Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05021172
Recruitment Status : Recruiting
First Posted : August 25, 2021
Last Update Posted : August 30, 2021
Sponsor:
Collaborator:
Mount Zion Health Fund
Information provided by (Responsible Party):
University of California, San Francisco

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
Breast Carcinoma Colorectal Carcinoma Other: Best Practice Other: Informational Intervention Other: Questionnaire Administration Other: Survey Administration Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 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 : August 24, 2021
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05021172


Contacts
Layout table for location contacts
Contact: Anita Ponce (415) 476-2860 Anita.Ponce@ucsf.edu

Locations
Layout table for location information
United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Anita Ponce    415-476-2860    Anita.Ponce@ucsf.edu   
Contact    877-827-3222    cancertrials@ucsf.edu   
Principal Investigator: Judith M. Walsh-Cassidy, MD         
Sponsors and Collaborators
University of California, San Francisco
Mount Zion Health Fund
Investigators
Layout table for investigator information
Principal Investigator: Judith M Walsh-Cassidy, MD University of California, San Francisco
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05021172    
Other Study ID Numbers: 21051
NCI-2021-08493 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: August 25, 2021    Key Record Dates
Last Update Posted: August 30, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Carcinoma
Colorectal Neoplasms
Breast Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Breast Diseases
Skin Diseases