Breast Cancer
Conditions
Keywords
Breast Cancer
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.
Interventions
OTHERCommunication Tool
Summarizes recommendations for clinicians and patients for surveillance mammography and follow-up care for breast cancer survivors
Sponsors
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Dana-Farber Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
75 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Change in Intentions for Mammography in the Next Year | 2 years | Survey measure on whether mammography will be done or not |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Satisfaction | 2 years | Survey asking about satisfaction with the tool |
| Preferred Decision-making Role | 2 years | Survey on preferred decision-making style |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
Communication Tool: Summarizes recommendations for clinicians and patients for surveillance mammography and follow-up care for breast cancer survivors | 45 |
| Total | 45 |
Baseline characteristics
| Characteristic | Surveillance Mammography Communication Tool |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 45 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 43 Participants |
| Region of Enrollment United States | 45 participants |
| Sex: Female, Male Female | 45 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Rate of Change in Intentions for Mammography in the Next Year
Survey measure on whether mammography will be done or not
Time frame: 2 years
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Surveillance Mammography Communication Tool | Rate of Change in Intentions for Mammography in the Next Year | Intention to undergo mammogram | 39 Participants |
| Surveillance Mammography Communication Tool | Rate of Change in Intentions for Mammography in the Next Year | Intention to not undergo mammogram | 1 Participants |
Secondary
Preferred Decision-making Role
Survey on preferred decision-making style
Time frame: 2 years
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Surveillance Mammography Communication Tool | Preferred Decision-making Role | I prefer to make the final decision. | 14 Participants |
| Surveillance Mammography Communication Tool | Preferred Decision-making Role | I prefer to make the final decision after seriously considering my health care provider's opinion. | 15 Participants |
| Surveillance Mammography Communication Tool | Preferred Decision-making Role | I prefer that my health care provider and I share responsibility for deciding . | 13 Participants |
| Surveillance Mammography Communication Tool | Preferred Decision-making Role | I prefer that my health care provider makes the final decision, but seriously considers my opinion. | 3 Participants |
Secondary
Rate of Satisfaction
Survey asking about satisfaction with the tool
Time frame: 2 years
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Surveillance Mammography Communication Tool | Rate of Satisfaction | Tool was very, somewhat, or a little helpful | 31 Participants |
| Surveillance Mammography Communication Tool | Rate of Satisfaction | Tool was not help | 6 Participants |
| Surveillance Mammography Communication Tool | Rate of Satisfaction | Did not respond | 3 Participants |