The Acceptability and Feasibility of a Diet and Physical Activity Intervention to Prevent Recurrence in Colorectal Cancer Survivors: a Phase 2 Study
试验速览
- 阶段
- 2 期
- 入组人数
- 224
- 试验地点
- 4
- 主要终点
- Whether the PA and dietary intake targets are met at the end of intervention;
研究概览
简要总结
Background - Colorectal cancer (CRC) incidence is increasing at an alarming rate in Hong Kong. A recent report concluded physical activity (PA) protects against colon cancer and foods low in dietary fibre, red meat and processed meat cause CRC. Yet, the influence of lifestyle factors on cancer outcome (i.e. recurrence and survival rates) in CRC survivors is largely unknown.
Objectives & hypothesis - Our study aims to evaluate the acceptability of two behavioural interventions for CRC survivors intended to improve cancer outcome and designed to (1) increase PA levels and (2) reduce consumption of a Western diet.
The investigators hypothesize that the proposed interventions are (1) efficacious in changing the two targeted behaviours; and (2) acceptable to CRC survivors.
Settings and methods - Phase 2 feasibility trial. Two hundred and twenty-four CRC survivors within 12 months of completion of cancer treatment and without evidence of persistent/recurrent disease will be recruited from four public hospitals in Hong Kong after informed consent. Subjects will be randomized in a 2x2 factorial design for the two targeted behaviours prescribed over 12 months. Primary outcome measure is whether the target levels of PA and dietary intake could be met at the end of intervention. Secondary outcome measures include: (1) magnitude of changes in PA level and dietary intakes; (2) rates and determinants of compliance; (3) facilitators and barriers to behavioural change; (4) measurement of theoretical constructs underlying PA and dietary interventions; (5) possible health benefits and side effects (PA-associated injury and nutritional deficiency) arising from the interventions. Outcome will be assessed at baseline, 6 months into intervention and then at 0, 6 and 12 months post-intervention.
Impact - If proven feasible, our intervention programme would pave way for a large randomized controlled trial testing the effect of PA and diet on the treatment outcome of CRC.
详细描述
Background - Colorectal cancer (CRC) incidence is increasing at an alarming rate in Hong Kong. A recent World Cancer Research Fund (WCRF) report concluded physical activity (PA) protects against colon cancer and foods low in dietary fibre, red meat and processed meat cause CRC. Yet, the influence of lifestyle factors on cancer outcome (i.e. recurrence and survival rates) in CRC survivors is largely unknown. Our literature review showed a paucity of published studies on lifestyle intervention in CRC survivors; none had investigated the effect of such intervention on cancer outcomes.
With advances in treatment, CRC survivors live longer. Many of them are motivated to make lifestyle changes. However, our qualitative research has shown a huge service gap in the provision of appropriate PA and dietary advice to CRC survivors. Many patients were unaware of the link between PA and diet with CRC outcome but most demonstrated acceptance of lifestyle intervention. Yet, there is currently no scientifically-based evidence to allow firm recommendations to be made.
Objectives & hypothesis - Our study aims to evaluate the acceptability of two behavioural interventions for CRC survivors intended to improve cancer outcome and designed to (1) increase PA levels (to 60 minutes of moderate PA 5 days/week) and (2) reduce consumption of a Western diet (<5 servings of red/processed meat weekly and 2 servings of refined grain daily).
We hypothesize that the proposed interventions are (1) efficacious in changing the two targeted behaviours; and (2) acceptable to CRC survivors with compliance rates of about 80%.
Settings and methods - The study follows the Medical Research Council Framework for the design and evaluation of complex interventions. Phases 0 and 1 (funded by WCRF) have been completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 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
- •Histologically proven colorectal adenocarcinoma;
- •Within one year of completion of main cancer treatment
排除标准
- •Persistent/recurrent disease upon recruitment;
- •Current cancer treatment;
- •Hereditary CRC syndromes;
- •Known contraindication to PA;
- •Illiteracy;
- •Weekly red/processed meat < 5 servings and daily refined grains < 2 servings
- •Weekly MPA > 300 minutes
结局指标
主要结局
Whether the PA and dietary intake targets are met at the end of intervention;
时间窗: at the end of 12 months of intervention
Whether the PA and dietary intake targets are met at the end of intervention; i.e. 1. PA group: achieve PA targets or not 2. Dietary group: achieve dietary target or not 3. PA + dietary group: achieve both PA and dietary targets or not 4. Control group: achieve PA or dietary target or not
次要结局
- Magnitude of change in PA level using objective accelerometry(6, 12, 18 and 24 months after start of intervention (i.e. interim, 0, 6 and 12 months post-intervention))
- Magnitude of change in each component of dietary target using validated food frequency questionnaire (FFQ);(6, 12, 18 and 24 months after start of intervention (i.e. interim, 0, 6 and 12 months post-intervention))
- Facilitators and barriers to intervention(at the end of intervention)
- Measurement of theoretical constructs underlying PA and dietary interventions(6, 12, 18 and 24 months after start of intervention (i.e. interim, 0, 6 and 12 months post-intervention))
- Other possible health benefits arising from the intervention(at 12 and 24 months after start of intervention (i.e. at 0 and 12 months post-intervention))
- Rate and determinants of compliance with intervention;(at the end of 12 months of intervention)
- Possible side effects arising from the intervention(at 6, 12, 18 and 24 months after start of intervention (i.e. interim, 0, 6 and 12 months post-intervention))
研究者
Dr. Judy Wai-Chu Ho
Consultant, Honorary Clinical Associate Professor
The University of Hong Kong