Patient Navigation and Time to Diagnostic Resolution: Results for a Cluster Randomized Trial Evaluating the Efficacy of Patient Navigation among Patients with Breast Cancer Screening Abnormalities, Tampa, FL

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Abstract

Objectives

The objective of this study was to evaluate a patient navigation (PN) program that attempts to reduce the time between a breast cancer screening abnormality and definitive diagnosis among medically underserved populations of Tampa Bay, Florida.

Methods

The Moffitt Patient Navigation Research Program conducted a cluster randomized design with 10 primary care clinics. Patients were navigated from time of a breast screening abnormality to diagnostic resolution. This paper examined the length of time between breast abnormality and definitive diagnosis, using a shared frailty Cox proportional hazard model to assess PN program effect.

Results

1,039 patients were eligible for the study because of an abnormal breast cancer screening/clinical abnormality (494 navigated; 545 control). Analysis of PN effect by two time periods of resolution (0-3 months and > 3 months) showed a lagged effect of PN. For patients resolving in the first three months, the adjusted Hazard Ratio (aHR) was 0.85 (95% Confidence Interval [CI]: 0.64-1.13) suggesting that PN had no effect on resolution time during this period. Beyond three months, however, navigated patients resolved more quickly to diagnostic resolution compared with the control group (aHR 2.8, 95%CI: 1.30-6.13). The predicted aHR at 3 months was 1.2, which was not statistically significant, while PN had a significant positive effect beyond 4.7 months.

Conclusions

PN programs may increase the timeliness of diagnostic resolution for patients with a breast cancer-related abnormality. PN did not speed diagnostic resolution during the initial three months of follow up but started to reduce time to diagnostic resolution after three months and showed a significant effect after 4.7 months.

Trial Registration

ClinicalTrials.gov NCT00375024

Related collections

Most cited references 23

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Influence of delay on survival in patients with breast cancer: a systematic review.

M. A. RICHARDS, A M Westcombe, S B Love … (1999)

Most patients with breast cancer are detected after symptoms occur rather than through screening. The impact on survival of delays between the onset of symptoms and the start of treatment is controversial and cannot be studied in randomised controlled trials. We did a systematic review of observational studies (worldwide) of duration of symptoms and survival. We identified 87 studies (101,954 patients) with direct data linking delay (including delay by patients) and survival. We classified studies for analysis by type of data in the original reports: category I studies had actual 5-year survival data (38 studies, 53,912 patients); category II used actuarial or multivariate analyses (21 studies, 25,102 patients); and category III was all other types of data (28 studies, 22,940 patients). We tested the main hypothesis that longer delays would be associated with lower survival, and a secondary hypothesis that longer delays were associated with more advanced stage, which would account for lower survival. In category I studies, patients with delays of 3 months or more had 12% lower 5-year survival than those with shorter delays (odds ratio for death 1.47 [95% CI 1.42-1.53]) and those with delays of 3-6 months had 7% lower survival than those with shorter delays (1.24 [1.17-1.30]). In category II, 13 of 14 studies with unrestricted samples showed a significant adverse relation between longer delays and survival, whereas four of five studies of only patients with operable disease showed no significant relation. In category III, all three studies with unrestricted samples supported the primary hypothesis. The 13 informative studies showed that longer delays were associated with more advanced stage. In studies that controlled for stage, longer delay was not associated with shorter survival when the effect of stage on survival was taken into account. Delays of 3-6 months are associated with lower survival. These effects cannot be accounted for by lead-time bias. Efforts should be made to keep delays by patients and providers to a minimum.

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Patient navigation: state of the art or is it science?

Darryll D. Dudley, Jonathan C. K. Wells, Richard A. Greene … (2008)

First implemented in 1990, patient navigation interventions are emerging today as an approach to reduce cancer disparities. However, there is lack of consensus about how patient navigation is defined, what patient navigators do, and what their qualifications should be. Little is known about the efficacy and cost-effectiveness of patient navigation. For this review, the authors conducted a qualitative synthesis of published literature on cancer patient navigation. By using the keywords 'navigator' or 'navigation' and 'cancer,' 45 articles were identified in the PubMed database and from reference searches that were published or in press through October 2007. Sixteen studies provided data on the efficacy of navigation in improving timeliness and receipt of cancer screening, diagnostic follow-up care, and treatment. Patient navigation services were defined and differentiated from other outreach services. Overall, there was evidence of some degree of efficacy for patient navigation in increasing participation in cancer screening and adherence to diagnostic follow-up care after the detection of an abnormality. The reported increases in screening ranged from 10.8% to 17.1%, and increases in adherence to diagnostic follow-up care ranged from 21% to 29.2% compared with control patients. There was less evidence regarding the efficacy of patient navigation in reducing either late-stage cancer diagnosis or delays in the initiation of cancer treatment or improving outcomes during cancer survivorship. There were methodological limitations in most studies, such as a lack of control groups, small sample sizes, and contamination with other interventions. Although cancer-related patient navigation interventions are being adopted increasingly across the United States and Canada, further research will be necessary to evaluate their efficacy and cost-effectiveness in improving cancer care. (c) 2008 American Cancer Society.

