An interventional study of TRIP Patient Navigation Intervention in Cancer, Breast, sponsored by Boston Medical Center. Completed at 5 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by Boston Medical Center · Not applicable, Interventional, and Health services research
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.
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:
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.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's enrollment of 1,725 is above the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Boston Medical Center is the lead sponsor of 323 studies on the registry; 33 are open to participants now.
Of its 34 completed or terminated interventional studies of FDA-regulated products, 28 (82%) have results posted.
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Exclusion Criteria:
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.
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.
Other: TRIP 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.
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
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.
| Milestone | Sequence 1 (Hospital 1) | Sequence 2 (Hospital 2) | Sequence 3 (Hospital 3) | Sequence 4 (Hospital 4) | Sequence 5 (Hospital 5) |
|---|---|---|---|---|---|
| Started | 111 | 38 | 177 | 83 | 141 |
| Completed | 111 | 38 | 177 | 83 | 141 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
| Milestone | Sequence 1 (Hospital 1) | Sequence 2 (Hospital 2) | Sequence 3 (Hospital 3) | Sequence 4 (Hospital 4) | Sequence 5 (Hospital 5) |
|---|---|---|---|---|---|
| Started | 317 | 75 | 372 | 144 | 267 |
| Completed | 317 | 75 | 372 | 144 | 267 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
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.
| days | Control- Usual Care | TRIP Patient Navigation Intervention |
|---|---|---|
| Time-to-treatment Post-diagnosis | 44.78 ± 39.54 | 45.40 ± 33.98 |
Collected over 3 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control- Usual Care | 14/550 (2.5%) | 0/550 (0%) | 0/550 (0%) |
| TRIP Patient Navigation Intervention | 16/1,175 (1.4%) | 0/1,175 (0%) | 0/1,175 (0%) |
| Age, Customized(Participants) | Control- Usual Care | TRIP Patient Navigation Intervention | Total |
|---|---|---|---|
| <50 years | 132 | 293 | 425 |
| 50-64 years | 213 | 483 | 696 |
| 65+ years | 205 | 399 | 604 |
| Sex: Female, Male(Participants) | Control- Usual Care | TRIP Patient Navigation Intervention | Total |
|---|---|---|---|
| Female | 550 | 1175 | 1725 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Control- Usual Care | TRIP Patient Navigation Intervention | Total |
|---|---|---|---|
| Hispanic | 127 | 296 | 423 |
| Nonhispanic White | 91 | 236 | 327 |
| Nonhispanic Black | 243 | 483 | 726 |
| Nonhispanic Asian | 70 | 129 | 199 |
| Other | 4 | 18 | 22 |
| Missing or Unknown | 15 | 13 | 28 |
| Region of Enrollment(Participants) | Control- Usual Care | TRIP Patient Navigation Intervention | Total |
|---|---|---|---|
| United States | 550 | 1175 | 1725 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Individual participant data will not be made available. Participant data will be shared after de-identification and only through aggregate form through publications. Supporting documentation such as the study protocol will be available for review. Data dictionaries are available upon reasonable request.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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