Patient-Informed Educational Intervention for the Improve... | NCT05093712

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

NCT05093712

Sponsor

M.D. Anderson Cancer Center

Status

Withdrawn

Last Update Posted

Apr 5, 2022Actual

Enrollment

0Actual

Phase

Not provided

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

Interventions

Educational Intervention
Survey Administration

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
NCI-2021-10696	Registry Identifier	CTRP (Clinical Trial Reporting Program)
2020-1269	Other Identifier	M D Anderson Cancer Center

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to the limited resources and staffing needed in order to run the trial.

Expanded Access Info

Start Date

Jun 28, 2021Actual

Primary Completion Date

Mar 23, 2022Actual

Completion Date

Mar 23, 2022Actual

First Submitted Date

Oct 13, 2021

First Submission Date that Met QC Criteria

Oct 13, 2021

First Posted Date

Oct 26, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2022

Last Update Posted Date

Apr 5, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Conditions Module

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

Keywords

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Educational Intervention	Other	Watch educational video	Phase II (survey, educational video)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

ID	Term
D018479	Early Intervention, Educational
D004522	Educational Status
D008722	Methods

ID	Term
D002662	Child Health Services
D003153	Community Health Services
D006296	Health Services
D005159	Health Care Facilities Workforce and Services
D011314	Preventive Health Services
D012959	Socioeconomic Factors
D011154	Population Characteristics
D008919	Investigative Techniques