Sidekick Health Digital Therapeutic Solution for Cancer Patients: A Feasibility Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 4
- 主要终点
- Cancer-specific Quality of Life
研究概览
简要总结
This is a randomized, controlled trial to assess the feasibility of Sidekick Health's digital programs for cancer patients. Participants will be treated with standard of care (SoC) in combination with the digital programs, or SoC only.
We will compare the effect of the digital programs in addition to SoC to SoC only, on the cancer-related quality of life (QoL), cancer-related fatigue, and side-effect management.
详细描述
In line with the growing need to support cancer patients with lifestyle modifications, education and disease management, Sidekick Health developed 14-week digital programs addressing the specific needs of patients with cancers. In this study, the effect of adding the Sidekick's digital program to the standard of care (SoC) treatment for cancer patients will be assessed, with focus on prostate cancer, colorectal cancer and lung cancer. The digital programs investigated are a general oncology program (SK-411), or specific programs tailored for patients diagnosed with prostate cancer (PC-SK-451), colorectal cancer (CRC-SK-441), or lung cancer (LC-SK-431).
The study will be a single center feasibility study with an intervention group and a comparison group recruiting 84 cancer patients in active cancer treatment from Landspítali University Hospital. Patients will be randomized to receive either the SoC treatment alone or SoC with the addition of the digital program. Active cancer treatment is defined as chemotherapy, hormonal therapy, targeted therapy, immunotherapy, or radiation therapy according to standard treatment guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (at least 18 years of age) diagnosed with cancer
- •Has started active cancer treatment (chemotherapy, hormonal therapy, targeted therapy, immunotherapy, radiotherapy) during the study
- •Cancer diagnosis (all stages), with a focus on prostate cancer, lung cancer, or colorectal cancer
- •Understands verbal and written Icelandic or English
- •Owning a smartphone compatible with the Sidekick Health app and capable of using it.
- •Capacity to give informed consent
- •Willing to comply with all scheduled visits, study interventions, and procedures
排除标准
- •Pregnancy
- •Surgeries in the last 4 weeks prior to participation in the study
- •Surgeries planned during the 14-weeks intervention
- •Not able to comply with study intervention or scheduled measures and visits, as assessed by oncologist
- •Current breast cancer diagnosis
结局指标
主要结局
Cancer-specific Quality of Life
时间窗: Baseline, 14 , 26, and 38 weeks after inclusion in the study
Difference in change in total score of the 30-item European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) between the intervention and control groups. The EORTC-QLQ-C30 is a 30-item questionnaire. It 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
- Cancer-related fatigue derived from the general cancer questionnaire subscale(Baseline, 14 , 26, and 38 weeks after inclusion in the study)
- Cancer-related fatigue(Baseline, 14 , 26, and 38 weeks after inclusion in the study)
- Health-related quality of life of lung cancer patients(Baseline, 14 , 26, and 38 weeks after inclusion in the study)
- Health-related quality of life of colorectal cancer patients(Baseline, 14 , 26, and 38 weeks after inclusion in the study)
- Health-related quality of life of prostate cancer patients(Baseline, 14 , 26, and 38 weeks after inclusion in the study)
- Cancer- and treatment-specific side effects(Baseline and 14 weeks after inclusion in the study)
- Sleep, energy, and stress levels(Baseline and 14 weeks after inclusion in the study)
- Self-assessed health-related quality of life for health economic evaluation(Baseline, 14 , 26, and 38 weeks after inclusion in the study)
- Patients' disease related self-efficacy(Baseline and 14 weeks after inclusion in the study)
- User satisfaction in intervention group(14 weeks)
- User retention(14 weeks)
- Depression, anxiety, and stress levels(Baseline and 14 weeks after inclusion in the study)
- User engagement(14 weeks)