Sidekick Health Digital Health Program (SK-421) for Breast Cancer Patients: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 4
- 主要终点
- Cancer-specific Quality of Life
研究概览
简要总结
Sidekick Health has developed an interactive digital health program (SK-421) to support breast cancer patients. The study will be a single center pilot study with an intervention group and a comparison group aiming to recruit 66 breast cancer patients prescribed to surgery, chemotherapy, radiation and/or hormonal therapy according to standard breast cancer treatment.
This pilot study will determine whether the digital health program, supporting lifestyle changes, can positively impact management of side effects, quality of life, physical activity and fitness and medication adherence in this patient population.
Patients will be randomized to receive either the standard of care (SoC) treatment alone or SoC with the addition of the digital healthprogram.
详细描述
Many cancer survivors do not achieve previous levels of function and report prolonged fatigue, cognitive limitations, depression, anxiety, sleep problems, pain, or sexual dysfunction for up to ten years after diagnosis. In addition to symptoms related to the cancer itself, most cancer treatments cause physical and psychosocial side-effects that can affect a patient's physical function, mental well-being, and overall quality of life (QoL). These treatment-related side effects are most prominent during treatment but can also persist long after completion of the treatment with some becoming chronic and others developing as late side effects.
The European Society of Medical Oncology (ESMO) recommends encouraging patients towards adopting a healthy lifestyle including diet modification and exercise as well as addressing psychosocial needs.
Sidekick Health developed a 14-week digital health program (SK-421) with patient support aiming to increase the health related quality of life of breast cancer patients and improve management of treatment-related side effects.
The aim of this study is to assess the effectiveness of this digital health program when added to standard of care treatment. By comparing the effect of adding a digital solution to the standard of care with standard of care only, this study will investigate the impact of a holistic, digitally delivered health program on quality of life, physical activity, medication and treatment-related side effects. The main analysis is done after 14 weeks, with exploratory follow-up analysis at 26 and 38 weeks.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female adults diagnosed with breast cancer stage 1, 2, 3 or 4
- •Treatment plan includes surgery and (neo)adjuvant treatments: targeted-, chemo-, endocrine-, or radiotherapy.
- •Fluent in verbal and written Icelandic or English
- •Capacity to give informed consent
- •Capacity to operate a smartphone
排除标准
- •Not owning a smartphone compatible with the Sidekick Health app or not willing to have it installed on their device
- •Not able to comply with study intervention/scheduled measures and visits, as assessed by oncologist
- •Pregnancy
研究组 & 干预措施
Digital intervention group
Participants will be instructed to download the Sidekick Health app and receive a code to access the 14-week digital intervention in addition to standard of care, as is defined for the control arm.
Beyond this, all patients in the interventional arm will also receive standard of care as defined for the control arm.
干预措施: A digital health program for patients with Breast Cancer (Device)
Standard of Care
The control arm will receive standard of care treatment. Standard of care includes medical treatment at Landspitali University Hospital, and optional cancer rehabilitation at the Ljósið Cancer Rehabilitation Center.
结局指标
主要结局
Cancer-specific Quality of Life
时间窗: 14 weeks
Difference in change in total score of the 30-item Quality of life Core Questionnaire (QLQ-C30) between the intervention and control groups. This 30-item questionnaire is composed of 28 questions with a Likert scale of 4 options where 1 represents "not at all" to 4 "very much", and 2 questions with a Likert scale of 7 options where 1 represents "very poor" to 7 "excellent". Scores on the QLQ-C30 range from 30 to 126, with a lower score representing a higher quality of life.
次要结局
- Depression, anxiety, and stress levels.(14 weeks)
- User satisfaction in intervention group(14 weeks)
- Breast cancer-specific Quality of Life(14 weeks)
- Weight(14 weeks)
- Body composition(14 weeks)
- Cancer related fatigue(14 weeks)
- Medication adherence in participants on antihormonal therapy.(14 weeks)
- Cardiorespiratory fitness(14 weeks)
- Self-assessed health-related quality of life for health economic evaluation(14 weeks)
- User experience(14 weeks)
- Patients' disease related self-efficacy(14 weeks)