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

Primary Purpose

Breast Carcinoma, Colorectal Carcinoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Best Practice
Informational Intervention
Questionnaire Administration
Survey Administration
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Breast Carcinoma

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University of California San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (Passport to Health booklet, ePrognosis)

Arm II (usual care)

Arm Description

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

Participants receive usual care before scheduled primary care visit.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 19, 2021
Last Updated
July 7, 2022
Sponsor
University of California, San Francisco
Collaborators
Mount Zion Health Fund
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1. Study Identification

Unique Protocol Identification Number
NCT05021172
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
August 24, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Mount Zion Health Fund

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Carcinoma, Colorectal Carcinoma

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (Passport to Health booklet, ePrognosis)
Arm Type
Experimental
Arm Description
Participants receive Passport to Health booklet and complete ePrognosis before scheduled primary care visit.
Arm Title
Arm II (usual care)
Arm Type
Active Comparator
Arm Description
Participants receive usual care before scheduled primary care visit.
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
standard of care, standard therapy
Intervention Description
Receive usual care
Intervention Type
Other
Intervention Name(s)
Informational Intervention
Intervention Description
Receive Passport to Health booklet
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Complete ePrognosis
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Proportion of participants enrolled
Description
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.
Time Frame
6 months
Title
Proportion of primary care physicians (PCPs) enrolled
Description
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.
Time Frame
6 months
Title
Percentage of participants enrolled at 6 months
Description
The investigators aim to attain at least 75% of recruited patients in each arm at the 6 month follow-up.
Time Frame
6 months
Title
Proportion of participants who received an ePrognosis report
Description
The proportion of participants who received an ePrognosis report will be reported
Time Frame
6 months
Title
Proportion of physicians who utilized the ePrognosis clinician report
Description
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
Time Frame
6 months
Title
Responses to Qualitative Acceptability survey
Description
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.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Proportion of patients screened for breast cancer
Description
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.
Time Frame
6 months
Title
Proportion of patients screened for colorectal cancer
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith M Walsh-Cassidy, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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