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

NCT ID: NCT05021172

Last Updated: 2022-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-24

Study Completion Date

2022-06-30

Brief Summary

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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

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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.

Conditions

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Breast Carcinoma Colorectal Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Arm I (Passport to Health booklet, ePrognosis)

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

Group Type EXPERIMENTAL

Informational Intervention

Intervention Type OTHER

Receive Passport to Health booklet

Questionnaire Administration

Intervention Type OTHER

Complete ePrognosis

Arm II (usual care)

Participants receive usual care before scheduled primary care visit.

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type OTHER

Receive usual care

Survey Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Best Practice

Receive usual care

Intervention Type OTHER

Informational Intervention

Receive Passport to Health booklet

Intervention Type OTHER

Questionnaire Administration

Complete ePrognosis

Intervention Type OTHER

Survey Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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standard of care standard therapy

Eligibility Criteria

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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)
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mount Zion Health Fund

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Judith M Walsh-Cassidy, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2021-08493

Identifier Type: REGISTRY

Identifier Source: secondary_id

21051

Identifier Type: -

Identifier Source: org_study_id

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