Individualizing Surveillance Mammography for Older Breast Cancer Survivors
2 other identifiers
interventional
45
1 country
1
Brief Summary
This research is being conducted to develop consensus on surveillance mammography and follow-up for breast cancer survivors who are age ≥75.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable breast-cancer
Started May 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2019
CompletedFirst Posted
Study publicly available on registry
March 7, 2019
CompletedStudy Start
First participant enrolled
May 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedResults Posted
Study results publicly available
August 24, 2022
CompletedAugust 24, 2022
August 1, 2022
2.1 years
March 5, 2019
June 21, 2022
August 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of Change in Intentions for Mammography in the Next Year
Survey measure on whether mammography will be done or not
2 years
Secondary Outcomes (2)
Rate of Satisfaction
2 years
Preferred Decision-making Role
2 years
Study Arms (1)
Surveillance Mammography Communication Tool
EXPERIMENTAL* 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
Interventions
Summarizes recommendations for clinicians and patients for surveillance mammography and follow-up care for breast cancer survivors
Eligibility Criteria
You may qualify if:
- 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)
- +35 more criteria
You may not qualify if:
- Are unable to consent
- Who do not read and write English (for this initial pilot)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- National Institutes of Health (NIH)collaborator
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Related Publications (1)
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.
PMID: 35908120DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Rachel Freedman, M.D., M.P.H.
- Organization
- Dana-Farber Cancer Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Rachel Freedman, MD, MPH
Dana-Farber Cancer Institute
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 5, 2019
First Posted
March 7, 2019
Study Start
May 16, 2019
Primary Completion
July 1, 2021
Study Completion
July 1, 2021
Last Updated
August 24, 2022
Results First Posted
August 24, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, 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
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