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

Withdrawn

• Conditions: Stage IIA Cervical Cancer FIGO 2018; Stage IIA1 Cervical Cancer FIGO 2018; Stage IB1 Cervical Cancer FIGO 2018; Stage II Cervical Cancer FIGO 2018; Stage III Cervical Cancer FIGO 2018; Stage IIIC2 Cervical Cancer FIGO 2018; Stage IB Cervical Cancer FIGO 2018; Stage IB2 Cervical Cancer FIGO 2018; Stage IB3 Cervical Cancer FIGO 2018; Stage IIB Cervical Cancer FIGO 2018
• Interventions: Other: Educational Intervention; Other: Survey Administration

• Registration Number: NCT05093712
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2021-06-28
• Study First Submitted: 2021-10-13
• Study First Submitted QC: 2021-10-13
• Study First Posted: 2021-10-26
• Status Verified: 2022-03
• Primary Completion: 2022-03-23
• Study Completion: 2022-03-23
• Last Update Submitted: 2022-03-25
• Last Update Posted: 2022-04-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

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Exclusion Criteria

• Physicians or nurses

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Phase II (survey, educational video)	Survey Administration	Patients watch educational video on cervical cancer. Patients also complete surveys over 5-10 minutes at baseline and after watching educational video.
Phase I (survey)	Survey Administration	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 (survey, educational video)	Educational Intervention	Patients watch educational video on cervical cancer. Patients also complete surveys over 5-10 minutes at baseline and after watching educational video.

Primary Outcome Measures

Name	Time	Method
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.