Clinical trial: NCT04544241
Section: Confidentiality
Subsections: How Will My Private Information Be Kept Confidential?

The researchers will do their best to keep your personal information confidential.  
However, researchers cannot promise total privacy. The research team will be contacting you via email as well as emailing you a copy of your signed consent form. This may include sensitive information (i.e. your name) and identification that you are participating in a study about cancer. We will do our best to ensure that this information is confidential, and data is secured, but there is always risk for data security. You will be given a study specific identification number and a pseudonym that starts with one letter after your original first name. No real names will be used. All references to your real name during sessions views will be redacted for confidentiality. The only people who will have access to the data will be the members of the research team. PI Dr Cobb, Co-Investigator, Mrs. Jenkins, and Research Assistants - Ms. Phoenix Williamson. Your health care provider will not know that you are part of the research study. All study materials including recordings and documents will be locked in a encrypted laptop, encrypted cloud drive files, or a cabinet of the office of the PI (Dr. Sharon Cobb) on the CDU campus. All study data will be shredded and destroyed after the study is completed. Data will be kept for seven years before destruction if no longer being used for publications or presentations
Clinical trial: NCT04544241
Section: Duration of Study Involvement
Subsections: What Will I Be Asked To Do And How Long Will I Be In The Study?

You are being asked to participate in an online training program for clergy wives and widows that focuses on various areas of the cancer survivorship experience, including the delivery of cultural competency and care and providing hope and comfort. This course was specially designed with input from underrepresented minority cancer survivors and caregivers, with a focus on various need assessments and oncology navigational training. You will meet monthly in a structured setting and participate in cancer and/or caregiver related online community seminars on Zoom. In addition, the program will culminate with four workshops you will develop and present in an online community event.  
Following, you will be invited to participate in a focus group to describe your experience in this program.
Clinical trial: NCT04544241
Section: Participant's Rights
Subsections: What Are My Rights If I Take Part In This Study?|Questions About Your Rights As A Research Participant

You may withdraw your consent at any time and end your participation without penalty. You are not waiving any legal claims, rights or remedies because of your participation in this research study. If you have questions regarding your rights as a research participant, please contact, Charles R. Drew University of Medicine and Science Institutional Review Board/Office of Research Integrity and Compliance 1731 East 120th Street, Los Angeles, CA 90059 Telephone: 323-563-5902 FAX: 323-563-4826 e-mail: irb@cdrewu.edu

Charles R. Drew University of Medicine and Science Institutional Review Board Office of Research Integrity and Compliance 1731 East 120th Street Los Angeles, CA 90059 Tel: 323-563-5902 FAX: 323-563-4826 E-mail: irb@cdrewu.edu
Clinical trial: NCT04544241
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Risks Or Discomforts Can I Expect From Being In The Study?|Are There Benefits To Taking Part In The Study?

There are no observable or substantial risks to you. There are also no invasive tests or physical risks that will occur with this study. Although we do not perceive any major problems, you may experience mild emotional distress at hearing the suffering of cancer patients. If so, we will provide emotional support and if necessary, referral to your personal provider for more in-depth follow-up. In addition, you may report time management issues with having to manage additional time for this study.

There are multiple potential benefits that may result of this study. For clergy wives and widows, the knowledge you will gain is cancer diagnosis and treatment, cultural perceptions and care of care of cancer and caregiving, knowledge and attitudes of cancer and caregiving, and consideration of age on the health of URM cancer survivors and caregivers.
Clinical trial: NCT04544241
Section: Procedures
Subsections: What Will Happen If I Take Part In The Research Study? During The Study

