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Patient-Informed Educational Intervention for the Improvement of Cervical Cancer Literacy

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT05093712
Collaborator
(none)
0
Enrollment
8.8
Actual Duration (Months)

Study Details

Study Description

Brief Summary

This study investigates the health literacy, cervical cancer knowledge, and radiation knowledge of patients with cervical cancer. The goal of this study is to develop a video that can improve patients 'understanding of cervical cancer and its treatment.

Condition or Disease Intervention/Treatment Phase
  • Other: Educational Intervention
  • Other: Survey Administration

Detailed Description

PRIMARY OBJECTIVES:
  1. To assess the baseline health literacy, cervical cancer knowledge and radiation knowledge in a diverse sample of patients from two hospitals in Houston, Texas. (Phase 1) II. To test improvement in comprehension of cervical cancer and radiation terminology in a diverse sample of cervical cancer patients after viewing the video-based educational tool developed in this study. (Phase 2)
SECONDARY OBJECTIVES:

  1. To assess barriers to care and assess baseline radiation adherence, defined as missing no treatments and time to radiation completion, in a diverse sample of patients from two hospitals in Houston, Texas.

  2. To describe the impact of the video on radiation treatment adherence in terms of radiation completion, defined as missing no treatments) and time to radiation completion.

  3. To describe the relationships between time to radiation completion, health literacy, sociodemographics, reported barriers to care, and baseline cervical cancer knowledge and misconceptions.

OUTLINE:

PHASE I: Patients complete surveys over 10 minutes on their background, health literacy level, barriers to cancer care, and knowledge of cervical cancer and its treatment.

PHASE II: Patients watch educational video on cervical cancer. Patients also complete surveys over 5-10 minutes at baseline and after watching educational video.

Study Design

Study Type:
Observational
Actual Enrollment :
0 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Patient-Informed Educational Intervention to Improve Cervical Cancer Literacy
Actual Study Start Date :
Jun 28, 2021
Actual Primary Completion Date :
Mar 23, 2022
Actual Study Completion Date :
Mar 23, 2022

Arms and Interventions

Arm Intervention/Treatment
Phase I (survey)

Patients complete surveys over 10 minutes on their background, health literacy level, barriers to cancer care, and knowledge of cervical cancer and its treatment.

Other: Survey Administration
Complete surveys
Phase II (survey, educational video)

Patients watch educational video on cervical cancer. Patients also complete surveys over 5-10 minutes at baseline and after watching educational video.

Other: Educational Intervention
Watch educational video
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

    • Other: Survey Administration
    Complete surveys

    Outcome Measures

    Primary Outcome Measures

    1. Health literacy (Phase I) [Baseline]

      The proportion of patients answering a particular knowledge item correctly will be calculated along with 95% score confidence intervals. As part of a secondary set of analyses, the percent of knowledge items answered correctly will be tabulated for each participant. Descriptive statistics and 95% confidence intervals will be calculated for percent of items answered correctly, both by site and combining data from both sites.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Biopsy proven carcinoma of the cervix

    • Federation of Gynecology and Obstetrics (FIGO) stage IB-IVA

    • N0 and N1 nodal status according to TNM staging

    • Planned for definitive chemoradiation with curative intent

    • Able to speak and read English or Spanish

    • Age 18 or older

    • Able to give informed consent

    Exclusion Criteria:
    • Physicians or nurses

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center

    Investigators

    • Principal Investigator: Ann H Klopp, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT05093712
    Other Study ID Numbers:
    • 2020-1269
    • NCI-2021-10696
    • 2020-1269
    First Posted:
    Oct 26, 2021
    Last Update Posted:
    Apr 5, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Uterine Cervical Neoplasms

    Study Results

    No Results Posted as of Apr 5, 2022