Breast Cancer Female Clinical Trial
Official title:
A Convergent Parallel Mixed-methods Feasibility Study of the [email protected] App Version 3.0 to Investigate Feasibility and Satisfaction
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 [email protected] app (intervention) and questionnaires (n=50) and the Qualitative data will be semi-structured interviews (n= 15 - 20)
AIM The aim is to investigate the feasibility and user satisfaction of an app [email protected] version 3.0 and if the app [email protected] can enhance self-efficacy and investigate user statistics and traffic in the app [email protected] by using a convergent parallel Mixed-Methods design. Recruitment and procedure For the quantitative data, the recruitment will follow a consecutive sampling strategy, the follow-up group with the electronic patient-reported outcome (ePRO) and systematic consultations (n= 50) will be recruited from the Endocrinology Out-Clinic at Rigshospitalet, Denmark. For the qualitative data, the participants will be recruited from the group participating in the quantitative data following a nested sampling. The patients will be recruited by the principal investigator Trine Lund-Jacobsen (TLJ), or clinical physicians from the Department of Endocrinology, Rigshospitalet, Denmark. The identification of patients will be given to the principal investigator (TLJ) in case the patients are accepted to be contacted for further written and oral information about the project, letter for the subject's rights is handed out and then be provided for obtaining written consent from the patient. The patients who regret or refuse to give consent to participate in the study will be registered and we will note the reason why the patients refuse or regret participating in the study. ;
| NCT number | NCT05367830 |
| Study type | Interventional |
| Source | Rigshospitalet, Denmark |
| Contact | Trine Lund-Jacobsen |
| Phone | +45 25318056 |
| [email protected] | |
| Status | Not yet recruiting |
| Phase | N/A |
| Start date | April 30, 2022 |
| Completion date | October 30, 2024 |
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