Clinical trial: NCT02165839
Section: Alternatives
Subsections: Alternatives

While there is no standard treatment for insomnia for breast cancer patients, you may choose to seek medical (pharmacological) treatment for your sleep difficulties. You may choose not to be in the study.
Clinical trial: NCT02165839
Section: Confidentiality
Subsections: Confidentiality|Authorization To Use Your Health Information For Research Purposes|What Personal Information Will Be Obtained, Used Or Disclosed?|Will Access To My Medical Record Be Limited During The Study?

Your identity will be kept as confidential as possible as required by law. Except as required by law, you will not be identified by name, social security number, address, telephone number, or any other direct personal identifier. Your research records may be disclosed outside of Stanford, but in this case, you will be identified only by a unique code number. Information about the code will be kept in a secure location and access limited to research study personnel.  
  
Protocol Title: Brief Behavioral Intervention for Management of Insomnia During Chemotherapy The results of this research study may be presented at scientific or medical meetings or published in scientific journals. However, your identity will not be disclosed. Patient information may be provided to Federal and other regulatory agencies as required. The Food and Drug Administration (FDA), for example, may inspect research records and learn your identity if this study falls within its jurisdiction.  
CERTIFICATE OF CONFIDENTIALITY
This research is covered by a Certificate of Confidentiality from the National Institutes of Health. The researchers with this Certificate may not disclose or use information, documents, or biospecimens that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other action, suit, or proceeding, or be used as evidence, for example, if there is a court subpoena, unless you have consented for this use. Information, documents, or biospecimens protected by this Certificate cannot be disclosed to anyone else who is not connected with the research except, if there is a federal, state, or local law that requires disclosure (such as to report child abuse or communicable diseases but not for federal, state, or local civil, criminal, administrative, legislative, or other proceedings, see below); if you have consented to the disclosure, including for your medical treatment; or if it is used for other scientific research, as allowed by federal regulations protecting research subjects. The Certificate cannot be used to refuse a request for information from personnel of the United States federal or state government agency sponsoring the project that is needed for auditing or program evaluation by the National Cancer Institute which is funding this project or for information that must be disclosed in order to meet the requirements of the federal Food and Drug Administration (FDA). You should understand that a Certificate of Confidentiality does not prevent you from voluntarily releasing information about yourself or your involvement in this research. If you want your research information released to an insurer, medical care provider, or any other person not connected with the research, you must provide consent to allow the researchers to release it.

Because information about you and your health is personal and private, it generally cannot be used in this research study without your written authorization. If you sign this form, it will provide that authorization. The form is intended to inform you about how your health information will be used or disclosed in the study. Your information will only be used in accordance with this authorization form and the informed consent form and as required or allowed by law. Please read it carefully before signing it.

Your health information related to this study may be used or disclosed in connection with this research study, including, but not limited to, information relating to your medical history, genetic information related to breast cancer, and treatment outcome. Who may use or disclose the information? The following parties are authorized to use and/or disclose your health information in connection with this research study:
- The Protocol Director: Oxana Palesh, Ph.D., M.P.H.  
- The Stanford University Administrative Panel on Human Subjects in Medical Research and any other unit of Stanford University as necessary
- Research Staff Who May Receive or Use the Information?  
The parties listed in the preceding paragraph may disclose your health information to the following persons and organizations for their use in connection with this research study:  
  
Protocol Title: Brief Behavioral Intervention for Management of Insomnia During Chemotherapy
- The Office for Human Research Protections in the U.S. Department of Health and Human Services
- FDA - National Cancer Institute
- University of Rochester, NY - Laval University, Quebec, Canada - MD Anderson Cancer Center
- Research investigators, staff, and other collaborators as identified by the study team Your information may be re-disclosed by the recipients described above, if they are not required by law to protect the privacy of the information.

To maintain the integrity of this research study, you may not have access to any health information developed as part of this study until it is completed. At that point, you would have access to such health information if it was used to make a medical or billing decision about you (e.g., if included in your official medical record). _____________________________________ _____________ Signature of Adult Participant Date ________________________________________ Print name of Adult Participant
Clinical trial: NCT02165839
Section: Duration of Study Involvement
Subsections: Duration Of Study Involvement

This research study is expected to take approximately 63 days of active participation by each participant; and approximately 13 months of collection of medical information for each participant.
Clinical trial: NCT02165839
Section: Participant Responsibilities
Subsections: Participant Responsibilities

As a participant, your responsibilities include:
- Follow the instructions of the Protocol Director and study staff. - Keep your study appointments. If it is necessary to miss an appointment, please contact the Protocol Director or research study staff to reschedule as soon as you know you will miss the appointment.  
- Tell the Protocol Director or research study staff about any side effects, doctor visits, or hospitalizations that you may have.  
- Tell the Protocol Director or research staff if you believe you might be pregnant. Complete your questionnaires as instructed.  
- Ask questions as you think of them.  
- Tell the Protocol Director or research staff if you change your mind about staying in the study.  
While participating in this research study, you should not take part in any other research project without approval from the Protocol Director of this study. This is to protect you from possible injury arising from such things possible interaction(s) of research drugs.
Clinical trial: NCT02165839
Section: Participant's Rights
Subsections: Participants Rights|Experimental Subjects Bill Of Rights

You should not feel obligated to agree to participate. Your questions should be answered clearly and to your satisfaction. If you decide not to participate, tell the Protocol Director. You will still receive care for your disease and will not lose any benefits to which you would otherwise be entitled. You will be told of any important new information that is learned during the course of this research study, which might affect your condition or your willingness to continue participation in this study.

As a research participant you have the following rights. These rights include but are not limited to the participant's right to:
- be informed of the nature and purpose of the experiment - be given an explanation of the procedures to be followed in the medical experiment, and any drug or device to be utilized
- be given a description of any attendant discomforts and risks reasonably to be expected - be given an explanation of any benefits to the subject reasonably to be expected, if applicable
- be given a disclosure of any appropriate alternatives, drugs or devices that might be advantageous to the subject, their relative risks and benefits
- be informed of the avenues of medical treatment, if any available to the subject after the experiment, if complications should arise
- be given an opportunity to ask questions concerning the experiment or the procedures involved
- be instructed that consent to participate in the medical experiment may be withdrawn at any time and the subject may discontinue participation without prejudice
- be given a copy of the signed and dated consent form - be given the opportunity to decide to consent or not to consent to a medical experiment without the intervention of any element of force, fraud, deceit, duress, coercion or undue influence on the subject's decision May we contact you about future studies that may be of interest to you? _____ Yes ____ No I give consent to be audio recorded during this study: Please initial: _________ Yes ________ No Signing your name means you agree to be in this study and that you were given a copy of this consent form. _____________________________________ ____________ Signature of Adult Participant Date ________________________________________ Print name of Adult Participant ____________________________________ ___________ Signature of Person Obtaining Consent Date ________________________________________ Print name of Person Obtaining Consent  
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Clinical trial: NCT02165839
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks And Discomforts

BBT-I may result in temporary increases in daytime fatigue and/or sleepiness, and/or memory and concentration difficulties. Completing questionnaires and neuropsychological testing can cause mild anxiety and fatigue; however, these feelings are transient. Blood drawing may cause pain and bruising at the site where the blood is taken, and sometimes, it causes people to feel light-headed or even to faint. Rarely you might get an infection at the site of the needle stick. Heart rate monitor electrodes and the gel used to attach them may cause a skin reaction. The Actiwatch device worn around the wrist may cause a skin reaction.
Clinical trial: NCT02165839
Section: Procedures
Subsections: Description Of Procedures Pre-Baseline|Baseline Appointment|Blood And Tissue Sampling For Research|Tissue Sampling For Genetic Testing

If the results of the preliminary screening indicate that you remain eligible to participate in the study, we will schedule you a baseline appointment. The week prior to your appointment, you will be asked to fill out baseline forms at home that keep track of your sleep habits (daily sleep diaries) for a period of one week. In addition during this time, we will ask you to wear a watch-like device (Actiwatch ®). The two days prior to your baseline visit, we will ask you to take saliva samples.

During your baseline appointment, we will ask you to complete questionnaires, neuropsychological testing, heart rate variability, and a fasting blood draw. We will also ask you to bring in your sleep diaries and saliva samples. All procedures are described in "Other Assessments." After these assessments are complete, you will be randomized to the treatment group.

Research using tissues is an important way to try to understand human disease. You have been given this information because the investigators want to include your blood and tissues in a research project and because they want to save the samples for future research. There are several things you should know before allowing your tissues to be studied.  
- Your blood sample might be linked to Stanford Tissue Bank - Your blood and tissue will be coded and the code number will be linked to your medical record, but only known in a secure manner to the Study Coordinators or Investigators involved in the study
- You have the right to refuse to allow your blood to be studied now or saved for future study. You may withdraw from this study at any time.  
- The results of the study of your samples will be used for research purposes only and you will not be told the results of the tests.
_____ I consent to my samples being saved for future research _____ I do not consent to my samples being saved for future research

As part of the analysis on your samples, the investigators will do genetic testing. Genetic research is research that studies genes, including gene characteristics and gene versions that are transmitted by parents to children. Genetic research may include looking at information, such as personal appearance and biochemistry, gene sequences, genetic landmarks, individual and family medical histories, reactions to medications and responses to treatment. Genetic research raises certain questions about informing you of any results. Possible risks of knowing results include: anxiety; other psychological distress; and the possibility of insurance and job discrimination. A possible risk of not knowing includes being unaware of the need for treatment. These risks can change depending on the results of the research and whether there is a treatment or cure for a particular disease.  
  
