An interventional study of Best Practice and Informational Intervention in Breast Carcinoma and Colorectal Carcinoma, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 70 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-11.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Screening
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.
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 75 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants receive Passport to Health booklet and complete ePrognosis before scheduled primary care visit.
Other: Informational Intervention · Other: Questionnaire Administration
Participants receive usual care before scheduled primary care visit.
Other: Best Practice · Other: Survey Administration
Receive usual care
Also known as: standard of care, standard therapy
Receive Passport to Health booklet
Complete ePrognosis
Ancillary studies
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
Proportion of participants who received an ePrognosis report
The proportion of participants who received an ePrognosis report will be reported
Time frame: 6 months
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
Time frame: 6 months
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.
Time frame: 6 months
Proportion of patients screened for breast cancer
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
Proportion of patients screened for colorectal cancer
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
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco