The Feasibility of a Multi-phasic Exercise-based Intervention Utilising the Health Action Process Approach, Dyadic Coping and Wearable Technology in Women Before and After Surgery for Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Number of participants recruited during the 36 week recruitment period
研究概览
简要总结
Background and study aims:
Nine out of ten women experience some negative effects due to their disease or its treatment such as anxiety, depression, weight gain and low quality of life. Research shows that exercise may help women overcome some of these effects. The investigators also know that most women become physically inactive after cancer treatment. Therefore, The investigators feel it is important that women get into a routine of doing regular exercise before they start their cancer treatment, this is called prehabilitation. The investigators believe that prehabilitation might help to build confidence and help women to continue exercising after their cancer treatment.
The investigators are doing this study to find out if a remote (NHS Attend Anywhere), multimodal (aerobic, resistance and targeted exercise), behavioural change (Health Action Process Approach (HAPA), dyadic coping (the collective effort to dealing with the stress of breast cancer diagnosis and treatment), and wearable technology), multiphasic (pre- and post-surgery) intervention is feasible in the short time frame between diagnosis of breast cancer and surgery (less than 31 days). The investigators would also like to find out whether it is feasible for women to begin an exercise rehabilitation programme two weeks after their operation. If successful, the results will potentially enable us in the future to tailor the support gievn to women to help them prepare and recover from breast cancer treatment.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Females aged 18 years or older
- •Scheduled to undergo elective surgery for biopsy-proven breast cancer (lumpectomy or mastectomy) for resection and/or reconstruction purposes
- •Patients scheduled after diagnosis of invasive breast cancer and ductal carcinoma in situ (DCIS)
- •Able to communicate in English and able to provide and understand informed consent
- •Willing to participate in supervised and home-based exercise
- •Have the approval of operating surgeon
- •At least 2 weeks until surgery
- •Access to a computer or smart device connected to the world wide web
排除标准
- •Evidence in the medical record of an absolute contraindication for exercise [e.g., Heart insufficiency > New York Heart Association (NYHA) III or uncertain arrhythmia; uncontrolled hypertension; severe renal dysfunction (Estimated Glomerular Filtration Rate (eGFR) < 30%, Creatinine> 3 mg/dl); insufficient haematological capacity like either haemoglobin value below 8 g/dl or thrombocytes below 30.000/µL; reduced standing or walking ability].
- •Metastatic breast cancer
- •Current smokers
- •Not fluent in written and spoken English
- •Engaging in regular exercise (at least 150 min per week of moderate exercise or at least 75 min per week of vigorous exercise, or an equivalent combination of moderate and vigorous exercise). This criterion will be assessed via the Physical Activity Vital Signs (PAVS) questionnaire, which asks the following two questions: 1) "Please describe your level of physical activity, [first by] minutes per day, [followed by] number of days each week", and 2) "At what intensity (how hard): light (like a casual walk), moderate (like a brisk walk), or vigorous (like a jog/run)?" (Ball et al., 2016). The questionnaire is scored by multiplying the days by minutes of physical activity to create an estimate of minutes per week of at least moderate-to-vigorous physical activity.
- •Symptoms of long-covid/post covid syndrome
结局指标
主要结局
Number of participants recruited during the 36 week recruitment period
时间窗: Assessed immediately after the 36 week recruitment period
The investigators aim to recruit 34 participants in 36 weeks, equating to a recruitment rate of approximately one patient each week.
Number of participants retained during the interventional period
时间窗: Assessed 2 weeks post-surgery (T1), and immediately after the 6-weeks of postoperative exercise (T2)
The investigators aim to retain 75% (n = 25) of our sample throughout the interventional period, which includes a perioperative (\~4 weeks) and post operative multimodal intervention (\~6 weeks)
Number of participants who completed at least 70% of supervised sessions and not lower than 60% for of unsupervised sessions, spanning both the pre- and postoperative periods.
时间窗: Assessed 2 weeks post-surgery (T1), and immediately after the 6-weeks of postoperative exercise (T2)
Adherence to remotely supervised exercise sessions (spanning both pre- and postoperative phases) is at least 70%, and not lower than 60% for adherence to unsupervised exercise sessions.
Number of participants who had an average daily wear time is ≥10 hours per day and ≥4 days per week
时间窗: Assessed 2 weeks post-surgery (T1), and immediately after the 6-weeks of postoperative exercise (T2)
Feasibility of using wearable technology in patients with cancer will be supported if daily wear time is ≥10 hours per day and ≥4 days per week
Number of participants who experienced adverse events during exercise testing, supervised exercise, or unsupervised exercise.
时间窗: Assessed 2 weeks post-surgery (T1), immediately after the 6-weeks of postoperative exercise (T2), and immediately after the 3 months follow up post exercise period (T3)
Safety of physical activity will be assessed by recording the number of adverse events occurring during exercise testing, remotely supervised exercise training, and unsupervised exercise training. Adverse events will be recorded on a standardised data collection form
次要结局
- Change from baseline in Health Action Process Approach (HAPA) after preoperative intervention and surgery, 6 weeks postoperative intervention, and after a three month observational period(Assessed at baseline (T0), within 1 week of completing the 2 weeks post-surgery (T1), within 1 week of completing the 6-weeks of postoperative exercise (T2), and within 1 week of completing the 3-months follow-up post-exercise (T3))
- Change from baseline in European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer-Specific Quality of Life (QLQ-BR23) after preoperative intervention and surgery, 6 weeks postoperative intervention, and a 3 month observation(Assessed at baseline (T0), within 1 week of completing the 2 weeks post-surgery (T1), within 1 week of completing the 6-weeks of postoperative exercise (T2), and within 1 week of completing the 3-months follow-up post-exercise (T3))
- Change from baseline in Dyadic coping after preoperative intervention and surgery, 6 weeks postoperative intervention, and after a three month observational period(Assessed at baseline (T0), within 1 week of completing the 2 weeks post-surgery (T1), within 1 week of completing the 6-weeks of postoperative exercise (T2), and within 1 week of completing the 3-months follow-up post-exercise (T3))
- Change from baseline in European Organization for Research and Treatment of Cancer (EORTC) after preoperative intervention and surgery, 6 weeks postoperative intervention, and after a three month observational period(Assessed at baseline (T0), within 1 week of completing the 2 weeks post-surgery (T1), within 1 week of completing the 6-weeks of postoperative exercise (T2), and within 1 week of completing the 3-months follow-up post-exercise (T3))
- Change from baseline in WHO Disability Assessment Schedule V.2.0 after preoperative intervention and surgery, 6 weeks postoperative intervention, and after a three month observational period(Assessed at baseline (T0), within 1 week of completing the 2 weeks post-surgery (T1), within 1 week of completing the 6-weeks of postoperative exercise (T2), and within 1 week of completing the 3-months follow-up post-exercise (T3))
- Change from baseline in Shoulder pain and disability index (SPADI) after preoperative intervention and surgery, 6 weeks postoperative intervention, and after a three month observational period(Assessed at baseline (T0), within 1 week of completing the 2 weeks post-surgery (T1), within 1 week of completing the 6-weeks of postoperative exercise (T2), and within 1 week of completing the 3-months follow-up post-exercise (T3))
- Change from baseline in Musculoskeletal Health Questionnaire (MSK-HQ) Schedule V.2.0 instrument after preoperative intervention and surgery, 6 weeks postoperative intervention, and after a three month observational period(Assessed at baseline (T0), within 1 week of completing the 2 weeks post-surgery (T1), within 1 week of completing the 6-weeks of postoperative exercise (T2), and within 1 week of completing the 3-months follow-up post-exercise (T3))
- Change from baseline in Habitual Physical Activity (active minutes) after preoperative intervention and surgery, 6 weeks postoperative intervention, and after a three month observational period(Assessed at baseline (T0), within 1 week of completing the 2 weeks post-surgery (T1), within 1 week of completing the 6-weeks of postoperative exercise (T2), and within 1 week of completing the 3-months follow-up post-exercise (T3))
- Change from baseline in 4 day food diary after preoperative intervention and surgery, 6 weeks postoperative intervention, and after a three month observational period(Assessed at baseline (T0), within 1 week of completing the 2 weeks post-surgery (T1), within 1 week of completing the 6-weeks of postoperative exercise (T2), and within 1 week of completing the 3-months follow-up post-exercise (T3))
- Number of participants who experienced treatment-related adverse events (AEs)(Assessed 2 weeks post-surgery (T1), immediately after the 6-weeks of postoperative exercise (T2), and immediately after the 3 months follow up post exercise period (T3))
- Change from baseline in BREAST-Q-Satisfaction after preoperative intervention and surgery, 6 weeks postoperative intervention, and after a three month observational period(Assessed at baseline (T0), within 1 week of completing the 2 weeks post-surgery (T1), within 1 week of completing the 6-weeks of postoperative exercise (T2), and within 1 week of completing the 3-months follow-up post-exercise (T3))
- Change from baseline in 30 second chair to stand (30CST) after preoperative intervention and surgery, 6 weeks postoperative intervention, and after a three month observational period(Assessed at baseline (T0), within 1 week of completing the 2 weeks post-surgery (T1), within 1 week of completing the 6-weeks of postoperative exercise (T2), and within 1 week of completing the 3-months follow-up post-exercise (T3))
- Change from baseline in Hand Grip dynamometry after preoperative intervention and surgery, 6 weeks postoperative intervention, and after a three month observational period(Assessed at baseline (T0), within 1 week of completing the 2 weeks post-surgery (T1), within 1 week of completing the 6-weeks of postoperative exercise (T2), and within 1 week of completing the 3-months follow-up post-exercise (T3))
- Change from baseline in Shoulder range of motion (RoM) after preoperative intervention and surgery, 6 weeks postoperative intervention, and after a three month observational period(Assessed at baseline (T0), within 1 week of completing the 2 weeks post-surgery (T1), within 1 week of completing the 6-weeks of postoperative exercise (T2), and within 1 week of completing the 3-months follow-up post-exercise (T3))
- Change from baseline in 6 minute walk test (6MWT) after preoperative intervention and surgery, 6 weeks postoperative intervention, and after a three month observational period(Assessed at baseline (T0), within 1 week of completing the 2 weeks post-surgery (T1), within 1 week of completing the 6-weeks of postoperative exercise (T2), and within 1 week of completing the 3-months follow-up post-exercise (T3))
- Change from baseline in Lymphedema after preoperative intervention and surgery, 6 weeks postoperative intervention, and after a three month observational period(Assessed at baseline (T0), within 1 week of completing the 2 weeks post-surgery (T1), within 1 week of completing the 6-weeks of postoperative exercise (T2), and within 1 week of completing the 3-months follow-up post-exercise (T3))
- Focus groups(Assessed immediately after the 6-weeks of postoperative exercise (T2), and immediately after the 3 months follow up post exercise period (T3))
- Chemotherapy completion rate(Assessed immediately after the 6-weeks of postoperative exercise (T2), and immediately after the 3 months follow up post exercise period (T3))