Trial Outcomes & Findings for Translating Research Into Practice: Patient Navigation for Breast Cancer (NCT NCT03514433)
NCT ID: NCT03514433
Last Updated: 2024-07-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1725 participants
Primary outcome timeframe
Within 365 days of enrollment
Results posted on
2024-07-03
Participant Flow
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.
Participant milestones
| Measure |
Sequence 1 (Hospital 1)
Sequence: 22 months of Usual Care, 2 months of implementation, then 38 months of Intervention Control (Usual Care): These patients will receive standard patient navigation at their care site and will act as controls in comparison to the TRIP experimental group.
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 wilt 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.
|
Sequence 2 (Hospital 2)
Sequence: 25 months of Usual Care, 2 months of implementation, then 35 months of intervention.
Control (Usual Care): These patients will receive standard patient navigation at their care site and will act as controls in comparison to the TRIP experimental group.
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 wilt 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.
|
Sequence 3 (Hospital 3)
Sequence: 28 months of Usual Care, 2 months of implementation, then 32 months of intervention.
Control (Usual Care): These patients will receive standard patient navigation at their care site and will act as controls in comparison to the TRIP experimental group.
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 wilt 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.
|
Sequence 4 (Hospital 4)
Sequence: 31 months of Usual Care, 2 months of implementation, then 29 months of intervention.
Control (Usual Care): These patients will receive standard patient navigation at their care site and will act as controls in comparison to the TRIP experimental group.
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 wilt 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.
|
Sequence 5 (Hospital 5)
Sequence: 36 months of Usual Care, 2 months of implementation, then 24 months of intervention.
Control (Usual Care): These patients will receive standard patient navigation at their care site and will act as controls in comparison to the TRIP experimental group.
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 wilt 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.
|
|---|---|---|---|---|---|
|
Usual Care
STARTED
|
111
|
38
|
177
|
83
|
141
|
|
Usual Care
COMPLETED
|
111
|
38
|
177
|
83
|
141
|
|
Usual Care
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Intervention
STARTED
|
317
|
75
|
372
|
144
|
267
|
|
Intervention
COMPLETED
|
317
|
75
|
372
|
144
|
267
|
|
Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Translating Research Into Practice: Patient Navigation for Breast Cancer
Baseline characteristics by cohort
| Measure |
Control- Usual Care
n=550 Participants
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
n=1175 Participants
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.
|
Total
n=1725 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<50 years
|
132 Participants
n=99 Participants
|
293 Participants
n=107 Participants
|
425 Participants
n=206 Participants
|
|
Age, Customized
50-64 years
|
213 Participants
n=99 Participants
|
483 Participants
n=107 Participants
|
696 Participants
n=206 Participants
|
|
Age, Customized
65+ years
|
205 Participants
n=99 Participants
|
399 Participants
n=107 Participants
|
604 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
550 Participants
n=99 Participants
|
1175 Participants
n=107 Participants
|
1725 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
127 Participants
n=99 Participants
|
296 Participants
n=107 Participants
|
423 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Nonhispanic White
|
91 Participants
n=99 Participants
|
236 Participants
n=107 Participants
|
327 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Nonhispanic Black
|
243 Participants
n=99 Participants
|
483 Participants
n=107 Participants
|
726 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Nonhispanic Asian
|
70 Participants
n=99 Participants
|
129 Participants
n=107 Participants
|
199 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Missing or Unknown
|
15 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
550 Participants
n=99 Participants
|
1175 Participants
n=107 Participants
|
1725 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Within 365 days of enrollmentPopulation: Data were available for 529 of the 550 controls and 1151 of the 1175 participants in the intervention group.
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.
Outcome measures
| Measure |
Control- Usual Care
n=529 Participants
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
n=1151 Participants
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.
|
|---|---|---|
|
Time-to-treatment Post-diagnosis
|
44.78 days
Standard Deviation 39.54
|
45.40 days
Standard Deviation 33.98
|
Adverse Events
Control- Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 14 deaths
TRIP Patient Navigation Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 16 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place