Cancer, Breast
Conditions
Keywords
Patient Navigation, Disparity, Social Determinants
Brief summary
The TRIP Project aims to overcome barriers to widespread implementation and dissemination of evidence-based practices that will improve the delivery of guideline-concordant care to vulnerable women with breast cancer. To accomplish this goal the study team will create (a) regional patient registries; (b) systematic screening for social barriers to care with a personalized referral plan; and (c) patient navigation services that integrate into one model of care to improve the quality and effectiveness of care delivery, for minority and/or low-income women with breast cancer in Boston.
Detailed description
This community-engaged program will demonstrate the feasibility of community-academic partnerships to provide innovations in information sharing and systems implementation targeted to reduce treatment disparities. Patient navigators will be able to utilize the patient database to track their patients throughout their treatment, and receive guidance regarding recommended social resources to patients experiencing hardships via the social determinants platform. Who: The four Massachusetts Clinical and Translational Science Award (CTSA) hubs (Boston University, Harvard University, Tufts University, and University of Massachusetts) partnered with the Boston Breast Cancer Equity Coalition, and the 5 hospitals that care for women with breast cancer. Patient population: about 1,300 vulnerable inner city women with risk for delay in breast cancer care. Massachusetts (MA) Cancer Registry data identified the following characteristics of Boston residents with greatest delays in breast cancer treatment: Black, Hispanic, non-English speaking, and public health insurance. Five health care institutions care for \>90% of these women: 1. Beth Israel Deaconess Medical Center (site PI: Ted James, MD) 2. Boston Medical Center (PI: Tracy Battaglia MD, MPH) 3. Brigham Women's Hospital/Dana-Farber Cancer Institute (PI: Jennifer Haas MD, MPH) 4. Massachusetts General Hospital (site PI: Beverly Moy, MD) 5. Tufts Medical Center (PI: Karen Freund MD, MPH) University of Massachusetts Medical Center (PI: Stephenie Lemon, PhD) will play an integral role in the planning and implementation of the TRIP intervention but is not a clinical site.
Interventions
OTHERTRIP Patient Navigation Intervention
The TRIP intervention will replace the current standard of care at the 5 participating hospitals once it is rolled out on-site. Any TRIP eligible patients receiving patient navigation services over the course of the study will receive the enhanced services.
Sponsors
Boston University
University of Massachusetts, Worcester
Beth Israel Deaconess Medical Center
Tufts Medical Center
Dana-Farber Cancer Institute
Massachusetts General Hospital
National Center for Advancing Translational Sciences (NCATS)
Boston Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Intervention model description
A randomized cluster stepped wedge design will be conducted. This pragmatic design involves a sequential, randomized roll-out of the intervention across 5 participating clinical sites or clusters over 3 month intervals or steps. Consistent with a stepped wedge design with one cluster per step, prior to the collection of data in the pre-intervention period, the investigators will generate a set of uniform random numbers for each of the five clusters to assign a starting period for the study intervention. There will be no crossover of patients from usual care to the intervention. That is, patients at each site during the pre-intervention period will experience only usual care and will act as historical controls and those enrolled after the initiation of intervention will experience the intervention.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. are an adult female 18 years of age or older; 2. reside within 25 miles of the City of Boston; 3. have any of the following risk factors for delays in care: are Black and/or Hispanic ethnicity, do not speak English as their primary language, and/or have only public insurance or are uninsured at the time of diagnosis.
