Patient Related Outcomes for Gynecologic Radiation Oncology

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Gynecologic Cancer

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gynecologic Cancer Pts<br>Gynecologic cancer patients being treated with radiation at UNC. | |

What is the study measuring?
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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 |