Clinical trial NCT05093712: Patient-Informed Educational Intervention for the Improvement of Cervical Cancer Literacy
Official title: Patient-Informed Educational Intervention to Improve Cervical Cancer Literacy
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
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
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-10-26
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: Health literacy (Phase I)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Ann H Klopp
role: PRINCIPAL_INVESTIGATOR
References: