A Randomised Controlled Trial to Evaluate the Impact of Complement Theory's Live CoActive Exercise Coaching and Personalized Digital Application on Cancer Survivors' Quality of Life

Complement Theory Inc.

Status: Active, not recruiting

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

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

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 Coactive Exercise Coaching and Personalized Digital Application on Cancer Survivors' Quality of Life

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 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.

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: Above 21 years
• 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 CoActive Coaching program, focusing on Exercise and Meditation, along with evidence-based information on Diet, for 18 months

Treatment:

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

Control Group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Digital application with expert guidelines on lifestyle modification