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Individualizing Surveillance Mammography for Older Breast Cancer Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03865654
Recruitment Status : Completed
First Posted : March 7, 2019
Results First Posted : August 24, 2022
Last Update Posted : August 24, 2022
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Rachel Freedman, MD, MPH, Dana-Farber Cancer Institute

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

Condition or disease Intervention/treatment Phase
Breast Cancer Other: Communication Tool Not Applicable

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Individualizing Surveillance Mammography for Older Breast Cancer Survivors
Actual Study Start Date : May 16, 2019
Actual Primary Completion Date : July 1, 2021
Actual Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 Other: Communication Tool
Summarizes recommendations for clinicians and patients for surveillance mammography and follow-up care for breast cancer survivors


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03865654


Locations
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United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Rachel Freedman, MD, MPH Dana-Farber Cancer Institute
  Study Documents (Full-Text)

Documents provided by Rachel Freedman, MD, MPH, Dana-Farber Cancer Institute:
Study Protocol  [PDF] July 1, 2020
Statistical Analysis Plan  [PDF] July 1, 2020

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Rachel Freedman, MD, MPH, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03865654    
Other Study ID Numbers: 19-001
1R21CA227615-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 7, 2019    Key Record Dates
Results First Posted: August 24, 2022
Last Update Posted: August 24, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data can be shared no earlier than 1 year following the date of publication.
Access Criteria: BCH - Contact the Technology & Innovation Development Office at www.childrensinnovations.org or email TIDO@childrens.harvard.edu BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu MGH - Contact the Partners Innovations team at http://www.partners.org/innovation

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rachel Freedman, MD, MPH, Dana-Farber Cancer Institute:
Breast Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases