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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Group | Experimental | Live CoActive Coaching program, focusing on Exercise and Meditation, along with evidence-based information on Diet, for 18 months |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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.
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Effect on Employee Absenteeism | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudio L. Battaglini, PhD | University of North Carolina | Principal Investigator |
| Erik Hanson, PhD | University of North Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complement Theory Inc. | Dover | Delaware | 19901 | United States |
De-identified data shall be shared. This includes both primary and secondary outcomes related data points.
Data will be available 3 months after the end trial and will be available for 2 years after the date of availability.
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 26, 2025 | Dec 9, 2025 |
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Treatment Group
Active Comparator (Control) Group
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| 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. |
|
Determine the program's impact on employee presenteeism by assessing changes in work motivation and employee performance review scores.
| 18 Months |
| Prot_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 9, 2024 | Apr 19, 2024 | ICF_001.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D008175 | Lung Neoplasms |
| D011471 | Prostatic Neoplasms |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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