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Brief Title: A Randomised Controlled Trial to Evaluate the Impact of Complement Theory's Live 1:1 Exercise Coaching and Personalised Digital Application on Cancer Survivors' Cost of Care
Official Title: A Decentralized, Double-blinded, Randomized, 18 Month, Parallel-group, Superiority Study to Evaluate the Impact of Complement Theory's Live 1:1 Exercise Coaching and Personalized Digital Application on Cancer Survivors' Cost of Care
Study ID: NCT06397651
Brief Summary: A Decentralized, Double-blinded, Randomized, 18 month, Parallel-group, Superiority Study to evaluate the impact of Complement Theory's Live 1:1 Exercise Coaching and Personalized Digital Application on Cancer Survivors' Cost of Care
Detailed Description: The randomized controlled trial (RCT) aims to evaluate the efficacy of Complement Theory's (CT) personalized and interactive, evidence-backed lifestyle program in reducing healthcare costs and improving health outcomes for survivors across all major cancer types. Distinct from conventional interventions, CT's program offers live 1:1 coaching through a mobile app, concentrating on Exercise and Meditation, and is enriched with evidence-based advice on Diet, Sleep, and comprehensive lifestyle modifications. 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 more effectively reduce healthcare utilization, through reduction of hospitalizations, urgent care visits, and outpatient visits. Furthermore, the trial seeks to measure adherence to treatment, and significant health outcomes, including improvements in Quality of Life Scores (QoLS) 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 cancer progression, recurrence in Prostate and Colorectal cancer survivors alone.
Minimum Age: 21 Years
Eligible Ages: ADULT
Sex: ALL
Healthy Volunteers: No
Complement Theory Inc., Dover, Delaware, United States
Name: Claudio L. Battaglini, PhD
Affiliation: University of North Carolina
Role: PRINCIPAL_INVESTIGATOR
Name: Erik Hanson, PhD
Affiliation: University of North Carolina
Role: PRINCIPAL_INVESTIGATOR