- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03480282
Discussing Stopping Cancer Screening and Prognosis With Older Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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:
- To learn from PCPs and older adults about how to discuss patient prognosis when recommending stopping cancer screening and to develop strategies for having these discussions.
- To study whether providing information on patient prognosis and scripts for discussing patient prognosis when recommending stopping cancer screening are useful to PCPs and older adults.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, United States, 02215
- BIDMC Affiliated Physicians Group
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- English-speaking
- Aged 76 to 89 years
- Scheduled for a routine visit or physical with their PCP in the next 3-12 weeks
- Patient aged 76-79 must have a least one Charlson Comorbidity
- Patient must have undergone CRC screening within the last 10 years
- Women only: patient must have undergone mammography screening within the last 3 years
Exclusion Criteria:
- older adults with dementia
- older adults with a history of colon cancer
- older adults whose last colonoscopy was read as abnormal
- older women who have a history of breast cancer
- older adults whose PCP has already had 5 patients participate in the study
- older women whose last mammogram was read as abnormal
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Intentions to be Screened for Colorectal Cancer.
Time Frame: 2 weeks
|
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.
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2 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Discussion of stopping cancer screening and prognosis
Time Frame: 1 week
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The investigators will report how many patients reported that their PCPs discussed stopping cancer screening and/or their prognosis
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1 week
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Perception of discussions
Time Frame: 1 week
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The investigators will report the patient perceptions of conversations that they had with their PCPs about stopping cancer screening and/or their prognosis
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1 week
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Prognostic information acceptability
Time Frame: 1 week
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The investigators will report whether PCPs found prognostic information useful and/or helpful [very, somewhat, a little, not at all] after using the intervention.
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1 week
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PCP Facilitators
Time Frame: 1 week
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The investigators will examine facilitators noted by PCPs when using the prognostic tools and scripts to discuss stopping cancer screening and life expectancy with older adult patients.
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1 week
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PCP Barriers
Time Frame: 1 week
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The investigators will examine barriers noted by PCPs when using the prognostic tools and scripts to discuss stopping cancer screening and life expectancy with older adult patients.
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1 week
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Difference in PCP experiences
Time Frame: Up to 18 months
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The investigators will report differences by sex and practice site (BIDMC/APG) of PCPs by using a chi-square test.
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Up to 18 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Mara A Schonberg, MD, MPH, Beth Israel Deaconess Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2016P000244
- R21CA212386 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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