Clinical trial · Interventional
MyHealth: Follow-up After Breast Cancer Treatment
MyHealth: Nurse-led Compared to Physician-led Breast Cancer Follow-up: A Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Approximately 24,000 women attend a follow-up care program after end of primary treatment for breast cancer (BC) in Denmark. There is no well-conducted, larger randomized controlled trials (RCT) outlining a gold standard for follow-up programs ensuring early detection of recurrence, good management of symptoms and cost-effectiveness. The primary aim of this randomised, controlled trial is to test whether a nurse-led individually tailored symptom management program (MyHealth) will significantly reduce reported symptoms among BC patients following primary treatment compared to physician-led scheduled follow-up. Secondary, the investigators will examine patient activation (self-management), anxiety, depression, fear of recurrence, work ability, time to recurrence, overall survival, health behavior changes, health care utilization and financial costs in the two arms. The MyHealth program provides patients with a nurse-led education focusing on management of symptoms, an electronic platform to report symptoms to the nurses and support in symptom management and navigation of patients to appropriate health care services.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MyHealth | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MyHealth intervention arm
- description
- Nurse-led follow-up
- interventionNames
- Behavioral: MyHealth
- type
- NO_INTERVENTION
- label
- MyHealth Control condition
- description
- Physician-led follow-up
Primary outcomes (1)
- measure
- Changes in breast cancer specific symptom burden (TOI-PFB)
- timeFrame
- at inclusion, 6 months,12 months, 24 months, 36 months and 60 months
- description
- Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) score of the Functional Assessment of Cancer Therapy -Breast (FACT-B) Domains: Physical well-being, Functional wellbeing,BC symptoms
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Complete remission following primary treatment for loco-regional BC (stage I-II) - No confirmed genetic predisposition to BC * Female gender * Performance status ≤3 * Read, understand and speak Danish * No severe cognitive problems * No severe psychiatric disease requiring treatment or any substance abuse. Exclusion Criteria: * Genetic predisposition for BC * Patient younger than 40 years of age at diagnosis * Control after recurrent breast cancer * Other active cancer except non-melanoma skin cancer * Severe cognitive problems or dementia * Severe psychiatric disease requiring treatment, e.g. schizophrenia, alcohol or narcotic dependence
References
Publications (1)
- DERIVEDSaltbaek L, Bidstrup PE, Karlsen RV, Hoeg BL, Horsboel TA, Belmonte F, Andersen EAW, Zoffmann V, Friberg AS, Svendsen MN, Christensen HG, Glavicic V, Nielsen DL, Dalton SO, Johansen C. Nurse-Led Individualized Follow-Up Versus Regular Physician-Led Visits After Early Breast Cancer (MyHealth): A Phase III Randomized, Controlled Trial. J Clin Oncol. 2024 Jun 10;42(17):2038-2049. doi: 10.1200/JCO.23.01447. Epub 2024 Mar 18. PMID 38498781