Patient Related Outcomes for Gynecologic Radiation Oncology

Gynecologic Cancer Clinical Trial

— PRO-GRO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04753086
• Other study ID #: LCCC 2052
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: September 27, 2026

Study information

• Verified date: January 2024
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: Victoria Xu
• Phone: 984-974-8744
• Email: victoria_xu[@]med.unc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 27, 2026
• Est. primary completion date: September 27, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Gynecologic Cancer

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill, Department of Radiation Oncology	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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