Investigating the Feasibility and Acceptability of a Technology Delivered Physical Activity (PA) Intervention in Cancer: The IMPETUS Cancer Trial. (IMproving Physical Activity and Exercise With Technology Use in Cancer Survivors)
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in self-report PA
研究概览
简要总结
Participants will take part in a 12 week intervention, with at least one follow up at 24 +/- 2 weeks. Each participant will be provided with support, motivation and professional guidance about improving physical activity (PA) levels and will be given a commercially available PA tracker. The PA tracker will also include a smartphone or web-based application, where participants can upload their exercise performed each day, and keep up to date with their goals using their smartphone or by logging on to their computer. The aim of the study is to find out how useful and effective technology with support from a healthcare professional is in helping cancer survivors to become more physically active.
This study will measure objective PA levels of the participants at the start of the study and at the end. The acceptability of using this intervention to promote PA in cancer survivors will also be investigated.
详细描述
The overall aim is to determine the feasibility of a specific PA intervention, combining technology and professional input, in the cancer survivor population.
Study Design: A single arm feasibility trial of a PA intervention using technology and behavioural change theories as tools to achieve increased PA. Participants in the study will receive 12 weeks of the intervention. Outcomes will be measured at baseline, 12 weeks and 24 weeks (+/- 2 weeks) post baseline.
Patient recruitment: Participants will be recruited from those attending the St. James' Hospital oncology and haematology services. Study personnel will provide further information to these patients and assess them for eligibility. Informed consent will be gained from each participant.
Sample size: Proposed sample size is 60 (based on Sim and Lewis, 2012 recommendations) and allowing for 20% drop-out.
Intervention: This study will use the commercially available 'Fitbit' wearable technology with its paired smartphone application. PA goals will be prescribed by a qualified, chartered physiotherapist using the American Cancer Society (ACS) guidelines (Doyle et al 2006). Participants will use the Fitbit and its paired application for 12 weeks. The Fitbit device is a tool for motivation and monitoring of PA behaviours in this intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Agreement of the participant's cancer clinician that he/she can participate, including medical clearance to exercise
- •Aged >18 years
- •Completed chemotherapy or radiotherapy with curative intent within the preceding 3 years. Patients may have had chemotherapy or radiotherapy as the sole treatment for cancer, but not surgery alone. Patients who are still on adjuvant hormone therapy and/or adjuvant Her2-directed therapy are eligible (with physician agreement as above).
- •Able to understand English
- •Owns or has access to a device which is compatible with the Fitbit app i.e. smartphone, tablet or computer.
排除标准
- •Diagnosis of prostate cancer or upper gastro-intestinal cancer.
- •Chronic medical and orthopaedic conditions that would preclude exercise (e.g uncontrolled congestive heart failure or angina, recent MI within 6 months recent Pulmonary embolism within 3 months, breathing difficulties requiring oxygen use or hospitalization, osteoarthritis causing significant mobility issues).
- •Confirmed pregnancy
- •Dementia, cognitive impairment or psychiatric illness that would preclude ability to participate in study.
- •Incomplete haematological recovery after chemotherapy (WCC < 3, Hb < 10 or Platelets < 100).
- •Patients<18 years
- •Evidence of active cancer
研究组 & 干预措施
Intervention
Participants in this group will receive the intervention. They will receive a Fitbit activity tracker, and will also receive support and goal setting with a view to improving their daily physical activity.
干预措施: Intervention (Behavioral)
结局指标
主要结局
Change in self-report PA
时间窗: Baseline, 12 weeks and 24 weeks
A modified version of the Godin Leisure Time Exercise Questionnaire will be used.
Change in Physical Activity (Objective)
时间窗: Baseline, 12 weeks, 24 weeks
Accelerometry will be used to monitor 7 days of activity at Week 0, Week 12 (+/- 2 weeks) and 24 weeks (+/- 2 weeks) post baseline.
Change in body composition
时间窗: Baseline, 12 weeks and 24 weeks
This will be measured at baseline, 12 weeks (Intervention end) and 24 weeks post -baseline (Follow-up). This will be measured in percentage body fat.
Change in Body Weight (kg)
时间窗: Baseline,12 weeks and 24 weeks
This will be measured at baseline, 12 weeks (Intervention end) and 24 weeks post -baseline (Follow-up). This will be measured in kg.
Evaluation of recruitment capability and resulting sample characteristics
时间窗: 12 weeks
The number of participants we can recruit will be assessed. This will explore the potential sample size of the randomised control trial.
Use of resources and ability to manage and implement the study and intervention
时间窗: 12 weeks
The ability of study personnel and the availability of resources to implement the study will be assessed, demonstrated by successful implementation of the intervention
Preliminary evaluation of participant responses to intervention
时间窗: 12 weeks
The qualitative outcome in this feasibility study will invite participants' to provide feedback on the intervention's likelihood of being successful. Satisfaction with the technological intervention will be measured using a questionnaire given to participants at study end (12 weeks).
Change in quality of life
时间窗: Baseline,12 weeks and 24 weeks
The physical functional measure of the SF-36 (Brazier et al 1992) will be used to measure quality of life.
Change in waist circumference
时间窗: Baseline,12 weeks and 24 weeks
This will be measured at baseline, 12 weeks (Intervention end) and 24 weeks post -baseline (Follow-up). This will be measured in cm.
Change in aerobic capacity/endurance
时间窗: Baseline,12 weeks and 24 weeks
This will be measured using the 6MWT (Six minute walk test).
Data collection procedures and outcome measures
时间窗: 12 weeks
Procedures to collect data will be assessed for suitability and outcome measures used will be analysed for optimisation of measurement of clinical outcomes
Acceptability and suitability of the intervention and study procedures
时间窗: 12 weeks
Compliance with daily logging of exercise information and adherence to the intervention duration will be assessed
Change in BMI
时间窗: Baseline, 12 weeks and 24 weeks
This will be measured at baseline, 12 weeks (Intervention end) and 24 weeks post -baseline (Follow-up). This will be measured in kg/m\^2.
次要结局
未报告次要终点
研究者
Ciaran Haberlin
PhD Candidate, Chartered Physiotherapist
University of Dublin, Trinity College