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Patient Satisfaction and Breast Cancer Treatment
INFORMED CONSENT FORM
: Elements of Perceived Communication and Quality of Life Determinants for Women Diagnosed with Breast Cancer
: Jennifer Forrester, phone: (925) 519-5037, email: firstname.lastname@example.org
Under the direction of Dr. Alette Coble-Temple in the PsyD Program in the College of Graduate and Professional Studies at John F. Kennedy University, the investigator is conducting a research study and is inviting you to participate.
CONSENT TO PARTICIPATE:
The main purpose of this form is to provide information that may affect your decision about whether or not you want to participate in this research project. If you choose to participate, please indicate your consent by clicking the “yes” box.
WHAT DOES PARTICIPATION IN THIS RESEARCH STUDY INVOLVE?
If you choose to participate, you will be asked to complete a short questionnaire regarding experiences with your treatment team after your breast cancer diagnosis. This survey consists of basic questions about yourself, questions about your breast cancer diagnoses and treatment, questions about the types of communication between you and your medical team, and questions about your overall quality of life. Altogether your participation should take no more than 20 minutes. There will be no follow-up sessions. No invasive techniques will be used. It is recommended that the questionnaire
completed in a quiet, private area to further protect your confidentiality if you so choose.
I BEING ASKED TO PARTICIPATE?
The field of psycho-oncology has made the assumptions that quality of life determinants are the same for all women diagnosed with breast cancer. We know from recent studies that there are specific differences in how women cope with a cancer diagnosis in relationship to race,
of diagnosis, and various quality of life determinants such as life course, relationship status, sexuality, body image, self-concept, and communication.
You have been asked to participate in this study because you are an English speaking adult female holding a current or previous diagnosis of breast cancer who does not hold a previous diagnosis of body dysmorphic disorder.
Your participation is not only greatly appreciated by the researchers involved, but the data collected could positively impact future communication and treatment protocols for women diagnosed with breast cancer.
WHAT ARE THE RISKS INVOLVED IN THIS STUDY?
There are no obvious physical hazards involved in participating in this study. Completing the questionnaire is not expected to be upsetting,
the possibility that some participants may find participation upsetting cannot be entirely ruled out. If you find that you have been distressed by your participation in this study, you will be given referral information for a psychologist to debrief you regarding your distress, and, if still needed, will give you a list of low-fee psychotherapy providers in your area.
WHAT ARE THE POSSIBLE BENEFITS IN THIS STUDY?
The information gained from this study will provide the medical community with information on the various ways communication with the treatment team effects quality of life for women diagnosed with breast cancer.
WILL IT COST ANYTHING TO PARTICIPATE IN THE STUDY? WILL I GET PAID TO PARTICIPATE?
There is no cost to you to participate in this study. Participants will be given the option to enter a drawing to win one of four $50 Visa gift cards upon completion of the survey.
WHAT HAPPENS IF THE RESEARCHER GETS NEW INFORMATION DURING THE STUDY?
The researcher will contact you if the researcher learns new information that could change your decision about participating in this study.
WILL MY PARTICIPATION BE CONFIDENTIAL AND ANONYMOUS?
Your participation in this study will be kept strictly confidential and anonymous. To protect your identity from being associated with your individual survey responses, the researcher has created two separate surveys. Survey (A) includes all the questions related to this research topic. Survey (B) exists only as a means for participants to enter an email address or phone number if they would like to be entered into the gift card drawing. By utilizing
survey, participants’ email addresses and phone numbers will be stored in separate Qualtrics databases that can in no way be connected to your responses provided in
(A). Participation in
(B) is not anonymous due to the fact that you are entering your email address and or phone number to enter a drawing for a $50 gift card. Participants may complete
(A) and decide not to complete
(B) thus opting out of the drawing if so desired.
In addition, the researcher has utilized the “anonymized” survey feature within the Qualtrics survey software to ensure that a participant’s IP address is not being tracked or logged.
It is strongly advised that completion of this survey be done in an environment where responses will be private and not viewed by others. It is also recommended that you complete the survey in one
and completely shut down the computer or browser window upon completion of the survey.
GIFT CARD DRAWING
The drawing is expected to occur within 3-6 months from the date data collection begins. The winner of the drawing will be notified via email or phone depending on which form of contact information is provided. There will be one drawing and four individuals will be randomly selected to receive a $50 Visa gift card. This study is seeking approximately 90 participants however, it is unknown how many participants will submit their email address or phone number in order to be entered into the drawing. Participants email and or phone number will remain in the survey (B) database and be deleted upon
of all visa gift cards.
No information from which you could be identified will appear in the final study. The only circumstance in which confidentiality may be breached is if a disclosure is made regarding imminent danger to someone, or abuse of a minor, elder, or dependent adult; it may be required to make mandated reports of such disclosures under California state law.
WHAT HAPPENS IF I DO NOT WANT TO CONTINUE IN THE STUDY?
Participation is voluntary. If you choose to stop participating, there will be no penalty or loss of benefits to which you are otherwise entitled.
WILL PARTICIPANTS BE COMPENSATED FOR ILLNESS OR INJURY?
You are not waiving any of your legal rights if you agree to participate in this study. However, no funds have been set aside to compensate you in the event of injury. If you suffer harm because you participated in this research project, you may write or call the Office of the Institutional Review Board for National University and John F. Kennedy University, 11255 North Torrey Pines Road, La Jolla, CA 92037; Telephone (858) 642-8384.
If you should have any concerns or complaints about any aspect of this research, you may contact either my Project Chair or the Research Director of the Doctor of Psychology program at John F. Kennedy University, whose names and contact information are listed below.
Alette Coble-Temple, PsyD, Sarah Carroll,
, Director of Research
Project Chair, Doctor of Psychology Program
Doctor of Psychology Program John F. Kennedy University
John F. Kennedy University 100 Ellinwood Way
100 Ellinwood Way Pleasant Hill, CA 94523
Pleasant Hill, CA 94523 (925) 969-3400
You may also contact the IRB
(858) 642-8384 or email@example.com. if you have questions regarding how this research is being conducted.
WHAT HAPPENS WITH THE DATA WHEN YOU ARE FINISHED?
In order to comply with federal regulations of secured data storage, National University IRB Policy requires that records shall be retained for at least 3 years, and records relating to research that is conducted shall be retained for at least 3 years after completion of the research. All records shall be accessible for inspection and copying by authorized representatives of the department or agency at reasonable times and in a reasonable manner. If you are interested in the outcome of this study, please contact the primary researcher and she will forward you a summary of the results and implications.
By selecting “yes”, you are saying (1) that you have read this form or have had it read to you and (2) that you understand this form, the research study, and its risks and benefits. The researcher will be happy to answer any questions you have about the research. If you have any questions, please feel free to contact Jennifer Forrester at (925) 519-5037 or firstname.lastname@example.org
If at any time you feel pressured to participate or if you have any questions about your rights or this form, please call the Office of the Institutional Review Board at (858) 642-8384.
Note: By selecting “yes” below, you are telling the researcher "Yes" you want to participate in this study.
Please keep one copy of this form for your records.
I certify that this form includes all information concerning the study relevant to the protection of the rights of the participants, including the nature and purpose of this research, benefits, risks, costs, and any experimental procedures.
I have described the rights and protections afforded to human research participants and have done nothing to pressure, coerce, or falsely entice this person to participate. I am available to answer the participant's questions and have encouraged him or her to ask additional questions at any time during the course of the study.
Investigator Name: Jennifer Forrester
I have read and understood the above consent form and agree to participate.
Yes, I consent
I do NOT consent
Dissertation Research Study by Jennifer Forrester
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