CAFE-MS Informed Consent Material - for Review Only

The CAFE-MS Informed Consent - For Review Only

The purpose of the informed consent document is to provide details about the study, including what to expect, and any potential risks and benefits to participants. It is crucial to review and understand all of the information, so please ask questions or seek clarification as needed before making a decision.

Participation is completely voluntary, and individuals have the right to withdraw at any time without any penalties.

Each participant will be required to electronically sign an official consent form, which will be sent by the clinical trial coordinators via DocuSign.

RESEARCH PARTICIPANT CONSENT FORM

TITLE: Confirmatory Trial for Alleviating FatiguE in Multiple Sclerosis
(CAFE-MS)

PROTOCOL NO.: None
WCG IRB Protocol #20240782

SPONSOR: Accelerated Cure Project, Inc.

INVESTIGATOR: Dr. Stephanie Buxhoeveden, PhD, MSN, FNP-BC, MSCN

Accelerated Cure Project, Inc.
800 Lexington Street STE 2 #1069
Waltham, MA, 02452
USA

STUDY-RELATED
PHONE NUMBER(S): 781-487-0008 (24 hours)

Taking part in this research is voluntary. You may decide not to participate, or you may leave the study at any time. Your decision will not result in any penalty or loss of benefits to which you are otherwise entitled.

If you have any questions, concerns, or complaints or think this research has hurt you, talk to the research team at the phone number(s) listed in this document.

RESEARCH CONSENT SUMMARY

You are being invited to take part in a research study. This document provides a concise summary of this research. It describes the key information that we believe most people need to decide whether to take part in this research. Later sections of this document will provide all relevant details. At the end of the document, you will be asked if you consent to take part in the study if you qualify.

How long will I be in this research?

We expect that your taking part in this research will last a total of 12 months.

Why is this research being done?

The purpose of this research is to test two different experimental online programs as potential treatments for fatigue in individuals diagnosed with multiple sclerosis (MS). These programs both contain potentially useful information on MS and fatigue. Experimental means the online programs have not been approved by the U.S. Food and Drug Administration (FDA) for the treatment of fatigue in individuals with MS.

What happens to me if I agree to take part in this research?

If you decide to take part in this research study and are eligible to participate, the general procedures include being assigned to one of three experimental groups, using one or both of the experimental online programs, and submitting responses to online questionnaires through the secure study website. Your involvement in the study is expected to last for approximately 12 months.

Could being in this research hurt me?

The most important risks or discomforts that you may expect from taking part in this research include the possible loss of privacy or breach of confidentiality. We will take steps to reduce this risk, such as assigning an de-identified study code to your data that is collected during the course of this study.

Any psychological risks involved are believed to be minimal; however, you may experience some momentary frustration when attempting to perform tasks during which you experience difficulty. The researchers will try to minimize any frustration that may occur.

Using the online programs associated with this study and/or completing the outcome questionnaires may worsen your fatigue.

There may be some unanticipated discomforts or risks in addition to those specified above, but every precaution will be taken to assure your personal safety and to minimize any discomforts.

Will being in this research benefit me?

We cannot promise any benefits to you or others from your taking part in this research. However, a possible benefit to you is that you may experience a reduction in your fatigue symptoms from participating in this study.

What other choices do I have instead of taking part in this research?

Your alternative is to not take part in the research. If you decide not to participate, you can review treatment options with your doctor. Other treatment options for fatigue in MS include medications or other fatigue management programs. If you consent to participate, you may withdraw at any time. If you choose to withdraw, it will have no effect on your future participation in research studies conducted by Accelerated Cure Project for MS or the Department of Veterans Affairs.

DETAILED RESEARCH CONSENT

You are being invited to take part in a research study. A person who takes part in a research study is called a study participant.

Why is this research being done?

Fatigue is commonly experienced by people with multiple sclerosis (MS) but there are few treatments available to help with this symptom. The experimental online programs in this study for fatigue in MS are being evaluated as possible treatment options. These online programs both contain potentially useful information on MS and fatigue. They differ in some aspects, but both are intended to provide information that could help you understand and manage any fatigue symptoms you are experiencing. Neither of these programs has been approved as a treatment by the Food and Drug Administration (FDA) in the United States.

How long will I be in this research?

You will be in this study for a total of 12 months. We will enroll 2000 participants in this study.

