Evaluating a personalized exercise coaching program for cancer survivors
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
This study is testing a personalized exercise coaching program to see if it can help cancer survivors improve their health and reduce hospital visits compared to regular lifestyle tips.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 146 (estimated) |
| Ages | 21 Years to 64 Years |
| Sex | All |
| Sponsor | Complement Theory Inc. Industry-sponsored |
| Locations | 1 site (Dover, Delaware) |
| Trial ID | NCT06397651 on ClinicalTrials.gov |
What this trial studies
This trial assesses the effectiveness of Complement Theory's personalized exercise coaching and digital application in reducing healthcare costs and improving health outcomes for cancer survivors. It employs a randomized controlled design, comparing the novel coaching approach against standard lifestyle modification resources. The program focuses on exercise, meditation, diet, sleep, and overall lifestyle changes, aiming to decrease hospitalizations and improve quality of life. The study will also explore cancer progression and recurrence in specific cancer types.
Who should consider this trial
Good fit: Ideal candidates include cancer survivors aged 21 to 64 who have completed treatment within the last year and have access to a smartphone or tablet.
Not a fit: Patients who have undergone recent surgery or are deemed medically unfit for physical exercise will not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly reduce healthcare costs and improve the quality of life for cancer survivors.
How similar studies have performed: Other studies have shown promise in using personalized coaching and digital applications for health improvement, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dover, Delaware
- Complement Theory Inc. — Dover, Delaware, United States (Recruiting)
Study contacts
- Principal investigator: Claudio L. Battaglini, PhD — University of North Carolina
- Study coordinator: Anupam Anand, BTech
- Email: anupam@compthealth.com
- Phone: +918473994735
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.