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Consent and Agreement

CONSENT TO TAKE PART IN A RESEARCH STUDY

TITLE OF STUDY:  Meaning-focused Group Intervention for Patients with Recurrent or Metastatic Pancreatic Adenocarcinoma.

This consent form is part of an informed consent process for a research study and it will provide information that will help you to decide whether you wish to volunteer for this research study.  It will help you to understand what the study is about, and what will happen in the course of the study.

If you have questions at any time during the research study, you should feel free to ask them and expect answers that you completely understand.

After all of your questions have been answered, if you still wish to take part in the study, you will be asked to sign this informed consent form by clicking on the "I agree to participate" button at the end of this form.

The Principal Investigator, Nicole Goetz, or another member of the study team (an investigator) will also be asked to sign this informed consent.  You can print a copy of the consent form to keep.

You are not giving up any of your legal rights by volunteering for this research study or by signing this consent form.

The Principal Investigator works for the Pancreas Center at Columbia University Medical Center and is a doctoral student at the University of Medicine and Dentistry of New Jersey.

The Principal Investigator is interested in learning if you can fully understand the information provided.  You need to fully understand the information before you can give your informed consent to enter into this research study.

If you agree to enter the study, the Principal Investigator will frequently check whether you are willing to stay in the study until you have completed your part in it.

The Principal Investigator's assessment of your ability to give your informed consent applies only to your volunteering for this research study.  It is not an assessment of your ability to make decisions for other purposes, such as making financial, legal, and/or medical decisions.

Why is this study being done?

This study is being done to determine whether Web group sessions that are focused on meaning will enhance your quality of life.

Why have you been asked to take part in this study?

You are being asked to participate in this study because you have recurrent or metastatic  pancreatic cancer and we would like to see if these types of Web group sessions will enhance your well-being.

Who may take part in this study?  And who may not?

Anyone who is older than 18 years old, has recurrent or metastatic pancreatic cancer, and can read and understand English may participate.  You must also be physically able to use a computer keyboard or have someone type for you to participate in the group.

How long will the study take and how many subjects will participate?

Your participation in this study will last two months.  As part of the study, you will be asked to be part of weekly meetings in an internet chat room that will take approximately an hour each week for 8 weeks.  It is estimated that between 10 and 15 people will participate.

What will you be asked to do if you take part in this research study?

Usually the consent process takes place in person.  You will not be consented in person. Since this is a Web group you will review the consent form online.  If you wish to email or speak with the Principal Investigator, Nicole Goetz, you may do so at any time before e-signing the consent.  Her email is nlgoetz@aol.com, but there is a direct link on the homepage.  Her cell phone number is 973-919-8311.  After electronically signing this consent you will be taken to a registration page that will ask your name, telephone number, email address, city and state where you live, and convenient times for you to participate in the group. The only person who will have access to this information is the Principal Investigator.  This information is necessary for your health and well-being so that we may assist you in obtaining the help you need if you are found to be currently severely depressed or if you become distressed while in the study..  After you complete the registration page the Principal Investigator will promptly contact you either by phone or email welcoming you to the study and will give you all the information you need to participate.  You may contact her at any time by the number listed on this consent form.  Through the website you will be given three questionnaires to complete before the first session starts, and then another three at the end of the last session.   There are eight sessions being conducted once a week for 8 weeks.  You may drop out at anytime without penalty whatsoever.  The questionnaires take about 15 minutes to complete.  These questionnaires will not have your name on them, but will be coded with a random number after being printed.  Only the Principal Investigator will keep a list as to which code identifies which person.  The questionnaires and forms can only be linked to you by your screen name which only the Principal Investigator knows. This is done to help you if one of your questionnaires indicates that you may have moderate or severe depression.  After the questionnaires are printed from the site's database, they will be locked in the filing cabinet of the Principal Investigator.  The master list will be kept in a different locked filing cabinet.  You will also be asked to complete a demographic sheet before the first session starts and a feedback form at the completion of the last session.

You will be asked to be part of approximately one-hour Web group sessions once a week for 8 weeks with other people who also have recurrent or metastatic pancreatic cancer.  These groups will be run by a nurse practitioner and a social worker.  You will be asked to complete assigned readings on a weekly basis.  These readings will be posted on the website for you to access.  These assignments will be discussed with the group the following week.  You will be asked to participate in group discussions related to each session's topic.  At the end of each session, or when you logout of the session, you will be asked to fill out a very short form, with 4 questions, asking you how you felt about that week's session.  This is done so that we may assist you if you are upset about a topic that was discussed.

What are the risks and/or discomforts you might experience if you take part in this study?

