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

Sponsor
University of California, San Francisco (Other)
Overall Status
Completed
CT.gov ID
NCT05021172
Collaborator
Mount Zion Health Fund (Other)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Best Practice
  • Other: Informational Intervention
  • Other: Questionnaire Administration
  • Other: Survey Administration
N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. 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.

  2. 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:
  1. Impact on breast and CRC screening versus usual care.

  2. 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 Design

Study Type:
Interventional
Actual Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Incorporating ePrognosis to Encourage "Smarter Screening" for Breast and Colorectal Cancer in Older Adults
Actual Study Start Date :
Aug 24, 2021
Actual Primary Completion Date :
Jun 30, 2022
Actual Study Completion Date :
Jun 30, 2022

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    3. 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.

    4. Proportion of participants who received an ePrognosis report [6 months]

      The proportion of participants who received an ePrognosis report will be reported

    5. 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

    6. 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.

    Other Outcome Measures

    1. Proportion of patients screened for breast cancer [6 months]

      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.

    2. Proportion of patients screened for colorectal cancer [6 months]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    70 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California San Francisco San Francisco California United States 94143

    Sponsors and Collaborators

    • University of California, San Francisco
    • Mount Zion Health Fund

    Investigators

    • Principal Investigator: Judith M Walsh-Cassidy, MD, University of California, San Francisco

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of California, San Francisco
    ClinicalTrials.gov Identifier:
    NCT05021172
    Other Study ID Numbers:
    • 21051
    • NCI-2021-08493
    First Posted:
    Aug 25, 2021
    Last Update Posted:
    Jul 11, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 11, 2022