Breast Cancer, Colorectal Cancer, Lung Cancer, Other Cancer, Prostate Cancer
Conditions
Keywords
Other cancer here refers to all cancers apart from Breast, Lung, Prostate and Colorectal Cancer
Brief summary
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
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 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.
Interventions
BEHAVIORALComplement Theory's Live CoActive Exercise Coaching and Personalized Digital Application
Participants will get access for 18 months to Complement Theory's Live CoActive Coaching program, focusing on Exercise and Meditation and supplemented with evidence-based information on Diet, 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.
BEHAVIORALDigital application with expert guidelines on lifestyle modification
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.
Sponsors
Complement Theory Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Treatment Group * Participants will get access to Complement Theory's Live 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.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact of the program cancer survivors' Quality of Life Scores (QoLS), measured by the FACT-G instrument. | 18 months | To quantify the impact of Complement Theory's Program on cancer survivors' Quality of Life, as measured by the change in FACT-G scores over the course of the trial. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect on Employee Absenteeism | 18 Months | Quantify the effect of CT's program on employee absenteeism by tracking changes in the number of sick days taken by participants. |
| Impact on Employee Presenteeism | 18 Months | Determine the program's impact on employee presenteeism by assessing changes in work motivation and employee performance review scores. |
Countries
United States
Outcome results
None listed