Clinical trial NCT05021172: Incorporating ePrognosis for the Encouragement of Smarter Screening for Breast and Colorectal Cancer in Older Adults
Official title: Incorporating ePrognosis to Encourage "Smarter Screening" for Breast and Colorectal Cancer in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Carcinoma
Colorectal Carcinoma
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Mount Zion Health Fund
First posted: 2021-08-25
Enrollment: 75
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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)

Primary outcomes:
measure: Proportion of participants enrolled
timeFrame: 6 months
measure: Proportion of primary care physicians (PCPs) enrolled
timeFrame: 6 months
measure: Percentage of participants enrolled at 6 months
timeFrame: 6 months
measure: Proportion of participants who received an ePrognosis report
timeFrame: 6 months
measure: Proportion of physicians who utilized the ePrognosis clinician report
timeFrame: 6 months
measure: Responses to Qualitative Acceptability survey
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
measure: Proportion of patients screened for breast cancer
timeFrame: 6 months
measure: Proportion of patients screened for colorectal cancer
timeFrame: 6 months
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Judith M Walsh-Cassidy, MD
role: PRINCIPAL_INVESTIGATOR
References: