LRG GIST Patient Registry Questionnaire

GIST Patient Registry Questionnaire
Today's date

MonthDayYear
Are you a Life Raft Group member?*

YesNo
Status of person submitting form:*

GIST patientFamily/Caregiver/FriendLRG Patient Registry Staff
Name of person submitting form*

First NameLast Name
Is the person giving the report to LRG staff*

a family/caregiver/friend?a patient?
Name of Patient*

First NameLast Name
Name of family/caregiver/friend*

First NameLast Name
Name of Patient*

First NameLast Name
Ethnicity*
If 'other', please specify:
Sex assigned at birth*
Marital Status*
Date of Birth*

MonthDayYear
Month/day/year
Country of Birth*
Country of Residence*
Please indicate the state, province, or region in which you live. If not applicable, please indicate N/A*
I am interested in:

The LRG NewsletterFundraising ActivitiesVolunteeringGIST Chat (Email Community)Local Support GroupsReceiving more information about Clinical Trials
LRG GIST Mentors are available to help patients & their caregivers through their GIST journey. (U.S. only)

I would like to request a GIST Mentor
How did you hear about The Life Raft Group? (choose all that apply)*

Another LRG MemberGIST Survivor Facebook pageInternetDoctorOther
If internet:

Through Google/other search engineThrough a pharmaceutical company websiteThrough a patient advocacy group websiteOther
If you heard about the LRG from your doctor, please indicate the physician's name.
First name/last name
CONTACT INFORMATION
Email*
example@example.com
Primary Phone Number*

Country CodeArea CodePhone Number
Is this a mobile or home phone (landline)?

MobileHome Phone (Landline)
Mobile Number

Country CodeArea CodePhone Number
Is this number your Whats App number?

YesNo
WhatsApp Number
Home Phone (landline)

Country CodeArea CodePhone Number
Preferred Method of Contact*
Preferred Time to Contact
Home Address

Street Address

Street Address Line 2

CityState / Province

Postal / Zip Code
Please provide details of an additional contact person who can be reached if we are unable to get in touch with you.
Secondary Contact Information

First NameLast Name
Email
example@example.com
Phone Number
Please enter a valid phone number.
GIST HISTORY
1. GIST Diagnosis Date*

MonthDayYear
Month/day/year
Misdiagnosed GIST*

YesNo
Misdiagnosed as:
ex. CML, hernia, etc.
Misdiagnosis date:

MonthDayYear
This date should be prior to GIST diagnosis date
2. Date of first symptoms

MonthDayYear
Month/day/year
Events that led to diagnosis:
Patient's GIST doctor or oncologist*

First NameLast Name
Is this doctor a GIST specialist?*

YesNoDon't Know
Name of institution where doctor practices:*
3. Tumor type at diagnosis*
4. Where is primary tumor located?*
ex. if location is unknown, write unknown
5. Other tumor/mets locations, if applicable:
If multiple locations, please separate with a comma
6. Primary tumor size:*
7. Tumor measurement
Please provide measurement in centimeters (ex. 8 x 3 cm)
8. Primary tumor mitotic rate:
ex. 10/50 HPF
Mutation
Gene:*
If 'other', please specify:
Exon
AA:
Test Date

MonthDayYear
Month/Day/Year
Additional comments:
Do you have a secondary mutation?*

YesNoDon't know
Gene
If 'other', please specify:
Exon
AA:
Test Date

MonthDayYear
Date
Additional comments:
Tested Stains
This information can be found on your pathology report.
c-KIT/CD117

PositiveNegative
CD34

PositiveNegative
DOG1:

PositiveNegative
SDHB:

PositiveNegative
SDHA:

PositiveNegative
No testing performed
I don't know
Evaluations
Date of most recent evaluation*

MonthDayYear
If you do not know exact date, please specify the 15th of the month it was performed.
Type of scan*
Pet Scan Results
CT Scan Results
Biopsy Results
MRI Results
Ultrasound Results
Colonoscopy Results
Endoscopy Results
Frequency of evaluation
ex. every ____ months
Trough Level (ng/ml)
Other details
Comments
Do you want to add another evaluation?*

YesNo
Date of evaluation

MonthDayYear
If you do not know exact date, please specify the 15th of the month it was performed.
Type of scan*
Pet Scan Results
CT Scan Results
Biopsy Results
MRI Results
Ultrasound Results
Colonoscopy Results
Endoscopy Results
Frequency of evaluation
ex. every ____ months
Trough Level (ng/ml)
Other details
Comments
Treatments
I am*

on medicationnot on medication
Medication:
Start date:

MonthDayYear
Date
End date (if applicable):

MonthDayYear
Date
Dosage:
ex. mg
If cycling:
Please specify Days/Week(s) On, Days/Week(s) Off
Are you in a clinical trial?

YesNoUnknown
Trial name
Reason for ending treatment (if applicable):
Side Effects Update
Please list your side effects as related to your current drug treatment:*

I am not currently on any drug treatmentI am not currently experiencing any side effects related to my current drug treatmentI have experienced or am experiencing side effects on my current drug treatmentI have experienced or am experiencing side effects but am not currently on any drug treatment
1. Side Effect
Please list one side effect at a time.
What is the location this side effect occurs?
For example: chest, face, head, legs, etc.
Rate the severity of this side effect
Start Date

MMDDYYYY
End Date

MMDDYYYY
Did you experience this side effect prior to your current treatment?

YesNo
Are you using any form of intervention to manage this side effect?

YesNo
Please list the interventions you are currently using to cope with this side effect.
Do you want to add another side effect?

YesNo
2. Side Effect
Please list one side effect at a time.
What is the location this side effect occurs?
For example: chest, face, head, legs, etc.
Rate the severity of this side effect
Start Date

MMDDYYYY
End Date

MMDDYYYY
Did you experience this side effect prior to your current treatment?

YesNo
Are you using any form of intervention to manage this side effect?

YesNo
Please list the interventions you are currently using to cope with this side effect.
Do you want to add another side effect?

YesNo
3. Side Effect
Please list one side effect at a time.
What is the location this side effect occurs?
For example: chest, face, head, legs, etc.
Rate the severity of this side effect
Start Date

MMDDYYYY
End Date

MMDDYYYY
Did you experience this side effect prior to your current treatment?

YesNo
Are you using any form of intervention to manage this side effect?

YesNo
Please list the interventions you are currently using to cope with this side effect.
Do you want to add another side effect?

YesNo
4. Side Effect
Please list one side effect at a time.
What is the location this side effect occurs?
For example: chest, face, head, legs, etc.
Rate the severity of this side effect
Start Date

MMDDYYYY
End Date

MMDDYYYY
Did you experience this side effect prior to your current treatment?

YesNo
Are you using any form of intervention to manage this side effect?

YesNo
Please list the interventions you are currently using to cope with this side effect.
Do you want to add another side effect?

YesNo
5. Side Effect
Please list one side effect at a time.
What is the location this side effect occurs?
For example: chest, face, head, legs, etc.
Rate the severity of this side effect
Start Date

MMDDYYYY
End Date

MMDDYYYY
Did you experience this side effect prior to your current treatment?

YesNo
Are you using any form of intervention to manage this side effect?

YesNo
Please list the interventions you are currently using to cope with this side effect.
Do you want to add another side effect?

YesNo
6. Side Effect
Please list one side effect at a time.
What is the location this side effect occurs?
For example: chest, face, head, legs, etc.
Rate the severity of this side effect
Start Date

MMDDYYYY
End Date

MMDDYYYY
Did you experience this side effect prior to your current treatment?

YesNo
Are you using any form of intervention to manage this side effect?

YesNo
Please list the interventions you are currently using to cope with this side effect.
Do you want to add another side effect?

YesNo
7. Side Effect
Please list one side effect at a time.
What is the location this side effect occurs?
For example: chest, face, head, legs, etc.
Rate the severity of this side effect
Start Date

MMDDYYYY
End Date

MMDDYYYY
Did you experience this side effect prior to your current treatment?

YesNo
Are you using any form of intervention to manage this side effect?

YesNo
Please list the interventions you are currently using to cope with this side effect.
Of all the side effects you have listed, which side effect impacts your life the most?
Please use this box for any comments or remarks you want to share with the patient registry staff about your side effects.
Quality of Life Update
Symptoms frequently interfere with how we feel and function. How often have your symptoms interfered with the following items in the last 7 days?

*Why does the Life Raft Group collect this information?
Your ability to take all of your medication as prescribed:*
Mood:*
Daily household activities:*
Relationship with family and friends:*
Sleep:*
Work:*
Eating:*
Energy level:*
Enjoyment of life:*
Surgery
Have you had surgery?

NoYes
Date of Surgery

MonthDayYear
Month/day/year
Reason for surgery
If 'other', please specify:
Clear margins?

YesNoNot sure
Tumor rupture?

YesNoNot sure
Additional details concerning surgery:
Would you like to enter another surgery?

YesNo
Date of Surgery

MonthDayYear
Date
Reason for surgery
If 'other', please specify:
Clear margins?

YesNoNot sure
Tumor rupture?

YesNoNot sure
Additional details concerning surgery:
Comments and Notes
Please tell us something about yourself or the patient professionally and/or personally. Include any special skills or interests.
Do you have any concerns, questions, or comments regarding GIST diagnosis or treatment?
Please use this space to provide any additional information you feel would be helpful to our staff or that you would like included in your file.
Do you have copies of your pathology and/or mutational report available?*

YesNo
You can upload digital copies here:

Cancelof
Patient Registry Options

We utilize the data from this registry to identify critical areas that require further investigation in the GIST research environment or by the traditional cancer research community, we de-identify your personal info to comply with HIPAA (Health Insurance Portability and Accountability Act).
Which of the following best describes you?

Patient under 18Patient 18 or overCaregiver or family member of patient
Please read the following, sign below, and then click "Submit" to participate:

WHAT IS THIS REGISTRY STUDY ABOUT?
An organization called the Life Raft Group (LRG) wants to find out more about a cancer called Gastrointestinal Stromal Tumors (GIST) as well as other cancers that may or may not be related to GIST. To collect this information, LRG has created a research registry.

A registry is a place where medical information, family history and other related information from patients is collected and stored for medical research. The purpose of the Life Raft Group GIST registry is to collect and store medical information and other information from individuals with the same disease or other cancers that share commonalities such as molecular targets, treatments, or other factors. Information from patients in this registry will be used for medical research to better understand GIST and these other diseases. Scientists studying GIST and these other diseases need more accurate, real-world information to understand how these diseases affect people.

People with GIST and other related or unrelated diseases are being asked if they would like to participate in the Life Raft Group registry. The Life Raft Group GIST registry is also linked to a tissue bank, which is a place that stores tumor tissue, blood or other samples from patients. You may also be asked to provide samples to the tissue bank. You would need to read and sign a separate consent form about the tissue bank. You do not have to take part in any other Life Raft Group activities, including the tissue bank and online forums, to take part in this registry.

If you have any questions about or do not understand something in this form, you should ask the investigator or his/her study staff. You should also discuss this study with anyone you choose in order to better understand this study and your options.

When reading this form, please note that the words “you” and “your” refer to the person in the study rather than to a parent or guardian or legally authorized representative who might sign this form on behalf of the person in the study.

WHO IS PAYING FOR THIS STUDY?
The Life Raft Group, the sponsor of the study, is paying for this study.

WILL BEING IN THIS STUDY HELP ME?
Being in this study will not directly benefit you. Information from this study might help researchers understand GIST and other cancers better and that may help others in the future.

WILL IT COST ANYTHING TO BE IN THIS STUDY?
This is not a treatment study. Expenses related to your condition and its therapies, doctor charges, other office visits, or other tests are not paid by the registry. You or your medical insurance provider will be responsible for all costs associated with your regular medical treatment.

HOW LONG WILL I BE IN THE REGISTRY?
If you decide to be in this study and the investigator says you can be in the study, your participation will last as long as the registry is active or until you decide to withdraw from the study.

WHAT WILL HAPPEN DURING THIS STUDY?

While you are in the study, you are expected to:
- Provide initial demographic information, such as your name, date of birth, gender, date of diagnosis and other similar information.
- Provide details about your treatment history.
- Provide regular updates including results of scans, current treatment (such as drug name and dose) and information related to recurrence or progression of your disease.
- Provide information to the registry on an ongoing basis (generally whenever you have a new scan performed).
- Tell the investigator or study staff if you want to stop being in the study at any time.
- Your family members or a caregiver may provide updates if you are not available.
DO I NEED TO COME IN FOR STUDY VISITS?
No, this is not a treatment study. You will be asked questions about your treatment, but no in-person visit is necessary. All information will be collected via phone interviews, via email, questionnaires or via internet updates.

The Life Raft Group maintains an electronic mailing list community (a listserv) that members are eligible to participate in. Members of this private listserv may discuss medical histories. This registry will not record information discussed by registry participants in this listserv or other social media (such as Facebook). Study staff may, however, contact you for a more formal update if staff notices a relevant posting (the posting may trigger a call or email from the study staff to confirm and authorize recording of the relevant information).

ARE THERE RISKS TO ME IF I AM IN THIS STUDY?
You will not change your regular medical care for this study. This study should not involve any physical risk to you. There is a risk of loss of confidentiality of your information. You will read more about the protection of your information later in this form. Please ask the investigator or study staff if you would like to know more about how your information will be protected while you are in this study.

WILL I RECEIVE PAYMENT?
No; participants will not receive any payment for study participation.

DO I HAVE TO BE IN THIS REGISTRY?
Your participation in the registry is voluntary. The care you receive from your regular doctor will not be affected in any way, whether or not you decide to be in the registry. If you want to stop being in the registry, tell the investigator or study staff. If you decide to withdraw from the registry, the investigator or staff may ask you some questions about being in the registry. The investigator or the sponsor can remove you from the registry at any time, even if you want to stay in the registry. You can still take part in other LRG activities even if you choose to leave this registry.

For adults considering whether to be in the study:

What if I work with the study center or sponsor? What if I am a family member of someone who works with the study center or sponsor?

Study center/sponsor employees and their family members do not have to be in this study. No one should influence or pressure you to be in this study. An employee’s or his/her family member’s decision to be in the study, or to leave the study early, will not affect the employee’s job or job benefits.

For parents/guardians who are considering whether to allow their child to be in the study:

What if I work with the study center or sponsor? What if I am a family member of someone who works with the study center or sponsor?

Study center/sponsor employees and their family members do not have to let their children be in this study. No one should influence or pressure you to let your child be in this study. An employee’s or his/her family member’s decision to allow a child to be in this study, or to have the child leave the study early, will not affect the employee’s job or job benefits.

WHO CAN I TALK TO ABOUT THIS STUDY?
In the event of an emergency, dial 911 immediately.

Do not contact the Life Raft Group with emergency situations. Registry updates of your medical condition can wait.

You can ask questions about the study at any time. You can call the investigator or study staff at any time if you have any concerns or complaints. You should call them at the phone number listed on page 1 of this form if you have questions about the study procedures or other questions. The study staff cannot answer questions about the reasons or validity of your medical treatment. This type of question should be referred to your regular doctor(s).

Quorum Review reviewed this study. Quorum Review is a group of people who review research studies to protect the rights and welfare of research participants. Review by Quorum Review does not mean that the study is without risks. If you have questions about your rights as a research participant, if you are not able to resolve your concerns with the investigator or study staff, if you have a complaint, or if you have general questions about what it means to be in a research study, you can call Quorum Review or visit the Quorum Review website at www.quorumreview.com.

Quorum Review is located in Seattle, Washington. Office hours are 8:00 AM to 5:00 PM Pacific Time, Monday through Friday. Ask to speak with a Research Participant Liaison at 8887769115 (toll free).

WHO WILL USE AND SHARE INFORMATION ABOUT MY BEING IN THIS REGISTRY?
This section explains who will use and share your private health information if you agree to be in this study. If you do not sign this form, you cannot be in the study.

During the study, the investigator and the study staff will use, collect, and share health information about you (your “records”). Your records may include any information about you that you provide, such as your name, address, phone number, and medical information.

The registry aims to share detailed medical and other information with researchers, while still protecting your privacy. This is done by hiding the name, address and other “identifying” information from the researchers. We call this information “de-identified” because it has been removed of all personal identifiers. Your personal information (such as your name, address, or other information that identifies you or your family) will be labeled with a code number and stored in a secure place and protected with a password. Only authorized people who work in the registry will know the code and be able to identify you if needed.

The de-identified data collected and compiled by the registry belongs to the GIST community. The Life Raft Group is the guardian of the information contained within the registry.

If a researcher wants to access your name or other identifying information, the study staff will ask your permission first. Otherwise, your name and identifying information will only be used or shared when required by law. Your records may be used and shared with these people in the following situations:
- The sponsor, The Life Raft Group, and people who work with or for the sponsor will use your records to review the study and to check the results of the study.
- If there is a federal audit of the study, some government workers, such as employees of the U.S. Food and Drug Administration (FDA), will be able to see your information.
- You release your information to other people not involved in the study.
- You agree in writing to the release of your information to other people.
- The investigator or study staff suspects things they must report under federal, state, or local law, including child or elder abuse, certain communicable diseases, or a possible threat to you or others. There may be other things the investigator or study staff must report under law.
You do not have a guarantee of absolute privacy because of the need to share your information. After the investigator shares your records with the sponsor and others, the laws may no longer protect the privacy of your records. The sponsor or others may share your records with other people who do not have to protect the privacy of your records. If all information that does or can identify you is removed from your records, the remaining information will no longer be subject to this authorization and may be used or shared for other purposes.

The investigator, the study staff, or LRG may use some facts about your being in this study in books, magazines, journals, and scientific meetings. If this happens, no one will use your name or other information that could be used to identify you.

You have the right to see and copy your records related to this research.

You can cancel this authorization to use and share your records at any time. If you want to cancel your authorization, you must write a letter to the investigator. If you cancel your authorization, you will not be able to continue in the study.

Even if you cancel your authorization and leave the study early, the investigator and study staff will still be able to use and share your records that they have already collected as described above.

This authorization to use and share your records expires in 50 years.
I have read this form, and I have been able to ask questions about this registry. The investigator or study staff has been made available for me to talk with about this registry.

I voluntarily agree to be in this registry. By signing this form, I have not given up any of my legal rights as a research participant. I will get a signed copy of this consent form for my records.
Name of Participant (Print)*
Date of Birth
Month/day/year
Signature of Participant
Today's Date

MonthDayYear

All information provided will be kept strictly confidential and is for the internal use of the Life Raft Group only. We are committed to protecting the privacy of our members. Any data or information that we share in any way is always cleansed of identifying information in order to protect confidentiality.
Please verify that you are human*
After you click the SUBMIT button, you should see a page that says THANK YOU. If you do not, please contact liferaft@liferaftgroup.org to make sure that we received your application.
Should be Empty:

GIST Patient Registry Questionnaire

CONTACT INFORMATION

GIST HISTORY

Mutation

Tested Stains

Evaluations

Treatments

Side Effects Update

Quality of Life Update

Surgery

Comments and Notes

Patient Registry Options