Clinical trial NCT03865654: Individualizing Surveillance Mammography for Older Breast Cancer Survivors
Official title: Individualizing Surveillance Mammography for Older Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2019-03-07
Enrollment: 45
Sex: FEMALE
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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)

Primary outcomes:
measure: Rate of Change in Intentions for Mammography in the Next Year
timeFrame: 2 years
Secondary outcomes:
measure: Rate of Satisfaction
timeFrame: 2 years
measure: Preferred Decision-making Role
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Rachel Freedman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.