Clinical trial: NCT06397651
Section: Alternatives
Subsections: Are There Benefits To Taking Part In The Study?|What Other Choices Do I Have If I Do Not Take Part In This Study?

Participation in this study may offer potential benefits to your health, although improvements are not guaranteed. There is a substantial body of research indicating that regular exercise, meditation, and dietary adjustments can positively affect overall health and well-being, particularly for individuals diagnosed with cancer. For instance, the program is expected to increase quality of life, reduce fatigue, reduce pain, improve sleep, improve medicine adherence, decrease hospitalizations and clinic visits in the short-medium term and even improve cancer outcomes, such as reduced recurrence in the medium-long term. While it is our hope that the Complement Theory's Digital Application Program will demonstrate effectiveness in supporting cancer care beyond the current standard of care, conclusive evidence on our Program is not yet available. Your participation is valuable as it will contribute to a deeper understanding of the program's impact on cancer care. The insights gained from this study have the potential to advance treatment approaches and benefit future cancer patients.

Your other choices may include:
- Continue with your current lifestyle along with treatment or care for your cancer, based on your physician's advice
- Taking part in another study involving lifestyle modification including exercise, meditation and nutrition
- Getting no lifestyle modification Talk to your doctor about your choices before you decide if you will take part in this study.
Clinical trial: NCT06397651
Section: Confidentiality
Subsections: Will My Medical Information Be Kept Private?

We will do our best to make sure that the personal information in your medical record will be kept private. Your privacy and confidentiality will be strictly maintained throughout the study, but absolute confidentiality cannot be guaranteed. All data you share through your hospital Electronic Health Records and through the surveys will be stored securely in a HIPAA-compliant system and will only be accessible to authorized personnel involved in the research or to the review board. However, your personal information may be given out if required by law. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used. The data will never be sold (e.g. third party entities) and will be used only for the purposes related to this research study. Your information will be assigned a code number. The list connecting your name to this code will be kept in a locked file. When the study is completed and the data have been analyzed, this list will be destroyed. A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time. What are the costs of taking part in this **study?** You will not need to pay anything to be a part of this study.
Clinical trial: NCT06397651
Section: Duration of Study Involvement
Subsections: How Long Will I Be In The Study?

Since this is a lifestyle modification program, you will be encouraged to make positive changes for the entire duration of 18 months. However, particular emphasis will be given by the Complement Theory's Digital Application Program for 24 weeks of the main intervention. Every month we will be in touch to assess your progress. We would like to do this by asking you to fill out digital forms and giving us access to your electronic health records (EHR). Keeping in touch with you and checking on your condition helps us look at the long-term effects of the study.
Clinical trial: NCT06397651
Section: Participant's Rights
Subsections: What Are My Rights If I Take Part In This Study?

Taking part in this study is your choice. You may choose either to take part or not to take part in the study. If you decide to take part in this study, you may leave the study at any time. No matter what decision you make, there will be no penalty to you. We will tell you about new information or changes in the study that may affect your health or your willingness to continue in the study.
Clinical trial: NCT06397651
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Side Effects Or Risks Can I Expect From Being In The Study?

Even though exercises and lifestyle modifications are considered safe for cancer patients, there is still a possibility that you may experience side effects or discomfort while participating in the study. Please ensure that you have no prohibitions on physical exercise based on instructions from your physician or oncologist. There is a risk that certain adverse changes can happen during exercise such as abnormal blood pressure, fainting and nausea. Everyone taking part in the study will be monitored carefully for any side effects or adverse reactions, and measures will be taken to manage any adverse events. Your study team may offer guidance or adjustments to the intervention to help manage or mitigate any discomfort. You are encouraged to communicate openly with the Principal Investigators about any discomfort or side effects that you experience during the study. It is crucial to follow all guidance provided by the Digital Application Program and to report any issues or concerns immediately to ensure your safety and well-being throughout the study. Reproductive **risks:** There are no known reproductive risks associated with participating in this study. There may be risks which are currently unforeseeable. For more information about risks and side effects, ask your Principal Investigators.
Clinical trial: NCT06397651
Section: Procedures
Subsections: What Will Happen If I Take Part In This Research Study?|During The Study: Main Intervention

