Cancer, BreastTRIPNCT03514433
Translating Research Into Practice: Patient Navigation for Breast Cancer
A study testing TRIP Patient Navigation Intervention in people with Cancer, Breast, run by Boston Medical Center at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cancer, Breast
- What is being tested?
- TRIP Patient Navigation Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,725 participants
- Where
- 5 sitesUnited States
- Study dates
- 5 Aug 2016to 22 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- are an adult female 18 years of age or older;
- reside within 25 miles of the City of Boston;
- 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.
Who cannot join
- cancer diagnosis made > 60 days prior to enrollment, such that the ability of the intervention to effect the outcome is limited;
- 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;
- home residence is outside of the city of Boston, Massachusetts.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Tufts Medical Center
Boston, Massachusetts, 02111
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston Medical Center
Boston, Massachusetts, 02118
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: Translating Research Into Practice: A Regional Collaborative to Reduce Disparities in Breast Cancer Care
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.
Read the 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:
- Beth Israel Deaconess Medical Center (site PI: Ted James, MD)
- Boston Medical Center (PI: Tracy Battaglia MD, MPH)
- Brigham Women's Hospital/Dana-Farber Cancer Institute (PI: Jennifer Haas MD, MPH)
- Massachusetts General Hospital (site PI: Beverly Moy, MD)
- 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.
- Conditions
- Cancer, Breast
- Being tested
- TRIP Patient Navigation Intervention
- Keywords
- Patient Navigation, Disparity, Social Determinants
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRIP Patient Navigation InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control- Usual Care | No intervention | 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. |
| TRIP Patient Navigation Intervention | Experimental | 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. Receives: Other: TRIP Patient Navigation Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 365 days of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start5 Aug 2016
- Primary completion22 Sep 2023
- Study completion22 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cancer, BreastStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,725 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- 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)
- Responsible party
- Sponsor
- Investigators
- Tracy Battaglia, MD., MPH, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03514433
- Sponsor's protocol ID
- H-37314
- Other IDs
- 1U01TR002070-01
- Acronym
- TRIP
- Status last verified
- Jun 2024
- First submitted
- 21 Apr 2018
- Last updated
- 3 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Rajabiun S, Xiao V, Bak S, Robbins C, Casanova N, Cabral HJ, Lemon SC, Haas JS, Freund KM, Battaglia T; TRIP Consortium. Using community-engaged methods to develop a study protocol for a cost analysis of a multi-site patient navigation intervention for breast cancer care. BMC Health Serv Res. 2022 Jul 8;22(1):881. doi: 10.1186/s12913-022-08192-y.
PubMed 35804359Loo S, Mullikin K, Robbins C, Xiao V, Battaglia TA, Lemon SC, Gunn C; TRIP Consortium. Patient navigator team perceptions on the implementation of a citywide breast cancer patient navigation protocol: a qualitative study. BMC Health Serv Res. 2022 May 21;22(1):683. doi: 10.1186/s12913-022-08090-3.
PubMed 35597947LeClair AM, Battaglia TA, Casanova NL, Haas JS, Freund KM, Moy B, Parsons SK, Ko NY, Ross J, Ohrenberger E, Mullikin KR, Lemon SC. Assessment of patient navigation programs for breast cancer patients across the city of Boston. Support Care Cancer. 2022 Mar;30(3):2435-2443. doi: 10.1007/s00520-021-06675-y. Epub 2021 Nov 12.
PubMed 34767089
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translating Research Into Practice: A Regional Collaborative to Reduce Disparities in Breast Cancer Care
- ClinicalTrials.gov ID
- NCT03514433
- Acronym / sponsor ID
- TRIP / H-37314
- Conditions
- Cancer, Breast
- Keywords
- Patient Navigation, Disparity, Social Determinants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,725 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- 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)
- Study start
- 5 Aug 2016 (actual)
- Primary completion
- 22 Sep 2023 (actual)
- Study completion
- 22 Sep 2023 (actual)
- First posted
- 2 May 2018 (actual)
- Results
- Posted 3 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Beth Israel Deaconess Medical Center (site PI: Ted James, MD)
- Boston Medical Center (PI: Tracy Battaglia MD, MPH)
- Brigham Women's Hospital/Dana-Farber Cancer Institute (PI: Jennifer Haas MD, MPH)
- Massachusetts General Hospital (site PI: Beverly Moy, MD)
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control- Usual Care | No intervention | –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. |
| TRIP Patient Navigation Intervention | Experimental | Other: TRIP Patient Navigation InterventionThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- are an adult female 18 years of age or older;
- reside within 25 miles of the City of Boston;
- 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.
Key exclusion criteria (3 listed)
- cancer diagnosis made > 60 days prior to enrollment, such that the ability of the intervention to effect the outcome is limited;
- 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;
- home residence is outside of the city of Boston, Massachusetts.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRIP Patient Navigation InterventionThe 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. | Other | TRIP Patient Navigation Intervention |
Primary outcome
Time-to-treatment Post-diagnosis
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35804359Rajabiun S, Xiao V, Bak S, Robbins C, Casanova N, Cabral HJ, Lemon SC, Haas JS, Freund KM, Battaglia T; TRIP Consortium. Using community-engaged methods to develop a study protocol for a cost analysis of a multi-site patient navigation intervention for breast cancer care. BMC Health Serv Res. 2022 Jul 8;22(1):881. doi: 10.1186/s12913-022-08192-y.
- Derived from this study: PubMed 35597947Loo S, Mullikin K, Robbins C, Xiao V, Battaglia TA, Lemon SC, Gunn C; TRIP Consortium. Patient navigator team perceptions on the implementation of a citywide breast cancer patient navigation protocol: a qualitative study. BMC Health Serv Res. 2022 May 21;22(1):683. doi: 10.1186/s12913-022-08090-3.
- Derived from this study: PubMed 34767089LeClair AM, Battaglia TA, Casanova NL, Haas JS, Freund KM, Moy B, Parsons SK, Ko NY, Ross J, Ohrenberger E, Mullikin KR, Lemon SC. Assessment of patient navigation programs for breast cancer patients across the city of Boston. Support Care Cancer. 2022 Mar;30(3):2435-2443. doi: 10.1007/s00520-021-06675-y. Epub 2021 Nov 12.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tracy Battaglia, MD., MPH principal investigator
Boston Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRIP Patient Navigation Intervention in people with Cancer, Breast, run by Boston Medical Center at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-to-treatment Post-diagnosis (time frame: Within 365 days of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03514433, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.