Cancer Leadership Training for Clergy Wives and Widows

March 12, 2024 updated by: Charles Drew University of Medicine and Science

Cancer Survivorship and Caregiver Leadership Education for Clergy Wives and Widows

Multiple cancer health disparities exist for underrepresented minority groups, such as higher late stage diagnoses and greater cancer-related deaths. Among African Americans, there is an increased cancer survivorship and caregiving burden, which necessitates more support and resources during these phases. The African American church has been evidenced to be a trusted source of resource and provide culturally competent care and contribute to decreasing these disparities. Importantly, the leadership of the African American churches are pivotal to the health and wellness of this population. One important leader is the clergy wife or widow, who is understudied but vital to the function of the church function and activities. The long-term goal of this proposed study is to develop a leadership training program for clergy wives and widows with emphasis on cancer survivorship and caregiving. The objective of this pilot project is to develop and test the Cancer Survivorship and Caregiver Leadership Education for Clergy Wives and Widows, with specific emphasis of cultural and spiritual considerations of African American cancer survivors and caregivers. The rationale for this project, is that African American clergy wives and widows can receive the necessary training to assist cancer survivors and caregivers in the management of physical, emotional, psychosocial, spiritual, and financial challenges. This study will be accomplished in four aims, which are 1) Develop skills and knowledge to perform an in-depth culturally sensitive need assessment and intervention map tailored for aging African American cancer survivors and caregivers, 2) To increase cancer survivorship and caregiving leadership education and activities for African American Clergy Wives and Widows, and 3) Enhance awareness of cancer-related health issues and its relationship to key determinants among aging cancer survivors and caregivers. This project is innovative in establishing a culturally and spiritually tailored intervention to develop the training of Clergy Wives and Widows to provide appropriate education for community dwelling African American survivors and caregivers. This research is significant because of its potential to inform cancer and caregiving related research and evidence-based practice for both health care professionals and community organizations and institutions to improve long term-health outcomes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
37

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90059
        • Charles R. Drew University of Medicine & Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Identify as either a clergy wife or widow
  • Identify as African American and/or Black
  • Live within the boundaries of Los Angeles County
  • Be at least 18 years of age
  • Speak and/or read English

Exclusion Criteria:

  • Does not identify as a clergy wife or widow
  • Does not self-identify as African American and/or Black
  • Lives outside the boundaries of Los Angeles County
  • Under the age of 18
  • Unable to speak and/or read English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Clergy Wives and Widows
We will provide cancer survivorship and caregiving leadership education and activities for African American Clergy Wives and Widows by creating an educational partnership program aimed towards church-based health education on cancer survivorship and caregiving
Behavioral: Cancer Survivorship Leadership Training for Clergy Wives and Widows
We will meet with Clergy Wives and Widows monthly for 2-3 hours over 10 months. These sessions will be delivered using innovative online format through Zoom over the ten months. During each meeting session, experienced community and academic leaders will present their expertise with relationship to cancer survivorship and caregiving. These individuals will have extensive experience in the particular area they are presenting in. In addition, allotted time will be given for discussion and group activities that can be performed virtually. To receive credit for completion of the training program, each participant must complete the training and deliver a group workshop. All clergy wives and widows will complete a demographic questionnaire, in addition to pre- and post- intervention questionnaires

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Target Levels in Cancer Knowledge Using the Cancer Awareness Measurement Survey
Time Frame: 10 months
By comparison from baseline to post-intervention, there will be a 30% increase in the cancer awareness, risk factors, and screening among study participants.
10 months
Percentage of Participants Achieving Improvement in Mental Status and Wellness Using Depression, Anxiety, and Stress Survey
Time Frame: 10 months
By comparison from baseline to post-intervention, there will be a 30% increase in the awareness of depression, anxiety and stress among study participants.
10 months
Percentage of Participants Achieving Decreased Perceived Stigma Levels Using Cancer Stigma Scale
Time Frame: 10 months
By comparison from baseline to post-intervention, there will be a 30% decrease in cancer stigma among study participants.
10 months
Percentage of Participants Achieving Decreased Perceived Stress Using Caregiver Self-Assessment Questionnaire
Time Frame: 10 months
By comparison from baseline to post-intervention, there will be a 30% decrease in perceived stress regarding cancer caregiving among study participants.
10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Charles Drew University of Medicine and Science

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sharon Cobb, PhD, Charles R. Drew University of Medicine & Science

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 10, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 10, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 31, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1530494-1
  • 5U54MD007598-15 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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