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| ID | Type | Description | Link |
|---|---|---|---|
| R21CA212386 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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Guidelines recommend not screening adults with <10-year life expectancy for cancer; however, primary care physicians feel uncomfortable talking to older adults about prognosis. The investigators aim to determine whether providing PCPs with scripts on patient prognosis and older adults with information on their prognosis would be useful when recommending stopping cancer screening.
The American Cancer Society and the American Board of Internal Medicine Choosing Wisely Campaign recommend clinicians not screen older adults who have <10 year life expectancy for breast (specific to women) or colorectal cancer (CRC). This is because these patients have little chance of experiencing the life prolonging benefits of cancer screening and instead may only experience harm from being screened. The most concerning harm of cancer screening is overdiagnosis - the diagnosis and treatment of cancers that otherwise would not have caused problems in an older adult's lifetime. Despite this, around half of adults >75 years with <10 year life expectancy are regularly screened for cancer. One reason for the overuse of these tests is that PCPs feel uncomfortable discussing stopping screening with older adults since it requires estimating and discussing patient prognosis. Some PCPs admit to recommending cancer screening to older adults with short life expectancy simply to avoid talking to patients about prognosis. However, by avoiding these discussions, PCPs may be impeding older adults' ability to make informed decisions about their care and may be putting patients at risk of the harms of cancer screening without any chance of benefit. Therefore, the investigators aim to interview PCPs and older adults about their thoughts and feelings on how PCPs may discuss older adults' prognosis in the context of talking about stopping cancer screening. Based on those findings, the investigators will develop strategies for PCPs to use to approach these discussions and will draft scripts to suggest language for PCPs to use when communicating about prognosis when recommending stopping cancer screening. Then, the investigators will study if providing PCPs with these scripts and information about their patients' prognosis is useful. Specifically, the investigators will provide 45 PCPs with information about their patients' prognosis and the example scripts before a clinic visit for up to 5 of their patients. The investigators aim to recruit 90 patients with approximately 5-10 year life expectancy. The investigators will interview PCPs and older adults after these visits to learn how and/or if the prognostic information and the scripts were used. These data are essential for improving the quality of PCP discussions around stopping cancer screening and will ultimately improve the care of older adults.
Specific Aims:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prognosis Information and Provider Scripts | Experimental | Investigators will send the PCP via secure email the patient's prognosis calculated by the Lee-Schonberg index three days before the patient visit. Investigators will also send PCPs information on patient life expectancy from Cho et al.'s US life tables and scripts developed to sensitively include information on patient prognosis when recommending patients stop being screened for cancer. After five of their patients have participated or recruitment goals are met, investigators will ask PCPs to complete a 10 minute web-based questionnaire about their experience. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prognosis information and Provider Scripts | Other | An individualized report including each patient's prognosis will be calculated by the Lee-Schonberg and will include information on patient life expectancy from Cho et al.'s US life tables. This report will be sent to the PCP three days before the patient visit. Example scripts for PCPs to use with patients when discussing life expectancy and stopping cancer screening will be sent with the patient prognostic information. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Intentions to be Screened for Colorectal Cancer. | Intentions to be screened was measured in a pretest-survey and again within 2 weeks of a PCP visit using the choice/predisposition scale which is measured from 1-15 on a 15 point scale. A score of 1 means that a person does not intend to be screened. A score of 15 means that the person does intend to be screened. A score of 8 means they are unsure. Scores between 2-7 means the person is leaning towards not being screened. A score of 9-14 means that person is leaning towards being screened. We examined the change in intentions to be screened from pretest to the posttest survey. The mean delta was determined at the time of the post-test survey which was completed within two weeks of the PCP visit. | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mara A Schonberg, MD, MPH | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States | ||
| BIDMC Affiliated Physicians Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32793815 | Derived | Schonberg MA, Karamourtopoulos M, Jacobson AR, Aliberti GM, Pinheiro A, Smith AK, Davis RB, Schuttner LC, Hamel MB. A Strategy to Prepare Primary Care Clinicians for Discussing Stopping Cancer Screening With Adults Older Than 75 Years. Innov Aging. 2020 Jul 7;4(4):igaa027. doi: 10.1093/geroni/igaa027. eCollection 2020. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prognosis Information and Provider Scripts | Investigators will send the PCP via secure email the patient's prognosis calculated by the Lee-Schonberg index three days before the patient visit. Investigators will also send PCPs information on patient life expectancy from Cho et al.'s US life tables and scripts developed to sensitively include information on patient prognosis when recommending patients stop being screened for cancer. After five of their patients have participated or recruitment goals are met, investigators will ask PCPs to complete a 10 minute web-based questionnaire about their experience. Prognosis information and Provider Scripts: An individualized report including each patient's prognosis will be calculated by the Lee-Schonberg and will include information on patient life expectancy from Cho et al.'s US life tables. This report will be sent to the PCP three days before the patient visit. Example scripts for PCPs to use with patients when discussing life expectancy and stopping cancer screening will be sent with the patient prognostic information. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Adults aged 76-89 seen at primary care practices in Boston.
