Colon CancerNCT04548531
Engaging Patients in Colon Cancer Screening Decisions During COVID-19
A study testing Shared Decision Making in people with Colon Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Shared Decision Making
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2020to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults, age 45-75
- Had screening or surveillance colonoscopy delayed or cancelled from March-June 2020
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
Read the 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).
- Conditions
- Colon Cancer
- Being tested
- Shared Decision Making
- Keywords
- Shared Decision Making, Colon Cancer Screening, COVID-19
- Medical subject headings
- Colonic Neoplasms, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared Decision MakingBehavioural
Also called Decision aid, Decision coaching
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).
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Arm | No intervention | This arm will be a usual care arm. Patients may call to schedule a colonoscopy or other tests as desired. |
| Shared Decision Making Arm | Experimental | 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. Receives: Behavioral: Shared Decision Making |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: About 8 weeks after intervention
Secondary outcomes (4)
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.
Measured: About 8 weeks after intervention
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.
Measured: About 8 weeks after intervention
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.
Measured: About 8 weeks after intervention
Colon Cancer Screening Rate
Percentage of patients who had completed colon cancer screening test
Measured: 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start10 Sep 2020
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-armed randomized control trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Karen Sepucha, Massachusetts General Hospital
- Investigators
- Karen Sepucha, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04548531
- Sponsor's protocol ID
- 2020P001579-2
- Status last verified
- May 2022
- First submitted
- 9 Sep 2020
- Last updated
- 22 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes To promote research replicability, transparency and future use of the data, de-identified data sets of the patient survey data will be created and will be available, by request, to outside researchers. After the main manuscripts have been published, de-identified data sets will also be deposited in an open access service such as, ICPSR (https://www.icpsr.umich.edu/icpsrweb/). Before a dataset is made available for access, ICPSR completes a detailed review of all datasets to assess disclosure risk. If necessary, ICPSR modifies data to reduce disclosure risk or limits access to datasets for which modifying the data would substantially limit their utility or the risk of disclosure remains high. No information that contains identifiers or that could be used to link an individual to the data will be included in the de-identified data set.
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Patients in Colon Cancer Screening Decisions During COVID-19
- ClinicalTrials.gov ID
- NCT04548531
- Acronym / sponsor ID
- 2020P001579-2
- Conditions
- Colon Cancer
- Keywords
- Shared Decision Making, Colon Cancer Screening, COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 14 Sep 2020 (actual)
- Results
- Posted 22 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-armed randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Usual Care Arm | No intervention | –This arm will be a usual care arm. Patients may call to schedule a colonoscopy or other tests as desired. |
| Shared Decision Making Arm | Experimental | Behavioral: Shared Decision MakingThis 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. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults, age 45-75
- Had screening or surveillance colonoscopy delayed or cancelled from March-June 2020
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shared Decision MakingAlso: Decision aid, Decision coachingThe 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). | Behavioural | Shared Decision Making Arm |
Primary outcome
Shared Decision Making (SDM) Process Scale Score
Time frame: 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.
4 secondary outcomes
No Decisional Conflict (Number With Score of 4 on SURE Scale)
Time frame: About 8 weeks after intervention
Patient's Preferred Approach to Screening
Time frame: About 8 weeks after intervention
Number Reporting "Very Likely" to Follow Through With Screening
Time frame: About 8 weeks after intervention
Colon Cancer Screening Rate
Time frame: 6 months after randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Yes To promote research replicability, transparency and future use of the data, de-identified data sets of the patient survey data will be created and will be available, by request, to outside researchers. After the main manuscripts have been published, de-identified data sets will also be deposited in an open access service such as, ICPSR (https://www.icpsr.umich.edu/icpsrweb/). Before a dataset is made available for access, ICPSR completes a detailed review of all datasets to assess disclosure risk. If necessary, ICPSR modifies data to reduce disclosure risk or limits access to datasets for which modifying the data would substantially limit their utility or the risk of disclosure remains high. No information that contains identifiers or that could be used to link an individual to the data will be included in the de-identified data set.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Sepucha, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shared Decision Making in people with Colon Cancer, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shared Decision Making (SDM) Process Scale Score (time frame: About 8 weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023.