Discussing Stopping Cancer Screening and Prognosis With Older Adults

January 22, 2024 updated by: Mara Schonberg, Beth Israel Deaconess Medical Center
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02215
        • BIDMC Affiliated Physicians Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

76 years to 89 years (Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.

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.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discussion of stopping cancer screening and prognosis
Time Frame: 1 week
The investigators will report how many patients reported that their PCPs discussed stopping cancer screening and/or their prognosis
1 week
Perception of discussions
Time Frame: 1 week
The investigators will report the patient perceptions of conversations that they had with their PCPs about stopping cancer screening and/or their prognosis
1 week
Prognostic information acceptability
Time Frame: 1 week
The investigators will report whether PCPs found prognostic information useful and/or helpful [very, somewhat, a little, not at all] after using the intervention.
1 week
PCP Facilitators
Time Frame: 1 week
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.
1 week
PCP Barriers
Time Frame: 1 week
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.
1 week
Difference in PCP experiences
Time Frame: Up to 18 months
The investigators will report differences by sex and practice site (BIDMC/APG) of PCPs by using a chi-square test.
Up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mara A Schonberg, MD, MPH, Beth Israel Deaconess Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2017

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

October 1, 2021

Study Registration Dates

First Submitted

March 9, 2018

First Submitted That Met QC Criteria

March 21, 2018

First Posted (Actual)

March 29, 2018

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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