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

Complement Theory Inc.

Status: Enrolling

Conditions: Breast Cancer; Other Cancer; Lung Cancer; Prostate Cancer; Colorectal Cancer

Treatments: Behavioral: Complement Theory's Live 1:1 Exercise Coaching and Personalized Digital Application; Behavioral: Digital application with expert guidelines on lifestyle modification

Study type: Interventional

Funder types: Industry

Identifiers

NCT06397651

Pro00077693

Details and patient eligibility

About

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

Full 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.

Enrollment: 146 estimated patients

Sex: All

Ages: 21 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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146 participants in 2 patient groups

Test Group

Experimental group

Description:

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

Treatment:

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

Control Group

Active Comparator group

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. Does not include live coaching and personalization.

Treatment:

Behavioral: Digital application with expert guidelines on lifestyle modification