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Breast Cancer FemaleBelieve@BCNCT05367830

A Feasibility Study of the Bone@BC App Version 3.0

A study testing the Bone@BC app in people with Breast Cancer Female, run by Copenhagen University Hospital, Rigshospitalet.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 70 years, women only
Conditions the study is for
Breast Cancer Female
What is being tested?
the Bone@BC app
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
1 Dec 2022to 30 Oct 2024
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  • Withdrawn or not given a consent form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.

Trine Lund-Jacobsen contact

+45 25318056

trine.lund-jacobsen@regionh.dk

About this study

Official title: 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)

Read the 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.

Being tested
the Bone@BC app

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • the Bone@BC appBehavioural

    The bone@BC app is a diary for patients with breast cancer that they can use if they want to.

Study groups in NCT05367830
Study groupRoleWhat they receive
the bone@bc appExperimentalIntervention group patients with breast cancer using the app Bone@BC
Receives: Behavioral: the Bone@BC app

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 12

  2. Feasibility parameters as adherence, acceptability, response rate, representativeness, recruitment rate, and satisfaction

    Semi-structured interviews

    Measured: Week 12

  3. 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 baseline and to week 12

Secondary outcomes (5)

  1. 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) and week 12

  2. 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 week 12

  3. 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: Week 4, week 8 end week 12

  4. 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.

    Measured: baseline (0 months) and week 12

  5. 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).

    Measured: week 4, week 8 and week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2022
  2. Study start1 Dec 2022 (estimated)
  3. Primary completion30 Oct 2024 (estimated)
  4. Study completion30 Oct 2024 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05367830
Sponsor's protocol ID
2
Acronym
Believe@BC
Status last verified
Oct 2022
First submitted
19 Apr 2022
Last updated
26 Oct 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Lund-Jacobsen T, Schwarz P, Martino G, Pappot H, Piil K. Development of an App for Symptom Management in Women With Breast Cancer Receiving Maintenance Aromatase Inhibitors: Protocol for a Mixed Methods Feasibility Study. JMIR Res Protoc. 2024 Feb 15;13:e49549. doi: 10.2196/49549.

    PubMed 38358787

  • Lund-Jacobsen T, Bentsen L, Schwarz P, Knop AS, Pappot H, Piil K. Aromatase Inhibitor-Related Symptoms Reported by Postmenopausal Women with Nonmetastatic, Estrogen Receptor-Positive Breast Cancer: A Systematic Review. Semin Oncol Nurs. 2023 Oct;39(5):151487. doi: 10.1016/j.soncn.2023.151487. Epub 2023 Aug 21.

    PubMed 37612223

Questions about this trial

What is this clinical trial studying?

A study testing the Bone@BC app in people with Breast Cancer Female, 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 26 Oct 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 (+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?

The System Usability Scale (SUS) (time frame: Week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05367830, which also lists 2 linked publications.

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 26 Oct 2022.

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