Neoplasms

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All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Breast Neoplasms

Prostatic Neoplasms

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Colorectal Neoplasms

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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

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.

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.

* 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.

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

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.

Digital application with expert guidelines on lifestyle modification

Anupam Anand, BTech

Trupti Mukker, MBA

Claudio L Battaglini, PhD

Erik Hanson, PhD

Claudio L. Battaglini, PhD

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

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.

Treatment Group

* 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.
* 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.

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

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

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

To quantify the impact of Complement Theory's Program on total healthcare expenditure in cancer survivors. This includes assessing both cancer-related and non-cancer-related costs, further categorized into planned and unplanned expenditures.

Evaluate the effects of CT's Digital Application Program on adherence to treatment (using MMAS-8 survey)

Measure the program's influence on Quality of Life, Physical Activity, Sleep Quality and Pain levels of participants.

Quantify the effect of CT's program on employee absenteeism by tracking changes in the number of sick days taken by participants.

Determine the program's impact on employee presenteeism by assessing changes in work motivation and employee performance review scores.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	NCT06397651	Breast Cancer Lung Cancer Prostate Cancer Colorectal Canc... Other Cancer	Complement Theo... Digital applica...	21 Years - 64 Years	Complement Theory Inc.
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	NCT06397651	Breast Cancer Lung Cancer Prostate Cancer Colorectal Canc... Other Cancer	Complement Theo... Digital applica...	21 Years - 64 Years	Complement Theory Inc.

Spots Global Cancer Trial Database for digital application with expert guidelines on lifestyle modification