Podcasting Cervical Cancer Prevention for AAW
Primary Purpose
Cervical Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cervical cancer podcast for African American women
Sponsored by
About this trial
This is an interventional prevention trial for Cervical Cancer focused on measuring Cervical cancer, African American Women, Cancer Prevention
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
• history of hysterectomy
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
African American Women
Arm Description
Outcomes
Primary Outcome Measures
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
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05359913
Brief Title
Podcasting Cervical Cancer Prevention for AAW
Official Title
Proof of Concept and Feasibility in Podcasting Cervical Cancer Prevention for African American Women
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Houston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
Cervical cancer, African American Women, Cancer Prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
African American Women
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Cervical cancer podcast for African American women
Intervention Description
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.
Primary Outcome Measure Information:
Title
Researcher-developed cervical cancer prevention measure that reflects salient socio-cultural perceptions of cervical cancer prevention (obtained through non-clinical qualitative inquiry)
Description
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
Time Frame
To be measured immediately before film viewing and immediately after film viewing
Title
Pap test intentions: Do you intend to obtain a Pap cytology screening? (single item)
Description
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.
Time Frame
To be measured immediately before film viewing and immediately after film viewing
Title
HPV vaccination intentions: Do you intend to get vaccinated for HPV? (single item)
Description
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.
Time Frame
To be measured immediately before film viewing and immediately after film viewing
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
• history of hysterectomy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chakema C Carmack, Ph.D.
Phone
713-743-6231
Email
ccarmack@central.uh.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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.
Learn more about this trial
Podcasting Cervical Cancer Prevention for AAW
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