Study on Fatigue in Colorectal Cancer Survivors, a Lifestyle Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 161
- 试验地点
- 2
- 主要终点
- Change in cancer-related fatigue
研究概览
简要总结
The SoFiT study is a randomized controlled trial examining the effects of a behaviour change guided lifestyle intervention on increasing adherence to the World Cancer Research Fund cancer prevention guidelines, compared to the wait-list usual care group, on diminishing cancer-related fatigue in colorectal cancer survivors.
详细描述
The SoFiT study is a randomized controlled trial examining the effects of a behaviour change guided lifestyle intervention on increasing adherence to the World Cancer Research Fund (WCRF) cancer prevention guidelines, compared to the wait-list usual care group, on diminishing cancer-related fatigue in colorectal cancer survivors.
Colorectal cancer survivors who completed treatment six months to five years ago and who suffer from cancer-related fatigue, are randomized into two parallel groups: an intervention group or the wait-list usual care group. The intervention group follows a six-month personalized lifestyle program, which is guided by behaviour change techniques, to increase adherence to the World Cancer Research Fund cancer prevention guidelines on healthy nutrition, physical activity and healthy weight. Participants are guided by a lifestyle coach specialized in behaviour change. The wait-list usual care group receives a lifestyle program after the intervention period of six months: this includes two personalized behavioural coaching sessions and any material that the intervention group also received.
Both groups participate in measurements at baseline, three months, at the end of the intervention (six months) and at follow-up (twelve months). The follow-up timepoint is included to study long-term behavioural lifestyle change. The primary outcome is the change in cancer-related fatigue, as measured by the FACIT-Fatigue questionnaire, between the intervention and wait-list usual care group from baseline till six months.
Secondary outcomes include cancer-related fatigue (at other timepoints), skeletal muscle fat infiltration and cross-sectional area, gut microbiota composition, health-related quality of life, physical performance, sleep quality and duration, depression and anxiety, behavioural determinants and adherence to the WCRF guidelines by assessing habitual dietary intake, physical activity level, height, weight, waist circumference and BMI. Other outcomes of interest include, blood pressure, chrono-nutrition, colorectal cancer related complaints, hemoglobin blood levels, self-reported weight (at three months) and cost-effectiveness evaluation. Moreover, the following data will be collected to characterize the population: sociodemographic information (age, sex, marital status, education, smoking) and clinical parameters (time since diagnosis, current and received treatment, comorbidities, medicine and supplement use).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The nature of the intervention does not allow for blinding of the participants or researchers. The baseline measurements are however blinded as both the participant and the researchers do not yet know in which group the participant will be classified. Randomization is done directly after the baseline measurements. After data collection, the database will be coded by an independent researcher to ensure that data analysis is conducted in a blinded way.
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
- •Aged 18 or above.
- •Completed curative stage I-III colorectal cancer treatment in the previous 6 months to 5 years.
- •Live on a reasonable distance from the research center at the Wageningen University & Research (WUR) (i.e. maximum of ± 1 hour away).
- •Classified as suffering from CRF through the Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale questionnaire with cut-off score below 34 indicating fatigue.
- •Willingness to be randomized into either the intervention or wait-list control group.
- •Willing and able to follow the lifestyle intervention.
- •Able to understand and provide informed consent in Dutch.
排除标准
- •Planning to participate or participating in another medical research that could possibly interfere with the study results.
- •Excessive alcohol consumption (i.e. more than 4 glasses per day).
- •Chronic drug use and unwillingly to stop using drugs.
- •Unable/unwilling to comply with the intervention (e.g. through dementia, Alzheimer or mental illness)
结局指标
主要结局
Change in cancer-related fatigue
时间窗: Baseline till six months
Cancer-related fatigue is assessed with the FACIT-Fatigue Scale, a 13 item questionnaire with scores ranging from 0-52. A score below 34 indicates fatigue. The minimal clinically important difference is reported to be 3.0 for this scale.
次要结局
- Physical performance (3-minute step test)(Baseline and six months)
- Skeletal muscle fat infiltration and muscle circumference(Baseline and six months)
- Anxiety(Baseline and six months)
- Sleep quality and duration (Pittsburgh Sleep Quality Index)(Baseline, six months and 12 months)
- Health-related quality of life(Baseline and six months)
- Physical performance (strength: hand dynamometer)(Baseline and six months)
- Depression(Baseline and six months)
- Behavioural determinants(Baseline, three months, six months and twelve months.)
- Anthropometric measurements (Height)(Baseline and six months)
- Anthropometric measurements (Waist circumference)(Baseline and six months)
- Cancer-related fatigue(Twelve months)
- Gut microbiota composition(Baseline and six months)
- Physical performance (5 times sit-to-stand test)(Baseline and six months)
- Physical performance (tandem test)(Baseline and six months)
- Physical performance (chair sit-and-reach test)(Baseline and six months)
- Sleep quality and duration (Consensus sleep diary morning)(Baseline and six months)
- Cost-effectiveness evaluation(Baseline, three months and six months)
- Habitual dietary intake (Food Frequency Questionnaire)(Baseline, six months and twelve months)
- Habitual dietary intake (Eetscore)(Baseline, three months, six months and twelve months)
- Physical activity level (Accelerometer)(Baseline and six months)
- Physical activity level (Short QUestionnaire to ASsess Health-enhancing physical activity)(Baseline, three months, six months and twelve months)
- Anthropometric measurements (Weight)(Baseline, three months (self-reported) and six months)
研究者
Renate Winkels
Dr.Ir.
Wageningen University