A Randomised Controlled Trial to Evaluate the Impact of Complement Theory's Live CoActive Exercise Coaching and Personalized Digital Application on Cancer Survivors' Quality of Life

December 9, 2025 updated by: Complement Theory Inc.

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Estimated)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Delaware
      • Dover, Delaware, United States, 19901
        • Complement Theory Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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: Above 21 years
  • 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test Group
Live CoActive Coaching program, focusing on Exercise and Meditation, along with evidence-based information on Diet, for 18 months
Behavioral: Complement Theory's Live CoActive Exercise Coaching and Personalized Digital Application

Participants will get access for 18 months to Complement Theory's Live CoActive Coaching program, focusing on Exercise and Meditation and supplemented with evidence-based information on Diet, adjunct to the core treatment.

  • 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.
  • 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.
Active Comparator: 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.
Behavioral: Digital application with expert guidelines on lifestyle modification
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of the program cancer survivors' Quality of Life Scores (QoLS), measured by the FACT-G instrument.
Time Frame: 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.
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect on Employee Absenteeism
Time Frame: 18 Months
Quantify the effect of CT's program on employee absenteeism by tracking changes in the number of sick days taken by participants.
18 Months
Impact on Employee Presenteeism
Time Frame: 18 Months
Determine the program's impact on employee presenteeism by assessing changes in work motivation and employee performance review scores.
18 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Complement Theory Inc.

Investigators

  • Principal Investigator: Claudio L. Battaglini, PhD, University of North Carolina
  • Principal Investigator: Erik Hanson, PhD, University of North Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2024

Primary Completion (Estimated)

February 28, 2026

Study Completion (Estimated)

February 28, 2026

Study Registration Dates

First Submitted

April 25, 2024

First Submitted That Met QC Criteria

April 30, 2024

First Posted (Actual)

May 3, 2024

Study Record Updates

Last Update Posted (Actual)

December 17, 2025

Last Update Submitted That Met QC Criteria

December 9, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00077693

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data shall be shared. This includes both primary and secondary outcomes related data points.

IPD Sharing Time Frame

Data will be available 3 months after the end trial and will be available for 2 years after the date of availability.

IPD Sharing Access Criteria

Anyone shall be able access after following a simple data request process. The person has to detail the purpose and expected outcomes, which will be reviewed and approved by the Principal Investigators.

Plus, we will also ensure appropriate documentation. We will employ a data use agreement to prohibit re-identification attempts and ensure data is used as per the agreed proposal.

The overall process has been designed to make the data access as open as possible and as closed as necessary, to protect participant privacy and reduce the risk of data misuse.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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