Healthy Eating and Active Lifestyle After Bowel Cancer - HEAL ABC Workbook: Development and Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 6
- 主要终点
- Recruitment rates
研究概览
简要总结
Trial Design:
This is a feasibility randomised controlled trial.
Aim:
The study aims to test the Healthy Eating and Active Lifestyle After Bowel Cancer - HEAL ABC intervention and HEAL ABC resources for feasibility and will inform a future definitive randomised controlled trial (RCT).
Objectives:
- Is it practical to run HEAL ABC study as a definitive randomised controlled trial?
- Adherence to intervention, motivations, barriers and facilitators of CRC survivors to follow HEAL ABC.
Study Population:
Colorectal cancer survivors who completed surgery and/or active treatment.
Intervention:
The intervention group will use HEAL ABC resource with supportive telephone calls every two weeks during the intervention period and once a month during the follow up period.
Control:
Participants follow standard care recommendations.
Timing and duration:
3 months intervention with 6 months follow up period
详细描述
Background:
Investigators were awarded a grant to develop a lifestyle resource called HEAL ABC - the Healthy Eating and Active Lifestyle After Bowel Cancer. This resource is based on prevention guidelines of World Cancer Research Fund and American Institute of Cancer Research. The resource was developed in cooperation with a psychologist and so has incorporated behaviour change theory. Investigators organised focused groups with patients and healthcare professionals, and amended the resource based on their feedback.
In this study, investigators will test the HEAL ABC resource and the HEAL ABC intervention for its practicality before further studies will be conducted.
HEAL ABC consists of 10 booklets and supportive materials. The order for using the booklets is not specified. Participants will be assigned their first booklet based on the one they perceive to be the easiest for setting an incremental goal and achieving it. This means the participant starts with the booklet of the highest self-efficacy and after the participant achieves successful behaviour change, he or she can move more confidently to the next booklet. During the follow up period, participants will use the follow up booklet which helps them to continue with changes they have made and encourage them to set a new goals.
Participants in the intervention group will receive a supportive telephone call every two weeks during the intervention period (three months) and once a month during the six months follow up.
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
- •Adults, age ≥18
- •Minimum 12 weeks post-surgery and/or active treatment
- •Completed all active anti-cancer treatments, including surgery, radiotherapy or chemotherapy
- •Body mass index ≥20 kg/m2 and no previous unintentional weight loss ≥5% of body weight in the previous six months.
- •Identified as living an unhealthy lifestyle based on current recommendations - follow less than four of the WCRF/AICR recommendations on eligibility questionnaire
- •Ability to work with computer, smart phone or tablet.
- •Able to give informed consent.
排除标准
- •Receiving treatment for malignancy.
- •Secondary malignancy.
- •Having short bowel syndrome, Crohn's disease, ulcerative colitis, diverticulitis or jejunostomy (due to requirement for a very specific diet).
- •Previous stroke, congested cardiac failure or oedema.
- •Hepatic or renal failure
- •Less than 12 weeks post-surgery or active treatment.
- •Meeting the requirements of a healthy lifestyle (follow four or more of the WCRF/AICR recommendations).
- •Being on any therapeutic diets, multiple food intolerances or allergies.
- •Unplanned weight loss of ≥10% in the previous 3-6 months.
- •Cannot read or communicate in English (due to resource constraints of this PhD study).
结局指标
主要结局
Recruitment rates
时间窗: 6 months
Cumulative recruitment against target rate each month.
Retention rates
时间窗: 6 months
Calculated as the number of participants who completed the study divided by the number of participants randomised.
Acceptability of the intervention
时间窗: 6 months
This will be qualitatively assessed through in depth interviews with a subset of the trial participants.
Data completion rates
时间窗: 6 months
Completeness of collected data will be assessed for all time points (% missing).
Adherence to intervention
时间窗: 6 months
Assessed as adherence to WCRF/AICR guidelines by using a scoring system for nutrition and physical activity guideline adherence developed by McCullough and colleagues. Number of goals set and number of changes implemented in everyday life during the 6 months follow up.
次要结局
- Change in waist to hip ratio(Baseline, 3 months and 6 months)
- Change in body composition (BIA)(Baseline, 3 months and 6 months)
- Change in body composition (CT scan)(Baseline, 3 months and 6 months)
- Change in BMI(Baseline, 3 months and 6 months)
- Change in physical activity(Baseline, 3 months and 6 months)
- Change in step count(Baseline, 3 months and 6 months)
- Contact with primary and secondary healthcare services(6 months)
- Mortality(6 months)
- Change in Quality of life(Baseline, 3 months and 6 months)
- Change in participants' experience, motivation, barriers and facilitators to use HEAL ABC resources and follow the intervention(3 months and 6 months)
- Change in behaviour(Baseline, 3 months and 6 months)
- Change in dietary intake(Baseline, 3 months and 6 months)
- Patients' socio-demographic characteristics(Baseline)
- Morbidity(6 months)
研究者
Jana Sremanakova
PhD student, Nutrition Research Assistant
University of Manchester