A Convergent Parallel Mixed-methods Feasibility Study of the Bone@BC App Version 3.0 to Investigate Feasibility and Satisfaction
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- The System Usability Scale (SUS)
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
研究组 & 干预措施
the bone@bc app
Intervention group patients with breast cancer using the app Bone@BC
干预措施: the Bone@BC app (Behavioral)
结局指标
主要结局
The System Usability Scale (SUS)
时间窗: Week 12
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.
Feasibility parameters as adherence, acceptability, response rate, representativeness, recruitment rate, and satisfaction
时间窗: Week 12
Semi-structured interviews
Bone@BC app
时间窗: From baseline and to week 12
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.
次要结局
- Changes in symptoms of depression and anxiety measured by Hospital Anxiety and Depression Scale(baseline (0 months) and week 12)
- Changes in Quality of life measured by the European Organization for Research and Treatment of Cancer Quality of Life(baseline (0 months) and week 12)
- Changes in patient empowerment measured by The Health Education Impact Questionnaire.(baseline (0 months) and week 12)
- Changes in self-efficacy measured by Self-efficacy for managing chronic disease 6-item scale (SES6G)(Week 4, week 8 end week 12)
- Changes in in app user measured by Open source web analytics application Matomo Analytics(week 4, week 8 and week 12)
研究者
Peter Schwarz
Professor
Rigshospitalet, Denmark