What happens to me if I agree to take part in this research?

All study activities will take place online. You have already created an account on the CAFE-MS trial website for participation in this study. If you consent to participate in this study and are eligible, you will be randomly assigned (like drawing straws) to one of three study groups. You may also be invited to create an account on the website of a company called GAIA, where the two online programs will take place. You will complete study questionnaires on the CAFE-MS website at various timepoints throughout the study.

Screening procedures

You will be asked to complete an online questionnaire to determine whether you are eligible for this study. This questionnaire will collect information about your MS, demographics (such as age and state of residence) and fatigue.

We may also need to obtain documentation of your MS diagnosis. If this is the case, we will ask you for the name and contact information of your MS healthcare provider. We will then reach out to your provider to request that they confirm your diagnosis.

There are rules to protect your private information. Federal and state laws and the federal medical Privacy Rule also protect your privacy. By signing this form, you provide your permission, called your ‘authorization,’ for the use and disclosure of information protected by the Privacy Rule.

The research team working on the study will collect information about you. This includes things learned from the procedures described in this consent form. The research team may also collect other information including your name, date of birth, and information from your medical records.

Questionnaires

You will be asked to complete a set of online questionnaires at the beginning of the study (baseline), and/or at 1 months, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months and 12 months. These questionnaires will include the following.
•    Questionnaires about your demographics (e.g., sex, race/ethnicity) and MS history (baseline only)
•    Questionnaires about your fatigue level (all timepoints)
•    Questionnaires about your MS symptoms and quality of life (all timepoints)
•    A questionnaire about any other fatigue treatment you are receiving (baseline, 3 months, 6 months and 12 months)
•    A questionnaire asking whether, in the 4 weeks prior to answering the questionnaire, you started a new medicine for your MS, experienced or were treated with a steroid (3 months, 6 months and 12 months)
•    A questionnaire about your ability to carry out daily activities (baseline, 3 months, 6 months and 12 months)
•    A questionnaire about your satisfaction with the program (6 months and 12 months)

You can expect to spend from 10 to 60 minutes at any given timepoint completing these questionnaires.

Experimental Phase (12 months in duration)

After completing the baseline questionnaires, you will be randomly assigned by the study portal to one of three study groups. It is important for you to understand what may happen as a result of assignment to an experimental group before deciding to participate. This random assignment helps ensure that the study results are unbiased and scientifically valid. Neither you nor the research team will have control over which group you are assigned to. You will not know whether you are in Fatigue Program A group or in Fatigue Program B group but participants in will be aware if they are assigned to Treatment-As-Usual group.

All study participants will continue to receive their usual treatment for their MS prescribed by their doctors throughout this study. This includes medications and other types of treatment. You can keep using any treatments for fatigue that you are already using.

The following list describes the three experimental groups you may be assigned to.

1. During the initial 6 month period of the study, you will be provided access to an online fatigue program (A), in addition to continuing to receive your usual treatment for MS as prescribed by your physician (Fatigue Program A group). You will be asked to complete questionnaires every month for 6 months.

2. During the initial 6 month period of the study, you will be provided access to an online fatigue program (B), in addition to continuing to receive your usual treatment for MS as prescribed by your physician (Fatigue Program B group). You will be asked to complete questionnaires every month for 6 months.

Note: Online fatigue program A is distinct from online fatigue program B.

3. You will continue to receive your usual treatment for your MS as prescribed by your physician during the initial 6 month period of the study (Treatment-As-Usual group). You will be asked to complete questionnaires every month for 6 months.

For participants in Fatigue Program A group or Fatigue Program B group:
•    Modules from the programs (A or B) can take between 15 minutes to one hour to review.
•    You will be asked to access the program once or twice per week, with the entire program to be completed over a 6-month period.
•    At the end of the 6 months, you may be offered the other online fatigue program for 6 months. Whether you are offered another online fatigue program or not, you will continue your usual treatment for your MS and will complete questionnaires every 3 months for the remainder of the study.

For participants in the Treatment-As-Usual group:
• At the end of the 6 months, you will be offered a choice between the two experimental online fatigue programs (A or B) for 6 months in addition to your usual treatment for your MS and will complete questionnaires every 3 months for the remainder of the study.
• Modules from the programs (A or B) can take between 15 minutes to one hour to review.

