Clinical trial: NCT03833817
Section: Alternatives
Subsections: Are There Any Benefits To Taking Part In The Study?

We cannot and do not guarantee that you will receive any benefits from this study. We hope the information learned from this study will benefit other patients with cancer and their caregivers in the future.
Clinical trial: NCT03833817
Section: Confidentiality
Subsections: What About Confidentiality?

Efforts will be made to protect your medical records and other personal information to the extent allowed by law. However, we cannot guarantee absolute confidentiality. Records of study participants are stored and kept according to legal requirements and may be part of your medial record. You will not be identified personally in any reports or publications resulting from this study. Organizations that may request to inspect and/or copy your research and medical records for quality assurance and data analysis include groups such as:  
o Weill Cornell Medical College and NewYork-PresbyterianHospital o Brooklyn Methodist Hospital/New York-Presbyterian Hospital o The Institutional Review Board(IRB)
Rev 10-2014  
IRB Protocol  
#1803019107 Consent version date: 07/17/2021  
o The Office of Human Research Protection(OHRP) o Department of Health and Human Services and National Institutes of Health o National Cancer Institute (NCI)
By signing this consent form, you authorize access to this confidential information. If information about your participation in this study is stored in a computer, we will take precautions to protect it from unauthorized disclosure, tampering, or damage by password protecting all computers, requiring a unique ID and password to log into the system and study-specific database, and storing all study information on the secure Weill Cornell Medicine and Brooklyn Methodist Hospital networks. Further, all computers used for the purpose of this study are kept in locked offices. Only personnel who are associated with the study will have access to the study specific records in the database. A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.
Clinical trial: NCT03833817
Section: Duration of Study Involvement
Subsections: How Many People Will Take Part In The Study?|How Long Will I Be In The Study?

Participants in the study are referred to as subjects. About 60 subjects will take part in this study worldwide: 30 patients and 30 caregivers; all 60 subjects will be recruited at this site.

You will be in this study for approximately one year. You can stop participating at any time. However, if you decide to stop participating in the study, we encourage you to talk to the researcher and your regular doctor first. If you choose to not participate in the study or to leave the study, your regular care will not be affected nor will your relations with WCMC, BMH, NewYork-Presbyterian Hospital, your physicians, or other personnel. In addition, you will not lose any of the benefitsto which you are entitled.
Clinical trial: NCT03833817
Section: Participant's Rights
Subsections: What Are My Rights As A Participant?

Taking part in this study is voluntary. You may choose to not take part in the study or to leave the study at any time. If you choose to not participate in the study or to leave the study, your regular care will not be affected nor will your relations with the Weill Cornell Medical College, Brooklyn Methodist Hospital, New YorkPresbyterian Hospital, your physicians, or other personnel. In addition, you will not lose any of the benefits to which you are entitled. We will tell you about new information that may affect your health, welfare, or participation in this study.
Clinical trial: NCT03833817
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Are The Risks Of The Study?

There are risks of participating in any study. There are minimal risks associated with participation in this study. These risks include: worsening distress or worry associated with talking about the patient's cancer; increased tension with the patient; and distress related to answering personal questions related to the patient's cancer, health, and treatment planning. You can stop your participation at any time. For more information about risks of participating in this study, ask the researcher, Dr. Holly Prigerson at 646962-2882 or hgp2001@med.cornell.edu.
Clinical trial: NCT03833817
Section: Procedures
Subsections: What Is Involved In The Study?

If you agree to participate, we will ask you to complete surveysthat will be administered over the telephone by a member of our team. These surveys will ask about the patients' cancer and treatment preferences and your distress, quality of life, and communication with the patient. These surveys will take approximately 40 minutes to complete. You will then be contacted by a social worker on the study team to start the intervention. You and the patient you care for will work with the same social worker. Some sessions will be conducted with the social worker and the person with cancer; some sessions will include only you and the social worker. The patient you care for will also have some sessions separately with the social worker. All sessions completed with just the social worker will be kept confidential and not shared with the patient. The intervention consists of seven sessions over the telephone. Each session lasts 45-60 minutes each. You will be asked to complete exercises between sessions related to the information you discuss with the social worker. These exercises will take 10-20 minutes to complete each week. After you finish the final session of the intervention, a study team member will contact you by telephone to complete another set of surveys. These surveys will take approximately 40 minutes to complete and will ask you about the patients' cancer and treatment preferences and your distress, quality of life, communication with the patient, and views of the intervention. Three months later, a member of the study team will contact by telephone to complete a final briefsurvey. This survey will ask about your treatment preferences and will take approximately 10 minutes to complete. All study surveys will be administered separate from the patient. If you agree to participate in this study, your interviews with study team members during which you complete study surveys and your intervention sessions with the social worker will be audio recorded. All recordings will be confidential and will be destroyed after the study is completed. If you do not agree to being audiotaped, you are not eligible to participate in the study. Do you give us permission to audio record our interviews and intervention sessions with you? (record caregiver response):
Yes No  
IRB Protocol  
#1803019107 Consent version date: 07/17/2021  
| WEILL CORNELL MEDICAL COLLEGE BROOKLYN METHODIST HOSPITAL Rev 10-2014   |
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Clinical trial: NCT03833817
Section: Purpose of Research
Subsections: Why Is The Study Being Done?

The purpose of this study is to examine the feasibility of a new intervention to help people with cancer and their primary caregivers communicate with each other about cancer and to examine the impact of the intervention on patients' and caregivers' understanding of the cancer, preferences for treatment, communication, and distress as part of a researchstudy. Thisresearch study is being done because interventionsthat improve communication between people with cancer and their caregivers are not currentlyavailable.
Clinical trial: NCT03833817
Section: Voluntary Participation
Subsections: Consent For Research Study

Project Title: A communication-based intervention for advanced cancer patient-caregiver dyads to increase engagement in advance care planning and reduce caregiver burden Principal Investigator: Dr. Holly Prigerson, PhD
Clinical trial: NCT03833817
Section: Withdrawal from Study
Subsections: Withdrawal By Investigator, Physician, Or Sponsor

The investigators, physicians or sponsors may stop the study or take you out of the study at any time should they judge that it is in your best interest to do so, if you experience a study-related injury or if you do not comply with the study plan. They may remove you from the study for various other administrative and medical reasons. They can do this without your consent.