Early-stage Breast CancerNCT05280288
Effect of the App Bone@BC Version 4.0 Under the Follow-up for Patients With Early Breast Cancer
A study testing Bone@BC app in people with Early-stage Breast Cancer, run by Copenhagen University Hospital, Rigshospitalet.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women only
- Conditions the study is for
- Early-stage Breast Cancer
- What is being tested?
- Bone@BC app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- Prior malignancy
- Pre-existing type 2 diabetes or other metabolic diseases
- Withdrawn or not given a consent form
Trial locations and contacts
No sites are listed yet.
Karin Piil contact
About this study
Official title: Effect of the App Bone@BC Version 4.0 Under the Follow-up for Patients With Early Breast Cancer - a Non-inferiority 2-year Randomized Controlled Trial (The BELIEVE@BC -Better Life Even After Breast Cancer Study)
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.
Read the detailed description
Background Worldwide, an increasing number of people are affected by cancer. In 2018, 18.1 million people were diagnosed with new cancer with a mortality rate of 9.6 million (53%). Breast Cancer is one of the most common cancers worldwide and the most frequent cancer diagnosis in Danish women. On average 4,700 new cases are diagnosed in Denmark per year among a total population of 5.7 million citizens.
Women with early non-metastatic breast cancer often experience a treatment-related physical and psychological burden.
Empowering people with the confidence and information to look after themselves when they can and visit the General Practice when they need to, gives people greater control of their health and encourages healthy behaviors that help prevent ill health in the long term. In many cases, people can care for their minor illnesses, reducing the number of consultations and enabling healthcare professionals to focus on caring for higher-risk patients, such as those with co-morbidities, the very young and elderly, managing long-term conditions, and providing new services. Around one in five visits to the General Practice are made for social needs such as isolation, debt management, low mood, and anxiety. Patient-reported outcomes (PROs) have the potential to improve patient-clinician communication, symptom management, involvement, and quality of life. Electronic patient-reported outcomes (ePROs) can facilitate appropriate and continuous symptom monitoring reported by the patients. A systematic review from 2019 finds that mobile Health (mHealth) apps with interventions focusing on breast cancer survivorship showed a positive effect by promoting weight loss, improving the Health-Related Quality of Life, and decreasing stress but they find that future research is needed exploring the impact of mHealth apps on breast cancer survivors undergoing follow-up.
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 Health-Related Quality of Life.
Study design and methods A two-arm prospective randomized controlled trial. The study will be a one-site non-inferiority 2- year RCT study. A total of (n=120) participants will be randomized into the intervention group (IG) (n=60), these participants will be invited to become active users of the app Bone@BC version 4.0 combined with usual care alone. The control group (CG) (n=60), consists of participants following have usual care alone, and therefore not able to use the app Bone@BC in any versions (access denied).
Recruitment and procedures Following a consecutive sampling strategy, the participants (total (n=120), intervention group (IG) (n=60), control group (CG) (n=60) in the RCT study will be recruited from the Endocrinology Out-Clinic at Rigshospitalet, Denmark. Today the Endocrinology Out-Clinic at Rigshospitalet receives 4-8 referrals a week from the Department of Oncology at Rigshospitalet, Denmark ward to treatment for metabolic symptoms. The patients will be recruited by the principal investigator Trine Lund-Jacobsen (TLJ) or the endocrinology physicians. 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 first 120 women who give written consent to participate in 1-year interim analysis and then until total inclusion. 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 to participate in the study. After providing consent and reflection time, the participants will be randomized for even the control group (CG) or the intervention group (IG) by closed letters.
Analytic plan An interim analysis is performed after one year. Following correlations analysis will be performed: Total score self-efficacy (SES6G), total score patient empowerment (heiQ), total score depression and anxiety (HADS), total score physical activity (SGPALS), and HRQoL (EORTC QLQ-C30).
The primary outcome is HRQoL and differences in HRQoL between using an app Bone@BC and standard usual care alone will be evaluated by a multivariable linear regression model adjusting for age, baseline HRQoL, baseline HADS, and baseline self-efficacy. Correlation analysis will identify correlations between specific symptoms and HRQoL. Paired t-tests will be used to compare the means for the control group (CG) and the intervention group (IG) and p-values < 0.05 are considered statistically significant.
- Conditions
- Early-stage Breast Cancer
- Being tested
- Bone@BC app
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone@BC appDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| The control group (Standard care) | No intervention | No 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 | Experimental | Intervention: 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. Receives: Device: Bone@BC app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline (0 months), and every three weeks
Secondary outcomes (6)
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.
Measured: baseline (0 months), 1 year, and 2 year
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.
Measured: baseline (0 months), and every six weeks
Changes in patient empowerment measured by The Health Education Impact Questionnaire.
The 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.
Measured: baseline (0 months), 1 year, and 2 year
Changes in physical activity measured by The Grimby Physical Activity Level Scale 4 item questionnaire.
The Grimby Physical Activity Level Scale 4 item questionnaire is a 4 items questionnaire with following response scale:
I (Sedentary). Mainly sedentary or engaged in light physical activity less than 2 h per week (e.g., reading books, watching television, or going to the cinema).
II (Light to moderate). Light-to-moderate physical activity 2-4 h per week (e.g., walking, cycling for pleasure, gardening, housework, light exercise).
III (Regular moderate). Moderate physical activity more than 4 h per week, or more strenuous activities 2-4 h per week (e.g. brisk walking, fast bicycling, heavy gardening, or exercises that makes you short of breath).
IV (Regular vigorous). More strenuous physical activities more than 4 h per week, or regular vigorous exercise (e.g. competitive sport) several times a week.
Measured: baseline (0 months), and every three weeks
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 measured by numbers, length of app sessions measured by time (hours and sec.), frequency of use measured in numbers, data app was first opened measured as the specific site, geographic place measured as country, how many pages measured as numbers, how long time on the pages measured as time (hours and sec.), bounce rate measured as numers, and returning for the first time measured as numbers.
Measured: 1 year and the 2 year
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.
Measured: From start of radomization until end of study 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start1 May 2022 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early-stage Breast CancerStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Schwarz, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05280288
- Sponsor's protocol ID
- BELIEVE@BC
- Status last verified
- Feb 2022
- First submitted
- 18 Jan 2022
- Last updated
- 15 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the App Bone@BC Version 4.0 Under the Follow-up for Patients With Early Breast Cancer - a Non-inferiority 2-year Randomized Controlled Trial (The BELIEVE@BC -Better Life Even After Breast Cancer Study)
- ClinicalTrials.gov ID
- NCT05280288
- Acronym / sponsor ID
- BELIEVE@BC
- Conditions
- Early-stage Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 15 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background Worldwide, an increasing number of people are affected by cancer. In 2018, 18.1 million people were diagnosed with new cancer with a mortality rate of 9.6 million (53%). Breast Cancer is one of the most common cancers worldwide and the most frequent cancer diagnosis in Danish women. On average 4,700 new cases are diagnosed in Denmark per year among a total population of 5.7 million citizens.
Women with early non-metastatic breast cancer often experience a treatment-related physical and psychological burden.
Empowering people with the confidence and information to look after themselves when they can and visit the General Practice when they need to, gives people greater control of their health and encourages healthy behaviors that help prevent ill health in the long term. In many cases, people can care for their minor illnesses, reducing the number of consultations and enabling healthcare professionals to focus on caring for higher-risk patients, such as those with co-morbidities, the very young and elderly, managing long-term conditions, and providing new services. Around one in five visits to the General Practice are made for social needs such as isolation, debt management, low mood, and anxiety. Patient-reported outcomes (PROs) have the potential to improve patient-clinician communication, symptom management, involvement, and quality of life. Electronic patient-reported outcomes (ePROs) can facilitate appropriate and continuous symptom monitoring reported by the patients. A systematic review from 2019 finds that mobile Health (mHealth) apps with interventions focusing on breast cancer survivorship showed a positive effect by promoting weight loss, improving the Health-Related Quality of Life, and decreasing stress but they find that future research is needed exploring the impact of mHealth apps on breast cancer survivors undergoing follow-up.
