Clinical trial · Interventional
Effect of the App Bone@BC Version 4.0 Under the Follow-up for Patients With Early Breast Cancer
Effect of the App Bone@BC Version 4.0 Under the Follow-up for Patients With Early Breast Cancer - a Non-inferiority 2-year Randomized Controlled Trial (The BELIEVE@BC -Better Life Even After Breast Cancer Study)
- 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)
Background Worldwide, an increasing number of people are affected by cancer. Breast Cancer is one of the most common cancers worldwide. Patients with early non-metastatic breast cancer are a growing group of survivors. The reason for this is that there has been an opportunity for early diagnosis, as well as improved treatment options. Patients with early breast cancer often experience endocrine side-effects such as loss of bone, increased weight, high levels of adipokine, lipids resistance, and hypertension after chemotherapy and anti-estrogen treatment resulting in reduced Health-Related Quality of Life. Aim The aim is to investigate whether a Bone@BC app version 4.0 compared to usual care alone improves self-efficacy and provides at least as good HRQoL. Methods A Randomized Controlled Trial (RCT) to decide whether the use of ePROs combined with usual care alone during follow-up for postmenopausal patients with early non-metastatic breast cancer in aromatase inhibitors with endocrine side-effects can maintain Health-Related Quality of Life, improve patient empowerment and self-efficacy compared to usual care alone.
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 |
|---|---|---|---|
| Early-stage Breast Cancer | Early Stage Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bone@BC app | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- The control group (Standard care)
- description
- No intervention. This arm will continue standard clinical practice consisting of clinical assessment regarding side effects and management under follow-up having usual care alone conducted by physicians and therefore not able to use the app Bone@BC in any versions (access denied).
- type
- EXPERIMENTAL
- label
- The intervention group
- description
- Intervention: This arm will be assigned to the intervention which will be that the participants will be invited to become active users of the app Bone@BC version 4.0 combined with usual care alone.
- interventionNames
- Device: Bone@BC app
Primary outcomes (1)
- measure
- Changes in Quality of life measured by the European Organization for Research and Treatment of Cancer Quality of Life
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Postmenopausal women * Age 50-70 years * Danish speaking * Diagnosed with EBC, stage I-III * Eligible to receive (neo-) adjuvant chemotherapy or adjuvant treatments * Access to an E-mail address * Access to smart mobile electronic devices connected to the internet * Willingness to have the app installed on the smart mobile electronic devices * Ability to work with the app Exclusion Criteria: * Prior malignancy * Pre-existing type 2 diabetes or other metabolic diseases * Withdrawn or not given a consent form
References
Publications (0)
Data not yet available