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Clinical Trials/NCT05021172
NCT05021172
Completed
Not Applicable

Incorporating ePrognosis to Encourage "Smarter Screening" for Breast and Colorectal Cancer in Older Adults

University of California, San Francisco1 site in 1 country75 target enrollmentAugust 24, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Carcinoma
Sponsor
University of California, San Francisco
Enrollment
75
Locations
1
Primary Endpoint
Percentage of participants enrolled at 6 months
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

This clinical trial assesses the feasibility and acceptability of a smarter screening intervention for breast and colorectal cancer in older adults. This study aims to learn more about how to support patients and physicians in making cancer screening decisions for older adults.

Detailed Description

PRIMARY OBJECTIVES: I. Complete development of and refine "Smarter Screening", a multi-component, patient-centered intervention centered around ePrognosis: Cancer Screening to facilitate shared decision-making screening discussions for breast and colorectal cancer in older adults. II. Assess feasibility and acceptability of the "Smarter Screening" intervention and assess its impact versus usual care on shared decision-making about whether or not to continue breast and colorectal cancer (CRC) screening among multi-ethnic and socioeconomically diverse primary care patients. EXPLORATORY OBJECTIVES: I. Impact on breast and CRC screening versus usual care. II. Risk perception, worry, and a patient-reported measure of decision quality. OUTLINE: Participants are randomized to 1 of 2 arms. ARM I: Participants receive Passport to Health booklet and complete ePrognosis before scheduled primary care visit. ARM II: Participants receive usual care before scheduled primary care visit. After completion of study, participants are followed up at 1 week post primary care visit.

Registry
clinicaltrials.gov
Start Date
August 24, 2021
End Date
June 30, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age 70 years and above
  • Ability to understand study procedures and to comply with them for the entire length of the study
  • Ability of individual to understand a written informed consent document, and the willingness to sign it
  • Have no prior history of cancer
  • Scheduled for an upcoming appointment in University of California, San Francisco (UCSF) General Internal Medicine or Women's Health Primary Care clinics
  • English-speaking

Exclusion Criteria

  • Contraindication to any study-related procedure or assessment
  • Non-English speaking
  • Are under the current medical care of either the study primary investigator (PI) or co-investigator (Co-I)

Outcomes

Primary Outcomes

Percentage of participants enrolled at 6 months

Time Frame: 6 months

The investigators aim to attain at least 75% of recruited patients in each arm at the 6 month follow-up.

Proportion of participants enrolled

Time Frame: 6 months

Ability to successfully recruit the target of approximately 40 patients will be determined by the overall number of participants who were screened for enrollment compared to the overall number of participants who were randomized to one of the groups.

Proportion of participants who received an ePrognosis report

Time Frame: 6 months

The proportion of participants who received an ePrognosis report will be reported

Responses to Qualitative Acceptability survey

Time Frame: 6 months

A survey will be provided to PCPs and used to measure acceptability of the ePrognosis report by asking patients and providers to provide feedback about the intervention, including likes and dislikes, and future recommendation of using the report provided.

Proportion of primary care physicians (PCPs) enrolled

Time Frame: 6 months

Ability to successfully recruit PCPs will be determined by the overall number of physicians who were contacted compared to the overall number of physicians who actively participated over the course of the study.

Proportion of physicians who utilized the ePrognosis clinician report

Time Frame: 6 months

All enrolled intervention PCPs will receive a web-based survey after each patient visit to record whether the physicians used and/or discussed ePrognosis in that visit. The proportion of physicians who use the ePrognosis clinician report in their cancer screening counseling with participants/patients will be reported

Study Sites (1)

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