The Colorectal Cancer Chemoprevention Acceleration and Improvement Platform (CRC-CHAMP) Study
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Measurement of Adverse Events
研究概览
简要总结
The overall goal of this study is to develop a platform for both large-scale chemoprevention trials and real-world chemoprevention studies for colorectal cancer (CRC) prevention. The specific objectives of this proof of concept study are to:
- Evaluate the feasibility of a real-world chemoprevention agent (CPA) intervention (3-months of daily low-dose acetylsalicylic (ASA)) in participants at increased risk for CRC (one or more high-risk adenomas removed during colonoscopy) based on participant uptake, adherence (days taking CPA), and adverse events;
- Evaluate factors related to uptake and adherence of ASA using validated surveys and interviews.
详细描述
Study Design and Duration:
This is a single arm (non-randomized), open-label prospective cohort pilot study.
Screening Phase: up to 2 weeks Treatment Phase: 90 days Follow-up Phase: 90 days
Screening Phase: up to 14 days. Participants will consent to being enrolled in the study and to the use of ASA for a 90 day period. Regardless of agreement to use ASA for the entire study period, all participants will complete 6 baseline questionnaires.
Active Treatment Phase: up to 90 days. Participants that agree to the use of ASAs will be instructed to take daily ASAs for 90 days. Participants will be contacted by telephone at 1, 2, and 3 months to determine adverse events, adherence, and discontinuation. At 3 months participants will fill out a chemoprevention questionnaire and the Adherence Barriers Questionnaire (ABQ).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women aged 50-59 at time of signing the informed consent
- •Documented history of high-risk adenomatous polyps diagnosed within the previous 12 months:
- •At least one villous or tubulovillous polyp of any size
- •At least one polyp with high-grade dysplasia of any size
- •At least one adenomatous polyp ≥1 cm in size
- •Three or more tubular adenomas <1 cm in size
- •Not currently using ASA for another condition
排除标准
- •Age < 50 or >= 60
- •Known allergy or hypersensitivity to ASA, salicylates or non-steroidal anti- inflammatory drugs.
- •Daily alcohol use > 3 units
- •Regular use of aspirin or non-steroidal anti-inflammatory drugs (> 2 dose/week)
- •Current use of corticosteroid (any dose) orally
- •Current use of methotrexate, valproic acid or digoxin
- •Currently taking any anti-cancer drug
- •Current use of anti-platelet agents or anticoagulants
- •Anticipated surgical procedure in the next 3 months
- •Current or past history of gastrointestinal ulcers
- •History of gastrointestinal bleeding (except hemorrhoidal or minor outlet type bleeding)
- •Known cirrhosis or hepatic impairment (for example, total bilirubin >1.25 Upper Limit of Normal, International Normalized Ratio >1.25)
- •Known bleeding disorder (hemorrhagic diathesis)
- •History of asthma or nasal polyps
- •History of colorectal cancer
- •Platelet count < 120 or > 450 (within previous 3 months)
- •Renal insufficiency (eGFR < 90 within previous 3 months)
- •History of congestive heart failure or left ventricular ejection fraction < 50 percent
研究组 & 干预措施
ASA 81mg
Acetylsalicylic acid delayed release tablets (81mg), single tablet taken once per day for 90 days.
干预措施: acetylsalicylic acid delayed release tablets, 81mg (Drug)
结局指标
主要结局
Measurement of Adverse Events
时间窗: 90 days
Measurement of Adverse Events reported through interviews with research study nurse and participant report over 90 days (active treatment phase).
Uptake of ASA
时间窗: 7 days
Initiation of daily ASA 81mg (Percentage of participants who complete first 7 days of treatment).
Adherence to ASA over 90 days
时间窗: 90 days
Number of days taking ASA over a 90 day period. The time (number of days) on ASA for participants that discontinued use will be quantified.
Adherence to at least 50 percent of total prescribed dose
时间窗: 90 days
Percentage of participants who take at least 50 percent of total prescribed dose. Descriptive statistics will be utilized to characterize participants that adhered to ASA and participants who did not.
次要结局
- Factors related to uptake and adherence to ASA(At enrollment)
- Factors related to uptake and adherence to ASA using measurement of health related quality of life(At enrollment)
- Factors related to uptake and adherence to ASA using measurement of self efficacy(At enrollment)
- Factors related to uptake, in-study adherence and post-study maintenance using measurement of chemoprevention knowledge(At enrollment through end of treatment at 90 days)
- Factors related to uptake, in-study adherence and post-study maintenance using measurement of adherence barriers(At enrollment through end of treatment at 90 days)