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

Breast Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05021172
• Other study ID #: 21051
• Secondary ID: NCI-2021-08493
• Status: Completed
• Phase: N/A
• Start date: August 24, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2022
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms
• Carcinoma
• Colorectal Carcinoma
• Colorectal Neoplasms

Intervention

Other:
• Best Practice
Receive usual care
• Informational Intervention
Receive Passport to Health booklet
• Questionnaire Administration
Complete ePrognosis
• Survey Administration
Ancillary studies

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Mount Zion Health Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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
Primary	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
Primary	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
Primary	Proportion of participants who received an ePrognosis report	The proportion of participants who received an ePrognosis report will be reported	6 months
Primary	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
Primary	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