Effect of the App Bone@BC Version 4.0 Under the Follow-up for Patients With Early Breast Cancer
1 other identifier
interventional
120
0 countries
N/A
Brief Summary
Background Worldwide, an increasing number of people are affected by cancer. Breast Cancer is one of the most common cancers worldwide. Patients with early non-metastatic breast cancer are a growing group of survivors. The reason for this is that there has been an opportunity for early diagnosis, as well as improved treatment options. Patients with early breast cancer often experience endocrine side-effects such as loss of bone, increased weight, high levels of adipokine, lipids resistance, and hypertension after chemotherapy and anti-estrogen treatment resulting in reduced Health-Related Quality of Life. Aim The aim is to investigate whether a Bone@BC app version 4.0 compared to usual care alone improves self-efficacy and provides at least as good HRQoL. Methods A Randomized Controlled Trial (RCT) to decide whether the use of ePROs combined with usual care alone during follow-up for postmenopausal patients with early non-metastatic breast cancer in aromatase inhibitors with endocrine side-effects can maintain Health-Related Quality of Life, improve patient empowerment and self-efficacy compared to usual care alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2022
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2022
CompletedFirst Posted
Study publicly available on registry
March 15, 2022
CompletedStudy Start
First participant enrolled
May 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedMarch 15, 2022
February 1, 2022
3.4 years
January 18, 2022
March 4, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 every three weeks
Secondary Outcomes (6)
Changes in symptoms of depression and anxiety measured by Hospital Anxiety and Depression Scale
baseline (0 months), 1 year, and 2 year
Changes in self-efficacy measured by Self-efficacy for managing chronic disease 6-item scale (SES6G)
baseline (0 months), and every six weeks
Changes in patient empowerment measured by The Health Education Impact Questionnaire.
baseline (0 months), 1 year, and 2 year
Changes in physical activity measured by The Grimby Physical Activity Level Scale 4 item questionnaire.
baseline (0 months), and every three weeks
Changes in in app user measured by Open source web analytics application Matomo Analytics
1 year and the 2 year
- +1 more secondary outcomes
Study Arms (2)
The control group (Standard care)
NO INTERVENTIONNo intervention. This arm will continue standard clinical practice consisting of clinical assessment regarding side effects and management under follow-up having usual care alone conducted by physicians and therefore not able to use the app Bone@BC in any versions (access denied).
The intervention group
EXPERIMENTALIntervention: This arm will be assigned to the intervention which will be that the participants will be invited to become active users of the app Bone@BC version 4.0 combined with usual care alone.
Interventions
Participants in the intervention group will be asked to use the Bone@BC app daily it will take them 1-3 minutes to answer the daily questions in the app concerning symptoms and physical activity. They will have access to a Questionnaire Prompt List in the app Bone@BC.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Prior malignancy
- Pre-existing type 2 diabetes or other metabolic diseases
- Withdrawn or not given a consent form
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
January 18, 2022
First Posted
March 15, 2022
Study Start
May 1, 2022
Primary Completion
October 1, 2025
Study Completion
October 1, 2025
Last Updated
March 15, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share