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 Health-Related Quality of Life.
Study design and methods A two-arm prospective randomized controlled trial. The study will be a one-site non-inferiority 2- year RCT study. A total of (n=120) participants will be randomized into the intervention group (IG) (n=60), these participants will be invited to become active users of the app Bone@BC version 4.0 combined with usual care alone. The control group (CG) (n=60), consists of participants following have usual care alone, and therefore not able to use the app Bone@BC in any versions (access denied).
Recruitment and procedures Following a consecutive sampling strategy, the participants (total (n=120), intervention group (IG) (n=60), control group (CG) (n=60) in the RCT study will be recruited from the Endocrinology Out-Clinic at Rigshospitalet, Denmark. Today the Endocrinology Out-Clinic at Rigshospitalet receives 4-8 referrals a week from the Department of Oncology at Rigshospitalet, Denmark ward to treatment for metabolic symptoms. The patients will be recruited by the principal investigator Trine Lund-Jacobsen (TLJ) or the endocrinology physicians. 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 first 120 women who give written consent to participate in 1-year interim analysis and then until total inclusion. 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 to participate in the study. After providing consent and reflection time, the participants will be randomized for even the control group (CG) or the intervention group (IG) by closed letters.
Analytic plan An interim analysis is performed after one year. Following correlations analysis will be performed: Total score self-efficacy (SES6G), total score patient empowerment (heiQ), total score depression and anxiety (HADS), total score physical activity (SGPALS), and HRQoL (EORTC QLQ-C30).
The primary outcome is HRQoL and differences in HRQoL between using an app Bone@BC and standard usual care alone will be evaluated by a multivariable linear regression model adjusting for age, baseline HRQoL, baseline HADS, and baseline self-efficacy. Correlation analysis will identify correlations between specific symptoms and HRQoL. Paired t-tests will be used to compare the means for the control group (CG) and the intervention group (IG) and p-values < 0.05 are considered statistically significant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The control group (Standard care) | No intervention | –No 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 | Experimental | Device: Bone@BC appIntervention: 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. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Postmenopausal women
- Age 50-70 years
- Danish speaking
- Diagnosed with EBC, stage I-III
- Eligible to receive (neo-) adjuvant chemotherapy or adjuvant treatments
Key exclusion criteria (3 listed)
- Prior malignancy
- Pre-existing type 2 diabetes or other metabolic diseases
- Withdrawn or not given a consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone@BC appParticipants 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. | Device | The intervention group |
Primary outcome
Changes in Quality of life measured by the European Organization for Research and Treatment of Cancer Quality of Life
Time frame: baseline (0 months), and every three weeks
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.
6 secondary outcomes
Changes in symptoms of depression and anxiety measured by Hospital Anxiety and Depression Scale
Time frame: baseline (0 months), 1 year, and 2 year
Changes in self-efficacy measured by Self-efficacy for managing chronic disease 6-item scale (SES6G)
Time frame: baseline (0 months), and every six weeks
Changes in patient empowerment measured by The Health Education Impact Questionnaire.
Time frame: baseline (0 months), 1 year, and 2 year
Changes in physical activity measured by The Grimby Physical Activity Level Scale 4 item questionnaire.
Time frame: baseline (0 months), and every three weeks
Changes in in app user measured by Open source web analytics application Matomo Analytics
Time frame: 1 year and the 2 year
Bone@BC app
Time frame: From start of radomization until end of study 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin Piil contact
Questions about this trial
What is this clinical trial studying?
A study testing Bone@BC app in people with Early-stage Breast Cancer, run by Copenhagen University Hospital, Rigshospitalet.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Trine Lund-Jacobsen, Ph.D. Student (+45 25318056, trine.lund-jacobsen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Quality of life measured by the European Organization for Research and Treatment of Cancer Quality of Life (time frame: baseline (0 months), and every three weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.