Patient Related Outcomes for Gynecologic Radiation Oncology (PRO-GRO)

May 1, 2026 updated by: UNC Lineberger Comprehensive Cancer Center

LCCC 2052: Patient Related Outcomes for Gynecologic Radiation Oncology (PRO-GRO)

The goal of this study is to see if it is feasible to use electronic questionnaires to measure patient related outcomes before, during, and after radiation for gynecologic cancer in a high-volume radiation oncology clinic.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Other studies have found benefits from using patient related outcome measurements (PROM) in clinical settings, and a paper PROM is part of standard of care treatment for prostate cancer patients at the University of North Carolina clinic. However, PROM are not routinely collected for gynecological cancer patients at UNC, and fewer studies have specifically focused on PROM for gynecological cancer patients receiving radiation. The primary objective of this study is to determine the feasibility of PRO monitoring of gynecologic symptoms before, during (at weekly intervals), and after radiation (external beam radiotherapy and brachytherapy) for gynecologic cancer patients at a high volume center.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill, Department of Radiation Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with gynecologic cancer receiving radiation treatment at the University of North Carolina

Description

Inclusion Criteria:

  • 18 years or older
  • English speaking
  • Informed consent reviewed and signed
  • Gynecologic cancer being treated by radiation at UNC
  • Able and willing to complete web-based symptom survey

Exclusion Criteria:

