Trial Outcomes & Findings for Engaging Patients in Colon Cancer Screening Decisions During COVID-19 (NCT NCT04548531)

Last Updated: 2023-02-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

800 participants

Primary outcome timeframe

About 8 weeks after intervention

Results posted on

2023-02-22

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Usual Care (Control) Arm This arm will be a usual care arm. Patients may call to schedule a colonoscopy or other tests as desired.	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).
Intervention Period STARTED	400	400
Intervention Period COMPLETED	399	399
Intervention Period NOT COMPLETED	1	1
8-week Follow-up Survey STARTED	252	252
8-week Follow-up Survey COMPLETED	124	119
8-week Follow-up Survey NOT COMPLETED	128	133

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Engaging Patients in Colon Cancer Screening Decisions During COVID-19

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care (Control) Arm n=399 Participants This arm will be a usual care arm. Patients may call to schedule a colonoscopy or other tests as desired.	Shared Decision Making (Intervention) Arm n=399 Participants 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).	Total n=798 Participants Total of all reporting groups
Age, Continuous	60 years STANDARD_DEVIATION 8 • n=5 Participants	61 years STANDARD_DEVIATION 8 • n=7 Participants	60 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	207 Participants n=5 Participants	217 Participants n=7 Participants	424 Participants n=5 Participants
Sex: Female, Male Male	192 Participants n=5 Participants	182 Participants n=7 Participants	374 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	44 Participants n=5 Participants	46 Participants n=7 Participants	90 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	296 Participants n=5 Participants	293 Participants n=7 Participants	589 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	59 Participants n=5 Participants	60 Participants n=7 Participants	119 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	19 Participants n=5 Participants	14 Participants n=7 Participants	33 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	25 Participants n=5 Participants	18 Participants n=7 Participants	43 Participants n=5 Participants
Race (NIH/OMB) White	292 Participants n=5 Participants	298 Participants n=7 Participants	590 Participants n=5 Participants
Race (NIH/OMB) More than one race	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	55 Participants n=5 Participants	60 Participants n=7 Participants	115 Participants n=5 Participants
Region of Enrollment United States	399 participants n=5 Participants	399 participants n=7 Participants	798 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Usual Care (Control) Arm n=124 Participants This arm will be a usual care arm. Patients may call to schedule a colonoscopy or other tests as desired.	Shared Decision Making (Intervention) Arm n=119 Participants 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).
Shared Decision Making (SDM) Process Scale Score	0.27 Score on a scale of 0-4 Standard Deviation 0.67	0.95 Score on a scale of 0-4 Standard Deviation 1.27

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Usual Care (Control) Arm n=124 Participants This arm will be a usual care arm. Patients may call to schedule a colonoscopy or other tests as desired.	Shared Decision Making (Intervention) Arm n=119 Participants 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).
No Decisional Conflict (Number With Score of 4 on SURE Scale)	52 Participants	73 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Usual Care (Control) Arm n=120 Participants This arm will be a usual care arm. Patients may call to schedule a colonoscopy or other tests as desired.	Shared Decision Making (Intervention) Arm n=112 Participants 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).
Patient's Preferred Approach to Screening Patients with a clear preference (stool card test or colonoscopy)	78 Participants	76 Participants
Patient's Preferred Approach to Screening Patients without a clear preference (unsure or no screening)	42 Participants	36 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Usual Care (Control) Arm n=120 Participants This arm will be a usual care arm. Patients may call to schedule a colonoscopy or other tests as desired.	Shared Decision Making (Intervention) Arm n=112 Participants 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).
Number Reporting "Very Likely" to Follow Through With Screening	87 Participants	94 Participants

SECONDARY outcome

Timeframe: 6 months after randomization

Population: At 6 months post-intervention, we assessed whether or not the 798 patients completed a colon cancer screening test.

Percentage of patients who had completed colon cancer screening test

Outcome measures

Outcome measures
Measure	Usual Care (Control) Arm n=399 Participants This arm will be a usual care arm. Patients may call to schedule a colonoscopy or other tests as desired.	Shared Decision Making (Intervention) Arm n=399 Participants 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).
Colon Cancer Screening Rate	91 Participants	140 Participants

Adverse Events

Usual Care (Control) Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Shared Decision Making (Intervention) Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Karen Sepucha

Massachusetts General Hospital

Phone: 6177243350

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place