Extension Phase after 180 days for certain program groups
After completion of 180 days of treatment in any of the three assigned groups, you may receive an email notification with an offer to use a different online program but you will not be aware of its exact identity for another 180 days. The purpose of the Extension phase is to examine longer term stability effects of experimental on-line programs. Your study doctor will discuss your options before transition to Extension phase after 180 days.

Participation is voluntary, and you may refuse to participate or leave the study at any time.

What are my responsibilities if I take part in this research?

If you consent to participate in this study and are eligible, you will be assigned to one of three experimental groups. You may also be invited to create an account on the website of a company called GAIA, where the two online programs will take place. You will be responsible for completing the online programs that you are assigned to. The goal of the study is to evaluate how helpful these programs might be in treating fatigue in people with MS. It is important that you use the program regularly over the course of the study.

You will also be responsible for completing a set of online questionnaires at the beginning of the study (baseline), and/or at 1 months, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months and 12 months.

You are also responsible for reporting any events or symptoms occurring during the study that cause you to think that this research may have hurt you or made you sick. These events should be reported to the research team at the phone number(s) listed on the first page of this document.

Could being in this research hurt me?

Identifiable Private Information
The risks of this study include the possible loss of privacy or breach of confidentiality. We will take steps to reduce this risk, such as assigning a de-identified study code to your data that is collected during the course of this study.

Psychological Discomfort
Any psychological risks involved are minimal; however, you may experience some momentary frustration when attempting to perform tasks during which you experience difficulty. The researchers will try to minimize any frustration that may occur.

Using the online programs and/or completing the outcome questionnaires may worsen your fatigue.

There may be some unanticipated discomforts or risks in addition to those specified above, but precautions will be taken to ensure your personal safety and to minimize any discomforts.

In addition to these risks, taking part in this research may harm you in unknown ways.

The risks to an embryo, fetus or infant from exposure to the study procedures are unknown.

Will it cost me money to take part in this research?

There will be no cost to you for participating in this study, other than the cost of your usual treatment. All study-related online programs are offered at no charge to you.

If you are a study participant, you or your insurance will not be charged for any experimental treatments or procedures that are part of this study. If you usually pay co-payments for care and medications, these co-payment requirements will continue to apply to medical care and services provided that are not part of the experimental treatments or procedures that are part of the study.

Will being in this research benefit me?

What other choices do I have instead of taking part in this research?

This research is not designed to diagnose, treat or prevent any disease. Your alternative is to not take part in the research. If you consent to participate, you may withdraw at any time. If you choose to withdraw, it will have no effect on your future participation in research studies conducted by Accelerated Cure Project for MS or the VA.

What happens to the information collected for this research?

The information that is contributed to this study will be stored securely in the study’s online database using industry-standard security controls and will be associated with a code that de-identifies the information. Your contact details will be stored separately in the same secure fashion in the database associated with the code and used only for communicating with you. De-identified information will be shared with individuals and organizations that conduct or watch over this research, including:
•    The research sponsor, Accelerated Cure Project, Inc.
•    Organizations collaborating with the research sponsor;
• Five (5) Veterans Health Administration Medical Centers (Washington, DC; Baltimore, MD; Seattle, WA; Portland, OR; and Nashville, TN), two (2) German universities (Charité – Universitätsmedizin Berlin and University Medical Centre Göttingen) and a German company (GAIA AG)
•    Government agencies, such as the Food and Drug Administration and Department of Defense (DOD)
•    WCG Institutional Review Board (IRB) that reviewed this research. An IRB is a group of people who perform independent review of research studies, following US Federal Government rules, to protect rights and welfare of the people taking part in research studies.

By consenting to participate in this study, you give permission for uses and disclosures of the information about you and your health that you or study personnel contribute to the CAFE-MS study website. Your information will be kept as confidential as possible under local, state, and federal law, but absolute confidentiality cannot be guaranteed.

Your study-related information will be used by members of the research team at ACP and the other collaborating organizations. If a regulatory audit takes place, government officials who oversee research are allowed to view research records. Representatives from the US Department of Defense, the funder of this study, will also be authorized to review research records.

