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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06397651
• Other study ID #: Pro00077693
• Status: Recruiting
• Phase: N/A
• Start date: May 12, 2024
• Est. completion date: February 28, 2026

Study information

• Verified date: May 2024
• Source: Complement Theory Inc.
• Contact: Anupam Anand, BTech
• Phone: +918473994735
• Email: anupam[@]compthealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 146
• Est. completion date: February 28, 2026
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Colorectal Cancer
• Colorectal Neoplasms
• Lung Cancer
• Other Cancer
• Prostate Cancer

Intervention

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

Locations

Country	Name	City	State
United States	Complement Theory Inc.	Dover	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Complement Theory Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Healthcare Expenditure Reduction	To quantify the impact of Complement Theory's Program on total healthcare expenditure in cancer survivors. This includes assessing both cancer-related and non-cancer-related costs, further categorized into planned and unplanned expenditures.	18 months
Secondary	Adherence to Treatment	Evaluate the effects of CT's Digital Application Program on adherence to treatment (using MMAS-8 survey)	18 Months
Secondary	Influence on Quality of Life Score (QoLS), Pain, Sleep and Physical Activity	Measure the program's influence on Quality of Life, Physical Activity, Sleep Quality and Pain levels of participants.	18 Months
Secondary	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
Secondary	Impact on Employee Presenteeism	Determine the program's impact on employee presenteeism by assessing changes in work motivation and employee performance review scores.	18 Months