CLINICAL TRIAL

Health is Wealth: A Cervical Health Program for Uterine Cervical Neoplasms

Recruiting · 18+ · Female · Lexington, KY

This study is evaluating whether a program can help increase cervical cancer screening among immigrants.

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About the trial for Uterine Cervical Neoplasms

Eligible Conditions
Uterine Cervical Neoplasms · Cervical Cancers

Treatment Groups

This trial involves 2 different treatments. Health Is Wealth: A Cervical Health Program is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Health is Wealth: A Cervical Health Program
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for female patients aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Self-identify as Black woman (African American or Sub-Saharan African Immigrant)
No pap smear within the last three years or no pap smear/HPV co-test within past five years
Able to speak and write in English
Reside in Kentucky
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 6 months (Baseline, immediately post-test, 6 month follow up)
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months (Baseline, immediately post-test, 6 month follow up)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 6 months (Baseline, immediately post-test, 6 month follow up).
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Health is Wealth: A Cervical Health Program will improve 5 primary outcomes and 3 secondary outcomes in patients with Uterine Cervical Neoplasms. Measurement will happen over the course of Baseline.

Completion of HPV self-sampling
BASELINE
HPV self-sampling kit return
BASELINE
Change in seriousness
6 MONTHS (BASELINE, IMMEDIATELY POST-TEST, 6 MONTH FOLLOW UP)
Seriousness will be assessed with 7 items measured on a five-point Likert-like scale response choices: strongly disagree (scores 1 point), disagree (scores 2 point), neutral (scores 3 point), agree (scores 4 point) and strongly agree (scores 5 points), with higher scores indicating stronger feelings toward the construct.
6 MONTHS (BASELINE, IMMEDIATELY POST-TEST, 6 MONTH FOLLOW UP)
Change in susceptibility
6 MONTHS (BASELINE, IMMEDIATELY POST-TEST, 6 MONTH FOLLOW UP)
Susceptibility will be assessed with 4 items measured on a five-point Likert-like scale response choices: strongly disagree (scores 1 point), disagree (scores 2 point), neutral (scores 3 point), agree (scores 4 point) and strongly agree (scores 5 points), with higher scores indicating stronger feelings toward the construct
6 MONTHS (BASELINE, IMMEDIATELY POST-TEST, 6 MONTH FOLLOW UP)
Change in benefits
6 MONTHS (BASELINE, IMMEDIATELY POST-TEST, 6 MONTH FOLLOW UP)
Benefits will be assessed with 4 items measured on a five-point Likert-like scale response choices: strongly disagree (scores 1 point), disagree (scores 2 point), neutral (scores 3 point), agree (scores 4 point) and strongly agree (scores 5 points), with higher scores indicating stronger feelings toward the construct
6 MONTHS (BASELINE, IMMEDIATELY POST-TEST, 6 MONTH FOLLOW UP)
Change in perceived barriers to screening
6 MONTHS (BASELINE, IMMEDIATELY POST-TEST, 6 MONTH FOLLOW UP)
Barriers will be assessed with 14 items measured on a five-point Likert-like scale response choices: strongly disagree (scores 1 point), disagree (scores 2point), neutral (scores 3 point), agree (scores 4 point) and strongly agree (scores 5 points), with higher scores indicating stronger feelings toward the construct
6 MONTHS (BASELINE, IMMEDIATELY POST-TEST, 6 MONTH FOLLOW UP)
Change in Self-efficacy
6 MONTHS (BASELINE, IMMEDIATELY POST-TEST, 6 MONTH FOLLOW UP)
Self-efficacy will be assessed with 10 items measured on a five-point Likert-like scale response choices: strongly disagree (scores 1 point), disagree (scores 2point), neutral (scores 3 point), agree (scores 4 point) and strongly agree (scores 5 points), with higher scores indicating stronger feelings toward the construct. This is a well validated and reliable instrument.
6 MONTHS (BASELINE, IMMEDIATELY POST-TEST, 6 MONTH FOLLOW UP)
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the latest research for uterine cervical neoplasms?

