CancerNCT04544241
Cancer Leadership Training for Clergy Wives and Widows
A study testing Cancer Survivorship Leadership Training for Clergy Wives and Widows in people with Cancer and Patient Empowerment, run by Charles Drew University of Medicine and Science at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, Patient Empowerment
- What is being tested?
- Cancer Survivorship Leadership Training for Clergy Wives and Widows
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2020to 10 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Charles R. Drew University of Medicine & Science
Los Angeles, California, 90059
About this study
Official title: 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.
- Conditions
- Cancer, Patient Empowerment
- Being tested
- Cancer Survivorship Leadership Training for Clergy Wives and Widows
- Keywords
- cancer, African American, church, clergy, leadership
- Medical subject headings
- Neoplasms, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cancer Survivorship Leadership Training for Clergy Wives and WidowsBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Cancer Survivorship Leadership Training for Clergy Wives and Widows |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start10 Nov 2020
- Primary completion1 Oct 2022
- Study completion10 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles Drew University of Medicine and Science
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Sharon Cobb, PhD, Principal investigator, Charles R. Drew University of Medicine & Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04544241
- Sponsor's protocol ID
- 1530494-1
- Other IDs
- 5U54MD007598-15
- Status last verified
- Mar 2023
- First submitted
- 31 Aug 2020
- Last updated
- 15 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Survivorship and Caregiver Leadership Education for Clergy Wives and Widows
- ClinicalTrials.gov ID
- NCT04544241
- Acronym / sponsor ID
- 1530494-1
- Conditions
- Cancer, Patient Empowerment
- Keywords
- cancer, African American, church, clergy, leadership
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Charles Drew University of Medicine and ScienceUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 10 Nov 2020 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 10 Sep 2020 (actual)
- Results
- Posted 12 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clergy Wives and Widows | Experimental | Behavioral: Cancer Survivorship Leadership Training for Clergy Wives and WidowsWe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cancer Survivorship Leadership Training for Clergy Wives and WidowsWe 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 | Behavioural | Clergy Wives and Widows |
Primary outcome
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.
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon Cobb, PhD principal investigator
Charles R. Drew University of Medicine & Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cancer Survivorship Leadership Training for Clergy Wives and Widows in people with Cancer and Patient Empowerment, run by Charles Drew University of Medicine and Science at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving Target Levels in Cancer Knowledge Using the Cancer Awareness Measurement Survey (time frame: 10 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.