Dataset Information

Investigation of the effects of cues to action on participation in colorectal (CRC) screening - the role of implementation intentions

ABSTRACT: Interventions: Fecal Immunochemical Tests (FIT) will be mailed to participants. An implementation plan will be included for the 3 intervention groups. The implementation plans provided serve as ‘cues to action’ to provide a plan for goal achievement. Two intervention groups will receive an implementation plan that asks participants to think about, for example, how they will remember to do the test and to write down how they will remind themselves. One group will send a copy of this plan back to CSIRO, the other group will retain the plan. The ‘prescriptive’ implementation plan will ‘tell’ participants how to act, eg place a reminder in a prominent place so that you do not forget to use the kit. Intervention 1: FIT kit + implementation plan to complete and retain. Receipt of completed kit by Bowel Health Service (BHS) within 35 days Intervention 2: FIT kit + implementation plan to complete and return to CSIRO. Receipt of completed kit by Bowel Health Service (BHS) within 35 days Intervention 3: FIT kit + prescriptive implementation plan to complete and return to CSIRO. Receipt of completed kit by Bowel Health Service (BHS) within 35 days Primary outcome(s): Return of completed FIT kit[Within 35 days of receipt by participant] Study Design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy

DISEASE(S): Colorectal Carcinoma (crc),Cancer-bowel-back Passage (rectum) Or Large Bowel (colon)

PROVIDER: 2453236 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Colorectal cancer (CRC) screening can reduce cancer deaths. However, screening and abnormal test follow-up rates are low among underserved populations. The screening rates of 19-58%, and rates of colonoscopy completion after abnormal stool tests of 18-57% in community health centers (CHC) systems are low. This highlights an opportunity to improve early detection and decrease burden of CRC in our region. Mailed outreach and navigation programs have been shown to increase colonoscopy completion rate. The next step is to understand how to best implement these programs in the community on a larger scale. To achieve this goal, the investigators propose a Hub-and-Spoke intervention combining centralized strategies to maximize CRC screening, follow-up, and referral-to-care. The investigators hypothesize that this intervention will be superior to usual care for increasing CRC screening, abnormal test follow-up, and referral-to-care. The investigators will conduct a randomized trial to determine effectiveness in: 1) improvement in proportion of individuals up-to-date with screening 3 years post implementation; 2) proportion with abnormal FIT who complete diagnostic colonoscopy within 6 months; and 3) proportion with CRC completing first treatment evaluation. The investigators will also evaluate the implementation, scalability, and sustainability of the multi-level implementation strategy. The intervention consists of: Mailed FIT and Reminders. Eligible individuals will receive an introductory letter describing the importance of CRC screening and noting that follow-up mail will include a FIT Kit. It will also be offered to patients who completed prior mailed FIT with normal test results. All materials will be in English and Spanish. Two weeks later, participants will receive a packet via mail containing the FIT kit, a one-page invitation inviting FIT completion and FIT instructions, a postage-paid envelope for return to the patient’s CHC, and COVID-19 message. For non-compliant individuals not returning the kit, a reminder phone call and text message will be delivered 2 weeks later. The investigators will track returned letters, individuals who are later found to be up-to date with screening, and those who decline screening. The CHC will provide care coordination for patients with an abnormal FIT result.

Project description:Bowel cancer is the second biggest cancer killer in the UK, accounting for over 16,000 deaths per year. Screening can reduce deaths from bowel cancer if the people invited participate. The challenge is that high uptake of bowel screening is hard to achieve, and remains persistently below 65%. The faecal immunochemical test (FIT) is the most widely used bowel screening test worldwide. In the UK, FIT kits are mailed to people’s homes without guidance on when the kit should be returned and only brief instruction on how to use it. Some people have said that even though they intend to complete and return the kit, they often forget or put off doing it. Two approaches are proposed to addressing this issue: i) providing a suggested deadline for FIT return, because it is known from breast and cervical cancer screening that giving people an appointment time increases uptake compared to an open invitation, and ii) planning sheets, that have been found to help people act on their intentions in other health contexts. This trial aims to evaluate the impact of providing a suggested deadline and a planning sheet on the return of FIT bowel screening kits. The trial is integrated within the Scottish Bowel Screening Programme. The investigators will randomly allocate 40,000 consecutive people that are due to be sent a FIT kit to one of eight groups: (i) control group (no deadline, no planning sheet), (ii) intervention group (1-week deadline, no planning sheet), (iii) intervention group (2-week deadline, no planning sheet), (iv) intervention group (4-week deadline, no planning sheet), (v) intervention group (no deadline, with planning sheet), (vi) intervention group (1-week deadline, with planning sheet), (vii) intervention group (2-week deadline, with planning sheet), (viii) intervention group (4-week deadline, with planning sheet). It will then be examined if having a suggested deadline and a planning sheet affects how many people send back their completed FIT kit. It will also be examined if the deadline length makes a difference and whether having both a deadline and a planning sheet affects the number of people returning their kit. Finally, the cognitive and behavioural mechanisms underlying any intervention effects will be assessed and the acceptability of the interventions explored, using questionnaires and in-depth interviews.

