Nurse-Led Individualized Follow-Up Versus Regular Physician-Led Visits After Early Breast Cancer (MyHealth): A Phase III Randomized, Controlled Trial
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Purpose
Follow-up after breast cancer with regular visits has failed to detect recurrences, be cost-effective, and address patient needs.
Methods
MyHealth is a phase III randomized controlled trial (ClinicalTrials.gov identifier: ). Patients, who recently completed primary treatment for stage I-II breast cancer, were randomly assigned in variable block sizes and stratified by age and human epidermal growth factor receptor 2 status to intervention or control follow-up. The nurse-led intervention comprised three to five individual self-management sessions, regular reporting of symptoms, and navigation to healthcare services. The control follow-up comprised regular outpatient visits with the physician. The primary outcome was breast cancer–specific quality of life (QoL) measured by the Trial Outcome Index-Physical/Functional/Breast summary score of the Functional Assessment of Cancer Therapy-Breast 2 years after random assignment. Secondary outcomes were fear of recurrence, anxiety, depression, and healthcare utilization. Analyses were intention-to-treat and P values were two-sided with 95% confidence level set at 0.005 because of multiple comparisons.
Results
Among 1,101 eligible patients, 875 were invited and 503 were randomly assigned to control (n = 252) or intervention (n = 251) follow-up. At 2 years, patients in the intervention group reported a significantly and clinically relevant higher QoL (mean 75.69, [standard deviation [SD] 12.27]) than patients in the control group (71.26, SD 14.08), with a mean difference of 5.05 (95% CI 3.30-6.79, P<0.001). The intervention group reported significantly less fear of recurrence, anxiety, and depression; they had fewer physician consultations but more nurse contacts and an unchanged diagnostic imaging pattern. The effect on all outcomes was stable through a 3-year follow-up.
Conclusion
The MyHealth study suggested a new strategy for follow-up after early breast cancer as it provided significant improvements in QoL.
Read an interview about the study here and expert commentary about it here.
Read the full article
Nurse-Led Individualized Follow-Up Versus Regular Physician-Led Visits After Early Breast Cancer (MyHealth): A Phase III Randomized, Controlled Trial
Primary Source
Journal of Clinical Oncology
Source Reference: