Consent to Take Part in Research

Kaiser Permanente Northwest

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.

Key Information:

The following is a short summary of this study to help you decide if you want to participate in this study. The remainder of this form has more detailed information about the study.

Introduction:

The COOP study team is inviting you to join a research study. Whether or not you want to be part of the study is entirely up to you.

What should I know about being part of a research study?

• Someone will explain the details and timeline of this study to you.
• You can agree to participate and later change your mind.
• Your decision about whether to join, or whether you continue to participate if you join today, will not affect your medical care in any way.
• You can ask all the questions you want and discuss it with your doctor, family, and friends, if you wish, before you decide.

Why are we doing this study?

We want to compare yearly at-home stool-based (fecal) testing, using a fecal immunochemical test (FIT), to colonoscopy as a test for early detection of colorectal cancer in adults age 70-82 who have had small growths, or polyps, in their colon or rectum.

Colonoscopy is a procedure that lets your doctor look inside your entire colon and rectum using a camera on the end of a flexible tube. This procedure can find cancer and polyps. If polyps are found, they can be removed. The procedure requires dietary changes and bowel preparation, and most people choose to take a day off work for the procedure.

Fecal immunochemical testing (called FIT) is an at-home test that looks for hidden blood in the stool. Blood in stool can be an early sign of colorectal cancer.  There are no risks to using FIT itself. However, if the FIT test result is abnormal, patients will need to obtain a colonoscopy to remove polyps.

Both FIT and colonoscopy are used to look for colorectal cancer. Currently in the United States, FIT is not used to monitor people your age who have had polyps. The COOP Research Study hopes to learn how well FIT works compared to colonoscopy at finding colorectal cancer in adults who have already had colorectal polyps. We will also learn more about people’s experiences using FIT.

A polyp is a growth on the inside wall of the colon or rectum. Colorectal cancer usually starts as a polyp. Adults who have had polyps are usually recommended to get regular colonoscopies, also called ‘surveillance colonoscopies’. However, research has shown there is very little (if any) increased risk of cancer if a person’s polyps are small. Also, adults who may benefit from surveillance may not want to have a colonoscopy. This may be due to concerns about the risks, the hassle, the challenges of getting ready (e.g., change in diet, laxative) and the worry or discomfort around the procedure itself. A FIT is a non-invasive at-home test and may be an alternative to colonoscopy for patients whose polyps are small.

By comparing patients who use FIT to patients who get surveillance colonoscopy, we hope to learn more about patients’ preferences and how well FIT works compared to colonoscopy for people who’ve had polyps.

Why am I being invited to take part in this research study?

We invite you to take part in this research study because you are between the ages of 70-82, have had small colorectal polyps on a recent colonoscopy, and are due for your surveillance colonoscopy within the next year.

How long will the research last and what will I need to do?

We hope that you will be part of this study for up to 6 years, with an additional 5 years of observation.

If you choose to participate, you will be asked to complete a survey with questions about you, your health, and your opinions about tests for colorectal cancer prevention. This survey needs to be completed before you can be assigned to your study group. The survey will take 15-20 minutes to complete. You will then be randomly assigned (like the flip of a coin) to one of two groups: FIT once per year or a surveillance colonoscopy. You have an equal chance of being assigned to either group.

If you are assigned to the colonoscopy group, you will be asked to complete a colonoscopy, like you would if you were not in this research study. If you are assigned to the FIT group, you will only be asked to come in for a colonoscopy if your FIT is positive for hidden blood. If your FIT is negative, you will be asked to complete another FIT each year for up to 5 additional years.

Participants in both groups will be asked to complete a follow-up survey (either online, by mail, or by phone) that will ask similar questions to the initial survey once per year for up to 5 additional years. The survey will take you 15-20 minutes to complete each year.

During the second part of the study, we will review your medical records as well as public databases (for example, National Death Index and state cancer registries) to gather information about possible changes in your health, including if you were diagnosed with colorectal cancer. We may also contact you to learn more about your health. This part of the study will last up to 5 years.

More detailed information about the study procedures can be found under “What happens if I say yes, I want to be part of this study?”

Is there any way being in this study could be bad for me?

We know that neither FIT nor colonoscopy is a “perfect” test, meaning either test has a chance of missing some polyps or cancers.

Will being in this study help me in any way?

Joining this study will not directly benefit you. However, if FIT is found to be just as good as surveillance colonoscopy to prevent colorectal cancer in people aged 70-82 with a history of polyps, it is possible that guidelines could change to recommend FIT as another option.

What happens if I do not want to be in this research study?

Your participation in this research study is completely voluntary. You can decide to participate or not to participate. You can choose to leave the study at any time. If you choose not to participate or to leave the study, you will receive care as usual.

Who is funding this research?

The Patient-Centered Outcomes Research Institute (PCORI), an independent, nonprofit, nongovernment organization, is funding this study.

Detailed Information:

The following is more detailed information about this study in addition to the information listed above.

How many people will be in this study?

We expect about 8,946 people to take part in this study, at several locations. We anticipate enrolling about 985 participants at Kaiser Permanente Northwest.

What happens if I say yes, I want to be in this research study?

If you choose to join this study, you will be asked to sign this consent form. Then you will be asked to complete a survey (either electronically, by mail, or by phone) that asks questions about you, your health, and your opinions about tests for colorectal cancer prevention. The survey should take you 15-20 minutes to complete.

After completing the survey, you will be randomly assigned (like the flip of a coin) to one of two groups: FIT once per year or a surveillance colonoscopy. You have an equal chance of being assigned to either group, and you cannot choose your study group. We will update your medical record to note that you are in the COOP Research Study and to record which group (FIT or colonoscopy) you were assigned. Your doctor will have access to this information.

After you are randomized, you will either have a surveillance colonoscopy (and any further care recommended by your doctor) or you will complete a FIT once per year at home for up to 6 years.

After approximately 6 years of participating in the study, you will enter the second, “observational part” of the study. At this time, if you are in the FIT group and would like to receive a colonoscopy, the Kaiser Permanente staff will help you schedule this. During this part of the study, we will review your medical records and publicly available databases (e.g., the National Death Index and state cancer registries) to look for changes in your health, including a diagnosis of colorectal cancer. We may also contact you to learn more about your health. While reviewing your medical record, we will also look for genetic test results in your medical record that can provide information on whether you have Lynch Syndrome or other hereditary cancer syndromes. This part of the study will last up to 5 years. During this time, you and your doctor will decide if you should complete any further colorectal cancer screening.

The National Death Index has information about people who have died, such as the date and cause of death. This information may be used during data analysis and in summarizing research results.

The state cancer registries have information about people who have been diagnosed with cancer, such as colorectal cancer. This information may be used during data analysis and in summarizing research results.

What are my responsibilities if I join this study?

If you join the COOP Research Study, you will be asked to:

• Complete the survey after enrollment and every year you are in the study.
• Follow instructions for your assigned group; that is, if you are in the colonoscopy group, complete your surveillance colonoscopy and if you are in the FIT group, complete the at-home stool-based test once per year.
• If you are in the FIT group and have a positive FIT result, complete a colonoscopy.
• After colonoscopy, answer a phone call from the research coordinator about any potential side-effects you may have had.
• If a provider wants to order a colonoscopy or FIT for colon cancer screening purposes, remind them that you are in this study.
• Reach out to the study team if you have any questions or concerns or wish to leave the study for any reason.

What happens if I say yes, but I change my mind later?

You can leave the study at any time; it will not affect your healthcare or your benefits. If any new study-related information comes up that may affect your health, welfare, or decision to stay in the research study, we will let you know.

If you decide to leave the research study, you should contact the investigator using the information listed above. Leaving this study early will not stop you from getting regular medical care, but it will be up to you to schedule any colorectal surveillance procedures on your own. If you leave the study early, any information collected before you leave will continue to be used in the research.

Is there a possibility being in this study could be bad for me or harm me? (Detailed Risks)

You are not receiving any experimental tests or procedures during this study. FIT and colonoscopy are both commonly used in clinical care and their side effects are well known. FIT and colonoscopy are both considered an acceptable follow-up for people without polyps and they are endorsed by the US Preventive Services Task Force and other gastroenterology organizations. Neither FIT nor colonoscopy is a “perfect” test for finding all polyps and cancer, meaning that either test has a chance of missing some polyps and cancer.

FIT is an easy test involving collection a stool sample at home. There are no risks to using FIT itself. We know FIT works well to detect early colorectal cancer. It is not as good as colonoscopy at detecting polyps. However, research has shown there is very little increased risk for cancer if the polyps are small. If your FIT results are negative, you will not have a colonoscopy. If the FIT comes back positive, then it is recommended that you undergo a colonoscopy for further evaluation.

If you receive a colonoscopy, there are no new risks as a result of joining this research study. The known risks of colonoscopy are rare. Out of 1,000 colonoscopies completed, about 12 people in this age group will experience one of the known risks, which include:

Major Risks

• Heart attack
• Arrhythmia (an irregular heart beat) resulting in overnight hospitalization
• Thromboembolic event (a blood clot in your lungs, extremities or brain (i.e., stroke)) resulting in overnight hospitalization
• Pneumonia resulting in overnight hospitalization
• Infection resulting in overnight hospitalization
• Perforation of the colon (a tear in the lining of the colon) requiring surgical intervention or hospitalization
• Gastrointestinal bleeding or anemia after colonoscopy that requires at least a transfusion of 1 unit of packed red blood cells, overnight hospitalization, or a repeat endoscopic exam
• Splenic injury requiring blood transfusion, embolization (i.e., a procedure to stop the bleeding), surgical intervention, or overnight hospitalization
• Overnight hospitalization for any other reason
• Death

Minor Risks

• Abdominal discomfort
• Diarrhea
• Constipation
• Minor gastrointestinal bleeding that was self-limited 
• Intravenous (IV) site problems
• Inability to return to normal activities typically for up to 1 day
• Need for additional care (e.g., doctor’s visit, urgent care visit)

There may be risks that are unknown at this time.

If you are injured or become ill because of colonoscopy, you will be provided with medical treatment as you would normally and this will be billed to you or your usual health insurance.

In summary, colonoscopy as a single test is more effective at detecting polyps and colorectal cancer, but is more invasive and can have more serious side effects, than FIT. FIT is easier to complete but, as a single test, is less effective than colonoscopy at finding polyps and colorectal cancer. This is why FIT is usually done every year and, if the result is positive, a follow-up colonoscopy is recommended. If you are assigned to the FIT group and it turns out FIT is not as good as colonoscopy for surveillance, you could have worse health outcomes. It is also possible because FIT is done every year, it may detect conditions missed by colonoscopy.

There is a potential risk of loss of confidentiality by taking part in this study; however, protections are put in place to minimize this risk. All information will be stored in a secure encrypted database to which only the researchers will have access.

Authorization to Use and Disclose (Release) your Health Information for Research

Why is this authorization required?

The Privacy Rule requires that researchers obtain your written authorization to use and disclose (release) your Protected Health Information (PHI). By signing this authorization, you give permission for researchers at Kaiser Permanente Northwest to use and/or disclose (release) your individually identifiable health information for the purpose of the research study named above.

Do I have to give you access to my health information?

Giving access to your health information is voluntary. You get to choose. No matter what you decide, now or in the future, it will not affect your medical care. You can change your mind at any time in the future. However, if you choose not to give us access to your health information now, we will not be able to enroll you in the research study.

What kind of information will be collected?

We will collect individually identifiable health information about you and your health for the purpose of this research. The following identifiable private information about you will be used and disclosed:

• Name
• Address
• Dates, including birth date, admission date, discharge date, date of death
• Telephone numbers
• Electronic mail (email) addresses
• Medical record number
• Health plan beneficiary number

This information may be obtained from:

• Study visits
• Your responses to study surveys or questionnaires
• Your electronic health record
• Laboratory test results related to this study or routine clinical care
• National death index

What is the purpose of the use or disclosure of my PHI?

