast cancer treatment compared to:
- usual care (i.e. superiority of the eHealth self-management support program) and
- a comprehensive pain rehabilitation program delivered face-to-face in a physical therapy setting (i.e. non-inferiority of the eHealth self-management support program)
on pain-related disability (measured with the Pain Disability Index). 2. The secondary scientific objectives of this study entails to examine if the eHealth self-management support program has a relative benefit for other biopsychosocial factors, including:
- Other dimensions of pain
- Health-related quality of life
- Physical functioning, including physical activity levels
- Psychosocial functioning, including self-efficacy, stress, anxiety, depression, coping style (key secondary outcome) and fear of cancer recurrence
- Participation in society, including return to work
- Healthcare-related costs for the patient and society
- The tertiary scientific objectives of this study are
- to identify moderators of treatment effect, including behavioural determinants (e.g. self-efficacy, motivation, coping style), in order to identify breast cancer survivors who would benefit the most of the eHealth self-management support program and to allow more stratified and efficient pain management care and more targeted allocation of budgets.
- To examine the implementation process, mechanisms of impact and contextual factors.
详细描述
The current state-of-the art advocates for a biopsychosocial rehabilitation approach for persistent pain after breast cancer treatment. Within this approach pain science education is combined with promotion of an active lifestyle based on self-regulation techniques. The investigators argue for testing an innovative eHealth self-management support program for this purpose. The assumption is that this delivery mode reduces barriers to pain self-management support, by bringing timely support near to people, creating a safe environment as opposed to hospital settings, providing a multidimensional support model taking into account the biopsychosocial needs of patients, and lowering costs. This program can provide patients with the knowledge, proactive, cognitive and self-management skills to master their situation and journey towards less pain and pain-related disability and participation in normal life again. Therefore, the general aim of the proposed project is to investigate the effectiveness of an eHealth self-management support program for pain-related disability (I) in breast cancer survivors with persistent pain (P). The program makes use of an innovative chatbot format for delivering pain science education and motivating and monitoring physical activity. The eHealth program is automated using comprehensive decision-tree-based algorithms in order to promote pain self-management support. The primary scientific objective of the study is to determine the effectiveness of this eHealth self-management support program for persistent pain after breast cancer treatment compared to 1) usual care (i.e. superiority of the eHealth self-management support program) (C1) and 2) a comprehensive pain rehabilitation program delivered face-to-face in a physical therapy setting (i.e. non-inferiority of the eHealth self-management support program) (C2) on pain-related disability (O).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patients (men and women) with primary breast cancer and with unilateral or bilateral axillary surgery (Axillary Lymph Node Dissection or Sentinel Node Biopsy);
- •Be non-metastatic and have finished their primary treatment with a curative intent at least 3 months prior to study participation;
- •Adjuvant hormonal therapy and immunotherapy form the exception to the rule are tolerated;
- •Presence of self-reported persistent pain in the last 3 months that interferes with daily activities (yes/no)
排除标准
- •Can not participate during the entire study period;
- •Mentally or physically unable to participate in the study;
- •Previous participation in a pain science education program.
- •No acces to a digital device
- •Do not speak/understand Dutch
研究组 & 干预措施
eHealth self-management support program
This web-based eHealth program consists of two parts. First participants will complete a pain science education program. After being primed in the educational program, barriers for a physically active lifestyle should be removed and participants should be able to apply the learned information in the second part. The second part of the self-management support program consists of daily activity planning and strategies to promote an active lifestyle.
干预措施: eHealth self-management support program (Behavioral)
Face-to-face rehabilitation program
The face-to-face rehabilitation program combines pain science education with an active behavioral approach. First, 2-3 individual face-to-face sessions are organized with a physical therapist (recruited and trained by the research team) to provide pain science education. The content of this pain science education program is the same as for the eHealth program. Similar as in the eHealth program, this education intervention includes advice for activity management, while experiencing pain and other symptoms, in order to remove barriers for an active lifestyle. The educational information will be presented verbally (explanation by the therapist) and written (information leaflet, summaries, pictures, metaphors and diagrams on computer and paper). After the education, the physical therapist will discuss proper goal setting with the patient to reach an active lifestyle and will coach the participant to reach these goals with maximum 6 face-to-face sessions.
干预措施: Face-to-face rehabilitation program (Behavioral)
Usual care group
Usual care for breast cancer survivors with persistent pain consists of primarily a pharmacological approach and general advice to stay or become active. This information is given to the participant by means of a brochure.
结局指标
主要结局
Pain-related disability
时间窗: at 6 months follow-up
Measured with Pain Disability Index, an instrument for measuring the impact that pain has on the ability of a person to participate in essential life activities. Scores between 0 and 70. The higher the score the greater the person's disability due to pain. The trial will be termed successful when superiority of the eHealth self-management to usual care and non-inferiority of the eHealth self-management program to face-to face rehabilitation program has been shown for the primary outcome at 6 months. Both tests will be based on the comparison of the mean value after correction for the baseline PDI (ANCOVA approach).
次要结局
- Pain related disability(at 12 weeks and 12 months follow-up)
- Medication use(at 12 weeks, 6 months and 12 months follow-up)
- Pain location(at 12 weeks, 6 months and 12 months follow-up)
- Pain Beliefs(at 6 weeks, 12 weeks, 6 months and 12 months follow-up)
- Pain severity(at 12 weeks, 6 months and 12 months follow-up)
- Severity of neuropathic Pain(at 12 weeks, 6 months and 12 months follow-up)
- Determinants for physical activity(at 12 weeks, 6 months and 12 months follow-up)
- Knowledge of neurophysiology of pain(at 6 weeks)
- Physical Activity pattern(at 12 weeks, 6 months and 12 months follow-up)
- Social Support(at 12 weeks, 6 months and 12 months follow-up)
- Return to work rate(at 12 weeks, 6 months and 12 months follow-up)
- Physical functioning(at 12 weeks, 6 months and 12 months follow-up)
- Fatigue(at 12 weeks, 6 months and 12 months follow-up)
- Sleep disturbance(at 12 weeks, 6 months and 12 months follow-up)
- Pain-related worrying(at 12 weeks, 6 months and 12 months follow-up)
- Vigilance and interpretation of physical sensations(at 12 weeks, 6 months and 12 months follow-up)
- Depression(at 12 weeks, 6 months and 12 months follow-up)
- Anxiety(at 12 weeks, 6 months and 12 months follow-up)
- Participation(at 12 weeks, 6 months and 12 months follow-up)
- Well-being(at 12 weeks, 6 months and 12 months follow-up)
- Medical costs of medical consumption(at 12 weeks, 6 months and 12 months follow-up)
- Indirect costs related to disease outside health care(at 12 weeks, 6 months and 12 months follow-up)
- Health-related quality of life(at 12 weeks, 6 months and 12 months follow-up)
- Patient Global Impression of Change(at 12 weeks follow-up)
研究者
An De Groef
Assistant Professor
Universiteit Antwerpen