Individualizing Surveillance Mammography for Older Breast Cancer Survivors

Breast Cancer Clinical Trial

Official title:

Individualizing Surveillance Mammography for Older Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03865654
• Other study ID #: 19-001
• Secondary ID: 1R21CA227615-01A
• Status: Completed
• Phase: N/A
• Start date: May 16, 2019
• Est. completion date: July 1, 2021

Study information

• Verified date: August 2022
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 75 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Communication Tool
Summarizes recommendations for clinicians and patients for surveillance mammography and follow-up care for breast cancer survivors

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Change in Intentions for Mammography in the Next Year	Survey measure on whether mammography will be done or not	2 years
Secondary	Rate of Satisfaction	Survey asking about satisfaction with the tool	2 years
Secondary	Preferred Decision-making Role	Survey on preferred decision-making style	2 years