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Randomized controlled trial of patient navigation for newly diagnosed cancer patients: effects on quality of life.

ABSTRACT: Patient navigation is a promising intervention to ameliorate cancer health disparities. This study objective was to measure patient navigation effects on cancer-specific quality of life (QOL) among patients with newly diagnosed cancer.A randomized controlled trial of patient navigation was conducted in Rochester, NY. Patients with breast cancer and colorectal cancer were randomly assigned to receive a patient navigation intervention or usual care. QOL was measured at baseline and four subsequent time points, using the validated Functional Assessment of Cancer Therapy (FACT-B, FACT-C) instruments.Among 319 randomized patients (165 patient navigation, 154 control), median age was 57 years and 32.5% were from minority race/ethnicity groups. Patient navigation and control groups were comparable on baseline factors, except home ownership versus renting (more home ownership among controls, P = 0.05) and race (more whites among controls, P = 0.05). Total and subscale FACT scores did not differ between groups when analyzed as a change from baseline to 3 months, or at various time points. The emotional well-being subscale change from baseline approached significance (better change among patient navigation group, P = 0.05). Time trends of QOL measures did not differ significantly between groups. Adjustment for baseline patient factors did not reveal a benefit of patient navigation on QOL.In this randomized trial of patient navigation, there was no statistically significant effect on disease-specific QOL.These results suggest that patient navigation may not affect QOL during cancer treatment, that social/medical support are adequate in this study's setting, or that the trial failed to target patients likely to experience QOL benefit from patient navigation.

SUBMITTER: Hendren S

PROVIDER: S-EPMC3468902 | biostudies-literature | 2012 Oct

REPOSITORIES: biostudies-literature

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Randomized controlled trial of patient navigation for newly diagnosed cancer patients: effects on quality of life.

Hendren Samantha S Griggs Jennifer J JJ Epstein Ronald R Humiston Sharon S Jean-Pierre Pascal P Winters Paul P Sanders Mechelle M Loader Starlene S Fiscella Kevin K

Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology 20121001 10

<h4>Background</h4>Patient navigation is a promising intervention to ameliorate cancer health disparities. This study objective was to measure patient navigation effects on cancer-specific quality of life (QOL) among patients with newly diagnosed cancer.<h4>Methods</h4>A randomized controlled trial of patient navigation was conducted in Rochester, NY. Patients with breast cancer and colorectal cancer were randomly assigned to receive a patient navigation intervention or usual care. QOL was measu ...[more]

PMID: 23045543

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Project description:BackgroundConcurrent treatment with temozolomide and radiotherapy followed by maintenance temozolomide is the standard of care for patients with newly diagnosed glioblastoma. Bevacizumab, a humanized monoclonal antibody against vascular endothelial growth factor A, is currently approved for recurrent glioblastoma. Whether the addition of bevacizumab would improve survival among patients with newly diagnosed glioblastoma is not known.MethodsIn this randomized, double-blind, placebo-controlled trial, we treated adults who had centrally confirmed glioblastoma with radiotherapy (60 Gy) and daily temozolomide. Treatment with bevacizumab or placebo began during week 4 of radiotherapy and was continued for up to 12 cycles of maintenance chemotherapy. At disease progression, the assigned treatment was revealed, and bevacizumab therapy could be initiated or continued. The trial was designed to detect a 25% reduction in the risk of death and a 30% reduction in the risk of progression or death, the two coprimary end points, with the addition of bevacizumab.ResultsA total of 978 patients were registered, and 637 underwent randomization. There was no significant difference in the duration of overall survival between the bevacizumab group and the placebo group (median, 15.7 and 16.1 months, respectively; hazard ratio for death in the bevacizumab group, 1.13). Progression-free survival was longer in the bevacizumab group (10.7 months vs. 7.3 months; hazard ratio for progression or death, 0.79). There were modest increases in rates of hypertension, thromboembolic events, intestinal perforation, and neutropenia in the bevacizumab group. Over time, an increased symptom burden, a worse quality of life, and a decline in neurocognitive function were more frequent in the bevacizumab group.ConclusionsFirst-line use of bevacizumab did not improve overall survival in patients with newly diagnosed glioblastoma. Progression-free survival was prolonged but did not reach the prespecified improvement target. (Funded by the National Cancer Institute; ClinicalTrials.gov number, NCT00884741.).

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Randomized controlled trial of patient navigation for newly diagnosed cancer patients: effects on quality of life.

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Randomized controlled trial of patient navigation for newly diagnosed cancer patients: effects on quality of life.

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