Upon submission of the screening form, you will undergo an initial eligibility assessment based on predefined inclusion and exclusion criteria. Once you are found to be eligible, you will then be randomized into either the treatment or control group. This randomization is performed after the completion of the screening process and is based solely on the cancer type, ensuring an equal distribution of participants across different cancer categories within both groups. We (Sponsors and investigators) don't have any choice in deciding which group you fall into. If you are in group 1 (often called "Arm A") then you will be given Complement One Digital Application, focusing on Exercise and Meditation for 24 weeks. You will be expected to attend exercise and meditation sessions 3-5 days per week. Along with that, you will be given evidence-based information on Diet, Sleep, and other lifestyle practices - which you will be encouraged to follow. On a predefined basis, data will be collected from you on Quality of Life, Sleep, Medicine Adherence, Pain, Physical Activity, Work and Medical Expenses. If you are in group 2 (often called "Arm B") then you'll be given access to expert guidelines on lifestyle modification focusing on exercise, meditation, as well as information on diet, sleep and other lifestyle practices through an App. You will receive instructions and guidance to complete exercise and meditation routines 3-5 times per week. You will be encouraged to follow them throughout 24 weeks and beyond. On a predefined basis, data will be collected from you on Quality of Life, Sleep, Medicine Adherence, Pain, Physical Activity, Work and Medical Expenses. Before the study begins: You will need to fill out the following forms:
1. Demographic Details 2. Morisky Medication Scale (MMAS-8) for Medicine Adherence Score 3. Functional Assessment of Cancer Therapy-General (FACT-G) for Quality of Life Score 4. Patient Reported Outcomes Measurement Information System (PROMIS) for measuring sleep quality 5. Godin Leisure-Time Exercise Questionnaire (GLTEQ) for physical function measurement 6. Brief Pain Inventory to report pain levels 7. Motivation to work 8. Employee Performance Review 9. Absenteeism Data 10. Medical Expenditure Form

In addition to your regular cancer care, the Program involves doing these for 24 weeks:
- Practicing suggested exercises and meditation at least three times, up to five times a week.  
- Implementing lifestyle modifications based on the program's advice.  
- Periodically completing these forms to track your progress:
- FACT-G for Quality of Life Score
- MMAS-8 for Adherence Score
- PROMIS for measuring sleep quality
- GLTEQ for physical function measurement
- Brief Pain Inventory to report pain levels
- Motivation to work
- Employee Performance Review
- Medical Expenditure Form
- Absenteeism Data
- Cancer Progression Status During the study: After main intervention After 24 weeks of the main intervention program, you will be encouraged to continue with the exercise and meditation program. You will be given access to our Application for the entire duration of 18 months to help you continue on the path of lifestyle modification. We will require all participants to regularly fill in these details to continuously track your progress till the end of the study at 18 months:
- FACT-G for Quality of Life Score - MMAS-8 for Adherence Score - PROMIS for measuring sleep quality - GLTEQ for physical function measurement
- Brief Pain Inventory to report pain levels
- Motivation to work
- Employee Performance Review
- Medical Expenditure Form
- Absenteeism Data
- Cancer Progression Status
Clinical trial: NCT06397651
Section: Purpose of Research
Subsections: Purpose Of The Study

The purpose of this research study is to test the safety, tolerability, and effectiveness of Complement Theory's Lifestyle Modification Application, when used for Breast, Prostate, Lung and Colorectal Cancer. You are being asked to participate in this study because you have been diagnosed with either of the 4 cancer types and may meet the study entry requirements.
Clinical trial: NCT06397651
Section: Withdrawal from Study
Subsections: Can I Stop Being In The Study?

Yes. You can decide to stop at any time. Tell the Principal Investigators if you are thinking about stopping or decide to stop. He or she will tell you how to stop safely. The Principal Investigators or the sponsor may stop you from taking part in this study at any time if he/she believes it is in your best interest; if you do not follow the study rules; or if the study is stopped.