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

NCT ID: NCT05093712

Last Updated: 2022-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-28

Study Completion Date

2022-03-23

Brief Summary

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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

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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.

Conditions

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Stage IB Cervical Cancer FIGO 2018 Stage IB1 Cervical Cancer FIGO 2018 Stage IB2 Cervical Cancer FIGO 2018 Stage IB3 Cervical Cancer FIGO 2018 Stage II Cervical Cancer FIGO 2018 Stage IIA Cervical Cancer FIGO 2018 Stage IIA1 Cervical Cancer FIGO 2018 Stage IIA2 Cervical Cancer FIGO 2018 Stage IIB Cervical Cancer FIGO 2018 Stage III Cervical Cancer FIGO 2018 Stage IIIA Cervical Cancer FIGO 2018 Stage IIIB Cervical Cancer FIGO 2018 Stage IIIC Cervical Cancer FIGO 2018 Stage IIIC1 Cervical Cancer FIGO 2018 Stage IIIC2 Cervical Cancer FIGO 2018 Stage IVA Cervical Cancer FIGO 2018

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Survey Administration

Intervention Type OTHER

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.

Educational Intervention

Intervention Type OTHER

Watch educational video

Survey Administration

Intervention Type OTHER

Complete surveys

Interventions

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Educational Intervention

Watch educational video

Intervention Type OTHER

Survey Administration

Complete surveys

Intervention Type OTHER

Other Intervention Names

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Education for Intervention Intervention by Education Intervention through Education Intervention, Educational

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ann H Klopp

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Related Links

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http://www.mdanderson.org

MD Anderson Cancer Center

Other Identifiers

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NCI-2021-10696

Identifier Type: REGISTRY

Identifier Source: secondary_id

2020-1269

Identifier Type: OTHER

Identifier Source: secondary_id

2020-1269

Identifier Type: -

Identifier Source: org_study_id

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