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Using navigators to improve care of underserved patients: current practices and approaches.

Daniel Dohan, Deborah Schrag (2005)

Logistic, cultural, educational, and other barriers can impede the delivery of high-quality cancer care to underserved patients. Patient navigation services represent one innovation for addressing perceived barriers to care encountered by disadvantaged patients. In this report, the authors have 1) defined patient navigation, distinguishing it from other cancer support services; 2) described how programs are organized; and 3) discussed the need for research on program effectiveness. Information was examined on navigation programs published in the scientific literature and on line. Qualitative research also was conducted, consisting of direct observation of patient care in cancer clinics with and without navigators in northern California, in-person interviews with personnel and patients in the clinics observed, and telephone interviews with navigators at four sites across the United States. The authors found that navigation services have been implemented at all stages of cancer care: prevention, screening, treatment, and survival. Navigators differ from other cancer support personnel in their orientation toward flexible problem solving to overcome perceived barriers to care rather than the provision of a predefined set of services. There are no rigorous demonstrations of the effects and effectiveness of navigation, although such studies are underway. Currently, patient navigation is understudied, and literature documenting its effects and effectiveness is scant. Rigorous studies are needed of the navigator role and program costs and benefits. Such studies will facilitate an assessment of program effectiveness, feasibility across a range of health care settings, and performance relative to alternative approaches for addressing barriers to care among the underserved.

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Author and article information

Contributors

Robert Lafrenie: Role: Editor

Journal

Journal ID (nlm-ta): PLoS One

Journal ID (iso-abbrev): PLoS ONE

Journal ID (publisher-id): plos

Journal ID (pmc): plosone

Title: PLoS ONE

Publisher: Public Library of Science (San Francisco, USA )

ISSN (Electronic): 1932-6203

Publication date Collection: 2013

Publication date (Electronic): 16 September 2013

Volume: 8

Issue: 9

Electronic Location Identifier: e74542

Affiliations

[1 ]H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States of America

[2 ]University of South Florida, College of Medicine, Tampa, Florida, United States of America

[3 ]San Diego State University and Moore’s Cancer Center, San Diego, California, United States of America

Sudbury Regional Hospital, Canada

Author notes

* E-mail: rroetzhe@ 123456health.usf.edu

Competing Interests: The authors have declared that no competing interests exist.

Conceived and designed the experiments: JHL RR CDM KW. Performed the experiments: EC RR CM KW. Analyzed the data: WF JHL. Wrote the manuscript: JHL RR CM KW WF.

Article

Publisher ID: PONE-D-13-00418

DOI: 10.1371/journal.pone.0074542

PMC ID: 3774725

PubMed ID: 24066145

SO-VID: ee34d4d7-f58e-4ed7-b4b4-b8b51e386eb1

License:

This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

History

Date received : 8 January 2013

Date accepted : 1 August 2013

Funding

This study was funded by the National Cancer Institute (NCI), through its Center to Reduce Cancer Health Disparities, National Institutes of Health, Department of Health and Human Services (U01 CA 117281-01). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NCI. KW's contribution to this study was also funded by a grant from NCI (R25 CA090314; Paul B. Jacobsen, Ph.D., Principal Investigator). CM was also supported by NCI (U01 CA114627 and U54 CA153509 ). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Patient Navigation and Time to Diagnostic Resolution: Results for a Cluster Randomized Trial Evaluating the Efficacy of Patient Navigation among Patients with Breast Cancer Screening Abnormalities, Tampa, FL

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Abstract

Objectives

Methods

Results

Conclusions

Trial Registration

Related collections

PLOS Climate

Most cited references 23

Influence of delay on survival in patients with breast cancer: a systematic review.

Patient navigation: state of the art or is it science?

Using navigators to improve care of underserved patients: current practices and approaches.

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Contributors

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