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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Carcinoma; Colorectal Carcinoma
• Intervention / Treatment: Other: Best Practice; Other: Survey Administration; Other: Informational Intervention; Other: Questionnaire Administration

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.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (Passport to Health booklet, ePrognosis); Participants receive Passport to Health booklet and complete ePrognosis before scheduled primary care visit.	Other: Informational Intervention; Receive Passport to Health booklet; Other: Questionnaire Administration; Complete ePrognosis
Active Comparator: Arm II (usual care); Participants receive usual care before scheduled primary care visit.	Other: Best Practice; Receive usual care; Other Names: standard of care; standard therapy; Other: Survey Administration; Ancillary studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants enrolled	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.	6 months
Proportion of primary care physicians (PCPs) enrolled	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.	6 months
Percentage of participants enrolled at 6 months	The investigators aim to attain at least 75% of recruited patients in each arm at the 6 month follow-up.	6 months
Proportion of participants who received an ePrognosis report	The proportion of participants who received an ePrognosis report will be reported	6 months
Proportion of physicians who utilized the ePrognosis clinician report	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	6 months
Responses to Qualitative Acceptability survey	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.	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients screened for breast cancer	The impact on breast cancer screening versus usual care will be measured by comparing the proportion or participants who were screened for cancers by treatment arm.	6 months
Proportion of patients screened for colorectal cancer	The impact on colorectal cancer screening versus usual care will be measured by comparing the proportion or participants who were screened for cancers by treatment arm.	6 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Mount Zion Health Fund
• Investigators: Principal Investigator: Judith M Walsh-Cassidy, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2021
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: August 19, 2021
• First Submitted That Met QC Criteria: August 19, 2021
• First Posted (Actual): August 25, 2021

Study Record Updates

• Last Update Posted (Actual): July 11, 2022
• Last Update Submitted That Met QC Criteria: July 7, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Breast Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Breast Neoplasms; Carcinoma; Colorectal Neoplasms
• Other Study ID Numbers: 21051; NCI-2021-08493 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No