Protocol Title: Brief Behavioral Intervention for Management of Insomnia During Chemotherapy Sometimes patients have been required to furnish information from genetic testing for health insurance, life insurance, and/or a job. A Federal law, the Genetic Information Nondiscrimination Act of 2008 (GINA), generally makes it illegal for health insurance companies, group health plans, and employers with 15 or more employees to discriminate against you based on your genetic information. The results of the study of your samples from this project will be used for research purposes only, and you will not be told the results of the tests.
Clinical trial: NCT02165839
Section: Purpose of Research
Subsections: Purpose Of The Study|What Is The Purpose Of This Research Study And How Will My Health Information Be Utilized In The Study?

Sleep disturbance, particularly insomnia, is a common problem for cancer patients. Insomnia can be described as difficulty falling asleep, waking up many times during the night or waking up earlier than you would like. Insomnia can increase fatigue and affect your quality of life in a negative way. The purpose of this study is to determine the efficacy of the Brief Behavioral Therapy for Insomnia (BBT-I) in comparison with Healthy Eating EducAtion Learning (HEAL) in reducing insomnia, fatigue, and cognitive difficulties in breast cancer patients. In addition, this study will examine the potential involvement of several demographic and medical variables (e.g., anxiety, hot flashes), specific behavioral mechanisms (maladaptive sleep behaviors, dysfunctional beliefs and attitudes), and physiological mechanisms (e.g., dysregulated circadian rhythms, inflammation disrupted wake-sleep cycles, and autonomic tone) as potential mediators of intervention-related changes in insomnia and the secondary outcomes of fatigue and cognitive difficulties. There will be approximately 180 participants in this study. The study has been divided into two parts. By signing this consent form you are agreeing to participate, if eligible, in both parts of the study. The purpose of the first part of the study, the Screening/Baseline Period is to determine if you will be eligible to participate in the second part of the study. The purpose of the second part of the study, which will last for 6 weeks, is to examine the effectiveness of BBT-I and HEAL interventions for the treatment and prevention of acute insomnia and subsequent chronic insomnia. In addition, there will be a follow-up assessment six and twelve months later. Some of your sessions with the therapist may be audio recorded for training purposes and to ensure that we are consistently following the study protocol. The audio recordings will be destroyed at the end of the study.

This study will examine the efficacy of BBT-I vs. HEAL for the treatment and prevention of acute insomnia and subsequent chronic insomnia for women undergoing treatment for breast cancer. Blood samples may be used for analysis of inflammation, telomeres, and genetic markers linked to symptoms such as sleep disruption and cognitive dysfunction  
  
Protocol Title: Brief Behavioral Intervention for Management of Insomnia During Chemotherapy associated with breast cancer. The saliva and blood samples may be used to investigate new approaches for developing biomarkers that can be used in behavioral and cancer research.  
Do I have to sign this authorization form?  
You do not have to sign this authorization form. But if you do not, you will not be able to participate in this research study and receive any research-related treatment. Signing the form is not a condition for receiving any medical care outside the study.
Clinical trial: NCT02165839
Section: Withdrawal from Study
Subsections: Withdrawal From Study|If I Sign, Can I Revoke It Or Withdraw From The Research Later?

If you first agree to participate and then you change your mind, you are free to withdraw your consent and discontinue your participation at any time. Your decision will not affect your ability to receive medical care for your disease and you will not lose any benefits to which you would otherwise be entitled. If you would like to withdraw from the study, you may phone Oxana Palesh, Ph.D., M.P.H. at Stanford University at xxx-xxx-xxxx. The Protocol Director may also withdraw you from the study without your consent for one or more of the following reasons:
- Failure to follow the instructions of the Protocol Director and study staff. - The Protocol Director decides that continuing your participation could be harmful to you.  
- You need treatment not allowed in the study.  
- The study is cancelled. - Other administrative reasons.  
  
  
Protocol Title: Brief Behavioral Intervention for Management of Insomnia During Chemotherapy
- Unanticipated circumstances.

If you decide to participate, you are free to withdraw your authorization regarding the use and disclosure of your health information (and to discontinue any other participation in the study) at any time. After any revocation, your health information will no longer be used or disclosed in the study, except to the extent that the law allows us to continue using your information (e.g., necessary to maintain integrity of research). If you wish to revoke your authorization for the research use or disclosure of your health information in this study, you must write to: Oxana Palesh, Ph.D., M.P.H., Department of Psychiatry and Behavioral Science, Stanford University School of Medicine, Quarry Road, Stanford, CA 94305-5718.