Gynecologic Cancer
Conditions
Brief 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.
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.
Interventions
None listed
Sponsors
UNC Lineberger Comprehensive Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of survey completion at acute timepoints | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of survey completion at late timepoints | 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 |
| Late, persistent, substantial, treatment-related symptoms (LAPERS) | 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. |
| Incidence of acute symptoms for all patients | 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. |
| Prevalence of acute symptoms for all patients | 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. |
| Time course of acute symptoms for all patients | 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. |
| Incidence of late symptoms for all patients | 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. |
| Prevalence of late symptoms for all patients | 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. |
| Time course of late symptoms for all patients | 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. |
| Incidence of acute symptoms for cervical cancer patients | 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. |
| Prevalence of acute symptoms for cervical cancer patients | 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. |
| Time course of acute symptoms for cervical cancer patients | 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. |
| Incidence of late symptoms for cervical cancer patients | 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. |
| Prevalence of late symptoms for cervical cancer patients | 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. |
| Time course of late symptoms for cervical cancer patients | 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. |
| Incidence of acute symptoms for endometrial cancer patients | 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. |
| Prevalence of acute symptoms for endometrial cancer patients | 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. |
| Time course of acute symptoms for endometrial cancer patients | 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. |
| Incidence of late symptoms for endometrial cancer patients | 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. |
| Prevalence of late symptoms for endometrial cancer patients | 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. |
| Time course of late symptoms for endometrial cancer patients | 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. |
| Incidence of acute symptoms for vulvar cancer patients | 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. |
| Prevalence of acute symptoms for vulvar cancer patients | 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. |
| Time course of acute symptoms for vulvar cancer patients | 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. |
| Incidence of late symptoms for vulvar cancer patients | 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. |
| Prevalence of late symptoms for vulvar cancer patients | 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. |
| Time course of late symptoms for vulvar cancer patients | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAshley Weiner, M.D., Ph.D.
UNC Chapel Hill
Outcome results
None listed