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)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Changes in Quality of life measured by the European Organization for Research and Treatment of Cancer Quality of Life
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Prior malignancy
- •Pre-existing type 2 diabetes or other metabolic diseases
- •Withdrawn or not given a consent form
结局指标
主要结局
Changes in Quality of life measured by the European Organization for Research and Treatment of Cancer Quality of Life
时间窗: 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.
次要结局
- 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 symptoms of depression and anxiety measured by Hospital Anxiety and Depression Scale(baseline (0 months), 1 year, and 2 year)
- Changes in patient empowerment measured by The Health Education Impact Questionnaire.(baseline (0 months), 1 year, and 2 year)
- Bone@BC app(From start of radomization until end of study 24 months)
- 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)
研究者
Peter Schwarz
professor
Rigshospitalet, Denmark