Breast Cancer Clinical Trial

Individualizing Surveillance Mammography for Older Breast Cancer Survivors

Summary

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

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Full Description

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.

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Eligibility Criteria

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)

Study is for people with:

Breast Cancer

Estimated Enrollment:

45

Study ID:

NCT03865654

Recruitment Status:

Completed

Sponsor:

Dana-Farber Cancer Institute

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There is 1 Location for this study

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Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

45

Study ID:

NCT03865654

Recruitment Status:

Completed

Sponsor:


Dana-Farber Cancer Institute

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