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Trial Title:
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
NCT ID:
NCT06397651
Condition:
Breast Cancer
Lung Cancer
Prostate Cancer
Colorectal Cancer
Other Cancer
Conditions: Official terms:
Colorectal Neoplasms
Complement System Proteins
Conditions: Keywords:
Other cancer here refers to all cancers apart from Breast, Lung, Prostate and Colorectal Cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
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.
Primary purpose:
Supportive Care
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
Complement Theory's Live 1:1 Exercise Coaching and Personalized Digital Application
Description:
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.
Arm group label:
Test Group
Intervention type:
Behavioral
Intervention name:
Digital application with expert guidelines on lifestyle modification
Description:
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.
Arm group label:
Control Group
Summary:
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
Detailed description:
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
21 Years
Maximum age:
64 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Complement Theory Inc.
Address:
City:
Dover
Zip:
19901
Country:
United States
Status:
Recruiting
Contact:
Last name:
Claudio L Battaglini, PhD
Phone:
919-843-6045
Email:
claudio@email.unc.edu
Contact backup:
Last name:
Erik Hanson, PhD
Phone:
919-962-0816
Email:
edhanson@email.unc.edu
Start date:
May 12, 2024
Completion date:
February 28, 2026
Lead sponsor:
Agency:
Complement Theory Inc.
Agency class:
Industry
Source:
Complement Theory Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06397651
