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

Clinicaltrials.gov ID: NCT06397651
db-list-check Status RECRUITING
b-loader Phase NA
b-people Age 21 - 64 Years
b-bullseye-arrow Enrollments 146

Conditions

Breast Cancer, Lung Cancer, Prostate Cancer, Colorectal Cancer, Other Cancer

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.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Claudio L. Battaglini, PhD

Eligibility Criteria

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 Plan

Test Group

EXPERIMENTAL

Live 1:1 Coaching program, focusing on Exercise and Meditation, along with app-guided evidence-based information on Diet, Sleep, and other lifestyle practices for 24 weeks

  • BEHAVIORAL:

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

    Description:

    Participants will get access to Complement Theory's 24-week Live 1:1 Coaching program, focusing on Exercise and Meditation and supplemented with evidence-based information on Diet, Sleep, and other lifestyle practices, adjunct to the core treatment.nn* Each week, up to five sessions of 45 minutes each will be offered, with a recommendation for participants to engage in a minimum of three sessions to ensure adequate program exposure and benefits.n* Each session will consist of 30 Minutes of Physical Exercise and 7 minutes of meditation. Each session will be a combination session focused on Aerobic and Strength, with flexibility and balance exercises included as supplements.

Control Group

ACTIVE_COMPARATOR

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.

  • BEHAVIORAL:

    Digital application with expert guidelines on lifestyle modification

    Description:

    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.

Outcome Measures

Primary Outcome Measures

Total Healthcare Expenditure Reduction

Time Frame: 18 months

Secondary Outcome Measures

Adherence to Treatment

Time Frame: 18 Months

Influence on Quality of Life Score (QoLS), Pain, Sleep and Physical Activity

Time Frame: 18 Months

Effect on Employee Absenteeism

Time Frame: 18 Months

Impact on Employee Presenteeism

Time Frame: 18 Months

Timeline

  • Last Updated
    May 17, 2024
  • Start Date
    May 3, 2024
  • Today
    February 5, 2025
  • Completion Date ( Estimated )
    February 28, 2026

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