Engaging Patients in Colon Cancer Screening Decisions During COVID-19
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|ClinicalTrials.gov Identifier: NCT04548531|
Recruitment Status : Enrolling by invitation
First Posted : September 14, 2020
Last Update Posted : September 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Colon Cancer||Behavioral: Shared Decision Making||Not Applicable|
The goal of the study is to examine whether a shared decision making intervention improves decision making about colon cancer screening for patients who had their colonoscopy delayed or postponed due to the COVID pandemic. Eligible patient (n=800) will randomly assigned to either the intervention or control arm. A subset will be surveyed about 6 weeks post intervention to determine the extent to which they report shared decision making, their intention to follow through with screening, and their decisional conflict. Study staff will also conduct medical chart review to track receipt of colon cancer screening within 6 months.
Intervention arm: In this arm, patients will get a shared decision making information sheet in the mail that describes three screening options: (1) schedule next available colonoscopy, (2) switch to a stool-based test, and (3) delay colonoscopy for a year. Study staff trained in decision coaching will follow up with patients to help them select an option and support implementation.
Control arm: This arm will be a usual care arm. The gastroenterology department department has schedulers calling patients and texting patients to schedule their procedure.
All 800 patients will be followed for their cancer screening outcomes, and a subset n=460 or 230 in each arm will be randomly selected to receive the survey.
Study staff who prepare the intervention mailing and the surveys will not be blinded to the study arm. The staff who enter the data from the paper surveys and who conduct chart review to collect screening will be blinded to the assignment. The statistician analyzing the results will also be blinded to the assignment.
The following hypotheses will be evaluated using an intention to treat approach, so patients will be analyzed based on their assigned arm.
Hypothesis 1: Compared to the control group, patients in intervention arm will report higher shared decision making (primary outcome).
Hypothesis 2: Compared to the control group, patients in the intervention arm will have (2a) stronger intention to follow through with colon cancer screening (whether colonoscopy, stool-based test or other approach) and (2b) will be more likely to have a screening test within 6 months.
Hypothesis 3: Compared to the control group, patients in the intervention arm will have less decisional conflict (SURE score).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||800 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Two-armed randomized control trial|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Patients will not be given any information on their assigned arm. Statistician will be blinded to the assignment when analyzing the results.|
|Primary Purpose:||Health Services Research|
|Official Title:||Engaging Patients in Colon Cancer Screening Decisions During COVID-19|
|Actual Study Start Date :||September 10, 2020|
|Estimated Primary Completion Date :||April 30, 2021|
|Estimated Study Completion Date :||May 30, 2021|
No Intervention: Usual Care Arm
This arm will be a usual care arm. Patients may call to schedule a colonoscopy or other tests as desired.
Experimental: Shared Decision Making Arm
This is the intervention arm. Patients will receive a shared decision making information sheet in the mail and will be able to receive decision coaching from study staff to support selection of an option if desired.
Behavioral: Shared Decision Making
The decision aid is a paper information sheet presenting the pros and cons of three screening options (colonoscopy, stool-based tests, and postponing cancer screening until next year).
The decision coaching is a structured interview to help patients clarify their preference for screening test and to support them in implementation (whether scheduling colonoscopy, ordering stool test or seeking additional advice from specialist).
- Shared Decision Making (SDM) Process Scale Score [ Time Frame: 6 weeks after intervention ]short patient reported scale asks patients about discussion of options, pros and cons of colonoscopy and discussion of patients' preferences. Total scores range from 0-4 with higher scores indicating higher shared decision making.
- Decisional Conflict (SURE scale) [ Time Frame: 6 weeks after intervention ]the 4-item version of the decisional conflict scale, total score ranges from 0-4 with greater scores indicating less decisional conflict.
- Patient's preferred approach to screening [ Time Frame: 6 weeks after intervention ]One item will assess patients' preferred approach to screening (with responses of colonoscopy, stool card test, no screening, not sure).
- Intention to screen [ Time Frame: 6 weeks after intervention ]One item will assess patients' intention to follow through with their preferred approach on a 5-point scale from not at all likely to extremely likely.
- Colon cancer screening rate [ Time Frame: 6 months after randomization ]Percentage of patients who had completed colon cancer screening test
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04548531
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Karen Sepucha, PhD||Massachusetts General Hospital|