Cervical CancerNCT05359913
Podcasting Cervical Cancer Prevention for AAW
A study testing Cervical cancer podcast for African American women in people with Cervical Cancer, run by University of Houston.
Trial summary
For African American women (AAW) in Houston, cervical cancer mortality is disproportionate to their racial and ethnic counterparts.Most notably, lack of human papillomavirus (HPV) screening, vaccination, and later diagnosis increase cervical cancer mortality. However, cervical cancer is largely preventable. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Cervical cancer podcast for African American women
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- self-identify as African American
- biological female sex
- speak and read English
- 18 years old or older
- not currently or previously diagnosed with cervical cancer or cervix dysplasia
Who cannot join
- history of hysterectomy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Proof of Concept and Feasibility in Podcasting Cervical Cancer Prevention for African American Women
For African American women (AAW) in Houston, cervical cancer mortality is disproportionate to their racial and ethnic counterparts.Most notably, lack of human papillomavirus (HPV) screening, vaccination, and later diagnosis increase cervical cancer mortality. However, cervical cancer is largely preventable. While previous research has identified only a few social determinants that are specifically related to cervical cancer, there may be a host of additional social and cultural factors that contribute to a lack of preventative behavior. The overall objective of the proposed study is to gather preliminary data to determine whether the use of concept mapping methodology is useful in identifying unique sociocultural determinants of cervical cancer prevention behavior, and to pilot test the feasibility of a podcast video developed using the information garnered from the concept mapping procedure. It is hypothesized that the resulting podcast video will increase HPV knowledge and behavioral intentions. Proof of concept and feasibility are needed first, in determining the utility of both the methodology and media development procedures, as well as data on preliminary effect outcomes, before further investigation and program development.
- Conditions
- Cervical Cancer
- Being tested
- Cervical cancer podcast for African American women
- Keywords
- Cervical cancer, African American Women, Cancer Prevention
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical cancer podcast for African American womenBehavioural
The video podcast will deliver cervical cancer prevention messages using entertainment education and behavioral journalism, and film production techniques such as "talking head" video, interview, animations, \& live-action skits. The research team will work closely with the production company in scripting the video vignettes and sequences, ensuring that video content reflects salient domains captured in the concept mapping research development phase of the study.
| Study group | Role | What they receive |
|---|---|---|
| African American Women | Experimental | Not described Receives: Behavioral: Cervical cancer podcast for African American women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Researcher-developed cervical cancer prevention measure that reflects salient socio-cultural perceptions of cervical cancer prevention (obtained through non-clinical qualitative inquiry)
To observe whether the podcast video significantly changed perceptions of cervical cancer prevention.
Items will be set to 5-pt Likert-type scale: (1) - (5); higher scale values indicating more positive perceptions to cervical cancer prevention
Measured: To be measured immediately before film viewing and immediately after film viewing
Pap test intentions: Do you intend to obtain a Pap cytology screening? (single item)
To observe whether the podcast video significantly changed intentions to obtain a Pap cytology test.
Item will be set to 5-pt Likert-type scale: (1) - (5); higher scale values indicating greater intentions for cervical cancer screening.
Measured: To be measured immediately before film viewing and immediately after film viewing
HPV vaccination intentions: Do you intend to get vaccinated for HPV? (single item)
For women who are within the HPV vaccination age range: to observe whether the podcast video significantly changed their intentions to obtain a HPV vaccination.
Items will be set to 5-pt Likert-type scale: (1) - (5); higher scale values indicating more positive intentions toward HPV vaccination.
Measured: To be measured immediately before film viewing and immediately after film viewing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start1 Sep 2022 (estimated)
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chakema Carmack, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05359913
- Sponsor's protocol ID
- STUDY00003472
- Status last verified
- Apr 2022
- First submitted
- 7 Apr 2022
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because this is a feasibility study with a very low sample size, the data is preliminary and it is not certain that the data will be appropriate or useful for public dissemination.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Concept and Feasibility in Podcasting Cervical Cancer Prevention for African American Women
- ClinicalTrials.gov ID
- NCT05359913
- Acronym / sponsor ID
- STUDY00003472
- Conditions
- Cervical Cancer
- Keywords
- Cervical cancer, African American Women, Cancer Prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 4 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
For African American women (AAW) in Houston, cervical cancer mortality is disproportionate to their racial and ethnic counterparts.Most notably, lack of human papillomavirus (HPV) screening, vaccination, and later diagnosis increase cervical cancer mortality. However, cervical cancer is largely preventable. While previous research has identified only a few social determinants that are specifically related to cervical cancer, there may be a host of additional social and cultural factors that contribute to a lack of preventative behavior. The overall objective of the proposed study is to gather preliminary data to determine whether the use of concept mapping methodology is useful in identifying unique sociocultural determinants of cervical cancer prevention behavior, and to pilot test the feasibility of a podcast video developed using the information garnered from the concept mapping procedure. It is hypothesized that the resulting podcast video will increase HPV knowledge and behavioral intentions. Proof of concept and feasibility are needed first, in determining the utility of both the methodology and media development procedures, as well as data on preliminary effect outcomes, before further investigation and program development.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| African American Women | Experimental | Behavioral: Cervical cancer podcast for African American women |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- self-identify as African American
- biological female sex
- speak and read English
- 18 years old or older
- not currently or previously diagnosed with cervical cancer or cervix dysplasia
Key exclusion criteria (1 listed)
- history of hysterectomy
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 |
|---|---|---|
| Cervical cancer podcast for African American womenThe video podcast will deliver cervical cancer prevention messages using entertainment education and behavioral journalism, and film production techniques such as "talking head" video, interview, animations, \& live-action skits. The research team will work closely with the production company in scripting the video vignettes and sequences, ensuring that video content reflects salient domains captured in the concept mapping research development phase of the study. | Behavioural | African American Women |
Primary outcome
Researcher-developed cervical cancer prevention measure that reflects salient socio-cultural perceptions of cervical cancer prevention (obtained through non-clinical qualitative inquiry)
Time frame: To be measured immediately before film viewing and immediately after film viewing
To observe whether the podcast video significantly changed perceptions of cervical cancer prevention. Items will be set to 5-pt Likert-type scale: (1) - (5); higher scale values indicating more positive perceptions to cervical cancer prevention
Pap test intentions: Do you intend to obtain a Pap cytology screening? (single item)
Time frame: To be measured immediately before film viewing and immediately after film viewing
To observe whether the podcast video significantly changed intentions to obtain a Pap cytology test. Item will be set to 5-pt Likert-type scale: (1) - (5); higher scale values indicating greater intentions for cervical cancer screening.
HPV vaccination intentions: Do you intend to get vaccinated for HPV? (single item)
Time frame: To be measured immediately before film viewing and immediately after film viewing
For women who are within the HPV vaccination age range: to observe whether the podcast video significantly changed their intentions to obtain a HPV vaccination. Items will be set to 5-pt Likert-type scale: (1) - (5); higher scale values indicating more positive intentions toward HPV vaccination.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Individual participant dataSharing planned: No. Because this is a feasibility study with a very low sample size, the data is preliminary and it is not certain that the data will be appropriate or useful for public dissemination.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical cancer podcast for African American women in people with Cervical Cancer, run by University of Houston.
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 1 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: status not confirmed, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chakema C Carmack, Ph.D. (713-743-6231, ccarmack@central.uh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Researcher-developed cervical cancer prevention measure that reflects salient socio-cultural perceptions of cervical cancer prevention (obtained through non-clinical qualitative inquiry) (time frame: To be measured immediately before film viewing and immediately after film viewing). The study lists 3 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 4 May 2022.