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

Last updated: May 15, 2024
Sponsor: Complement Theory Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Non-small Cell Lung Cancer

Colon Cancer; Rectal Cancer

Colorectal Cancer

Treatment

Digital application with expert guidelines on lifestyle modification

Complement Theory's Live 1:1 Exercise Coaching and Personalized Digital Application

Clinical Study ID

NCT06397651
Pro00077693
  • Ages 21-64
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Excludes individuals who have undergone surgery within the last 4 weeks or willundergo 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

Total Participants: 146
Treatment Group(s): 2
Primary Treatment: Digital application with expert guidelines on lifestyle modification
Phase:
Study Start date:
May 12, 2024
Estimated Completion Date:
February 28, 2026

Study 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.

Connect with a study center

  • Complement Theory Inc.

    Dover, Delaware 19901
    United States

    Active - Recruiting

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