N/A
N=45
Individualizing Surveillance Mammography for Older Breast Cancer Survivors
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03865654 ↗Enrolled (actual)
45
Serious AEs
—
Results posted
Aug 2022
Primary outcome: Primary: Rate of Change in Intentions for Mammography in the Next Year — 39; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Communication Tool (Other)
- Age
- Older Adult · 75+ yrs
- Sex
- Female
- Sponsor
- Dana-Farber Cancer Institute
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Change in Intentions for Mammography in the Next Year |
39; 1 | — |
| SECONDARY Rate of Satisfaction |
31; 6; 3 | — |
| SECONDARY Preferred Decision-making Role |
14; 15; 13; 3 | — |
Summary
This research is being conducted to develop consensus on surveillance mammography and follow-up for breast cancer survivors who are age ≥75.
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)
Data sourced from ClinicalTrials.gov (NCT03865654). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.