  • Inability to read and speak English
  • Current incarceration
  • Pregnancy
  • Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rending of informed consent (with the caveat that if they initially are hospitalized with delirium which is subsequently resolved, they can then be consented for participation at a later time)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Gynecologic Cancer Pts
Gynecologic cancer patients being treated with radiation at UNC.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of survey completion at acute timepoints
Time Frame: First week of radiation to 6 weeks after completing radiation
Percentage of patients who complete at least 75% of the questionnaires given after the baseline and up to and including the 6-week post-treatment survey
First week of radiation to 6 weeks after completing radiation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of survey completion at late timepoints
Time Frame: 6 months post-treatment to 2 years post-treatment
Percentage of patients who complete at least 75% of the questionnaires given after and including the 6-month post-treatment survey and up to and including the 2-year post-treatment survey
6 months post-treatment to 2 years post-treatment
Late, persistent, substantial, treatment-related symptoms (LAPERS)
Time Frame: 6 months post-treatment to 2 years post-treatment
LAPERS will only be calculated for patients who have baseline symptoms (actual baseline or 3 months post-treatment, whichever is lower), one early follow up assessment (1, 2, or 6 week post-treatment), and at least 3 late follow ups (6 months post-treatment or later). If a patient's symptom worsened to "quite a bit" or "very much" in at least half of the late follow-ups, this will be considered LAPERS. Thus LAPERS is a binary score that will be assessed for each symptom in each patient.
6 months post-treatment to 2 years post-treatment
Incidence of acute symptoms for all patients
Time Frame: First week of radiation to 6 weeks after completing radiation
We will calculate incidence of each symptom, for all patients. Incidence is defined as the number of patients who have a symptom in any follow up.
First week of radiation to 6 weeks after completing radiation
Prevalence of acute symptoms for all patients
Time Frame: First week of radiation to 6 weeks after completing radiation
We will calculate prevalence of each symptom, for all patients. Prevalence is the number of patients with a given symptom at a set time point.
First week of radiation to 6 weeks after completing radiation
Time course of acute symptoms for all patients
Time Frame: First week of radiation to 6 weeks after completing radiation
We will evaluate the time course by creating a graphical representation of each symptom severity at each time point.
First week of radiation to 6 weeks after completing radiation
Incidence of late symptoms for all patients
Time Frame: 6 months post-treatment to 2 years post-treatment
We will calculate incidence of each symptom, for all patients. Incidence is defined as the number of patients who have a symptom in any follow up.
6 months post-treatment to 2 years post-treatment
Prevalence of late symptoms for all patients
Time Frame: 6 months post-treatment to 2 years post-treatment
We will calculate prevalence of each symptom, for all patients. Prevalence is the number of patients with a given symptom at a set time point.
6 months post-treatment to 2 years post-treatment
Time course of late symptoms for all patients
Time Frame: 6 months post-treatment to 2 years post-treatment
We will evaluate the time course by creating a graphical representation of each symptom severity at each time point.
6 months post-treatment to 2 years post-treatment
Incidence of acute symptoms for cervical cancer patients
Time Frame: First week of radiation to 6 weeks after completing radiation
We will calculate incidence of each symptom for cervical cancer patients. Incidence is defined as the number of patients who have a symptom in any follow up.
First week of radiation to 6 weeks after completing radiation
Prevalence of acute symptoms for cervical cancer patients
Time Frame: First week of radiation to 6 weeks after completing radiation
We will calculate prevalence of each symptom for cervical cancer patients. Prevalence is the number of patients with a given symptom at a set time point.
First week of radiation to 6 weeks after completing radiation
Time course of acute symptoms for cervical cancer patients
Time Frame: First week of radiation to 6 weeks after completing radiation
We will evaluate the time course by creating a graphical representation of each symptom severity at each time point.
First week of radiation to 6 weeks after completing radiation
Incidence of late symptoms for cervical cancer patients
Time Frame: 6 months post-treatment to 2 years post-treatment
We will calculate incidence of each symptom for cervical cancer patients. Incidence is defined as the number of patients who have a symptom in any follow up.
6 months post-treatment to 2 years post-treatment
Prevalence of late symptoms for cervical cancer patients
Time Frame: 6 months post-treatment to 2 years post-treatment
We will calculate prevalence of each symptom for cervical cancer patients. Prevalence is the number of patients with a given symptom at a set time point.
6 months post-treatment to 2 years post-treatment
Time course of late symptoms for cervical cancer patients
Time Frame: 6 months post-treatment to 2 years post-treatment
We will evaluate the time course by creating a graphical representation of each symptom severity at each time point.
6 months post-treatment to 2 years post-treatment
Incidence of acute symptoms for endometrial cancer patients
Time Frame: First week of radiation to 6 weeks after completing radiation
We will calculate incidence of each symptom for endometrial cancer patients. Incidence is defined as the number of patients who have a symptom in any follow up.
First week of radiation to 6 weeks after completing radiation
Prevalence of acute symptoms for endometrial cancer patients
Time Frame: First week of radiation to 6 weeks after completing radiation
We will calculate prevalence of each symptom for endometrial cancer patients. Prevalence is the number of patients with a given symptom at a set time point.
First week of radiation to 6 weeks after completing radiation
Time course of acute symptoms for endometrial cancer patients
Time Frame: First week of radiation to 6 weeks after completing radiation
We will evaluate the time course by creating a graphical representation of each symptom severity at each time point.
First week of radiation to 6 weeks after completing radiation
Incidence of late symptoms for endometrial cancer patients
Time Frame: 6 months post-treatment to 2 years post-treatment
We will calculate incidence of each symptom for endometrial cancer patients. Incidence is defined as the number of patients who have a symptom in any follow up.
6 months post-treatment to 2 years post-treatment
Prevalence of late symptoms for endometrial cancer patients
Time Frame: 6 months post-treatment to 2 years post-treatment
We will calculate prevalence of each symptom for endometrial cancer patients. Prevalence is the number of patients with a given symptom at a set time point.
6 months post-treatment to 2 years post-treatment
Time course of late symptoms for endometrial cancer patients
Time Frame: 6 months post-treatment to 2 years post-treatment
We will evaluate the time course by creating a graphical representation of each symptom severity at each time point.
6 months post-treatment to 2 years post-treatment
Incidence of acute symptoms for vulvar cancer patients
Time Frame: First week of radiation to 6 weeks after completing radiation
We will calculate incidence of each symptom for vulvar cancer patients. Incidence is defined as the number of patients who have a symptom in any follow up.
First week of radiation to 6 weeks after completing radiation
Prevalence of acute symptoms for vulvar cancer patients
Time Frame: First week of radiation to 6 weeks after completing radiation
We will calculate prevalence of each symptom for vulvar cancer patients. Prevalence is the number of patients with a given symptom at a set time point.
First week of radiation to 6 weeks after completing radiation
Time course of acute symptoms for vulvar cancer patients
Time Frame: First week of radiation to 6 weeks after completing radiation
We will evaluate the time course by creating a graphical representation of each symptom severity at each time point.
First week of radiation to 6 weeks after completing radiation
Incidence of late symptoms for vulvar cancer patients
Time Frame: 6 months post-treatment to 2 years post-treatment
We will calculate incidence of each symptom for vulvar cancer patients. Incidence is defined as the number of patients who have a symptom in any follow up.
6 months post-treatment to 2 years post-treatment
Prevalence of late symptoms for vulvar cancer patients
Time Frame: 6 months post-treatment to 2 years post-treatment
We will calculate prevalence of each symptom for vulvar cancer patients. Prevalence is the number of patients with a given symptom at a set time point.
6 months post-treatment to 2 years post-treatment
Time course of late symptoms for vulvar cancer patients
Time Frame: 6 months post-treatment to 2 years post-treatment
We will evaluate the time course by creating a graphical representation of each symptom severity at each time point.
6 months post-treatment to 2 years post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
UNC Lineberger Comprehensive Cancer Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ashley Weiner, M.D., Ph.D., UNC Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 15, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 15, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LCCC 2052

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings