NCT03480282

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 3, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

January 30, 2024

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

2 years

First QC Date

March 9, 2018

Results QC Date

November 17, 2023

Last Update Submit

January 22, 2024

Conditions

Keywords

Life expectancyOlder adultsPrimary careCancer screening

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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.

Other: Prognosis information and Provider Scripts

Interventions

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.

Prognosis Information and Provider Scripts

Eligibility Criteria

Age76 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

BIDMC Affiliated Physicians Group

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • 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.

Results Point of Contact

Title
Mara Schonberg
Organization
Beth Israel Deaconess Medical Center

Study Officials

  • Mara A Schonberg, MD, MPH

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator - Staff Physician

Study Record Dates

First Submitted

March 9, 2018

First Posted

March 29, 2018

Study Start

October 3, 2017

Primary Completion

October 1, 2019

Study Completion

October 1, 2021

Last Updated

January 30, 2024

Results First Posted

January 30, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations