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

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: Active, not recruiting
• Conditions: Gynecologic Cancer

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: Observational
• Enrollment (Actual): 100

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Gynecologic Cancer Pts; Gynecologic cancer patients being treated with radiation at UNC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of survey completion at acute timepoints	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

Outcome Measure	Measure Description	Time Frame
Rate of survey completion at late timepoints	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)	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Investigators: Principal Investigator: Ashley Weiner, M.D., Ph.D., UNC Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): April 1, 2026
• Study Completion (Estimated): February 15, 2028

Study Registration Dates

• First Submitted: February 3, 2021
• First Submitted That Met QC Criteria: February 10, 2021
• First Posted (Actual): February 15, 2021

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID 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