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N/A N=536 Randomized Single-blind Health Services Research

Promoting Informed Decisions About Cancer Screening in Older Adults

Colorectal Cancer Screening

Enrolled (actual)
536
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Shared Decision Making Process (SDMP) Scale Score — 1.1; 1.5 Score on a scale — p=.011

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Notification (Behavioral); Training (Behavioral)
Age
Adult, Older Adult · 21+ yrs
Sex
All
Sponsor
Massachusetts General Hospital
Primary completion
Apr 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Shared Decision Making Process (SDMP) Scale Score
1.1; 1.5 .011 sig
SECONDARY
Patients' Colorectal Cancer Screening Knowledge Score
61; 63 0.36
SECONDARY
Percentage of Patients Who Received Preferred Approach to Colorectal Cancer Testing
103; 115 0.47
SECONDARY
Physician's Shared Decision Making Skills
5.5; 6.1 0.19
SECONDARY
Colorectal Cancer Screening Rates
29.1; 38.6 0.032 sig
SECONDARY
Clinician Satisfaction With the Visit
138; 171 0.64

Summary

This project aims to examine the impact of different interventions designed to help individualize colorectal cancer (CRC) screening decisions in adults aged 76-85. Clinicians will be assigned by chance to one of two arms. In the Intervention arm, clinician participants will complete a training course and will also be notified of patients in the target age group who are due for a discussion about CRC screening. In the Comparator arm, clinician participants will be notified of their patients in the target age group with an upcoming visit who are due for a discussion about CRC screening. The investigators expect that patients seen by clinicians in the intervention arm will report more involvement in the decision making process, be more knowledgeable about the risks and benefits of CRC screening, and will have better quality decisions. Further, the investigators expect that the physicians in the intervention arm will have greater confidence in and demonstrate more skills for conducting shared decision making conversations as compared to those in the control arm.

Eligibility Criteria

For Clinicians, eligibility will not be decided by sex, gender, or age

Inclusion Criteria for clinicians:

  • Primary Care Physician (MD or NP)
  • Manages a panel of patients
  • Has ≥20 potentially eligible patients (age 76-85 and due for colorectal cancer screening) in their panel
  • Practices at participating site

Exclusion Criteria for clinicians:

  • Residents, medical students
  • Does not manage panel of patients (e.g. urgent care clinician)

Patients of participating clinicians will be enrolled to evaluate the impact of the interventions.

Inclusion Criteria for patients:

  • Adults, age 76-85 at the time of the scheduled visit
  • Scheduled for non-urgent office visit with a participating clinician during the study period
  • Due or overdue for colorectal cancer screening (e.g. never been screened, 1 year or less to follow-up interval indicated on previous test).

Exclusion Criteria for patients:

  • Prior diagnosis of colon or rectal cancer, inflammatory bowel disease or genetic disorder that raises CRC risk (e.g. hereditary non-polyposis CRC and familial adenomatous polyposis)
  • Unable to consent for themselves (e.g. moderate to severe dementia or other major cognitive limitations)
  • Unable to read or write in English or Spanish
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03959696). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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