Survivor Choices for Eating and Drinking - Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Adherence
研究概览
简要总结
Epidemiologic data suggest that a Western dietary pattern after diagnosis of colorectal cancer increases risk of disease recurrence and death. High intake of red and processed meat, dairy, refined grains, and sweets/desserts characterize a 'Western dietary pattern'. This study aims to translate the epidemiologic findings into a patient-centered, web-based dietary intervention with text messaging to inform and modify users' dietary choices. The investigators' specific aims are to: 1) Develop a web-based dietary intervention with text messaging for colorectal cancer survivors; and 2) Conduct a 12-week pilot randomized controlled trial to determine the acceptability and feasibility of the dietary intervention among 50 colorectal cancer survivors. All participants will receive standard of care print materials regarding diet following a colorectal cancer diagnosis. Participants in the intervention group will also receive access to a web-based dietary intervention with text messaging for 12 weeks. This study will generate preliminary data on the effect of the intervention on dietary choices among colorectal cancer survivors for future studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
盲法说明
Statistician who analyzes the data will be masked to intervention/control status.
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
- •diagnosed with colon or rectal adenocarcinoma
- •completed standard cytotoxic chemotherapy prior to enrollment, if medically indicated
- •considered disease-free or have stable disease at baseline
- •able to speak and read English
- •access to a mobile phone with Internet and text messaging capabilities
- •able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the Internet
排除标准
- •Individuals who are already meeting four or more of the six target dietary behaviors will be excluded:
- •≥5 servings/day of fruits & vegetables
- •≥3 servings/day of whole grains
- •≥2 servings/week of fish
- •no processed meat
- •no sugar-sweetened beverages
- •≤1 alcoholic drink/d for women and ≤2 alcoholic drinks/d for men.
研究组 & 干预措施
Intervention
Participants will be given print material on diet for cancer survivors and access to a web-based dietary intervention with text messaging for 12 weeks.
干预措施: Website and text messages (Behavioral)
Control
Participants randomized to the control arm will receive print materials on diet for cancer survivors. After completion of their 12-week follow-up assessments, control participants will be given access to the web-based dietary intervention with text messaging for 12 weeks.
结局指标
主要结局
Adherence
时间窗: 12-weeks
Frequency of logging on to website and responding to text messages
次要结局
- Dietary change assessed via diet records(12-weeks)
- Quality-of-life (EORTC C30)(12-weeks)
- Colorectal cancer-specific quality-of-life (EORTC C30 CR29)(12-weeks)
- Change in body mass index(12-weeks)
- Change in fasting blood lipids(12-weeks)
- Change in fasting glucose(12-weeks)
- Change in waist circumference(12-weeks)