Clinical trial NCT05367830: A Feasibility Study of the Bone@BC App Version 3.0
Official title: A Convergent Parallel Mixed-methods Feasibility Study of the Bone@BC App Version 3.0 to Investigate Feasibility and Satisfaction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer Female
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2022-05-10
Enrollment: 50
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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)

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The System Usability Scale (SUS)
timeFrame: Week 12
measure: Feasibility parameters as adherence, acceptability, response rate, representativeness, recruitment rate, and satisfaction
timeFrame: Week 12
measure: Bone@BC app
timeFrame: From baseline and to week 12
Secondary outcomes:
measure: Changes in symptoms of depression and anxiety measured by Hospital Anxiety and Depression Scale
timeFrame: baseline (0 months) and week 12
measure: Changes in Quality of life measured by the European Organization for Research and Treatment of Cancer Quality of Life
timeFrame: baseline (0 months) and week 12
measure: Changes in self-efficacy measured by Self-efficacy for managing chronic disease 6-item scale (SES6G)
timeFrame: Week 4, week 8 end week 12
measure: Changes in patient empowerment measured by The Health Education Impact Questionnaire.
timeFrame: baseline (0 months) and week 12
measure: Changes in in app user measured by Open source web analytics application Matomo Analytics
timeFrame: week 4, week 8 and week 12
Other outcomes:
Locations:
Study officials:
affiliation: Rigshospitalet, Denmark
name: Peter Schwarz
role: PRINCIPAL_INVESTIGATOR
References: