NCT04753086Active, not recruitingNot Applicable
LCCC 2052: Patient Related Outcomes for Gynecologic Radiation Oncology (PRO-GRO)
UNC Lineberger Comprehensive Cancer Center1 site in 1 country100 target enrollmentStarted: June 1, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Rate of survey completion at acute timepoints
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts 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)
Arms & Interventions
Gynecologic Cancer Pts
Gynecologic cancer patients being treated with radiation at UNC.
Outcomes
Primary Outcomes
Rate of survey completion at acute timepoints
Time Frame: 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 Outcomes
- Time course of late symptoms for vulvar cancer patients(6 months post-treatment to 2 years post-treatment)
- Late, persistent, substantial, treatment-related symptoms (LAPERS)(6 months post-treatment to 2 years post-treatment)
- Incidence of acute symptoms for all patients(First week of radiation to 6 weeks after completing radiation)
- Prevalence of acute symptoms for all patients(First week of radiation to 6 weeks after completing radiation)
- Rate of survey completion at late timepoints(6 months post-treatment to 2 years post-treatment)
- Time course of acute symptoms for all patients(First week of radiation to 6 weeks after completing radiation)
- Incidence of late symptoms for all patients(6 months post-treatment to 2 years post-treatment)
- Time course of late symptoms for all patients(6 months post-treatment to 2 years post-treatment)
- Prevalence of late symptoms for all patients(6 months post-treatment to 2 years post-treatment)
- Incidence of acute symptoms for cervical cancer patients(First week of radiation to 6 weeks after completing radiation)
- Prevalence of late symptoms for cervical cancer patients(6 months post-treatment to 2 years post-treatment)
- Time course of acute symptoms for endometrial cancer patients(First week of radiation to 6 weeks after completing radiation)
- Incidence of late symptoms for endometrial cancer patients(6 months post-treatment to 2 years post-treatment)
- Prevalence of late symptoms for endometrial cancer patients(6 months post-treatment to 2 years post-treatment)
- Time course of late symptoms for endometrial cancer patients(6 months post-treatment to 2 years post-treatment)
- Prevalence of acute symptoms for vulvar cancer patients(First week of radiation to 6 weeks after completing radiation)
- Incidence of late symptoms for vulvar cancer patients(6 months post-treatment to 2 years post-treatment)
- Prevalence of acute symptoms for cervical cancer patients(First week of radiation to 6 weeks after completing radiation)
- Time course of acute symptoms for cervical cancer patients(First week of radiation to 6 weeks after completing radiation)
- Incidence of acute symptoms for endometrial cancer patients(First week of radiation to 6 weeks after completing radiation)
- Incidence of late symptoms for cervical cancer patients(6 months post-treatment to 2 years post-treatment)
- Time course of late symptoms for cervical cancer patients(6 months post-treatment to 2 years post-treatment)
- Prevalence of acute symptoms for endometrial cancer patients(First week of radiation to 6 weeks after completing radiation)
- Incidence of acute symptoms for vulvar cancer patients(First week of radiation to 6 weeks after completing radiation)
- Time course of acute symptoms for vulvar cancer patients(First week of radiation to 6 weeks after completing radiation)
- Prevalence of late symptoms for vulvar cancer patients(6 months post-treatment to 2 years post-treatment)
Investigators
Study Sites (1)
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