Strength After Breast Cancer: Clinical Implementation of an Evidence-based Group Exercise Intervention for Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Enrollment Rate
研究概览
简要总结
The goal of this study is to explore whether a group exercise program called Strength After Breast Cancer can be delivered in an outpatient physical therapy clinic to improve physical function among women after treatment for breast cancer.
The main questions this study aims to answer are:
- Can the Strength After Breast Cancer program and the associated outcome battery be successfully delivered in an outpatient physical therapy clinic at Massachusetts General Hospital and do participants find the program practical?
- What are the barriers to and facilitators of delivering the group exercise program in a clinical setting and what changes need to be made to the program to improve sustainability and to facilitate implementation at other clinical sites?
Participants will complete study questionnaires before and after engaging in the group exercise program and they will participate in interviews following participation in the program.
详细描述
The goal of this single arm feasibility study of the Strength After Breast Cancer (SABC) evidence-based group exercise intervention for women after treatment for breast cancer is to determine if investigators can feasibly deliver the program out of the outpatient physical therapy clinic at Massachusetts General Hospital Waltham.
- Following a one-on-one physical therapy evaluation, the four-session SABC program provides a group-based but individualized exercise plan and encourages engagement in independent home-based exercises to improve physical function. The SABC program has previously been found to be safe and led to improvements in physical function among women after treatment for breast cancer. Therefore, the focus of this study is to explore clinical implementation barriers, facilitators, and necessary program adaptations to enhance sustainability and facilitate implementation at other clinical sites.
Study procedures include screening for eligibility, in-clinic visits, questionnaires, and a semi-structured interview.
Participation in this research study is expected to last up to 5 months. It is expected that up to 40 people will take part in this research study.
This is an unfunded study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age
- •Diagnosed with Stage I-III breast cancer, having completed primary cancer treatment (e.g., surgery, chemotherapy, radiation therapy); hormonal therapies and adjuvant targeted therapies will be permitted
排除标准
- •Any injury or medical condition that would prohibit being able to safely perform exercise as indicated by the Physical Activity Readiness Questionnaire (i.e., atrial fibrillation, chest pain or angina, uncontrolled high blood pressure or hypertension, loss of balance due to dizziness in the past 12 months, or loss of consciousness in the past 12 months).
- •Non-English speaking
结局指标
主要结局
Enrollment Rate
时间窗: At screening
Number participants enrolled / Number screened positive \& eligible. A rate of at least 75% will indicate feasibility.
Intervention session completion rate
时间窗: Up to 2 months
Number of completed sessions per participant. For this study, the investigators will consider it feasible if the mean number of sessions completed per participant is ≥ 3.
Assessment completion rate
时间窗: Up to 5 months
Number participants completing each of the 4 study assessments / Number of participants enrolled. For this study, an assessment completion rate of 75% will indicate feasibility.
Program completion rate
时间窗: Up to 2 months
Number participants completing 4 sessions of the SABC intervention / Number of participants enrolled. For this study, the investigators will consider it feasible if 75% of participants complete all 4 sessions.
Screening Rate
时间窗: At screening
Number patients screened / Number patients identified as potentially eligible. Screening rate of at least 75% will indicate feasibility.
Eligibility Rate
时间窗: At screening
Number patients screening eligible / Number screened. Eligibility rate of at least 75% will indicate feasibility.
次要结局
- Participant Satisfaction(Up to 2 months)
- Exercise Self-Efficacy(Up to 5 months)
- Physical Activity Level(Up to 5 months)
- Quality of Life: Functional Assessment of Cancer Therapy - General(Up to 5 months)
- Cancer-Related Fatigue: Functional Assessment of Chronic Illness Treatment - Fatigue, Fatigue subscale(Up to 5 months)
研究者
Stephen Wechsler
Principal Investigator
MGH Institute of Health Professions