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| ID | Title | Description |
|---|---|---|
| BG000 | Prognosis Information and Provider Scripts | Investigators will send the PCP via secure email the patient's prognosis calculated by the Lee-Schonberg index three days before the patient visit. Investigators will also send PCPs information on patient life expectancy from Cho et al.'s US life tables and scripts developed to sensitively include information on patient prognosis when recommending patients stop being screened for cancer. After five of their patients have participated or recruitment goals are met, investigators will ask PCPs to complete a 10 minute web-based questionnaire about their experience. Prognosis information and Provider Scripts: An individualized report including each patient's prognosis will be calculated by the Lee-Schonberg and will include information on patient life expectancy from Cho et al.'s US life tables. This report will be sent to the PCP three days before the patient visit. Example scripts for PCPs to use with patients when discussing life expectancy and stopping cancer screening will be sent with the patient prognostic information. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Intentions to be Screened for Colorectal Cancer. | Intentions to be screened was measured in a pretest-survey and again within 2 weeks of a PCP visit using the choice/predisposition scale which is measured from 1-15 on a 15 point scale. A score of 1 means that a person does not intend to be screened. A score of 15 means that the person does intend to be screened. A score of 8 means they are unsure. Scores between 2-7 means the person is leaning towards not being screened. A score of 9-14 means that person is leaning towards being screened. We examined the change in intentions to be screened from pretest to the posttest survey. The mean delta was determined at the time of the post-test survey which was completed within two weeks of the PCP visit. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks |
|
1 week. Patients completed a pre-test survey 3-12 weeks before a PCP visit and then completed a post-test survey immediately after or within 2 weeks of a primary care visit where they may have discussed stopping cancer screening with their PCP.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prognosis Information and Provider Scripts | Investigators will send the PCP via secure email the patient's prognosis calculated by the Lee-Schonberg index three days before the patient visit. Investigators will also send PCPs information on patient life expectancy from Cho et al.'s US life tables and scripts developed to sensitively include information on patient prognosis when recommending patients stop being screened for cancer. After five of their patients have participated or recruitment goals are met, investigators will ask PCPs to complete a 10 minute web-based questionnaire about their experience. Prognosis information and Provider Scripts: An individualized report including each patient's prognosis will be calculated by the Lee-Schonberg and will include information on patient life expectancy from Cho et al.'s US life tables. This report will be sent to the PCP three days before the patient visit. Example scripts for PCPs to use with patients when discussing life expectancy and stopping cancer screening will be sent with the patient prognostic information. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mara Schonberg | Beth Israel Deaconess Medical Center | 16177541414 | mschonbe@bidmc.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 16, 2019 | Dec 11, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 20, 2019 | Nov 17, 2023 | ICF_001.pdf |
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|
| Boston |
| Massachusetts |
| 02215 |
| United States |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 90 |
| 0 |
| 90 |
| 0 |
| 90 |
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