Incorporating ePrognosis for the Encouragement of Smarter Screening for Breast and Colorectal Cancer in Older Adults
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|ClinicalTrials.gov Identifier: NCT05021172|
Recruitment Status : Recruiting
First Posted : August 25, 2021
Last Update Posted : August 30, 2021
|Condition or disease||Intervention/treatment||Phase|
|Breast Carcinoma Colorectal Carcinoma||Other: Best Practice Other: Informational Intervention Other: Questionnaire Administration Other: Survey Administration||Not Applicable|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
Active Comparator: Arm II (usual care)
Participants receive usual care before scheduled primary care visit.
Other: Best Practice
Receive usual care
Other: Survey Administration
- 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.
- 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.
- 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.
- Proportion of participants who received an ePrognosis report [ Time Frame: 6 months ]The proportion of participants who received an ePrognosis report will be reported
- 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
- 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.
- 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.
- 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.
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
|Contact: Anita Ponce||(415) 476-2860||Anita.Ponce@ucsf.edu|
|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 email@example.com|
|Principal Investigator: Judith M. Walsh-Cassidy, MD|
|Principal Investigator:||Judith M Walsh-Cassidy, MD||University of California, San Francisco|