Colon Cancer
Conditions
Keywords
Shared Decision Making, Colon Cancer Screening, COVID-19
Brief summary
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 patients (n=800) will be randomly assigned to either the intervention or control arm. A subset will be surveyed about 6-8 weeks post intervention to measure shared decision making, their intention to follow through with screening, and their decisional conflict. Study staff will conduct medical chart review to track receipt of colon cancer screening within 6 months. The statistician will test whether patients in the intervention arm report more shared decision making, less decisional conflict, higher intention to follow through on screening and have higher screening rates compared to those in the control arm.
Detailed description
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 6-8 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).
Interventions
BEHAVIORALShared 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).
Sponsors
Patient-Centered Outcomes Research Institute
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
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.
Intervention model description
Two-armed randomized control trial
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adults, age 45-75 * Had screening or surveillance colonoscopy delayed or cancelled from March-June 2020
Exclusion criteria
* Diagnostic colonoscopy * High risk for colorectal cancer as indicated by 1 year follow up schedule * Prior history of colon cancer * Unable to read or write in English or Spanish * Have already scheduled or completed a colonoscopy since restrictions were lifted
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shared Decision Making (SDM) Process Scale Score | About 8 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| No Decisional Conflict (Number With Score of 4 on SURE Scale) | About 8 weeks after intervention | The 4-item version of the decisional conflict scale, total score ranges from 0-4 and is reported as top score or percentage who score 4 which indicates no decisional conflict. |
| Patient's Preferred Approach to Screening | About 8 weeks after intervention | One item will assess patients' preferred approach to screening (with responses of colonoscopy, stool card test, no screening, not sure). We report on the percent of patients who had a clear preference for screening with either a stool card test or colonoscopy and those without a clear preference who chose no screening or not sure. |
| Number Reporting Very Likely to Follow Through With Screening | About 8 weeks after intervention | One item will assess patients' intention to follow through with their preferred approach on a 5-point scale from Very Unlikely to Very Likely. We report on the percent of patients who selected Very Likely to follow through with screening. |
| Colon Cancer Screening Rate | 6 months after randomization | Percentage of patients who had completed colon cancer screening test |
Countries
United States
Participant flow
Recruitment details
On June 1, 2020, the co-investigators from the gastroenterology department extracted a list of patients aged 45-75, with preferred language of English or Spanish, who had a screening or surveillance colonoscopy that was cancelled, who had a referral for a screening colonoscopy that had not been processed, or who should have been contacted by the GI department to schedule a screening colonoscopy but had not been due to COVID-19 restrictions.
Participants by arm
| Arm | Count |
|---|---|
| Usual Care (Control) Arm This arm will be a usual care arm. Patients may call to schedule a colonoscopy or other tests as desired. | 399 |
| Shared Decision Making (Intervention) 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.
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). | 399 |
| Total | 798 |
Baseline characteristics
| Characteristic | Usual Care (Control) Arm | Total | Shared Decision Making (Intervention) Arm |
|---|---|---|---|
| Age, Continuous | 60 years STANDARD_DEVIATION 8 | 60 years STANDARD_DEVIATION 8 | 61 years STANDARD_DEVIATION 8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 44 Participants | 90 Participants | 46 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 296 Participants | 589 Participants | 293 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 59 Participants | 119 Participants | 60 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 19 Participants | 33 Participants | 14 Participants |
| Race (NIH/OMB) Black or African American | 25 Participants | 43 Participants | 18 Participants |
| Race (NIH/OMB) More than one race | 8 Participants | 16 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 55 Participants | 115 Participants | 60 Participants |
| Race (NIH/OMB) White | 292 Participants | 590 Participants | 298 Participants |
| Region of Enrollment United States | 399 participants | 798 participants | 399 participants |
| Sex: Female, Male Female | 207 Participants | 424 Participants | 217 Participants |
| Sex: Female, Male Male | 192 Participants | 374 Participants | 182 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 400 | 0 / 400 |
| other Total, other adverse events | 0 / 400 | 0 / 400 |
| serious Total, serious adverse events | 0 / 400 | 0 / 400 |
Outcome results
Primary
Shared Decision Making (SDM) Process Scale Score
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.
