A Feasibility Study of the Bone@BC App Version 3.0 (Believe@BC)

Rigshospitalet

Status: Not yet enrolling

Conditions: Breast Cancer Female

Treatments: Behavioral: the Bone@BC app

Study type: Interventional

Funder types: Other

Identifiers

NCT05367830

2

Details and patient eligibility

About

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)

Full description

AIM The aim is to investigate the feasibility and user satisfaction of an app Bone@BC version 3.0 and if the app Bone@BC can enhance self-efficacy and investigate user statistics and traffic in the app Bone@BC 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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

the bone@bc app

Experimental group

Description:

Intervention group patients with breast cancer using the app Bone@BC

Treatment:

Behavioral: the Bone@BC app