NCT04544241

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 10, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

November 10, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2022

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

March 12, 2024

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2023

Enrollment Period

1.9 years

First QC Date

August 31, 2020

Results QC Date

November 22, 2023

Last Update Submit

March 12, 2024

Conditions

Keywords

cancerAfrican Americanchurchclergyleadership

Outcome Measures

Primary Outcomes (4)

  • Percentage of Participants Achieving Target Levels in Cancer Knowledge Using the Cancer Awareness Measurement Survey

    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

    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

    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

    By comparison from baseline to post-intervention, there will be a 30% decrease in perceived stress regarding cancer caregiving among study participants.

    10 months

Study Arms (1)

Clergy Wives and Widows

EXPERIMENTAL

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

Interventions

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

Clergy Wives and Widows

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charles R. Drew University of Medicine & Science

Los Angeles, California, 90059, United States

Location

MeSH Terms

Conditions

NeoplasmsPatient Participation

Interventions

Widowhood

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Marital StatusFamily CharacteristicsDemographyPopulation CharacteristicsSocioeconomic Factors

Results Point of Contact

Title
Sharon Cobb
Organization
Charles R. Drew University of Medicine & Science

Study Officials

  • Sharon Cobb, PhD

    Charles R. Drew University of Medicine & Science

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2020

First Posted

September 10, 2020

Study Start

November 10, 2020

Primary Completion

October 1, 2022

Study Completion

October 10, 2022

Last Updated

March 15, 2024

Results First Posted

March 12, 2024

Record last verified: 2023-03

Locations