Some of the persons or groups that receive your study information may not be required to comply with the Health Insurance Portability and Accountability Act (HIPAA) privacy laws. Your information may lose its federal protection if those persons or groups disclose it. Permission granted on this date to use and disclose your health information remains in effect indefinitely. By electronically signing this form you give permission for the use and disclosure of your information for the purposes of the study at any time in the future. Any research information that is placed in your medical record may be kept indefinitely.

We may publish the results of this research. However, we will keep your name and other identifying information confidential. We protect your information from disclosure to others to the extent required by law. We cannot promise complete privacy.

While we will do our best to keep the information you share with us confidential, it cannot be absolutely guaranteed. Individuals from WCG IRB and Federal regulatory agencies may look at records related to this study to make sure we are adhering to research regulations and the protocol and minimizing risks to human subjects. The results of this research may be published or presented to others. You will not be named in any reports of the results.

In addition, we will share study data with our collaborating organizations and may use de-identified data (data without your name or information that can be used to directly identify you) for future studies. Data will be transmitted via a HIPAA-approved confidential server. Efforts will be made to limit the use and sharing of your personal research information to people who have a need to review this information.

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.

Additionally, you will be able to view the research results of this study, when available, on the Accelerated Cure Project website (www.acceleratedcure.org), the iConquerMS website (www.iconquerms.org), and the study trial CAFE-MS website. These research results may also be shared with other advocates and interested partners in MS.

Data collected in this research might be used for future research or distributed to another investigator for future research without your additional consent. Neither you nor your doctors will be informed of your individual results from these future research and future research will not affect your current treatment in any ways.

If your data is used for commercial profit you will not share in this commercial profit.

Who can answer my questions about this research?

If you have questions, concerns, or complaints, or think this research has hurt you or made you sick, talk to the research team at the phone number(s) listed in this document.

This research is being overseen by WCG IRB. An IRB is a group of people who perform independent review of research studies. You may contact WCG IRB at 855-818-2289 or clientcare@wcgclinical.com if:
•    You have questions, concerns, or complaints that are not being answered by the research team
•    You want to talk to someone else about the research
•    You have questions about your rights as a research subject

You can also contact your Clinical Trial Coordinator at cafe-ms-sc@iconquerms.org or 781-487- 0066 if you have any questions about this study or the informed consent process. You may also call the researcher at 781-487-0066 if any problems occur as a result of participating in this research.

What if I am injured because of taking part in this research?

If you are injured or get sick because of being in this research study, you should seek medical treatment where you usually seek medical care. Your insurance may be billed for this treatment. Your health insurance company may or may not pay for treatment of injuries as a result of your participation in this study.

If you are a VA study participant, the VA (not you or your insurance) will provide necessary medical treatment should you be injured by being in this study. You will be treated for the injury at no cost to you. This care may be provided by the local Veterans Affairs Medical Center or arrangements may be made for contracted care at another facility. You have not released this institution from liability for negligence. In case of research related injury resulting from this study, you should contact your study team.

You do not give up any legal rights by signing this form.

Can I be removed from this research without my approval?

The person in charge of this research can remove you from this research without your approval.
Possible reasons for removal include:
•    You have an event or symptom that requires stopping the research
•    You need a treatment not allowed in this research
•    The research is canceled by the FDA, IRB, DOD, or the sponsor

We will tell you about any new information that may affect your health, welfare, or choice to stay in this research.

What happens if I agree to be in this research, but I change my mind later?

If you decide to leave this research, please contact the research team at cafe-ms- sc@iconquerms.org.

This authorization to use and disclose your health information collected during your participation in this study will never expire unless you withdraw your permission. You may withdraw or take back your permission to use and share your health information at any time. If you want to cancel permission to use your health information, you must submit the request in writing to the Study doctor listed on the first page this document.

If you cancel permission to use your health information, the research team will stop collecting any additional information about you and will not be able to stay in this study. Please note that the research team may use and disclose information that was gathered before they received your cancellation. However, to join this study you must sign this form to allow use and disclosure of your health information.

Will I be paid for taking part in this research?

If you are eligible for the study, you will be compensated $15 (paid via a digital or physical gift card) for completing questionnaires at each of the 8 time-points after completing the baseline questionnaires, for a maximum of $120. You will receive a total of $120 if you complete all the questionnaires.

Attachment

CAFE-MS Informed Consent Form - FOR REVIEW ONLY.pdf