IMpact of PRehabilitation in Oncology Via Exercise - Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Feasibility of the exercise intervention (assessed via exercise logs)
研究概览
简要总结
The purpose of this study is to determine whether patients are able to participate in a so called prehabilitation program (prior to the beginning of cancer treatment) which includes (1) a supervised and home-based exercise program plus one educational session or (2) just home-based exercise plus one educational session or (3) just one educational session.
Breast cancer surgery may have potential for several side effects, including functional (e.g. flexibility in the affected arm, lymphedema [swelling that generally occurs in the arms or legs that occurs as a result of the removal of or damage to lymph nodes as a part of cancer treatment], shoulder pain) and psychosocial (e.g. reduced quality of life, increased fatigue) aspects.
Evidence shows that exercise is considered to be an effective treatment approach in breast cancer patients during and after treatment with regard to the above mentioned side-effects. Also, prehabilitative exercise in colon and lung cancer patients was shown as feasible and effective. However, no experience exits with regard to prehabilitation exercise in breast cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Unilateral or bilateral primary carcinoma of the breast, confirmed histologically by core biopsy
- •Not metastatic (stage <4)
- •Females and males ≥18 years of age
- •Fluent in written and spoken English
- •Must be able to provide and understand informed consent
- •Must have an ECOG PS of ≤ 2
- •Scheduled for lump- or mastectomy at Penn State Cancer Institute
- •≥ 2 weeks till primary treatment
- •Primary attending surgeon approval
排除标准
- •Receiving neoadjuvant chemotherapy, radiotherapy or hormone therapy
- •Not fluent in written and spoken English
- •Evidence in the medical record of an absolute contraindication (e.g. Heart insufficiency > NYHA III or uncertain arrhythmia; uncontrolled hypertension; severe renal dysfunction (GFR < 30%, Creatinine> 3mg/dl; insufficient hematological capacity like either hemoglobin value below 8 g/dl or thrombocytes below 30.000/µL; reduced standing or walking ability) for exercise
- •Pregnant women
- •Engaging in systematic intense exercise training (at least 1h twice per week)
结局指标
主要结局
Feasibility of the exercise intervention (assessed via exercise logs)
时间窗: Through study intervention, an average of 3 weeks
The exercise intervention will be considered feasible if 50% of included patients actually do at least half of the exercise sessions prescribed for 2 weeks or more.
Acceptability of the exercise intervention (assessed via patient flow diagram)
时间窗: During Recruitment till first intervention is delivered (with one week after enrolment)
The intervention will be considered acceptable if more than 50% of the patients randomized to the control group agree to receive at least the first exercise session.
Safety of the exercise intervention (assessed by standardized questionnaire)
时间窗: Through study intervention, an average of 3 weeks
Within the questionnaire we will assess whether musculoskeletal occur (yes/no; ongoing; location; severity (mild-life threatening); daily activities affected). The intervention will be considered as safe if less than 25% of included patients report mild musculoskeletal impairments and less than 5% experienced musculoskeletal injuries (defined as symptoms lasting a week or longer and or requiring the attention of a medical professional).
次要结局
- Breast cancer-related symptoms and quality of Life(Through study intervention, an average of 3 weeks; 6 weeks after surgery; and after the end of primary treatment, an average of 6 month after surgery)
- Sleep(Through study intervention, an average of 3 weeks; 6 weeks after surgery; and after the end of primary treatment, an average of 6 month after surgery)
- Shoulder Problems(Through study intervention, an average of 3 weeks; 6 weeks after surgery; and after the end of primary treatment, an average of 6 month after surgery)
- Health-Related Quality of Life: EORTC QLQ-C30, version 3.0(Through study intervention, an average of 3 weeks; 6 weeks after surgery; and after the end of primary treatment, an average of 6 month after surgery)
- Fatigue(Through study intervention, an average of 3 weeks; 6 weeks after surgery; and after the end of primary treatment, an average of 6 month after surgery)
- Depression(Through study intervention, an average of 3 weeks; 6 weeks after surgery; and after the end of primary treatment, an average of 6 month after surgery)
- Physical activity behavior(Through study intervention, an average of 3 weeks; 6 weeks after surgery; and after the end of primary treatment, an average of 6 month after surgery)
- Symptoms(Weekly from baseline to 6 weeks after Surgery)
研究者
Kathryn Schmitz
Professor, Public Health Sciences
Milton S. Hershey Medical Center