Clinical trial · Interventional
Individualizing Surveillance Mammography for Older Breast Cancer Survivors
NCT03865654CI-TRIAL-00060519completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This research is being conducted to develop consensus on surveillance mammography and follow-up for breast cancer survivors who are age ≥75.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Communication Tool | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Surveillance Mammography Communication Tool
- 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
- interventionNames
- Other: Communication Tool
Primary outcomes (1)
- measure
- Rate of Change in Intentions for Mammography in the Next Year
- timeFrame
- 2 years
- description
- Survey measure on whether mammography will be done or not
Secondary outcomes (2)
- measure
- Rate of Satisfaction
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 75 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDFreedman 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 35908120