Incorporating ePrognosis for the Encouragement of Smarter Screening for Breast and Colorectal Cancer in Older Adults

Not Applicable

Completed

• Conditions: Breast Carcinoma; Colorectal Carcinoma
• Interventions: Other: Informational Intervention; Other: Best Practice; Other: Questionnaire Administration; Other: Survey Administration

• Registration Number: NCT05021172
• Lead Sponsor: University of California, San Francisco

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-08-19
• Study First Submitted QC: 2021-08-19
• Study Start: 2021-08-24
• Study First Posted: 2021-08-25
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-07
• Last Update Posted: 2022-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (Passport to Health booklet, ePrognosis)	Questionnaire Administration	Participants receive Passport to Health booklet and complete ePrognosis before scheduled primary care visit.
Arm I (Passport to Health booklet, ePrognosis)	Informational Intervention	Participants receive Passport to Health booklet and complete ePrognosis before scheduled primary care visit.
Arm II (usual care)	Survey Administration	Participants receive usual care before scheduled primary care visit.
Arm II (usual care)	Best Practice	Participants receive usual care before scheduled primary care visit.

Primary Outcome Measures

Name	Time	Method
Percentage of participants enrolled at 6 months	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	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	6 months	The proportion of participants who received an ePrognosis report will be reported
Responses to Qualitative Acceptability survey	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	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	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

Trial Locations

Locations (1)

University of California San Francisco; 🇺🇸 San Francisco, California, United States