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Clinical Trials/NCT05093712
NCT05093712
Withdrawn
Not Applicable

Patient-Informed Educational Intervention to Improve Cervical Cancer Literacy

M.D. Anderson Cancer Center0 sitesJune 28, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stage IB Cervical Cancer FIGO 2018
Sponsor
M.D. Anderson Cancer Center
Primary Endpoint
Health literacy (Phase I)
Status
Withdrawn
Last Updated
4 years ago

Overview

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.

Detailed Description

PRIMARY OBJECTIVES: I. 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: I. 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. II. 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. III. 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.

Registry
clinicaltrials.gov
Start Date
June 28, 2021
End Date
March 23, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Health literacy (Phase I)

Time Frame: 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.

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