Time frame: About 8 weeks after intervention
Population: This analytic sample was a subset of the initial 798 patients at baseline who completed a survey about 8-weeks after the start of the intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (Control) Arm | Shared Decision Making (SDM) Process Scale Score | 0.27 Score on a scale of 0-4 | Standard Deviation 0.67 |
| Shared Decision Making (Intervention) Arm | Shared Decision Making (SDM) Process Scale Score | 0.95 Score on a scale of 0-4 | Standard Deviation 1.27 |
p-value: <0.00195% CI: [0.41, 0.94]t-test, 2 sided
Secondary
Colon Cancer Screening Rate
Percentage of patients who had completed colon cancer screening test
Time frame: 6 months after randomization
Population: At 6 months post-intervention, we assessed whether or not the 798 patients completed a colon cancer screening test.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care (Control) Arm | Colon Cancer Screening Rate | 91 Participants |
| Shared Decision Making (Intervention) Arm | Colon Cancer Screening Rate | 140 Participants |
Comparison: Assessed how many patients completed any colorectal cancer screening test within 6-months after randomization.p-value: <0.00195% CI: [6, 18]Chi-squared
Secondary
No Decisional Conflict (Number With Score of 4 on SURE Scale)
The 4-item version of the decisional conflict scale, total score ranges from 0-4 and is reported as top score or percentage who score 4 which indicates no decisional conflict.
Time frame: About 8 weeks after intervention
Population: This analytic sample was a subset of the initial 798 patients at baseline who were sent a survey about 8-weeks after the start of the intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care (Control) Arm | No Decisional Conflict (Number With Score of 4 on SURE Scale) | 52 Participants |
| Shared Decision Making (Intervention) Arm | No Decisional Conflict (Number With Score of 4 on SURE Scale) | 73 Participants |
p-value: 0.00395% CI: [7, 35]Chi-squared
Secondary
Number Reporting Very Likely to Follow Through With Screening
One item will assess patients' intention to follow through with their preferred approach on a 5-point scale from Very Unlikely to Very Likely. We report on the percent of patients who selected Very Likely to follow through with screening.
Time frame: About 8 weeks after intervention
Population: This analytic sample was a subset of the initial 798 patients at baseline who were sent a survey about 8-weeks after the start of the intervention. There were 4 participants missing in the usual care arm and 7 patients missing in the intervention arm due to missing data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care (Control) Arm | Number Reporting Very Likely to Follow Through With Screening | 87 Participants |
| Shared Decision Making (Intervention) Arm | Number Reporting Very Likely to Follow Through With Screening | 94 Participants |
Comparison: We categorized for likelihood to follow through with screening. We reported on results from patients who indicated 'Very Likely' on their response option vs. the other options (likely, unsure, unlikely, very unlikely)p-value: 0.1495% CI: [-3, 26]Chi-squared
Secondary
Patient's Preferred Approach to Screening
One item will assess patients' preferred approach to screening (with responses of colonoscopy, stool card test, no screening, not sure). We report on the percent of patients who had a clear preference for screening with either a stool card test or colonoscopy and those without a clear preference who chose no screening or not sure.
Time frame: About 8 weeks after intervention
Population: This analytic sample was a subset of the initial 798 patients at baseline who were sent a survey about 8-weeks after the start of the intervention. There were 4 participants missing in the usual care arm and 7 patients missing in the intervention arm due to missing data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care (Control) Arm | Patient's Preferred Approach to Screening | Patients with a clear preference (stool card test or colonoscopy) | 78 Participants |
| Usual Care (Control) Arm | Patient's Preferred Approach to Screening | Patients without a clear preference (unsure or no screening) | 42 Participants |
| Shared Decision Making (Intervention) Arm | Patient's Preferred Approach to Screening | Patients with a clear preference (stool card test or colonoscopy) | 76 Participants |
| Shared Decision Making (Intervention) Arm | Patient's Preferred Approach to Screening | Patients without a clear preference (unsure or no screening) | 36 Participants |
Comparison: We tested for a clear preference for screening, if a patient chose a colonoscopy or a stool-based test vs. the other response options.p-value: 0.7595% CI: [-10, 16]Chi-squared