Abstract PS02-09: Nurse-led individualized follow-up versus regular physician-led visits after early breast cancer (MyHealth) - a randomized, controlled trial
Authors: Saltbæk Lena , Bidstrup Pernille , Karlsen Randi , Høeg Beverley , Horsboel Trine , Belmonte Federica , Andersen Elisabeth , Zoffmann Vibeke , Friberg Anne , Svendsen Mads , Christensen Helle , Glavicic Vesna , Nielsen Dorte , Dalton Susanne , Johansen Christoffer 
Published: May 2024

Abstract
Background:
Follow-up after breast cancer with regular specialist-led visits has failed to prove superiority over other strategies in terms of recurrence detection and survival, but it is still a cornerstone in breast cancer follow-up in many healthcare systems. Follow-up provided by the general practitioner or a specialist nurse has been reported more cost-effective and non-inferior in terms of patient-reported health-related quality of life (HRQoL) and in meeting the needs of breast cancer survivors. However, no follow-up strategies have demonstrated indisputable superiority over other strategies.
Methods:
In this randomized controlled trial (MyHealth), patients who recently completed surgery, and chemo-/radiotherapy if indicated, for stage I–II breast cancer were randomly assigned to intervention or control follow-up at Zealand University Hospital, Denmark. The nurse-led intervention comprised three to five individual self-management sessions during the first six months, and regular reporting of symptoms with nurse navigation to relevant healthcare services during three years of follow-up. The control comprised outpatient visits with oncologist every six months for three years. The primary outcome was breast cancer-specific HRQoL measured by the Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) summary score of the Functional Assessment of Cancer Therapy-Breast (FACT-B) two years after randomization. Secondary outcomes were fear of recurrence, anxiety, depression, and healthcare utilization.
Results:
From January 2017 to January 2019, 503 patients were randomly assigned to intervention (n=251) or control (n=252) follow-up. At two years, patients in the intervention group reported a significantly higher HRQoL (mean 75·69 (SD 12·27)) than patients in the control group (mean 71·26 (SD 14·08)), a mean difference of 5·05 (95% CI; 3·30–6·79), which is considered clinically relevant. The intervention group also reported significantly less fear of recurrence, anxiety, and depression as shown in Table 1. Furthermore, patients in the intervention group had fewer physician consultations but more nurse contacts, and an unchanged diagnostic imaging pattern as shown in Table 2. The effect on all outcomes was stable through three years of follow up.
Conclusions:
The MyHealth study suggests a new strategy for follow-up after early breast cancer providing significant improvements in HRQoL, fear of recurrence, anxiety, and depression without inflicting extra expenses to the healthcare system.
(Funded by the Danish Cancer Society, Region Zealand and Copenhagen University Hospital; Clinicaltrials.gov number; NCT02949167.)
Table 1: Outcome findings by study group at baseline, 6, 12, 24, and 36 months Data are mean (SD) unless otherwise stated. The effect estimates are based on the mixed model assuming no difference between groups at baseline. The QoL and fear of recurrence variables are continuous, and the estimates describe the mean difference in score between patients in the two groups. For anxiety and depression, data were zero-inflated. These estimates describe the exponential coefficients of anxiety and depression scores in the intervention group compared to the control group. Cohen’s d is a measure of effect size, and interpreted as small for Cohen’s d = 0·2, medium for Cohen’s d = 0·5, and large for Cohen’s d = 0·8
Table 2: Number of contacts and diagnostic imaging examinations during the first three years of follow-up by study group Data are numbers and mean (SD) per patient during the first three years of follow-up. 1 Most telephone consultations were scheduled as outpatient visits according to the protocol, but changed to telephone consultations due to the COVID-19 pandemic
Citation Format: Lena Saltbæk, Pernille Bidstrup, Randi Karlsen, Beverley Høeg, Trine Horsboel, Federica Belmonte, Elisabeth Andersen, Vibeke Zoffmann, Anne Friberg, Mads Svendsen, Helle Christensen, Vesna Glavicic, Dorte Nielsen, Susanne Dalton, Christoffer Johansen. Nurse-led individualized follow-up versus regular physician-led visits after early breast cancer (MyHealth) - a randomized, controlled trial [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PS02-09.