Individualizing Surveillance Mammography for Older Breast Cancer Survivors

Dana-Farber Cancer Institute

Status: Completed

Conditions: Breast Cancer

Treatments: Other: Communication Tool

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03865654

1R21CA227615-01A1 (U.S. NIH Grant/Contract)

19-001

Details and patient eligibility

About

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

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.

Enrollment: 45 patients

Sex: Female

Ages: 75+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Surveillance Mammography Communication Tool

Experimental group

Description:

* 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

Treatment:

Other: Communication Tool