One of the risks of participating in this study may involve becoming upset about a sensitive topic that is discussed.  You may choose not to take part in any part of a session if doing so makes you upset. If you need help, every effort will be made to make counseling available to you through a mental health professional.  If you need psychological assistance, the Principal Investigator will contact an oncology psychiatrist on your behalf and arrange for you to see him as soon as possible. If you do not live in the New York/New Jersey metropolitan area, every effort will be made to connect you with a mental health professional in your area through the National Association for Social Workers or a recommendation through your primary medical doctor.   An oncology social worker will be present at every session.  She will also be available to you to discuss privately any psychological concerns you may have.

Are there any benefits for you if you choose to take part in this research study?

The benefits of taking part in this study may be an enhanced quality of life and a greater sense of meaning to your life, although this cannot be guaranteed.  Your participation in this study may also benefit other members of this study by the support in which you may provide to them.

However, you might receive no direct benefit from taking part in this study.

What are your alternatives if you don't want to take part in this study?

You can seek out other online support groups or we can give you the names of some reputable on-line support groups that may be helpful to you.

How will you know if new information is learned that may affect whether you are willing to stay in this research study?

During the course of the study, you will be updated about any new information that may affect whether you are willing to go on taking part in the study.  If new information is learned that may affect you after the study or your follow-up is completed, you will be contacted by the phone number that you give us today.

Who will be allowed to look at your research records from this study?

In addition to key members of the research team, the following people will be allowed to inspect the questionnaires related to this study:

- The Institutional Review Board (a committee that reviews research studies)
- Officials of the University of Medicine and Dentistry of New Jersey
- Department of Health and Human Services (DHHS) (regulatory agency that oversees human subject research)
- Office for Human Research Protections (OHRP) (regulatory agency that oversees human subject research)

By taking part in this study, you should understand that the study collects demographic data.  This data will be recorded by the Principal Investigator who may store and process your data with electronic data processing systems.  The data will be kept as long as the study is being conducted and for six years following study closure. Other than your name, email address, and phone number, no other identifiers will be recorded. 
 
Your data may be used in scientific publications.  If the findings from the study are published, you will not be identified by name.  Your identity will be kept confidential.  The exception to this rule will be when there is a court order or when a law exists requiring the Principal Investigator to report communicable diseases.  In this case, you will be informed of the intent to disclose this information to the state agency.  Such a law exists in New Jersey for diseases such as cancer, infectious diseases such as hepatitis, HIV, viruses and many others.

The Principal Investigator will be allowed to examine the data in order to analyze the information obtained from this study, and for general health research.

Will there be any cost to you to take part in this study?

There should not be any costs associated with participating in this study.  We will provide, by posting on this site, any readings that we want to discuss.  Any additional costs (such as internet costs or purchasing non-required books) that may be incurred by being part of this study will not be covered.

Will you be paid to take part in this study?

No, you will not be paid to participate in this study.
 
What will happen if you are injured during this study?

It is possible that during the course of this study that psychological disturbance may occur.   Medical and/or psychological treatment will be arranged by UMDNJ for participants who develop psychological distress as a direct consequence of participation in this research.  Your insurance carrier or other third party payer will be billed for the cost of this treatment.  No additional financial payment to you is available.

You are not giving up any of your legal rights by signing this informed consent form or by taking part in this research study.

What will happen if you do not wish to take part in the study or if you later decide not to stay in the study?

You may choose not to be in the study.  If you do choose to take part it is voluntary.  You may refuse to take part or may change your mind at any time.

If you do not want to enter the study or decide to pull out of the study, your relationship with the study staff will not change, and you may do so without penalty and without loss of benefits to which you are otherwise entitled.

You may also withdraw your consent for the use of your data, but you must do this in writing to Nicole Goetz, NP  161 Fort Washington Avenue Suite # 820 New York, NY  10032.
At any time, the Principal Investigator can remove you from this study because it would not be in your best interest to stay in it.

Who can you call if you have any questions?

If you have any questions about taking part in this study you can call the Principal Investigator:

Nicole Goetz, NP
973-919-8311

If you have any questions about your rights as a research subject, you can call:
 
Chair, Institutional Review Board
(973) 972-3608
and/or
IRB Director
(973)-972-3608

What are your rights if you decide to take part in this research study?

You have the right to ask questions about any part of the study at any time.  You should not sign this form unless you have had a chance to ask questions and have been provided answers to all of your questions.

Agreement to Participate

I have read this entire form, or it has been read to me, and I believe that I understand what has been discussed. All of my questions about this form and this study have been answered.

Pancreatic Cancer User Support Group

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