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

A Convergent Parallel Mixed-methods Feasibility Study of the Bone@BC 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 Bone@bc app (intervention) and questionnaires (n=50) and the Qualitative data will be semi-structured interviews (n= 15 - 20)

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer Female
• Intervention / Treatment: Behavioral: the Bone@BC app

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Trine Lund-Jacobsen; Phone Number: +45 25318056; Email: trine.lund-jacobsen@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: the bone@bc app; Intervention group patients with breast cancer using the app Bone@BC	Behavioral: the Bone@BC app; The bone@BC app is a diary for patients with breast cancer that they can use if they want to.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The System Usability Scale (SUS)	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.	Week 12
Feasibility parameters as adherence, acceptability, response rate, representativeness, recruitment rate, and satisfaction	Semi-structured interviews	Week 12
Bone@BC app	Patient-reported outcome(s) from the app on the questions provided daily on Health-Related Quality of Life, late side-effects, symptoms and concerns perspectives, and level of Physical Activity in the app Bone@BC). The daily questions will be from the Eortc Library and will be analysed in percentages.	From baseline and to week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in symptoms of depression and anxiety measured by Hospital Anxiety and Depression Scale	The Hospital Anxiety and Depression scale is a 14-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >8 denotes anxiety or depression.	baseline (0 months) and week 12
Changes in Quality of life measured by the European Organization for Research and Treatment of Cancer Quality of Life	Health-related quality of life scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.	baseline (0 months) and week 12
Changes in self-efficacy measured by Self-efficacy for managing chronic disease 6-item scale (SES6G)	The Self-efficacy for managing chronic disease 6 item scale is a 6 item scale. Scoring for each item ranges from zero to ten. A high scale score represents a high self-efficacy.	Week 4, week 8 end week 12
Changes in patient empowerment measured by The Health Education Impact Questionnaire.	he Health Education Impact Questionnaire i a 42 items questionnaire with a 4 point response scale (strongly disagree, disagree, agree and strongly agree). Higher values in the Health Education Impact Questionnaire scales indicate better status, except for Emotional distress, where higher values indicate higher distress.	baseline (0 months) and week 12
Changes in in app user measured by Open source web analytics application Matomo Analytics	In-app user analytics will be collected to track user behavior such as the number of app sessions the user have measured by numbers (quantity). Length of app sessions measured by time (hours and sec.). Frequency of use measured in numbers (quantity). Data on when the app was first opened measured as the specific site. Geographic place measured as country. How many pages the users use measured as numbers (quantity). How long time the users spend on the pages measured as time (hours and sec.). Bounce rate measured as numbers (quantity). Returning for the first time measured as numbers (quantity).	week 4, week 8 and week 12

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Peter Schwarz, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): October 30, 2024
• Study Completion (Anticipated): October 30, 2024

Study Registration Dates

• First Submitted: April 19, 2022
• First Submitted That Met QC Criteria: May 5, 2022
• First Posted (Actual): May 10, 2022

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No