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Individualizing Surveillance Mammography for Older Breast Cancer Survivors

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Communication Tool
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Breast Cancer focused on measuring Breast Cancer

Eligibility Criteria

75 Years - undefined (Older Adult)FemaleDoes not accept 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)

Sites / Locations

  • Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Surveillance Mammography Communication Tool

Arm 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

Outcomes

Primary Outcome Measures

Rate of Change in Intentions for Mammography in the Next Year
Survey measure on whether mammography will be done or not

Secondary Outcome Measures

Rate of Satisfaction
Survey asking about satisfaction with the tool
Preferred Decision-making Role
Survey on preferred decision-making style

Full Information

First Posted
March 5, 2019
Last Updated
August 1, 2022
Sponsor
Dana-Farber Cancer Institute
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03865654
Brief Title
Individualizing Surveillance Mammography for Older Breast Cancer Survivors
Official Title
Individualizing Surveillance Mammography for Older Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 16, 2019 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
July 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surveillance Mammography Communication Tool
Arm Type
Experimental
Arm 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
Intervention Type
Other
Intervention Name(s)
Communication Tool
Intervention Description
Summarizes recommendations for clinicians and patients for surveillance mammography and follow-up care for breast cancer survivors
Primary Outcome Measure Information:
Title
Rate of Change in Intentions for Mammography in the Next Year
Description
Survey measure on whether mammography will be done or not
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Rate of Satisfaction
Description
Survey asking about satisfaction with the tool
Time Frame
2 years
Title
Preferred Decision-making Role
Description
Survey on preferred decision-making style
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Freedman, MD, MPH
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication.
IPD Sharing 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
Citations:
PubMed Identifier
35908120
Citation
Freedman RA, Revette AC, Gagnon H, Perilla-Glen A, Kokoski M, Hussein SO, Leone E, Hixon N, Lovato R, Loeser W, Lin NU, Minami CA, Canin B, LeStage B, Faggen M, Poorvu PD, McKenna J, Ruddy KJ, Keating NL, Schonberg MA. Acceptability of a companion patient guide to support expert consensus guidelines on surveillance mammography in older breast cancer survivors. Breast Cancer Res Treat. 2022 Sep;195(2):141-152. doi: 10.1007/s10549-022-06676-3. Epub 2022 Jul 30.
Results Reference
derived

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Individualizing Surveillance Mammography for Older Breast Cancer Survivors

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