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Discussing Stopping Cancer Screening and Prognosis With Older Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03480282
Recruitment Status : Active, not recruiting
First Posted : March 29, 2018
Last Update Posted : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
Mara Schonberg, Beth Israel Deaconess Medical Center

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.

Condition or disease Intervention/treatment Phase
Cancer Screening Other: Prognosis information and Provider Scripts Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Discussing Stopping Cancer Screening and Prognosis With Older Adults
Actual Study Start Date : October 3, 2017
Actual Primary Completion Date : October 1, 2019
Estimated Study Completion Date : October 3, 2024

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.
Other: 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.




Primary Outcome Measures :
  1. Intentions to be screened [ Time Frame: 1 week ]
    The investigators will use the paired t-test (or Wilcoxon Signed Rank Test when data are not normal) to examine the effect of the intervention on participants' intentions to be screened.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   76 Years to 89 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03480282


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
BIDMC Affiliated Physicians Group
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: Mara A Schonberg, MD, MPH Beth Israel Deaconess Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mara Schonberg, Principle Investigator - Staff Physician, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT03480282    
Other Study ID Numbers: 2016P000244
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mara Schonberg, Beth Israel Deaconess Medical Center:
Life expectancy
Older adults
Primary care
Cancer screening