- You are being asked to participate in an online year-long training program for clergy wives and widows that focuses on various areas of the cancer survivorship experience, including the delivery of cultural competency and care and providing hope and comfort. This course was specially designed with input from underrepresented minority cancer survivors and caregivers, with a focus on various need assessments and oncology navigational training.  
- Initially, you will be able to answer a few questions on the *SurveyMonkey* site that will determine if you are eligible for this study. If you are eligible, you can decide to proceed to the next section of the SurveyMonkey site in which you can read this consent form and electronically sign the consent. After you submit the consent form on the SurveyMonkey *site,* you will receive a signed digital copy of the consent form via email.  
- You will meet monthly in a structured setting and participate in cancer and/or caregiver related online community seminars on a digital teleconferencing platform, Zoom. In addition, the program will culminate with four workshops you will develop and present in an online community event. Following, you will be invited to participate in a focus group to describe your experience in this program.  
- You will complete the CSC for CWWs program and also complete pre- and postquestionnaires that will assess your self-efficacy and knowledge of both cancer survivorship and cancer caregiving. To receive full credit for completion of the CSC for CWWs training program, you must assist in the organization and presentation on cancer and/or caregiver related topic at one of four faithbased/community workshops. You will also be invited to participate in a postintervention focus group to describe your experience in the program. Our research team will send dates and times and you will select which times are preferable for you. Once we receive responses for preferable dates and times, we will select a specific date and time and notify you via email/phone. We plan to have focus group session on a digital teleconferencing platform (*Zoom),* which is likely to be preferable for you since you can participate from anywhere. The focus group session is expected to last one hour.  
- After the completion the CSC for CWWs program, an online conference in which you will present your workshop presentations to the university audience and community members. You will provide written consent to participate in the CSC for CWWs program and for collection of data. You will complete a demographic questionnaire and a self-efficacy and knowledge survey prior and after completion of the CSC for CWWs program.  
- After fulfilling all requirements of the CSC for CWWs program, you will be compensated with a $200 digital gift card and certificate for your time and participation in the CSC for CWWs program. You will also receive a $50 digital gift card if you participate in the post-intervention focus group. Scheduling of the sessions will be accordance with the preference of your time.
Clinical trial: NCT04544241
Section: Purpose of Research
Subsections: Key Information About This Research Study|What Are Some Reasons Why I Might Want To Take Part In This Study?|Why Am I Being Asked To Take Part In The Study?|Are There Any Benefits To Others?

You are being invited to take part in a research study about the development of a cancer survivorship and caregiver leadership educational course for clergy wives and widows.

There are various reasons why you may want to take part in this study: 1) able to gain knowledge on cancer survivorship and caregiving, 2) effectively understand how oncology navigation plays a role in cancer diagnosis, treatment, and management, especially for underrepresented minorities, and 3) clergy members can benefit by applying cancer-related knowledge with their church congregation. What are some reasons why I might not want to take part in this study? There are various reasons why you may not want to take part in this study: 1) unable to participate due to other commitments, 2) unable to provide time to participate in the study, and 3) not interested in partaking in a cancer-related study.

To be eligible for this study, you must: 1) be either a clergy wife or widow, 2) identify as African American/Black, 3) live within the boundaries of Los Angeles County, 4) speak and/or read English, and 5) have access to a computer laptop or desktop with internet, tablet with internet, or phone with internet. You are being asked to take part in this research study because you are eligible for this study based on the criteria above.

Information collected in this study has the potential to be used to create a leadership education training program targeting clergy members, including wives and widows that will be designed to meet the needs of cancer survivorship, including underrepresented minority cancer survivors and caregivers
Clinical trial: NCT04544241
Section: Withdrawal from Study
Subsections: Can I Stop Being In The Study?|Can The Researchers Remove Me From The Study?

Your participation in this research is VOLUNTARY. If you choose not to take part in the research study, that will not affect your relationship with CDU, or your right to health care or other services to which you are otherwise entitled. If you decide to take part in the study, you are free to withdraw your consent and stop at any time without affecting your relationship with CDU. If you are a CDU student, you may choose not to take part or drop out of the study at any time. This will not affect your grades or class standing at CDU. You will not be offered or receive any special consideration if you take part in this research. If you are a CDU employee, your participation in this research is in no way part of your university duties, and your refusal to take part will not in any way affect your employment with the university, or the benefits, privileges, or opportunities associated with your employment. You will not be offered or received any special consideration if you take part in research.

The researcher may remove you from taking part in this research for several reasons.  
If you do not meet the inclusion criteria or if you become sick during the research, you may have to drop out, even if you would like to continue. The PIs will make the decision and let you know. The decision may be made to protect your health and safety, or because it is part of the research plan that people who develop certain conditions, missed scheduled visits, or did not follow instructions may not continue to take part in the study.