Clinical trial NCT06397651: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Lung Cancer
Prostate Cancer
Colorectal Cancer
Other Cancer
Keywords: Other cancer here refers to all cancers apart from Breast, Lung, Prostate and Colorectal Cancer
Lead sponsor: Complement Theory Inc.
Sponsor class: INDUSTRY
First posted: 2024-05-03
Enrollment: 146
Sex: ALL
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

Brief 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.

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

Primary outcomes:
measure: Total Healthcare Expenditure Reduction
timeFrame: 18 months
Secondary outcomes:
measure: Adherence to Treatment
timeFrame: 18 Months
measure: Influence on Quality of Life Score (QoLS), Pain, Sleep and Physical Activity
timeFrame: 18 Months
measure: Effect on Employee Absenteeism
timeFrame: 18 Months
measure: Impact on Employee Presenteeism
timeFrame: 18 Months
Other outcomes:
Locations:
city: Dover
country: United States
facility: Complement Theory Inc.
state: Delaware
Study officials:
affiliation: University of North Carolina
name: Claudio L. Battaglini, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina
name: Erik Hanson, PhD
role: PRINCIPAL_INVESTIGATOR
References: