Individualizing Surveillance Mammography for Older Breast Cancer Survivors

NCT ID: NCT03865654

Last Updated: 2022-08-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-16

Study Completion Date

2021-07-01

Brief Summary

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This research is being conducted to develop consensus on surveillance mammography and follow-up for breast cancer survivors who are age ≥75.

Detailed Description

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The investigators will develop a communication tool that summarizes recommendations for clinicians and patients for surveillance mammography and follow-up care for breast cancer survivors age ≥75. Developing expert-panel recommendations, examining clinician and patient attitudes towards these recommendations, and testing a strategy for communication of expert recommendations on mammography cessation through direct engagement of specialists, primary care clinicians (PCs), and patients.

This is a multi-step study, the investigators will build on prior steps to develop consensus on surveillance mammography and follow-ups for breast cancer survivors who are age \>= 75.

This study includes a physician focus group.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Surveillance Mammography Communication Tool

* Conduct 30 telephone-based patient interviews
* 4-6 focus groups with oncologists and primary care providers (PCs) to learn their perceptions and thoughts about when to stop surveillance mammography
* Perform cognitive testing of the communication tool

Group Type EXPERIMENTAL

Communication Tool

Intervention Type OTHER

Summarizes recommendations for clinicians and patients for surveillance mammography and follow-up care for breast cancer survivors

Interventions

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Communication Tool

Summarizes recommendations for clinicians and patients for surveillance mammography and follow-up care for breast cancer survivors

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Female gender, given that screening guidelines do not exist for men
* Receiving part or all of their care at DFCI
* Ages 75-79 (approximately 15 patients)
* Age ≥80 (approximately 15 patients)
* History of stage 0-II breast cancer

-≥1 Charlson comorbidity present72, defined as one of the following:
* Diabetes
* Liver disease
* History of or other active malignancy other than non-melanoma skin cancers
* HIV or AIDS
* Chronic kidney disease
* History of myocardial infarction and/or congestive heart failure
* Chronic lung disease (emphysema/chronic bronchitis/chronic obstructive pulmonary disease \[COPD\], interstitial lung disease)
* Peripheral vascular disease
* Cerebrovascular disease (history of TIA or stroke)
* Dementia
* Hemiplegia/paralysis
* Connective tissue disorder
* Underwent breast conserving surgery for treatment of this cancer
* Completed all active breast cancer therapy \>3 months prior to enrollment (i.e. any chemotherapy, trastuzumab, radiation). Ongoing hormonal therapy or enrollment in survivorship clinical trials (aspirin, exercise, etc) is allowed.
* English-speaking and reading (for this initial work)
* Aim 1.1. Cognitive testing of the communication tool. The criteria for this are intentionally more flexible than in other aims, as we are simply working to initially test the tool and its readability and understandability. Patients will be eligible to cognitively test the tool if they meet the following criteria:
* Female gender
* Previous diagnosis of breast cancer
* Age ≥75
* Receive some/all care at Dana-Farber Cancer Institute
* English speaking-reading
* Aim 1.2. Pilot testing the communication tool in clinic.
* Previous diagnosis of stage 0-II breast cancer
* Receive some/all care at Dana-Farber Cancer Institute (main campus or St. Elizabeth's site)
* Completed any active breast cancer therapy \> 3 months prior to enrollment (i.e. any chemotherapy, trastuzumab, radiation). Ongoing hormonal therapy or enrollment in survivorship clinical trials (aspirin, exercise, etc) is allowed.
* Age ≥75
* Had breast-conserving surgery to treat this cancer

-≥1 the following comorbid conditions72 present, defined as the following:
* Diabetes
* Liver disease
* History of or other active malignancy other than non-melanoma skin cancers
* HIV or AIDS
* Chronic kidney disease
* History of myocardial infarction and/or congestive heart failure
* Chronic lung disease (COPD, interstitial lung disease)
* Peripheral vascular disease
* Cerebrovascular disease (history of TIA or stroke)
* Dementia
* Hemiplegia/paralysis
* Connective tissue disorder
* Provider does not opt out of the patient's enrollment via email notification
* Blessed Orientation Memory Concentration (COMC) score is \<10 and capacity is met73 (see Appendix A for BOMC scale)
* Providers of participating patients will be sent a one-time survey but there are no other eligibility for providers to participate in this other than their patient participated
* English speaking and reading

Exclusion Criteria

* Are unable to consent
* Who do not read and write English (for this initial pilot)
Minimum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Rachel Freedman, MD, MPH

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rachel Freedman, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

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Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Freedman RA, Revette AC, Gagnon H, Perilla-Glen A, Kokoski M, Hussein SO, Leone E, Hixon N, Lovato R, Loeser W, Lin NU, Minami CA, Canin B, LeStage B, Faggen M, Poorvu PD, McKenna J, Ruddy KJ, Keating NL, Schonberg MA. Acceptability of a companion patient guide to support expert consensus guidelines on surveillance mammography in older breast cancer survivors. Breast Cancer Res Treat. 2022 Sep;195(2):141-152. doi: 10.1007/s10549-022-06676-3. Epub 2022 Jul 30.

Reference Type DERIVED
PMID: 35908120 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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1R21CA227615-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-001

Identifier Type: -

Identifier Source: org_study_id

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