The Breast Cancer Online Rehabilitation Program: A Feasibility Study of Individually Tailored Online Rehabilitation After Breast Cancer Surgery The Copenhagen BRECOR Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 12
- 主要终点
- Recruitment Rate
研究概览
简要总结
The investigators have developed an online rehabilitation platform to guide women in their home-based upper-body exercises after breast cancer surgery. The platform includes rehabilitation videos that will guide the women in performing home-based early post-surgery upper-body rehabilitation tailored for each individual.
The primary objective is to assess the feasibility and acceptability of a home-based rehabilitation program supported by a supplemental online platform for women after breast cancer surgery before conducting a larger pragmatic trial in the future. The feasibility of the platform will be tested in 11 municipalities in Denmark.
详细描述
More and more women are being diagnosed with breast cancer worldwide. While a vast majority will survive their disease, adverse treatment effects are common, and may persist beyond the treatment period and contribute to the burden of cancer. After surviving breast cancer, women often struggle with upper-body side effects from the cancer treatment such as tight scar tissue, arm swelling, decreased shoulder function. This limits the woman's physical well-being, affects her ability to take care of her family, return to work, and ultimately impacts her quality of life. Specific upper-body rehabilitation exercises and participation in general exercise have been shown to prevent, attenuate or rehabilitate many of the physical and psychosocial side effects of breast cancer treatment.
New ways of delivering rehabilitation are needed to ensure continued capacity to undertake the growing demand for cancer rehabilitation. There is currently great diversity in the quality and access to cancer rehabilitation. Equal access to evidence-based, homogeneous, and high-quality rehabilitation is needed independent of geographical area of residence and setting of rehabilitation (municipality or hospital).
Online rehabilitation integrated in the current survivorship rehabilitation programs offers the opportunity to deliver this homogeneous intervention across the country. At this time, little effort has been made to develop online rehabilitation platforms for breast cancer survivors, thus no evidence to support the expected benefits of online rehabilitation is available.
Study objective:
The study aims to test if the platform is feasible and acceptable for women who have received treatment for breast cancer. The hypothesis is that the support of filmed accessible upper-body rehabilitation exercises through a website will promote improved adherence and motivation to do the home-based exercises illustrated by ≥75% of participants will perform the home-based program 5-7 times weekly and ≥ 75% of participants report to be somewhat or very satisfied with the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of breast cancer
- •Part 1 only: Surgery for breast cancer within the past eight weeks (mastectomy or lumpectomy with either sentinel or axillar dissection), including those women with a history of previous surgery for breast cancer, radiation therapy or chemotherapy
- •Part 2 only: Completion of surgery and radiation therapy for breast cancer within the past six weeks.
- •Home access to internet from stationary computer, lab top or tablet
- •Ability to use internet
- •Ability to read and understand Danish
排除标准
- •Surgery for breast cancer with immediate breast reconstruction
- •Diagnosis of primary lymphedema
- •Metastatic or inflammatory breast cancer
- •Planned use of chemotherapy within the next 6 weeks
- •Surgical complications: infection, drainage issues, seroma, hematoma
- •Severe physical, cognitive, or psychiatric illness causing inability to follow the study protocol: i.e. severe depression, anxiety, dementia, poor physical health with likely possibility of hospitalization within the next twelve weeks.
- •Planned hospitalization or surgery within the next twelve weeks
- •Participation in another clinical trial with a rehabilitation or exercise intervention
结局指标
主要结局
Recruitment Rate
时间窗: 10 weeks for part 1 and 20 weeks for part 2
This outcome represent the number and proportion (%) of eligible patients who consented to participate in the study. Recruitment was open for 10 weeks for participants in Part 1 and for 20 weeks for participants in Part 2.
Retention
时间窗: 12 weeks
Participants who are enrolled in the study but fail to complete the end of study assessment will be recorded as dropouts. Feasibility will be defined as a drop out of \<10%
Number of Participants Reporting Being "Very Satisfied" or "Somewhat Satisfied" With the Program
时间窗: 12 weeks
At the end of the study data describing participant satisfaction will be collected to answers questions on acceptability. All participants in part 1 and part 2 will be given a questionnaire, delivered by Easy Research, and will be asked to rank various aspects of the intervention such as the home-based exercises supported by videos, mode of delivery, software, etc. "as not at all satisfied", "not very satisfied", "somewhat satisfied" or "very satisfied". Feasibility will be defined as \>75% of participants reporting they are "very" or "somewhat satisfied" with the intervention.
Capacity/ Resources
时间窗: 12 weeks
The amount of time spent with each participant during the standard upper-body assessments, instruction of the home-based intervention and assistance needed with using the website during the study period will be tracked. In addition, any additional appointments required to teach the home-based rehabilitation program or to assist in using the website will be recorded. This information will help to determine the resources needed to administer the online component of the home-based program on a larger scale to a broader group of participants. This data was only collected for Part 1.
Adherence
时间窗: 12 weeks
Participants in part 1 and part 2 were asked to perform the rehabilitation program at least four times weekly for the duration of the study (12 weeks). Adherence was calculated as the number and proportion of participants who reported in a follow-up questionnaire that they had performed four or more weekly sessions. As such, participants who reported to have completed the home-based rehabilitation program 4 times per week were categorized as having adhered to the program. Likewise, participants who reported to have completed the program 3 times or fewer per week were categorized as not having adhered to the program.
次要结局
- Motivation for Rehabilitation Exercises(12 weeks)
- Clinical Outcomes in Upper-body Function: Muscle Strength(12 weeks)
- Clinical Outcomes in Upper-body Function: Arm Circumference(12 weeks)
- Clinical Outcomes in Upper-body Function: Pain(12 weeks)
- Ability to Perform Activities of Daily Living(12 weeks)
- Clinical Outcomes in Upper-body Function: Mobility(12 weeks)
研究者
Kristin Campbell
Associate Professor
University of British Columbia