Clinical trial · Interventional
A Feasibility Study of the Bone@BC App Version 3.0
A Convergent Parallel Mixed-methods Feasibility Study of the Bone@BC App Version 3.0 to Investigate Feasibility and Satisfaction
- 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)
Introduction Due to improvements in diagnostics and treatments, the 5-year survival for patients with breast cancer is 80-90% after initial diagnosis. During treatments, patients typically have consultations weekly and then gradually reduce to annual visits. During this transition from hospital-based care to health self-management, the breast cancer survivors are encouraged to e.g. exercise because of accumulating evidence for the efficacy of exercise training in cancer survivorship, and in the majority of cases, adhere to endocrine treatments to reduce the risk of breast cancer recurrence. Design and methods The study is a one-arm convergent parallel mixed-methods feasibility intervention study. The quantitative data will be the use of the Bone@bc app (intervention) and questionnaires (n=50) and the Qualitative data will be semi-structured interviews (n= 15 - 20)
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 Female | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| the Bone@BC app | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- the bone@bc app
- description
- Intervention group patients with breast cancer using the app Bone@BC
- interventionNames
- Behavioral: the Bone@BC app
Primary outcomes (3)
- measure
- The System Usability Scale (SUS)
- timeFrame
- Week 12
- description
- a self-administrated questionnaire with 10 items with five response options for respondents; from Strongly agree to Strongly disagree. A SUS score above a 68 would be considered above average and anything below 68 is below average.
- measure
- Feasibility parameters as adherence, acceptability, response rate, representativeness, recruitment rate, and satisfaction
- timeFrame
- Week 12
- description
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 (2)
- DERIVEDLund-Jacobsen T, Schwarz P, Martino G, Pappot H, Piil K. Development of an App for Symptom Management in Women With Breast Cancer Receiving Maintenance Aromatase Inhibitors: Protocol for a Mixed Methods Feasibility Study. JMIR Res Protoc. 2024 Feb 15;13:e49549. doi: 10.2196/49549. PMID 38358787
- DERIVEDLund-Jacobsen T, Bentsen L, Schwarz P, Knop AS, Pappot H, Piil K. Aromatase Inhibitor-Related Symptoms Reported by Postmenopausal Women with Nonmetastatic, Estrogen Receptor-Positive Breast Cancer: A Systematic Review. Semin Oncol Nurs. 2023 Oct;39(5):151487. doi: 10.1016/j.soncn.2023.151487. Epub 2023 Aug 21. PMID 37612223