Cancer, Colorectal Cancer

Phase 2

Interventional Study

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

Sponsor

University of Calgary

Start Date

01/07/2022

Completion Date

01/03/2023

Sex

ALL

Enrollment

100

Ages From

50

Healthy Volunteers?

Yes

Contact

Robert Hilsden

Location

Forzani & MacPhail Colon Cancer Screening Centre, University of Calgary

Trial Details

Brief Summary

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.

Official Title

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

Detailed Description

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.

Selection Criteria

Eligibility Inclusion Criteria

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

Eligibility Exclusion Criteria

- Age = 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 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

ARMS & Interventions

PARTICIPANT GROUP ARMINTERVENTION TREATMENT
Other: ASA 81mg Acetylsalicylic acid delayed release tablets (81mg), single tablet taken once per day for 90 days.Drug: acetylsalicylic acid delayed release tablets, 81mg acetylsalicylic acid delayed release tablets, 81mg taken once per day for 90 days Other Names: ASPIRIN 81mg Drug Identification Number 02237726

Primary Outcome

MeasuresMeasure DescriptionMEASURE TIME FRAME
Uptake of ASAInitiation of daily ASA 81mg (Percentage of participants who complete first 7 days of treatment).7 days
Adherence to ASA over 90 daysNumber 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 dosePercentage 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 EventsMeasurement of Adverse Events reported through interviews with research study nurse and participant report over 90 days (active treatment phase).90 days

Secondary Outcome

MEASURESMEASURE DESCRIPTIONMEASURE TIME FRAME
Factors related to uptake and adherence to ASABehavioral, 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 lifeBehavioral, 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 efficacyBehavioral, 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 ASAMeasurement 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 barriersMeasurement 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 knowledgeMeasurement 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

Other Outcome

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