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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05093712
Other study ID # 2020-1269
Secondary ID NCI-2021-1069620
Status Withdrawn
Phase
First received
Last updated
Start date June 28, 2021
Est. completion date March 23, 2022

Study information

Verified date March 2022
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 23, 2022
Est. primary completion date March 23, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms

  • Stage IB 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
  • Uterine Cervical Neoplasms

Intervention

Other:
Educational Intervention
Watch educational video
Survey Administration
Complete surveys

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04580771 - A Vaccine (PDS0101) and Chemoradiation for the Treatment of Stage IB3-IVA Cervical Cancer, the IMMUNOCERV Trial Phase 2
Recruiting NCT04574635 - Human Papilloma Virus (HPV) Circulating Tumor DNA (ctDNA) in Cervical Cancer
Active, not recruiting NCT04622670 - Yoga Therapy During Chemotherapy and Radiation Treatment for the Improvement of Physical and Emotional Well-Being in Patients With Stage IB2-IIIB Cervical Cancer N/A
Recruiting NCT05722288 - Time-Restricted Eating Versus Nutritional Counseling for the Reduction of Radiation or Chemoradiation Tx Side Effects in Patients With Prostate, Cervical, or Rectal Cancers Phase 2

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