Effect of the App Bone@BC Version 4.0 Under the Follow-up for Patients With Early Breast Cancer

NCT ID: NCT05280288

Last Updated: 2022-03-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2025-10-01

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

The control group (Standard care)

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

The intervention group

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.

Group Type: EXPERIMENTAL

Bone@BC app

Intervention Type: DEVICE

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.

Interventions

Bone@BC app

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Peter Schwarz

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Trine Lund-Jacobsen, Ph.D. Student

Role: CONTACT

trine.lund-jacobsen@regionh.dk

+45 25318056

Karin Piil

Role: CONTACT

karin.piil@regionh.dk

Other Identifiers

BELIEVE@BC

Identifier Type: -

Identifier Source: org_study_id