Breast Cancer
Conditions
Keywords
Breast Cancer, Breast Cancer Survivor, Breast Cancer Survivorship
Brief summary
This study evaluates the effectiveness of a Shared Decision-Making (SDM) toolkit designed to support older breast cancer survivors aged 80 and above in making informed decisions about continuing surveillance mammography.
Detailed description
This study evaluates the effectiveness of a Shared Decision-Making (SDM) toolkit designed to support older breast cancer survivors aged 80 and above in making informed decisions about continuing surveillance mammography. A participant will be placed into one of two groups: Group A: Usual Care vs. Group B: SDM Toolkit according to the randomized placement of the assigned study clinician. Study procedures include questionnaires and option interviews with study staff. Participation in this research study is expected to last about 2 years. It is expected about 52 clinicians and 312 participants will take part in this research study. The National Institute on Aging is providing funding for this research study
Interventions
BEHAVIORALShared Decision-Making Toolkit
The SDM toolkit is designed to support discussions on the continuation of surveillance mammography. It provides evidence-based guidelines, communication strategies, and education materials to aid in personalized decision-making.
Sponsors
Dana-Farber Cancer Institute
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
randomized to having educational material or not.
Intervention model description
Randomized at the clinician level in a 1:1 fashion, stratified by site
Eligibility
Sex/Gender
FEMALE
Age
80 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Participant Inclusion Criteria: * Women aged ≥ 80 years at the time of registration * History of stage 0-III breast cancer (Of note: ductal carcinoma in situ \[DCIS\], pleomorphic lobular carcinoma in situ \[because it is typically treated like DCIS\], or invasive breast cancer of any subtype are all eligible) * No history of a recurrent breast cancer (i.e., a breast cancer that is deemed metastatic or a locoregional recurrence of a prior cancer per clinician judgement rather than a new primary breast cancer). If a person has been diagnosed with multiple distinct breast cancers over time (e.g., history of left and right breast cancer), they are eligible as long as they meet other requirements for time since surgery, etc. * Has at least one intact breast * Has had mammogram screening/surveillance within the last 24 months -≥ 12 months since most recent breast surgery to affected breast (e.g., breast reduction surgery on an unaffected breast within 12 months is ok) * No active cancer-directed therapy other than hormonal therapy and/or CDK 4/6 inhibitor therapy * Ability and willingness to take surveys * Receiving at least some of their oncology follow-up care at a participating site * Most recent mammogram report for the potential participant did not recommend additional diagnostic work-up or close interval follow-up imaging * If a patient required diagnostic breast testing in the past or at the time of the most recent mammogram AND the results were resolved to benign findings with no additional diagnostics recommended, they are eligible. * If a patient's most recent mammogram result isn't yet available at the time of approach or study consent, the patient is eligible to proceed with consent and enrollment. If this mammogram then abnormal or requires additional imaging, that patient will not be included in the study analyses or surveys. This patient will be replaced. Participant
Exclusion criteria
* Inability to provide informed consent * Assigned male sex at birth * Breast or recent imaging findings requiring diagnostic testing at baseline * Prior discontinuation of mammography by electronic medical record (EMR) review or patient report * Prior atypical ductal hyperplasia (ADH) or non-pleomorphic LCIS only * Psychiatric illness situations that would limit compliance with study requirements * Those with metastatic breast cancer * Those in hospice care * Those whose clinician is not willing to participate * Pregnant women, young patients, and those in prison will not be eligible for enrollment given the study design and aims supporting study in a different population focused on older adults Clinician Inclusion Criteria: * Must be an active clinician (MD, NP, or PA) at a participating institution * Sees at least one breast-cancer survivor aged ≥ 80 * Clinician must be able to read, speak, and write in English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mammography Rate | Assessed at 2 years post-enrollment. | Mammography Rate is defined as the proportion of participants that undergo mammography by 2 years post-enrollment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mammography Count | Assessed at 2 years post-enrollment. | Mammography Count is defined as the count of all mammograms each participant underwent during study follow-up. |
| Participant Knowledge Score | Annually through 2 years of follow-up post-enrollment. | Participant Knowledge Score will be defined as the proportion of correct knowledge questions (range: 0 to 1). |
| Participant Decisional Quality Score | Annually through 2 years of follow-up post-enrollment. | Participant Decisional Quality Score will be defined as the sum of response scores (range of 0-4), with each individual response scored 0 or 1. Higher scores indicate higher decisional quality. |
Countries
United States
Contacts
CONTACTRachel Freedman, MD, MPH
PRINCIPAL_INVESTIGATORRachel Freedman, MD, MPH
Dana-Farber Cancer Institute
Outcome results
None listed