Breast Carcinoma, Colorectal Carcinoma
Conditions
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.
Interventions
OTHERBest Practice
Receive usual care
OTHERInformational Intervention
Receive Passport to Health booklet
OTHERQuestionnaire Administration
Complete ePrognosis
OTHERSurvey Administration
Ancillary studies
Sponsors
Mount Zion Health Fund
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Responses to Qualitative Acceptability survey | 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 participants who received an ePrognosis report | 6 months | The proportion of participants who received an ePrognosis report will be reported |
| Proportion of physicians who utilized the ePrognosis clinician report | 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 |
| Proportion of participants enrolled | 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 | 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 | 6 months | The investigators aim to attain at least 75% of recruited patients in each arm at the 6 month follow-up. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients screened for colorectal cancer | 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. |
| Proportion of patients screened for breast cancer | 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. |
Countries
United States
Outcome results
None listed