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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-08493 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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| Name | Class |
|---|---|
| Mount Zion Health Fund | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (Passport to Health booklet, ePrognosis) | Experimental | Participants receive Passport to Health booklet and complete ePrognosis before scheduled primary care visit. |
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| Arm II (usual care) | Active Comparator | Participants receive usual care before scheduled primary care visit. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive usual care |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 6 months |
| Proportion of participants who received an ePrognosis report | The proportion of participants who received an ePrognosis report will be reported | 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 | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Proportion of patients screened for colorectal cancer |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judith M Walsh-Cassidy, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94143 | United States |
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| Informational Intervention | Other | Receive Passport to Health booklet |
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| Questionnaire Administration | Other | Complete ePrognosis |
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| Survey Administration | Other | Ancillary studies |
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| 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. |
| 6 months |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
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