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

NCT05093712 | Withdrawn

• 2 other identifiers: 2020-1269NCI-2021-10696
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Health literacy (Phase I)

  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.

  Baseline

Study Arms (2)

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

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; Other: Survey Administration

Interventions

Educational Intervention OTHER

Watch educational video

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Phase II (survey, educational video)

Survey Administration OTHER

Complete surveys

Phase I (survey); Phase II (survey, educational video)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women from MD Anderson Cancer Center and Harris Health System's Smith Clinic with biopsy proven carcinoma of the cervix

You may qualify if:

• 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

You may not qualify if:

• Physicians or nurses

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Related Links

• MD Anderson Cancer Center

MeSH Terms

Interventions

Early Intervention, Educational; Educational Status; Methods

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques

Study Officials

• Ann H Klopp

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: October 26, 2021
• Study Start: June 28, 2021
• Primary Completion: March 23, 2022
• Study Completion: March 23, 2022
• Last Updated: April 5, 2022

Record last verified: 2022-03