There have been many advancements in the prevention, diagnosis, and management of uterine cervical neoplasms. Larger studies are needed to determine whether surgery alone is an acceptable alternative strategy in localized disease.

Anonymous Patient Answer

How does health is wealth: a cervical health program work?

In this pilot study we demonstrated that women enrolled into the cervical health program had significant improvements in their health status compared to the control group, and the scores on many of the scales were higher than those reported in the literature. Further research is needed to confirm our findings before implementing an intervention targeting low socio-economic groups in our setting.

Anonymous Patient Answer

What is the average age someone gets uterine cervical neoplasms?

Results from a recent clinical trial shows that women who have a biopsy of an endometrial lesion at an earlier age (40-49 years old) are more likely to have a high-grade endometrial carcinoma than women who were older (50-59 years old). A pilot study showed that these histologic criteria could be used to identify patients who might benefit from adjuvant therapy.

Anonymous Patient Answer

Is health is wealth: a cervical health program safe for people?

The cost of cervical screening programs should not be driven by economic considerations alone; instead, equity and social justice needs must be considered. The negative socio-economic consequences of cervical screening programs would need to be balanced against the positive benefits of screened participants being able to receive both early and regular care when needed (without waiting until they were sick enough to require treatment); and, if they are treated appropriately, have better outcomes.

Anonymous Patient Answer

What is the primary cause of uterine cervical neoplasms?

Results from a recent paper of this study have shown no significant difference in the prevalence of a number of risk factors (age, nulliparity, BMI, smoking, alcohol, and sexual activity) between patients with and without pathology, and therefore, we conclude that uterine cervical neoplasm is not caused primarily by environmental factors.

Anonymous Patient Answer

What are the signs of uterine cervical neoplasms?

A pelvic examination and endometrial biopsy should be performed in every woman with abnormal vaginal bleeding, regardless of age. In women without abnormal vaginal bleeding, examination of the cervix is recommended after completion of menopause.

Anonymous Patient Answer

How quickly does uterine cervical neoplasms spread?

Patients with uterine cervical neoplasms are at increased risk for distant metastases after initial diagnosis. Unlike other cancers where large-volume disease is associated with more distant metastases, in patients with uterine cervical neoplasms small-volume disease seems to be associated with an increased likelihood of systemic spread.

Anonymous Patient Answer

How serious can uterine cervical neoplasms be?

The 5-year survival rate for women diagnosed with stage I-III uterine cervical carcinoma was 80% (95% confidence interval, 69 to 87%) and 92% (95% confidence interval, 84 to 97%) for women diagnosed with stage IIIA1 and IIIA1 primary tumors, respectively. On the basis of this study, it appears that stage I, grade 1 carcinomas are more likely than stage III, grade 2 carcinomas to develop into myometrial invasion at time of diagnosis, whereas grade 3 carcinomas may be more likely to be associated with parametrial involvement.

Anonymous Patient Answer

What is uterine cervical neoplasms?

The presence of endometrial polyps and adenomyosis in women with uterine cervical neoplasms increases the risk of developing dysplasia. Dysplastic lesions were found on the cervix in 28% of women with histologically proven cervical neoplasms. Women with adenomyosis showed an increased likelihood of dysplastic lesions (25%). Patients with endometrial polyps had a higher prevalence of dysplastic lesions than those without endometrial polyps (43% vs. 23%, p = 0.02). Patients with endometrial polyps tended to develop more severe dysplastic lesions than those with adenomyosis (67% vs. 56%, p = 0.51).

Anonymous Patient Answer

Does uterine cervical neoplasms run in families?

Based on the results of our study, we conclude that uterine cervical neoplasms are genetically heterogeneous. Further studies on large number of patients are needed to define the genetic background of uterine cervical neoplasms.

Anonymous Patient Answer

Does health is wealth: a cervical health program improve quality of life for those with uterine cervical neoplasms?

The HAHP was effective in improving HRQOL among women with UCA, particularly in terms of reduction in symptoms associated with cancer or treatment. Therefore, the HAHP should be considered an integral component of the multidisciplinary care of women with UCA.

Anonymous Patient Answer
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