Implementation of a Patient Navigation Program to Support Representative Participation in Cancer Clinical Trials
ABSTRACT Background Achieving adequate, timely, and diverse trial enrollment remains a major challenge in clinical research. Insufficiently diverse patient representation compromises the generalizability of clinical trial findings and remains a persistent issue in oncology. Navigation services may h...
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| Format: | Article |
| Language: | English |
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Wiley
2025-08-01
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| Series: | Cancer Medicine |
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| Online Access: | https://doi.org/10.1002/cam4.71125 |
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| author | Sukh Makhnoon Fabian Robles Jessica L. Lee D'Angelo Grant Marisol Rojas Ang Gao Carla Pezzia Venkata Eluri Navid Sadeghi Song Zhang Thomas Hulsey Rebecca Renn Erin L. Williams Heather Kitzman David E. Gerber |
| author_facet | Sukh Makhnoon Fabian Robles Jessica L. Lee D'Angelo Grant Marisol Rojas Ang Gao Carla Pezzia Venkata Eluri Navid Sadeghi Song Zhang Thomas Hulsey Rebecca Renn Erin L. Williams Heather Kitzman David E. Gerber |
| author_sort | Sukh Makhnoon |
| collection | DOAJ |
| description | ABSTRACT Background Achieving adequate, timely, and diverse trial enrollment remains a major challenge in clinical research. Insufficiently diverse patient representation compromises the generalizability of clinical trial findings and remains a persistent issue in oncology. Navigation services may help patients learn about clinical trials, identify and overcome barriers, and progress through the care pathway to trial enrollment and retention. Methods We implemented a patient navigation program to support diverse enrollment and retention of patients in cancer clinical trials; the proximal outcomes were receipt of financial navigation and trial interest. The study was conducted from July 2023 to July 2024 at two demographically diverse health care settings: a university‐based tertiary healthcare system and an integrated safety‐net healthcare system. Evaluation was guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework and incorporated programmatic data, structured surveys of patients and staff, and qualitative patient interviews. Results The program navigated 429 oncology patients (52% female, 28% Hispanic/Latino (HL), and 16% non‐HL Black). Compared to the underlying patient population of the clinical settings, program participants were more likely to be Hispanic (31% vs. 21%; p < 0.01), female (52% vs. 48%; p = 0.01) and from a minority race (30% vs. 24%, p ≤ 0.01). Within the population who were successfully contacted, 325 of 408 (92%) patients already enrolled in a trial received financial navigation to help with trial retention. Among the remaining 83 patients not enrolled in a cancer clinical trial at the time of referral, 39 (47%) expressed interest in participating in a clinical trial in thefuture. Conclusion A patient navigation program to influence enrollment and retention of diverse patients into trials was feasible to implement, highly acceptable to patients, and reached a priority population of patients generally underrepresented in cancer clinical trials. Further research into the effect of navigation on trial enrollment and retention is warranted. |
| format | Article |
| id | doaj-art-a65c9d0f26e04832b75f8168fda6a1cb |
| institution | DOAJ |
| issn | 2045-7634 |
| language | English |
| publishDate | 2025-08-01 |
| publisher | Wiley |
| record_format | Article |
| series | Cancer Medicine |
| spelling | doaj-art-a65c9d0f26e04832b75f8168fda6a1cb2025-08-20T03:06:40ZengWileyCancer Medicine2045-76342025-08-011415n/an/a10.1002/cam4.71125Implementation of a Patient Navigation Program to Support Representative Participation in Cancer Clinical TrialsSukh Makhnoon0Fabian Robles1Jessica L. Lee2D'Angelo Grant3Marisol Rojas4Ang Gao5Carla Pezzia6Venkata Eluri7Navid Sadeghi8Song Zhang9Thomas Hulsey10Rebecca Renn11Erin L. Williams12Heather Kitzman13David E. Gerber14Harold C. Simmons Comprehensive Cancer Center UT Southwestern Medical Center Dallas Texas USAHarold C. Simmons Comprehensive Cancer Center UT Southwestern Medical Center Dallas Texas USAHarold C. Simmons Comprehensive Cancer Center UT Southwestern Medical Center Dallas Texas USAHarold C. Simmons Comprehensive Cancer Center UT Southwestern Medical Center Dallas Texas USAHarold C. Simmons Comprehensive Cancer Center UT Southwestern Medical Center Dallas Texas USAHarold C. Simmons Comprehensive Cancer Center UT Southwestern Medical Center Dallas Texas USABiology Department University of Dallas Irving Texas USAHarold C. Simmons Comprehensive Cancer Center UT Southwestern Medical Center Dallas Texas USAParkland Health Dallas Texas USAHarold C. Simmons Comprehensive Cancer Center UT Southwestern Medical Center Dallas Texas USAHarold C. Simmons Comprehensive Cancer Center UT Southwestern Medical Center Dallas Texas USAHarold C. Simmons Comprehensive Cancer Center UT Southwestern Medical Center Dallas Texas USAHarold C. Simmons Comprehensive Cancer Center UT Southwestern Medical Center Dallas Texas USAHarold C. Simmons Comprehensive Cancer Center UT Southwestern Medical Center Dallas Texas USAHarold C. Simmons Comprehensive Cancer Center UT Southwestern Medical Center Dallas Texas USAABSTRACT Background Achieving adequate, timely, and diverse trial enrollment remains a major challenge in clinical research. Insufficiently diverse patient representation compromises the generalizability of clinical trial findings and remains a persistent issue in oncology. Navigation services may help patients learn about clinical trials, identify and overcome barriers, and progress through the care pathway to trial enrollment and retention. Methods We implemented a patient navigation program to support diverse enrollment and retention of patients in cancer clinical trials; the proximal outcomes were receipt of financial navigation and trial interest. The study was conducted from July 2023 to July 2024 at two demographically diverse health care settings: a university‐based tertiary healthcare system and an integrated safety‐net healthcare system. Evaluation was guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework and incorporated programmatic data, structured surveys of patients and staff, and qualitative patient interviews. Results The program navigated 429 oncology patients (52% female, 28% Hispanic/Latino (HL), and 16% non‐HL Black). Compared to the underlying patient population of the clinical settings, program participants were more likely to be Hispanic (31% vs. 21%; p < 0.01), female (52% vs. 48%; p = 0.01) and from a minority race (30% vs. 24%, p ≤ 0.01). Within the population who were successfully contacted, 325 of 408 (92%) patients already enrolled in a trial received financial navigation to help with trial retention. Among the remaining 83 patients not enrolled in a cancer clinical trial at the time of referral, 39 (47%) expressed interest in participating in a clinical trial in thefuture. Conclusion A patient navigation program to influence enrollment and retention of diverse patients into trials was feasible to implement, highly acceptable to patients, and reached a priority population of patients generally underrepresented in cancer clinical trials. Further research into the effect of navigation on trial enrollment and retention is warranted.https://doi.org/10.1002/cam4.71125cancerclinical trialsdiversityimplementation sciencepatient navigation |
| spellingShingle | Sukh Makhnoon Fabian Robles Jessica L. Lee D'Angelo Grant Marisol Rojas Ang Gao Carla Pezzia Venkata Eluri Navid Sadeghi Song Zhang Thomas Hulsey Rebecca Renn Erin L. Williams Heather Kitzman David E. Gerber Implementation of a Patient Navigation Program to Support Representative Participation in Cancer Clinical Trials Cancer Medicine cancer clinical trials diversity implementation science patient navigation |
| title | Implementation of a Patient Navigation Program to Support Representative Participation in Cancer Clinical Trials |
| title_full | Implementation of a Patient Navigation Program to Support Representative Participation in Cancer Clinical Trials |
| title_fullStr | Implementation of a Patient Navigation Program to Support Representative Participation in Cancer Clinical Trials |
| title_full_unstemmed | Implementation of a Patient Navigation Program to Support Representative Participation in Cancer Clinical Trials |
| title_short | Implementation of a Patient Navigation Program to Support Representative Participation in Cancer Clinical Trials |
| title_sort | implementation of a patient navigation program to support representative participation in cancer clinical trials |
| topic | cancer clinical trials diversity implementation science patient navigation |
| url | https://doi.org/10.1002/cam4.71125 |
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