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OpenTrials
Completed

NCT Number: NCT05021172

Incorporating ePrognosis for the Encouragement of 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.

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California San Francisco

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Best Practice

Other

Receive usual care

Other names: standard of care, standard therapy

Informational intervention

Other

Receive Passport to Health booklet

Questionnaire Administration

Other

Complete ePrognosis

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. Proportion of participants enrolled

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 6 months

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

  5. Proportion of physicians who utilized the ePrognosis clinician report

    Time frame: 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

    Time frame: 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 outcomes

  1. Proportion of patients screened for breast cancer

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Mount Zion Health Fund

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 25, 2021
Registry last updated
Jul 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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