A Decentralized, Double-blinded, Randomized, 18 Month, Parallel-group, Superiority Study to Evaluate the Impact of Complement Theory's Live Coactive Exercise Coaching and Personalized Digital Application on Cancer Survivors' Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Impact of the program cancer survivors' Quality of Life Scores (QoLS), measured by the FACT-G instrument.
研究概览
简要总结
A Decentralized, Double-blinded, Randomized, 18 month, Parallel-group, Superiority Study to evaluate the impact of Complement Theory's Live Coactive Exercise Coaching and Personalized Digital Application on Cancer Survivors' Quality of Life
详细描述
The randomized controlled trial (RCT) aims to evaluate the efficacy of Complement Theory's (CT) personalized and interactive, evidence-backed lifestyle program in improving Cancer Survivors' Quality of Life across all major cancer types.
Distinct from conventional interventions, CT's program offers live CoActive coaching through a mobile app, concentrating on Exercise and Meditation, and is enriched with evidence-based advice on Diet. This trial is pivotal in assessing the program's effectiveness against an active comparator - expert-recommended lifestyle modification resources suitable for cancer survivors -- to isolate the impact of coaching and personalization.
The primary objective is to investigate whether CT's novel approach can significantly improve Quality of Life for survivors. Furthermore, the trial seeks to measure absenteeism and presenteeism at work to provide a holistic evaluation of the program's impact on patient care and well-being. As an exploratory effort, the trial will also measure changes in healthcare expenditure across all survivors along with assessing cancer progression, recurrence in Prostate, Lung and Colorectal cancer survivors.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cancer Type: Breast, Prostate, Colorectal, Lung and Other Cancer
- •Cancer Stage: Stage 1 to 4
- •Treatment Status: Has undergone any cancer-related treatment in last 12 months
- •Age: Above 21 years
- •Permission to access to last 1 year digital health records
- •Access to smartphone or a tablet
排除标准
- •Excludes individuals who have undergone surgery within the last 4 weeks or will undergo surgery in the next 4 weeks
- •Participants declared medically unfit by their physicians to do physical exercise
- •ECOG Score 3,4 or 5
研究组 & 干预措施
Test Group
Live CoActive Coaching program, focusing on Exercise and Meditation, along with evidence-based information on Diet, for 18 months
干预措施: Complement Theory's Live CoActive Exercise Coaching and Personalized Digital Application (Behavioral)
Control Group
18 months access to Digital application with expert guidelines on lifestyle modification focusing on exercise, meditation, as well as information on diet, sleep and other lifestyle practices. Does not include live coaching and personalization.
干预措施: Digital application with expert guidelines on lifestyle modification (Behavioral)
结局指标
主要结局
Impact of the program cancer survivors' Quality of Life Scores (QoLS), measured by the FACT-G instrument.
时间窗: 18 months
To quantify the impact of Complement Theory's Program on cancer survivors' Quality of Life, as measured by the change in FACT-G scores over the course of the trial.
次要结局
- Impact on Employee Presenteeism(18 Months)
- Effect on Employee Absenteeism(18 Months)
- Effect on Employee Absenteeism(18 Months)
- Impact on Employee Presenteeism(18 Months)