TY - JOUR

T1 - Nurse-Led Individualized Follow-Up Versus Regular Physician-Led Visits After Early Breast Cancer (MyHealth)

T2 - A Phase III Randomized, Controlled Trial

AU - Saltbæk, Lena

AU - Bidstrup, Pernille E.

AU - Karlsen, Randi V.

AU - Høeg, Beverley L.

AU - Horsboel, Trine A.

AU - Belmonte, Federica

AU - Andersen, Elisabeth A.W.

AU - Zoffmann, Vibeke

AU - Friberg, Anne S.

AU - Svendsen, Mads N.

AU - Christensen, Helle G.

AU - Glavicic, Vesna

AU - Nielsen, Dorte L.

AU - Dalton, Susanne O.

AU - Johansen, Christoffer

N1 - Publisher Copyright: © American Society of Clinical Oncology.

PY - 2024

Y1 - 2024

N2 - PURPOSEFollow-up after breast cancer with regular visits has failed to detect recurrences, be cost-effective, and address patient needs.METHODSMyHealth is a phase III randomized controlled trial (ClinicalTrials.gov identifier: NCT02949167). 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 health care 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 health care utilization. Analyses were intention-to-treat and P values were two-sided with 95% confidence level set at 0.005 because of multiple comparisons.RESULTSAmong 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 to 6.79; P <.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.CONCLUSIONThe MyHealth study suggested a new strategy for follow-up after early breast cancer as it provided significant improvements in QoL.

AB - PURPOSEFollow-up after breast cancer with regular visits has failed to detect recurrences, be cost-effective, and address patient needs.METHODSMyHealth is a phase III randomized controlled trial (ClinicalTrials.gov identifier: NCT02949167). 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 health care 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 health care utilization. Analyses were intention-to-treat and P values were two-sided with 95% confidence level set at 0.005 because of multiple comparisons.RESULTSAmong 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 to 6.79; P <.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.CONCLUSIONThe MyHealth study suggested a new strategy for follow-up after early breast cancer as it provided significant improvements in QoL.

U2 - 10.1200/JCO.23.01447

DO - 10.1200/JCO.23.01447

M3 - Journal article

C2 - 38498781

AN - SCOPUS:85195435976

VL - 42

SP - 2038

EP - 2049

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

SN - 0732-183X

IS - 17

ER -