Back to resultsThe Colorectal Cancer Chemoprevention Acceleration and Improvement Platform (CRC-CHAMP) Study
Primary Purpose
Colorectal Cancer, Colorectal Adenoma, Colorectal Adenomatous Polyp
Status
Not yet recruiting
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
acetylsalicylic acid delayed release tablets, 81mg
Sponsored by
About this trial
This is an interventional health services research trial for Colorectal Cancer
Eligibility 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
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
Sites / Locations
- Forzani & Macphail Colon Cancer Screening Centre, University of Calgary
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
ASA 81mg
Arm Description
Acetylsalicylic acid delayed release tablets (81mg), single tablet taken once per day for 90 days.
Outcomes
Primary Outcome Measures
Uptake of ASA
Initiation of daily ASA 81mg (Percentage of participants who complete first 7 days of treatment).
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.
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.
Measurement of Adverse Events
Measurement of Adverse Events reported through interviews with research study nurse and participant report over 90 days (active treatment phase).
Secondary Outcome Measures
Factors related to uptake and adherence to ASA
Behavioral, sociodemographic and health characteristics, measured using Health & Lifestyle Questionnaire and presented as percentages.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05402124
First Posted
May 24, 2022
Last Updated
May 27, 2022
Sponsor
University of Calgary
Collaborators
Canadian Institutes of Health Research (CIHR), Canadian Cancer Society (CCS)
1. Study Identification
Unique Protocol Identification Number
NCT05402124
Brief Title
The Colorectal Cancer Chemoprevention Acceleration and Improvement Platform (CRC-CHAMP) Study
Official Title
The Colorectal Cancer Chemoprevention Acceleration and Improvement Platform (CRC-CHAMP) Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2022 (Anticipated)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Calgary
Collaborators
Canadian Institutes of Health Research (CIHR), Canadian Cancer Society (CCS)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Colorectal Adenoma, Colorectal Adenomatous Polyp
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
This is a single arm, open-label, prospective cohort pilot study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ASA 81mg
Arm Type
Other
Arm Description
Acetylsalicylic acid delayed release tablets (81mg), single tablet taken once per day for 90 days.
Intervention Type
Drug
Intervention Name(s)
acetylsalicylic acid delayed release tablets, 81mg
Other Intervention Name(s)
ASPIRIN 81mg, Drug Identification Number 02237726
Intervention Description
acetylsalicylic acid delayed release tablets, 81mg taken once per day for 90 days
Primary Outcome Measure Information:
Title
Uptake of ASA
Description
Initiation of daily ASA 81mg (Percentage of participants who complete first 7 days of treatment).
Time Frame
7 days
Title
Adherence to ASA over 90 days
Description
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.
Time Frame
90 days
Title
Adherence to at least 50 percent of total prescribed dose
Description
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.
Time Frame
90 days
Title
Measurement of Adverse Events
Description
Measurement of Adverse Events reported through interviews with research study nurse and participant report over 90 days (active treatment phase).
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Factors related to uptake and adherence to ASA
Description
Behavioral, sociodemographic and health characteristics, measured using Health & Lifestyle Questionnaire and presented as percentages.
Time Frame
From enrollment to 90 days
Title
Factors related to uptake and adherence to ASA using measurement of health related quality of life
Description
Behavioral, sociodemographic and health characteristics, measured using Short-Form 36 Health Survey Questionnaire to measure quality of life and presented as percentages.
Time Frame
At enrollment
Title
Factors related to uptake and adherence to ASA using measurement of self efficacy
Description
Behavioral, sociodemographic and health characteristics, measured using National Institutes of Health (NIH) Self-efficacy questionnaire and presented as percentages.
Time Frame
At enrollment
Title
Factors related to uptake and adherence to ASA
Description
Measurement of beliefs, attitudes and values about medicines using Beliefs about Medicines questionnaire and expressed as percentages.
Time Frame
At enrollment
Title
Factors related to uptake, in-study adherence and post-study maintenance using measurement of adherence barriers
Description
Measurement of Adherence barriers using Adherence Barriers Questionnaire (at baseline and 3m follow-up) and expressed as percentages.
Time Frame
At enrollment through end of treatment at 90 days
Title
Factors related to uptake, in-study adherence and post-study maintenance using measurement of chemoprevention knowledge
Description
Measurement of knowledge about chemoprevention using Chemoprevention Questionnaires (baseline and 3m follow-up) and expressed as percentages.
Time Frame
At enrollment through end of treatment at 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Hilsden
Phone
403 592 5089
Email
rhilsden@ucalgary.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Hilsden
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Forzani & Macphail Colon Cancer Screening Centre, University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Hilsden
Phone
1 403 592 5089
Email
rhilsden@ucalgary.ca
First Name & Middle Initial & Last Name & Degree
Susanna Town
Phone
1 403 592 5052
Email
susanna.town@ucalgary.ca
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared with researchers other than the Principal and Co-investigators. The results of this study will be published in a scientific peer reviewed journal. Both the chemoprevention intervention results and the feasibility results for scaling a chemoprevention program to all individuals attending a screening center will be presented. The qualified investigator holds the primary responsibility for publication of study results.
Learn more about this trial
The Colorectal Cancer Chemoprevention Acceleration and Improvement Platform (CRC-CHAMP) Study
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