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

Not Applicable

Recruiting

• Conditions: Colorectal Cancer; Lung Cancer; Other Cancer; Prostate Cancer; Breast Cancer
• Interventions: Behavioral: Digital application with expert guidelines on lifestyle modification

• Registration Number: NCT06397651
• Lead Sponsor: Complement Theory Inc.

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.

Study Timeline

• Study First Submitted: 2024-04-25
• Study First Submitted QC: 2024-04-30
• Status Verified: 2024-05
• Study First Posted: 2024-05-03
• Study Start: 2024-05-12
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-17
• Primary Completion: 2026-02-28
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

• 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: 21 to 64
• Permission to access to last 1 year digital health records
• Access to smartphone or a tablet

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Digital application with expert guidelines on lifestyle modification	24 weeks 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.

Primary Outcome Measures

Name	Time	Method
Total Healthcare Expenditure Reduction	18 months	To quantify the impact of Complement Theory's Program on total healthcare expenditure in cancer survivors. This includes assessing both cancer-related and non-cancer-related costs, further categorized into planned and unplanned expenditures.

Secondary Outcome Measures

Name	Time	Method
Influence on Quality of Life Score (QoLS), Pain, Sleep and Physical Activity	18 Months	Measure the program's influence on Quality of Life, Physical Activity, Sleep Quality and Pain levels of participants.
Adherence to Treatment	18 Months	Evaluate the effects of CT's Digital Application Program on adherence to treatment (using MMAS-8 survey)
Effect on Employee Absenteeism	18 Months	Quantify the effect of CT's program on employee absenteeism by tracking changes in the number of sick days taken by participants.
Impact on Employee Presenteeism	18 Months	Determine the program's impact on employee presenteeism by assessing changes in work motivation and employee performance review scores.

Trial Locations

Locations (1)

Complement Theory Inc.; 🇺🇸 Dover, Delaware, United States