The Colorectal Cancer Chemoprevention Acceleration and Improvement Platform (CRC-CHAMP) Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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). Follow-up Phase: 90 days. During the follow-up phase, participants will not be provided with ASA through the study nor will a specific recommendation be made to continue ASA. All participants will be contacted via telephone at the end of this period to determine the prevalence of continued use of ASA on their own. Total study commitment will be up to 194 days. After consent, participants complete a 90 day active treatment phase followed by a 90 day follow-up phase. The trial is expected to be completed within one year.

Official Title
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The Colorectal Cancer Chemoprevention Acceleration and Improvement Platform (CRC-CHAMP) Study

Conditions
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Colorectal Cancer, Colorectal Adenoma, Colorectal Adenomatous Polyp

Intervention / Treatment
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* Drug: acetylsalicylic acid delayed release tablets, 81mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: This is a single arm, open-label, prospective cohort pilot study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ASA 81mg<br>Acetylsalicylic acid delayed release tablets (81mg), single tablet taken once per day for 90 days. | Drug: acetylsalicylic acid delayed release tablets, 81mg<br>* acetylsalicylic acid delayed release tablets, 81mg taken once per day for 90 days<br>* Other names: Drug Identification Number 02237726;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uptake of ASA | Initiation of daily ASA 81mg (Percentage of participants who complete first 7 days of treatment). | 7 days | 
| Adherence to ASA over 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. | 90 days | 
| Adherence to at least 50 percent of total prescribed dose | 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. | 90 days | 
| Measurement of Adverse Events | Measurement of Adverse Events reported through interviews with research study nurse and participant report over 90 days (active treatment phase). | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors related to uptake and adherence to ASA | Behavioral, sociodemographic and health characteristics, measured using Health & Lifestyle Questionnaire and presented as percentages. | From enrollment to 90 days | 
| Factors related to uptake and adherence to ASA using measurement of health related quality of life | Behavioral, sociodemographic and health characteristics, measured using Short-Form 36 Health Survey Questionnaire to measure quality of life and presented as percentages. | At enrollment | 
| Factors related to uptake and adherence to ASA using measurement of self efficacy | Behavioral, sociodemographic and health characteristics, measured using National Institutes of Health (NIH) Self-efficacy questionnaire and presented as percentages. | At enrollment | 
| Factors related to uptake and adherence to ASA | Measurement of beliefs, attitudes and values about medicines using Beliefs about Medicines questionnaire and expressed as percentages. | At enrollment | 
| Factors related to uptake, in-study adherence and post-study maintenance using measurement of adherence barriers | Measurement of Adherence barriers using Adherence Barriers Questionnaire (at baseline and 3m follow-up) and expressed as percentages. | At enrollment through end of treatment at 90 days | 
| Factors related to uptake, in-study adherence and post-study maintenance using measurement of chemoprevention knowledge | Measurement of knowledge about chemoprevention using Chemoprevention Questionnaires (baseline and 3m follow-up) and expressed as percentages. | At enrollment through end of treatment at 90 days |