Individualizing Surveillance Mammography for Older Breast Cancer Survivors

• 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: Dana-Farber Cancer Institute
• Collaborators: National Institutes of Health (NIH); National Cancer Institute (NCI)
• Information provided by (Responsible Party): Rachel Freedman, MD, MPH, Dana-Farber Cancer Institute

Tracking Information

• First Submitted Date: March 5, 2019
• First Posted Date: March 7, 2019
• Results First Submitted Date: June 21, 2022
• Results First Posted Date: August 24, 2022
• Last Update Posted Date: August 24, 2022
• Actual Study Start Date: May 16, 2019
• Actual Primary Completion Date: July 1, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 1, 2022)

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

Original Primary Outcome Measures (submitted: March 5, 2019)

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

Current Secondary Outcome Measures (submitted: August 1, 2022)

• Rate of Satisfaction [ Time Frame: 2 years ]
  Survey asking about satisfaction with the tool
• Preferred Decision-making Role [ Time Frame: 2 years ]
  Survey on preferred decision-making style

Original Secondary Outcome Measures (submitted: March 5, 2019)

• Rate of satisfaction [ Time Frame: 2 years ]
  Survey asking about satisfaction with the tool
• Preferred decision-making role [ Time Frame: 2 years ]
  Survey on preferred decision-making style

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Individualizing Surveillance Mammography for Older Breast Cancer Survivors
• Official Title: Individualizing Surveillance Mammography for Older Breast Cancer Survivors
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research
• Condition: Breast Cancer

Intervention

Other: Communication Tool

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

Study Arms

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

Intervention: Other: Communication Tool

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 5, 2019): 45
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: July 1, 2021
• Actual Primary Completion Date: July 1, 2021 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 75 Years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03865654
• Other Study ID Numbers: 19-001; 1R21CA227615-01A1 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

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
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: 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

• Current Responsible Party: Rachel Freedman, MD, MPH, Dana-Farber Cancer Institute
• Original Responsible Party: Same as current
• Current Study Sponsor: Dana-Farber Cancer Institute
• Original Study Sponsor: Same as current

Collaborators

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

Investigators

• Principal Investigator: Rachel Freedman, MD, MPH; Dana-Farber Cancer Institute

• PRS Account: Dana-Farber Cancer Institute
• Verification Date: August 2022