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
NCT ID: NCT06397651
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
146 participants
INTERVENTIONAL
2024-05-12
2026-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* 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.
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Test Group
Live CoActive Coaching program, focusing on Exercise and Meditation, along with evidence-based information on Diet, for 18 months
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Participants declared medically unfit by their physicians to do physical exercise
* ECOG Score 3,4 or 5
21 Years
ALL
No
Sponsors
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Complement Theory Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Claudio L. Battaglini, PhD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina
Erik Hanson, PhD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina
Locations
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Complement Theory Inc.
Dover, Delaware, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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Pro00077693
Identifier Type: -
Identifier Source: org_study_id