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Discussing Stopping Cancer Screening and Prognosis With Older Adults

Discussing Stopping Cancer Screening and Prognosis With Older Adults

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03480282
Enrollment
90
Registered
2018-03-29
Start date
2017-10-03
Completion date
2021-10-01
Last updated
2024-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Screening

Keywords

Life expectancy, Older adults, Primary care, Cancer screening

Brief summary

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.

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: 1. 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. 2. 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.

Interventions

OTHERPrognosis 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.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Beth Israel Deaconess Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
76 Years to 89 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Intentions to be Screened for Colorectal Cancer.2 weeksIntentions 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
90
Total90

Baseline characteristics

CharacteristicPrognosis Information and Provider Scripts
Age, Continuous80.0 years
STANDARD_DEVIATION 2.9
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
11 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
79 Participants
Region of Enrollment
United States
90 participants
Sex: Female, Male
Female
43 Participants
Sex: Female, Male
Male
47 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 90
other
Total, other adverse events
0 / 90
serious
Total, serious adverse events
0 / 90

Outcome results

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.

Time frame: 2 weeks

ArmMeasureValue (MEAN)Dispersion
Prognosis Information and Provider ScriptsChange in Intentions to be Screened for Colorectal Cancer.2.5 score on a scaleStandard Deviation 1.9
Comparison: This was an exploratory and descriptive study to learn if it was feasible to provide PCPs with their patients (aged 76-89) with information about their 10-year prognosis and engage in shared decision making around stopping screening. We measured among the 90 patients that the 45 PCPs saw whether their intentions to be screened declined after seeing their PCP.p-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: This was a descriptive feasibility study.p-value: <0.001Wilcoxon (Mann-Whitney)

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026