Cervical CancerOCEAPNCT06365450
Breast and Cervical Cancer Education Program
A study testing Educational Intervention in people with Cervical Cancer and Breast Cancer, run by Johns Hopkins University at 1 site in United States.
Trial summary
The primary goal of this study is to improve cancer literacy in Black women living with HIV and ultimately improve breast and cervical cancer screening uptake. This study involves an educational intervention delivered virtually and in person, depending on the participants' preference. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, Breast Cancer, Health Behavior
- What is being tested?
- Educational Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2022to 5 Apr 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- able to read and write in English
- self-identify as HIV positive -
- Black/African American.
Who cannot join
- Acutely ill
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Nursing
Baltimore, Maryland, 21205
About this study
Official title: OWEL Cancer Education and Awareness Program (OCEAP)
The primary goal of this study is to improve cancer literacy in Black women living with HIV and ultimately improve breast and cervical cancer screening uptake. This study involves an educational intervention delivered virtually and in person, depending on the participants' preference.
Read the detailed description
The aims of this study are to:
- develop educational materials on breast and cervical cancer screening;
- administer the intervention using a PowerPoint presentation;
- evaluate changes in breast and cervical cancer literacy levels after the intervention; and
- assess participants'; satisfaction with the program
- Conditions
- Cervical Cancer, Breast Cancer, Health Behavior
- Being tested
- Educational Intervention
- Medical subject headings
- Uterine Cervical Neoplasms, Breast Neoplasms, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Participants will receive hybrid educational intervention on breast and cervical cancer
| Study group | Role | What they receive |
|---|---|---|
| Educational Single-group | Experimental | 1 educational session on cervical cancer and one educational session on breast cancer Receives: Other: Educational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Literacy in Cancer Screening as assessed by the Assessment of Health Literacy in Cancer Screening (AHL-C) tool.
The dimensions of health literacy adapted from the AHL-C tool are:
- Numeracy (2 items)
- Familiarity (9 items)
- Comprehension (1 item)
- Navigation (7 items).
To determine health literacy scores of participants, each item will be scored on a scale of 0 to 1. A higher score would mean a better outcome. Items will be summed for each of the four sub-scales as well as the entire scale (AHL-C) and then determine the mean and standard deviation.
Assessment will be completed immediately post intervention (after two sessions on breast and cervical cancer)
Measured: Immediately Post intervention
Secondary outcomes (4)
Number of participants recruited from each community partner
Participants recruited from each community partner
Measured: Immediately Post intervention
Number of participants who preferred virtual or in person sessions
Participant session attendance preference
Measured: Immediately Post intervention
Number of participants who were lost of follow up
Participants lost to follow up
Measured: Immediately post intervention
Number of participants who needed help redeeming their gift codes
Participants needing help redeeming gift cards
Measured: Immediately post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start22 Sep 2022
- Primary completion28 Feb 2024
- Study completion5 Apr 2024
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.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each participant is required to attend (in person or virtually via Zoom) two educational sessions one on breast cancer and the other on cervical cancer.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Older Women Embracing Life, The John G. Bartlett Specialty Practice
- Responsible party
- Sponsor
- Investigators
- Hae-Ra Han, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06365450
- Sponsor's protocol ID
- IRB00315481
- Acronym
- OCEAP
- Status last verified
- Apr 2024
- First submitted
- 10 Apr 2024
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OWEL Cancer Education and Awareness Program (OCEAP)
- ClinicalTrials.gov ID
- NCT06365450
- Acronym / sponsor ID
- OCEAP / IRB00315481
- Conditions
- Cervical Cancer, Breast Cancer, Health Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Older Women Embracing Life, The John G. Bartlett Specialty Practice
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 5 Apr 2024 (actual)
- First posted
- 15 Apr 2024 (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.
The primary goal of this study is to improve cancer literacy in Black women living with HIV and ultimately improve breast and cervical cancer screening uptake. This study involves an educational intervention delivered virtually and in person, depending on the participants' preference.
Detailed description
The aims of this study are to:
- develop educational materials on breast and cervical cancer screening;
- administer the intervention using a PowerPoint presentation;
- evaluate changes in breast and cervical cancer literacy levels after the intervention; and
- assess participants'; satisfaction with the program
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each participant is required to attend (in person or virtually via Zoom) two educational sessions one on breast cancer and the other on cervical cancer.
| Arm | Type | Receives |
|---|---|---|
| Educational Single-group | Experimental | Other: Educational Intervention1 educational session on cervical cancer and one educational session on breast cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- able to read and write in English
- self-identify as HIV positive -
- Black/African American.
Key exclusion criteria (1 listed)
- Acutely ill
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 |
|---|---|---|
| Educational InterventionParticipants will receive hybrid educational intervention on breast and cervical cancer | Other | Educational Single-group |
Primary outcome
Health Literacy in Cancer Screening as assessed by the Assessment of Health Literacy in Cancer Screening (AHL-C) tool.
Time frame: Immediately Post intervention
The dimensions of health literacy adapted from the AHL-C tool are: 1. Numeracy (2 items) 2. Familiarity (9 items) 3. Comprehension (1 item) 4. Navigation (7 items). To determine health literacy scores of participants, each item will be scored on a scale of 0 to 1. A higher score would mean a better outcome. Items will be summed for each of the four sub-scales as well as the entire scale (AHL-C) and then determine the mean and standard deviation. Assessment will be completed immediately post intervention (after two sessions on breast and cervical cancer)
4 secondary outcomes
Number of participants recruited from each community partner
Time frame: Immediately Post intervention
Number of participants who preferred virtual or in person sessions
Time frame: Immediately Post intervention
Number of participants who were lost of follow up
Time frame: Immediately post intervention
Number of participants who needed help redeeming their gift codes
Time frame: Immediately post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Cervical Cancer
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
Not yet recruitingObservational study
Serum Treg/Th17-Related Cytokines and Systemic Inflammatory Indices in Differentiated Thyroid Cancer
Differentiated Thyroid Cancer (DTC), Papillary Thyroid Carcinoma
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.
Hae-Ra Han, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention in people with Cervical Cancer and Breast Cancer, run by Johns Hopkins University 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 3 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: finished, as of the sponsor's last update on 15 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Health Literacy in Cancer Screening as assessed by the Assessment of Health Literacy in Cancer Screening (AHL-C) tool. (time frame: Immediately Post intervention). 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 Apr 2024.