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Completed

NCT Number: NCT03865654

Individualizing Surveillance Mammography for Older Breast Cancer Survivors

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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Key information

Age range

75 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Communication Tool

Other

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

Primary outcomes

  1. Rate of Change in Intentions for Mammography in the Next Year

    Time frame: 2 years

    Survey measure on whether mammography will be done or not

Secondary outcomes

  1. Rate of Satisfaction

    Time frame: 2 years

    Survey asking about satisfaction with the tool

  2. Preferred Decision-making Role

    Time frame: 2 years

    Survey on preferred decision-making style

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 7, 2019
Registry last updated
Aug 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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