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

NCT05021172 | Completed

• 2 other identifiers: 21051NCI-2021-08493
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Carcinoma; Colorectal Carcinoma

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• Proportion of patients screened for breast cancer

  6 months

• Proportion of patients screened for colorectal cancer

  6 months

Study Arms (2)

Arm I (Passport to Health booklet, ePrognosis)

EXPERIMENTAL

Participants receive Passport to Health booklet and complete ePrognosis before scheduled primary care visit.

Other: Informational Intervention; Other: Questionnaire Administration

Arm II (usual care)

ACTIVE COMPARATOR

Participants receive usual care before scheduled primary care visit.

Other: Best Practice; Other: Survey Administration

Interventions

Best Practice OTHER

Receive usual care

Also known as: standard of care, standard therapy

Arm II (usual care)

Informational Intervention OTHER

Receive Passport to Health booklet

Arm I (Passport to Health booklet, ePrognosis)

Questionnaire Administration OTHER

Complete ePrognosis

Arm I (Passport to Health booklet, ePrognosis)

Survey Administration OTHER

Ancillary studies

Arm II (usual care)

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, San Francisco: lead
• Mount Zion Health Fund: collaborator

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Study Officials

• Judith M Walsh-Cassidy, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: August 25, 2021
• Study Start: August 24, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: July 11, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)