Exclusion criteria
1. cancer diagnosis made \> 60 days prior to enrollment, such that the ability of the intervention to effect the outcome is limited; 2. presence of a cognitive impairment such as dementia or delirium from any cause (e.g. metabolic, medication or drug induced), given the unique challenges to their treatment decision making/ adherence and the fact that the intervention would not include the patient directly, but rather the family; 3. home residence is outside of the city of Boston, Massachusetts.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time-to-treatment Post-diagnosis | Within 365 days of enrollment | The receipt of care will be defined as initiation of care within 365 days. This will be a continuous outcome defined as the number of days from definitive tissue biopsy (Time 0) to treatment initiation (Time 1). Treatment initiation is defined as the date of first cancer treatment: surgical, radiation, or systemic therapy (including chemotherapy, immunotherapy, targeted therapy, hormonal therapy). Time to treatment initiation can take any value from 0 days to 365 days (study period). The clinical outcome will be derived from data in the patient's medical record. |
Countries
United States
Participant flow
Recruitment details
Participants are newly diagnosed breast oncology patients at one of the five participating clinical sites. Over 18 months in a stepped wedge design sites were randomized to the time they began to implement the intervention, with a new site initiating the intervention about every 3 months. Control- Usual Care data from each serves as the comparison.
Participants by arm
| Arm | Count |
|---|---|
| Control- Usual Care This study will be utilizing electronic health record data to identify patients that match the TRIP eligibility criteria and received patient navigation prior to study rollout. These patients will receive standard patient navigation at their care site and will act as controls in comparison to the TRIP experimental group. | 550 |
| TRIP Patient Navigation Intervention This study will be enhancing current patient navigation at the participating 5 hospitals with the 3 components of the TRIP intervention (a shared patient registry, a social determinants of health platform, and additional training and support for Patient Navigators). All patients that are identified as TRIP eligible will receive these intervention benefits and will be categorized into the experimental arm of the study.
TRIP Patient Navigation Intervention: The TRIP intervention will replace the current standard of care at the 6 participating hospitals once it is rolled out on-site. Any TRIP eligible patients receiving patient navigation services over the course of the study will receive the enhanced services. | 1,175 |
| Total | 1,725 |
Baseline characteristics
| Characteristic | Control- Usual Care | TRIP Patient Navigation Intervention | Total |
|---|---|---|---|
| Age, Customized 50-64 years | 213 Participants | 483 Participants | 696 Participants |
| Age, Customized <50 years | 132 Participants | 293 Participants | 425 Participants |
| Age, Customized 65+ years | 205 Participants | 399 Participants | 604 Participants |
| Race/Ethnicity, Customized Hispanic | 127 Participants | 296 Participants | 423 Participants |
| Race/Ethnicity, Customized Missing or Unknown | 15 Participants | 13 Participants | 28 Participants |
| Race/Ethnicity, Customized Nonhispanic Asian | 70 Participants | 129 Participants | 199 Participants |
| Race/Ethnicity, Customized Nonhispanic Black | 243 Participants | 483 Participants | 726 Participants |
| Race/Ethnicity, Customized Nonhispanic White | 91 Participants | 236 Participants | 327 Participants |
| Race/Ethnicity, Customized Other | 4 Participants | 18 Participants | 22 Participants |
| Region of Enrollment United States | 550 Participants | 1175 Participants | 1725 Participants |
| Sex: Female, Male Female | 550 Participants | 1175 Participants | 1725 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 14 / 550 | 16 / 1,175 |
| other Total, other adverse events | 0 / 550 | 0 / 1,175 |
| serious Total, serious adverse events | 0 / 550 | 0 / 1,175 |
Outcome results
Primary
Time-to-treatment Post-diagnosis
The receipt of care will be defined as initiation of care within 365 days. This will be a continuous outcome defined as the number of days from definitive tissue biopsy (Time 0) to treatment initiation (Time 1). Treatment initiation is defined as the date of first cancer treatment: surgical, radiation, or systemic therapy (including chemotherapy, immunotherapy, targeted therapy, hormonal therapy). Time to treatment initiation can take any value from 0 days to 365 days (study period). The clinical outcome will be derived from data in the patient's medical record.
Time frame: Within 365 days of enrollment
Population: Data were available for 529 of the 550 controls and 1151 of the 1175 participants in the intervention group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control- Usual Care | Time-to-treatment Post-diagnosis | 44.78 days | Standard Deviation 39.54 |
| TRIP Patient Navigation Intervention | Time-to-treatment Post-diagnosis | 45.40 days | Standard Deviation 33.98 |