Kaiser Permanente Northwest researchers will use your PHI, including your research and/or medical record, to conduct the study, monitor your health status, and determine research results. In addition, others at Kaiser Permanente, for example the Institutional Review Board that approved the study, and other representatives of Kaiser Permanente, may also review your research or medical record, or both, to monitor the study.

Information from your research record and medical record used and disclosed for the study may include, for example, laboratory and other test results, and both clinical and research observations relating to your participation in the study.

How will my health information be used or disclosed (released)?

Kaiser Permanente Northwest researchers and the research team will use your PHI for the purposes of this study as described in this consent form.

The Kaiser Permanente Northwest research team may also disclose your PHI to others outside of Kaiser Permanente. Your PHI may be viewed by or sent to the following:

• Dartmouth-Hitchcock Medical Center
• Dartmouth College
• Data Safety and Monitoring Board
• Kaiser Permanente of Northern California
• Patient-Centered Outcomes Research Institute (PCORI)
• University of Pennsylvania
• National Death Index
• State cancer registries
• Western Copernicus Institutional Review Board (WCG IRB)

Your PHI may also be sent to persons outside of KP Northwest assisting with this study or to others as required by law.

How is my health information protected?

State and federal privacy laws protect your health information. We will do our best to protect your confidentiality by using standard security measures as required by law. We will also remove or separate information that identifies you (such as your name or address) from the rest of your health information whenever possible. Everyone at KP Northwest with access to your information has received training in the protection of sensitive information. Still, there is a small chance your information could be released accidentally. There are also certain situations where we may be required by law to release your information.

In certain situations, we would not be able to keep your information confidential. State law requires us to report cases of child abuse, elder abuse, and certain diseases. We may also disclose your information in response to serious threats of harm to you or others.

Once your information has been given to others, it may no longer be protected by state or federal privacy laws. It will be protected by other rules and agreements with the recipients. However, there is still a risk that a recipient could share your information without your permission.

Will I have access to my information?

Some of the information collected and created in this study may be placed in your health record.  During the study, you may not have access to this information.  After the study is done, you will only be able to access study information that was added to your health record.  If you have questions about what study information you will be able to access, and when you can access it, ask the researchers.

When will this authorization expire?

This Authorization will expire on 12/31/2040.

What if I change my mind?

If you decide you want to stop sharing your health information for this study, you need to tell us in writing. You can tell us by writing to:

When we receive your request, we will stop using and disclosing (releasing) your health information. We may continue to use information we collected before we received your request. If we have already disclosed (released) your information to someone else, we will probably not be able to get it back.

What happens to the information collected for the study?

Efforts will be made to limit the use and disclosure of your personal information, including research study and medical records, to people who have a need to review this information. See “How will my health information be used or disclosed (released)?” for a list of places your data will be shared.

Your private information and your medical record will be shared with individuals and organizations that conduct or watch over this research, including:

• The research sponsor
• People who work with the research sponsor
• Government agencies, such as the Food and Drug Administration
• The Institutional Review Board (IRB) that reviewed this research

A description of this clinical trial will be available on https://www.clinicaltrials.gov, as required by U.S. Law. This website will not include information that can identify you. At the most, the website will include a summary of the trial and, once the trial ends and the data has been analyzed, a summary of the results. You can search this website at any time. If you would like to review the information for this study or a summary of the results, ask the study team for the ClinicalTrials.gov study registration number.

Your permission to use your health information for this study will not end until the study is completed. During this study, you and others who take part in the study will not have access to the study data. You have a right to receive a copy of the information in your medical record at any time.

Your name, address, and social security number may be given to an office at Kaiser Permanente that arranges and reports payments to the IRS.

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 secrecy.

Any risks to your privacy and information are small. If you prefer to have study communication over email, the COOP Research Study cannot guarantee that your information will be encrypted when it is sent by email. Encryption means your information is scrambled so that only a person with a secret code can unscramble the information. All study information will be stored in a secure encrypted database which only the researchers can access.

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

If you are injured or harmed by this study, Kaiser Permanente will provide necessary medical treatment as covered by your usual health benefits. If you are on Medicare, and you are injured by being in this study, the sponsor must tell Medicare about any payments made to you, or any payments made for treatment of the injury. Your name, birth date, social security number, and the fact that you had been part of this study would be sent to Medicare.

Kaiser Permanente, the sponsor (Dartmouth – Hitchcock), and funder (PCORI) do not offer any other financial compensation if you are injured or harmed as a result of participating in this research.  However, you do not give up any of your legal rights by signing this form.

Can I be removed from the research without my permission?

There are a number of ways that changes in your health could result in changes to your participation in the study that are initiated by the study, rather than by you. For example, if you experience a major change in your health, the study team may decide, after reviewing your medical record and/or talking to your doctor, that you no longer should continue to complete planned tests and surveys. It is possible that even if you are no longer eligible to participate in tests and surveys, the COOP Research Study will still collect data gathered by reviewing your medical records to look for changes in your colon health (the observational phase the study) and will continue to use data that you already provided to the study. It is also possible that the entire study may be stopped for some reason, and in this case you will be notified by either the person in charge or a monitoring committee.

What else do I need to know?

1. Who can I talk to?

   If you have questions, concerns, or complaints, or think the research has hurt you, talk to the principal investigator at the number listed above during normal business hours. After hours, you may contact the gastroenterology doctor on call at the number listed above.

2. What is the Institutional Review Board (IRB) and how does it protect me?

   This research is overseen by an Institutional Review Board (“IRB”). An IRB is a group of people who perform independent review of research studies. IRBs protect the rights and welfare of people taking part in studies. You may talk to the Kaiser Permanente Interregional IRB at (951) 739-6781 or email KPINTERREGIONALIRB@kp.org if:

   • You have questions, concerns, or complaints that are not being answered by the research team.
   • You are not getting answers from the research team.
   • You cannot reach the research team.
   • You want to talk to someone else about the research.
   • You have questions about your rights as a research participant.

3. Cost to you:

   If you are randomized to the FIT group, you will not be charged for any FIT tests received as a part of this study. Any other types of medical care received as part of this study will be billed to your insurance. This includes colonoscopies and any follow-up care if you have a positive FIT test while in the study. If you are randomized to the colonoscopy group, that procedure and any follow-up care will be billed to your insurance as if you were not a part of the study.

   Any costs for surveys and mailings will be paid by the research team.

4. Compensation:

   If you choose to participate in this research, you may be paid up to a total of $175, depending on when you enroll in the research study. Your payment will be as follows:

   • You will receive a $25 gift card once per year after you complete each survey.
   • You will receive $50 for completion of the survey in the last year
   • You will not receive any money for the 5 years of observation at the end of the trial.
   • If you do not complete the yearly survey, you will not be compensated that year.

   Federal tax law requires that you report your research payments when you file your taxes. If you participate in other research studies at KPNW and your total payments from KPNW exceed $600 per year, KPNW will report these payments to the Internal Revenue Service (IRS) and you will receive a 1099-MISC form from us. This form tells the IRS that payment was made to you, but it does not name the study or studies in which you participated. You will be asked to provide your Social Security Number for tax reporting purposes. This information is stored confidentially and separate from research data.

5. Copy of this Consent and Authorization Form:

   The researcher who is obtaining this form must give you a copy of this form after you sign it.

Consent for Future Research

In addition to participating in the main part of the study, you are being asked to provide permission for members of the research team or others at the research team’s institution to contact you about future research. Your signature on this consent form means that you are granting permission for members of the research team or others at the research team’s institution to contact you about future research. If you do not want to be contacted about future research, please initial here: ____________. You can still be in the main study even if you decline to grant these members access to your contact information for future research.

Signature

Your signature on this form means:

1. You understand the information given to you in this form and all of your questions have been answered
2. You accept the details of this form
3. You agree to join the study
4. You agree to share your health information as described above

You will not give up any legal rights by signing this form. We will give you a copy of this signed and dated consent form for your records.