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

NCT06397651 | Active Not Recruiting DMC

• 1 other identifier: Pro00077693
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer; Lung Cancer; Prostate Cancer; Colorectal Cancer; Other Cancer

Keywords

Other cancer here refers to all cancers apart from Breast, Lung, Prostate and Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Impact of the program cancer survivors' Quality of Life Scores (QoLS), measured by the FACT-G instrument.

  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 Outcomes (2)

• Effect on Employee Absenteeism

  18 Months

• Impact on Employee Presenteeism

  18 Months

Study Arms (2)

Test Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Interventions

Complement Theory's Live CoActive Exercise Coaching and Personalized Digital Application BEHAVIORAL

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.

Test Group

Digital application with expert guidelines on lifestyle modification BEHAVIORAL

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.

Control Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Complement Theory Inc.: lead

Study Sites (1)

Complement Theory Inc.

Dover, Delaware, 19901, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Lung Neoplasms; Prostatic Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Claudio L. Battaglini, PhD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

• Erik Hanson, PhD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Treatment Group * Participants will get access to Complement Theory's Live 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. * Each week, up to five sessions of 45 minutes each will be offered, with a recommendation for participants to engage in a minimum of 3 sessions. * 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 * Participants in this group will receive access to a curated collection of publicly available guidelines for lifestyle modification. These resources, presented through a digital application, will focus on exercise, meditation, diet, and sleep, but without the live coaching or program personalization.

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: May 3, 2024
• Study Start: May 12, 2024
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available 3 months after the end trial and will be available for 2 years after the date of availability.
• 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.

Locations

US (1)