Clinical trial NCT04753086: Patient Related Outcomes for Gynecologic Radiation Oncology
Official title: LCCC 2052: Patient Related Outcomes for Gynecologic Radiation Oncology (PRO-GRO)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gynecologic Cancer
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with gynecologic cancer receiving radiation treatment at the University of North Carolina

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Rate of survey completion at acute timepoints
timeFrame: First week of radiation to 6 weeks after completing radiation
Secondary outcomes:
measure: Rate of survey completion at late timepoints
timeFrame: 6 months post-treatment to 2 years post-treatment
measure: Late, persistent, substantial, treatment-related symptoms (LAPERS)
timeFrame: 6 months post-treatment to 2 years post-treatment
measure: Incidence of acute symptoms for all patients
timeFrame: First week of radiation to 6 weeks after completing radiation
measure: Prevalence of acute symptoms for all patients
timeFrame: First week of radiation to 6 weeks after completing radiation
measure: Time course of acute symptoms for all patients
timeFrame: First week of radiation to 6 weeks after completing radiation
measure: Incidence of late symptoms for all patients
timeFrame: 6 months post-treatment to 2 years post-treatment
measure: Prevalence of late symptoms for all patients
timeFrame: 6 months post-treatment to 2 years post-treatment
measure: Time course of late symptoms for all patients
timeFrame: 6 months post-treatment to 2 years post-treatment
measure: Incidence of acute symptoms for cervical cancer patients
timeFrame: First week of radiation to 6 weeks after completing radiation
measure: Prevalence of acute symptoms for cervical cancer patients
timeFrame: First week of radiation to 6 weeks after completing radiation
measure: Time course of acute symptoms for cervical cancer patients
timeFrame: First week of radiation to 6 weeks after completing radiation
measure: Incidence of late symptoms for cervical cancer patients
timeFrame: 6 months post-treatment to 2 years post-treatment
measure: Prevalence of late symptoms for cervical cancer patients
timeFrame: 6 months post-treatment to 2 years post-treatment
measure: Time course of late symptoms for cervical cancer patients
timeFrame: 6 months post-treatment to 2 years post-treatment
measure: Incidence of acute symptoms for endometrial cancer patients
timeFrame: First week of radiation to 6 weeks after completing radiation
measure: Prevalence of acute symptoms for endometrial cancer patients
timeFrame: First week of radiation to 6 weeks after completing radiation
measure: Time course of acute symptoms for endometrial cancer patients
timeFrame: First week of radiation to 6 weeks after completing radiation
measure: Incidence of late symptoms for endometrial cancer patients
timeFrame: 6 months post-treatment to 2 years post-treatment
measure: Prevalence of late symptoms for endometrial cancer patients
timeFrame: 6 months post-treatment to 2 years post-treatment
measure: Time course of late symptoms for endometrial cancer patients
timeFrame: 6 months post-treatment to 2 years post-treatment
measure: Incidence of acute symptoms for vulvar cancer patients
timeFrame: First week of radiation to 6 weeks after completing radiation
measure: Prevalence of acute symptoms for vulvar cancer patients
timeFrame: First week of radiation to 6 weeks after completing radiation
measure: Time course of acute symptoms for vulvar cancer patients
timeFrame: First week of radiation to 6 weeks after completing radiation
measure: Incidence of late symptoms for vulvar cancer patients
timeFrame: 6 months post-treatment to 2 years post-treatment
measure: Prevalence of late symptoms for vulvar cancer patients
timeFrame: 6 months post-treatment to 2 years post-treatment
measure: Time course of late symptoms for vulvar cancer patients
timeFrame: 6 months post-treatment to 2 years post-treatment
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill, Department of Radiation Oncology
state: North Carolina
Study officials:
affiliation: UNC Chapel Hill
name: Ashley Weiner, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: