Cancer ScreeningNCT03480282
Discussing Stopping Cancer Screening and Prognosis With Older Adults
A study testing Prognosis information and Provider Scripts in people with Cancer Screening, run by Beth Israel Deaconess Medical Center at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 76 to 89 years
- Conditions the study is for
- Cancer Screening
- What is being tested?
- Prognosis information and Provider Scripts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Oct 2017to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 76 to 89 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
BIDMC Affiliated Physicians Group
Boston, Massachusetts, 02215
About this study
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.
Read the 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.
- Conditions
- Cancer Screening
- Being tested
- Prognosis information and Provider Scripts
- Keywords
- Life expectancy, Older adults, Primary care, Cancer screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prognosis information and Provider ScriptsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Prognosis information and Provider Scripts |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start3 Oct 2017
- Primary completion1 Oct 2019
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Mara Schonberg, Beth Israel Deaconess Medical Center
- Investigators
- Mara A Schonberg, MD, MPH, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03480282
- Sponsor's protocol ID
- 2016P000244
- Other IDs
- R21CA212386
- Status last verified
- Jan 2024
- First submitted
- 9 Mar 2018
- Last updated
- 30 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32793815
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discussing Stopping Cancer Screening and Prognosis With Older Adults
- ClinicalTrials.gov ID
- NCT03480282
- Acronym / sponsor ID
- 2016P000244
- Conditions
- Cancer Screening
- Keywords
- Life expectancy, Older adults, Primary care, Cancer screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 3 Oct 2017 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 29 Mar 2018 (actual)
- Results
- Posted 30 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prognosis Information and Provider Scripts | Experimental | Other: Prognosis information and Provider ScriptsInvestigators 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. |
Who may qualify
- Ages
- 76 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prognosis information and Provider ScriptsAn 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. | Other | Prognosis Information and Provider Scripts |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32793815Schonberg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mara A Schonberg, MD, MPH principal investigator
Beth Israel Deaconess Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prognosis information and Provider Scripts in people with Cancer Screening, run by Beth Israel Deaconess Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Intentions to be Screened for Colorectal Cancer. (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03480282, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.