A Flexible Individualized ExeRcise Programme for Cancer Patients During ChEmotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Feasibility: Attendance rates
研究概览
简要总结
The primary aim of this study is to measure the feasibility of delivering a co-designed exercise programme for patients with cancer receiving chemotherapy treatment.
详细描述
Exercise has been shown to play an important role in reducing many of the side effects associated with chemotherapy treatment. Exercise can help to improve symptoms of fatigue, nausea, muscle weakness, and pain, which in turn can help to improve patients overall quality of life and wellbeing. In addition to this, exercising during chemotherapy can also help to maintain physical fitness and preserve muscle mass, which has been shown to significantly reduce treatment toxicities. Despite these benefits of exercise, performing regular physical activity during chemotherapy poses significant challenges. Patients are faced with a number of physical and logistical barriers during chemotherapy which makes it difficult to engage in regular exercise. In addition to this, exercise programs that are being designed lack flexibility and individualization, and don't account for the unpredictable nature of chemotherapy treatment. It is, therefore, no surprise that patients struggle to meet the exercise recommendations during chemotherapy, and highlights the need for careful consideration when prescribing exercise during this time. In preparation for this study, the research team held a number of workshops which included a mixture of patients and healthcare professionals with the aim of co-designing an exercise intervention for patients during chemotherapy. Including public and patient involvement (PPI) in the design process will help to ensure that the exercise program that is developed is pragmatic and, most importantly, patient-centred.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Not indicated for this feasibility study.
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
- •Histological confirmed diagnosis of stage I to IIIc breast, ovarian or colorectal cancer.
- •Scheduled to receive chemotherapy ± immunotherapy with curative intent.
- •Medical clearance from oncologist to partake in regular exercise in accordance with American College of Sports Medicine (ACSM) preparticipation screening algorithm.
- •Ability to provide written informed consent.
排除标准
- •Advanced/metastatic disease.
- •Scheduled to receive concurrent chemoradiotherapy.
- •Scheduled to receive high-dose chemotherapy during hospital admission.
研究组 & 干预措施
Pedometer programme
Participants randomized to the pedometer programme will receive individualised advice about exercising during chemotherapy and will also receive a pedometer to encourage daily activity. Participant in both groups will receive a personal exercise consultation to identify their individual needs and understand their exercise preferences.
干预措施: Health Behaviour Change (Pedometer) (Behavioral)
FIERCE Programme
The FIERCE programme will consist of an aerobic and resistance exercise program delivered for the duration of chemotherapy.
Exercise will be prescribed with the aim of achieving an overall exercise volume over the course of a chemotherapy cycle. The total volume of exercise prescribed in each cycle will be targeted towards achieving the exercise guidelines for cancer survivors which recommends 90 minutes of aerobic activity per week, in addition to resistance exercise at least two times per week.
Exercise intensity will be autoregulated by participants based on how they are feeling on a given day. Participants will be given a choice of exercising at low, moderate, or higher intensity based on how BORG rating of perceived exertion (RPE) scale.
Weekly check ins will be made to each participant over the phone by an exercise physiologist for goal setting. Participants will also be given a pedometer to monitor daily physical activity levels.
干预措施: Exercise (Behavioral)
FIERCE Programme
The FIERCE programme will consist of an aerobic and resistance exercise program delivered for the duration of chemotherapy.
Exercise will be prescribed with the aim of achieving an overall exercise volume over the course of a chemotherapy cycle. The total volume of exercise prescribed in each cycle will be targeted towards achieving the exercise guidelines for cancer survivors which recommends 90 minutes of aerobic activity per week, in addition to resistance exercise at least two times per week.
Exercise intensity will be autoregulated by participants based on how they are feeling on a given day. Participants will be given a choice of exercising at low, moderate, or higher intensity based on how BORG rating of perceived exertion (RPE) scale.
Weekly check ins will be made to each participant over the phone by an exercise physiologist for goal setting. Participants will also be given a pedometer to monitor daily physical activity levels.
干预措施: Health Behaviour Change (Pedometer) (Behavioral)
结局指标
主要结局
Feasibility: Attendance rates
时间窗: Through study completion, on average 6 months
Exercise attendance will be calculated as the total number of exercise classes attended, either in-person or online, regardless of how much exercise was performed.
Feasibility: Retention Rates
时间窗: Through study completion, on average 6 months
Retention rates will be calculated as the number of participants who remained in the study at the end of the intervention as a proportion of the total number of participants recruited.
Feasibility: Adherence rates
时间窗: Through study completion, on average 6 months
Exercise adherence will be used to measure the degree to which the participants performed the exercise at the desired intensity and time. After each exercise session, participants will be asked to rate their perceived exertion that they actually achieved during the exercise class. This RPE will be compared to the prespecified intensity that was chosen by the participant on the BORG scale at the beginning of the class to determine adherence to the intensity of the exercise session. Adherence to exercise time will be calculated by recording the total number of minutes spent exercising in each class compared to the total duration of the class.
Feasibility: Recruitment rates
时间窗: At enrolement
Recruitment rates will be calculated as the percentage of eligible participants who agreed to take part in the study. Recruitment rates will be calculated for each recruitment timepoint to determine which timepoint yields optimal recruitment. Reasons for declining recruitment will also be recorded.
Feasibility: Reason for drop0out
时间窗: Through study completion, on average 6 months
Reasons for dropout will be recorded descriptively
次要结局
- Waist Circumference(Pre and Post intervention, on average 6 months)
- Muscular Strength(Pre and Post intervention, on average 6 months)
- Body Mass Index(Pre and Post intervention, on average 6 months)
- Bioimpedance Analysis(Pre and Post intervention, on average 6 months)
- Cardiorespiratory Fitness(Pre and post intervention (on average 6 months))
- Mid-arm circumference(Pre and Post intervention, on average 6 months)
- Health Related Quality of Life(Pre and Post intervention, on average 6 months)
- Fatigue(Pre and Post intervention, on average 6 months)
研究者
Emer Guinan
Associate Professor
University of Dublin, Trinity College