Project description:Participants will be mailed an invitation to complete CRC screening along with a fecal immunochemical test (FIT) kit, containing a 1-sample "Polymedco Over the Counter (OC) Sensor FIT", simplified English/Spanish instructions on performing the test, educational information about colorectal cancer screening and a return mailer with prepaid postage. Processes that will be used to promote screening completion include automated and "live" phone call reminders to encourage completion of FIT testing. Participants will be randomly assigned to 1 of 5 interventions across 3 conditions, described below: 1. Condition 1 (Standard Intervention): * Branch I: Participants assigned to the control condition will receive a FIT kit and the standard invitation letter to participate in free screening. 2. Condition 2 (Time Guideline): * Branch II: Participants will receive a FIT kit and invitation letter to participate in free screening with a 1-week time restriction. * Branch III: Participants will receive a FIT kit and invitation letter to participate in free screening with a 3-week time restriction. 3. Condition 3 (Time Guideline + Incentive): * Branch IV: Participants will receive a FIT kit and invitation letter to participate in free screening requesting they return the kit within 1-week for a "higher" monetary incentive or within 3 weeks for a "lower" (half of the higher) monetary incentive. * Branch V: Participants will receive a FIT kit and invitation letter to participate in free screening requesting they return the kit within 1-week for a "higher" (same as lower in Branch IV) monetary incentive or within 3 weeks for a "lower" (half of the higher) monetary incentive. Participants with a normal test result will receive a personal letter confirming this with invitations to complete a repeat screening in subsequent year(s). Participants receiving an abnormal FIT result will be navigated to complete a diagnostic colonoscopy. Participants continuing in the screening program in subsequent years will receive letters emphasizing the importance of repeat screening to prevent adverse CRC outcomes.

Project description:Interventions: This prospective, cross-sectional, multi-centre, blinded clinical trial evaluates the performance of the ColoSTAT as an in vitro diagnostic test (IVD) for the early detection of colorectal cancer. Participants will be recruited from two cohorts: Chort 1, patients recently diagnosed via colonoscopy with colorectal cancer who are progressing to colorectal surgery or neoadjuvant treatment as part of their normal standard of care; Cohort 2, patients with no prior history of colorectal cancer who have been referred for colonoscopy by their consulting physician. Participants will be asked to donate around 18 mL of blood for use in the ColoSTAT test. Further, if they do not have a valid result from a faecal immunochemical test (FIT) completed within the preceding 6 months, participants will be asked to complete a FIT sample collection using a commercial FIT home collection kit (provided) and return the samples to the study site for shipment to a central laboratory for testing . Physically, participation in the trial will involve collection of the blood sample for the ColoSTAT test, completion of a home FIT sample collection if needed and return of the completed kit to the the study site. Additionally, information that will be collected at that first visit will comprise: Details of smoking status and age (known risk factors for colorectal cancer), any personal and/or family medical history of colorectal cancer, results from a FIT performed within the previous 6 months and a listing of any concomitant medications. Vital signs, including height, weight, waist circumference, body mass index, blood pressure and heart rate will also be collected and reported. This first Visit is expected to take around 1-2 hour to complete. Sometime during the period Day 10 through 28 Primary outcome(s): Assessment of the sensitivity of ColoSTAT for detection of colorectal cancers compared with the gold standard - colonoscopy. This is calculated as the % of true colorectal cancers (as defined by colonoscopy) that are correctly classified by the ColoSTAT test. [One year from commencement of recruitment.];Assessment of the specificity of ColoSTAT for detection of colorectal cancers compared with the gold standard - colonoscopy. This is calculated as the % of true cancer-negative participants (as defined by colonoscopy) that are correctly classified as negative by the ColoSTAT test.[One year after commencement of recruitment] Study Design: Purpose: Diagnosis; Allocation: Non-randomised trial

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Investigation of the effects of cues to action on participation in colorectal (CRC) screening - the role of implementation intentions

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