Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Patients complete surveys over 10 minutes on their background, health literacy level, barriers to cancer care, and knowledge of cervical cancer and its treatment.

Patients watch educational video on cervical cancer. Patients also complete surveys over 5-10 minutes at baseline and after watching educational video.

Educational Intervention

Survey Administration

Ann H Klopp

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.

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.

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

Patient-Informed Educational Intervention to Improve Cervical Cancer Literacy

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.

M.D. Anderson Cancer Center

Symptoms and General Pathology

Infections

Carcinoma

Carcinoma, Squamous Cell

Recurrence

Virus Diseases

Papilloma

Carcinoma, Adenosquamous

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

All Drugs and Chemicals

Immunomodulating Agents

Patients undergo collection of blood samples at baseline prior to surgery, at 6 weeks, 3, 6, and 12 months post-surgery, every 6 months during year 2, and at the time of recurrence (if applicable).

Patients undergo collection of blood samples at baseline prior to the first fraction of radiation, during week 4 of radiotherapy, at 6 weeks, 3, 6, and 12 months post-radiotherapy, every 6 months during year 2, and at the time of recurrence (if applicable).

Patients undergo collection of blood samples at baseline prior to the first fraction of radiation, during week 4 of radiotherapy, on the day of the final fraction of radiotherapy, at 3 months post-radiotherapy, every 3 months during years 1 and 2, and at the time of recurrence (if applicable).

Patients undergo collection of blood samples at baseline prior to initiation of chemotherapy or immunotherapy, at 4 weeks and 8 weeks after initiation of chemotherapy or immunotherapy, every 3 months during years 1 and 2, and at the time of recurrence (if applicable).

Biospecimen Collection

Clinical Trials Referral Office

Allison E. Garda, M.D.

This study collects blood samples to determine if the DNA of HPV that causes cervical cancer can be detected in patients with cervical cancer that is new (primary), has come back (recurrent), or has spread to other places in the body (metastatic) and are undergoing treatment with surgery, radiotherapy, chemotherapy, and/or immunotherapy. Researchers may use this information to predict response (good or bad) of the cervical cancer to treatment and detect recurrent cancer sooner.

PRIMARY OBJECTIVES:

I. To estimate the ctDNA detection rate in cervix cancer patients undergoing surgery, radiotherapy, chemotherapy, and/or immunotherapy in the setting of primary, recurrent or metastatic disease.

II. Association of ctDNA baseline levels and clearance kinetics with clinical and radiographic tumor response.

III. To explore the association of detectable ctDNA at each time point with invasive recurrence-free survival and overall survival.

IV. To explore the use of ctDNA for surveillance and detection of disease recurrence.

V. To create a repository for future exploratory studies including analyzing changes in T cell and other immune cell subpopulations during and following therapy for cervix cancer.

OUTLINE: Patients are assigned to 1 of 4 cohorts.

COHORT 1: Patients undergo collection of blood samples at baseline prior to surgery, at 6 weeks, 3, 6, and 12 months post-surgery, every 6 months during year 2, and at the time of recurrence (if applicable).

COHORT 2: Patients undergo collection of blood samples at baseline prior to the first fraction of radiation, during week 4 of radiotherapy, at 6 weeks, 3, 6, and 12 months post-radiotherapy, every 6 months during year 2, and at the time of recurrence (if applicable).

COHORT 3: Patients undergo collection of blood samples at baseline prior to the first fraction of radiation, during week 4 of radiotherapy, on the day of the final fraction of radiotherapy, at 3 months post-radiotherapy, every 3 months during years 1 and 2, and at the time of recurrence (if applicable).

COHORT 4: Patients undergo collection of blood samples at baseline prior to initiation of chemotherapy or immunotherapy, at 4 weeks and 8 weeks after initiation of chemotherapy or immunotherapy, every 3 months during years 1 and 2, and at the time of recurrence (if applicable).

Human Papilloma Virus (HPV) Circulating Tumor DNA (ctDNA) in Cervical Cancer

The proportion will be reported along with the exact 95% binomial confidence interval. Additionally will report the mean standard deviation and median interquartile range ctDNA post-treatment in these patients.

Will be associated with Federation of Gynecology and Obstetrics stage and assessed using linear regression, reporting the correlation as well as the model estimates.

Will be assessed for association with baseline and post-treatment ctDNA using logistic regression. Depending on the number of tumor response, or non-response patients whichever is fewer, multiple variable models may be considered including additional relevant baseline covariates such as disease stage.

Baseline ctDNA and ctDNA at measured time points will be considered in Cox models.

Baseline ctDNA and ctDNA at measured time points will be considered in Cox models. ctDNA other than at baseline will be considered in these models as a time dependent covariate. Depending on the number of events, multiple variable models may be considered including additional relevant baseline covariates such as disease stage.

Will be correlated with recurrence-free survival. ctDNA other than at baseline will be considered in these models as a time dependent covariate. Depending on the number of events, multiple variable models may be considered including additional relevant baseline covariates such as disease stage.

Will be correlated during the active monitoring phase with recurrence-free survival.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Patient-Informed Educational Intervention for the Improvement of Cervical Cancer Literacy	NCT05093712	Stage IB Cervic... Stage IB1 Cervi... Stage IB2 Cervi... Stage IB3 Cervi... Stage II Cervic... Stage IIA Cervi... Stage IIA1 Cerv... Stage IIA2 Cerv... Stage IIB Cervi... Stage III Cervi... Stage IIIA Cerv... Stage IIIB Cerv... Stage IIIC Cerv... Stage IIIC1 Cer... Stage IIIC2 Cer... Stage IVA Cervi...	Educational Int... Survey Administ...	18 Years -	M.D. Anderson Cancer Center
Human Papilloma Virus (HPV) Circulating Tumor DNA (ctDNA) in Cervical Cancer	NCT04574635	Cervical Adenos... Cervical Squamo... Infiltrating Ce... Metastatic Cerv... Recurrent Cervi... Stage I Cervica... Stage IA Cervic... Stage IA1 Cervi... Stage IA2 Cervi... Stage IB Cervic... Stage IB1 Cervi... Stage IB2 Cervi... Stage IB3 Cervi... Stage II Cervic... Stage IIA Cervi... Stage IIA1 Cerv... Stage IIA2 Cerv... Stage IIB Cervi... Stage III Cervi... Stage IIIA Cerv... Stage IIIB Cerv... Stage IIIC Cerv... Stage IIIC1 Cer... Stage IIIC2 Cer... Stage IV Cervic... Stage IVA Cervi... Stage IVB Cervi...	Biospecimen Col...	18 Years -	Mayo Clinic
Human Papilloma Virus (HPV) Circulating Tumor DNA (ctDNA) in Cervical Cancer	NCT04574635	Cervical Adenos... Cervical Squamo... Infiltrating Ce... Metastatic Cerv... Recurrent Cervi... Stage I Cervica... Stage IA Cervic... Stage IA1 Cervi... Stage IA2 Cervi... Stage IB Cervic... Stage IB1 Cervi... Stage IB2 Cervi... Stage IB3 Cervi... Stage II Cervic... Stage IIA Cervi... Stage IIA1 Cerv... Stage IIA2 Cerv... Stage IIB Cervi... Stage III Cervi... Stage IIIA Cerv... Stage IIIB Cerv... Stage IIIC Cerv... Stage IIIC1 Cer... Stage IIIC2 Cer... Stage IV Cervic... Stage IVA Cervi... Stage IVB Cervi...	Biospecimen Col...	18 Years -	Mayo Clinic

Spots Global Cancer Trial Database for stage iii cervical cancer figo 2018