Measuring patient outcomes for gynecologic cancer radiation treatment
LCCC 2052: Patient Related Outcomes for Gynecologic Radiation Oncology (PRO-GRO)
UNC Lineberger Comprehensive Cancer Center · NCT04753086
This study is trying to see if using electronic questionnaires can help track how women with gynecologic cancer feel during and after their radiation treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | UNC Lineberger Comprehensive Cancer Center (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT04753086 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the feasibility of using electronic questionnaires to monitor patient-related outcomes in individuals undergoing radiation therapy for gynecologic cancer. It will collect data on symptoms before, during, and after treatment at a high-volume radiation oncology clinic. The study builds on previous findings that highlight the benefits of patient-reported outcome measurements (PROM) in clinical settings, particularly for prostate cancer, and seeks to establish similar practices for gynecologic cancer patients. By implementing weekly assessments, the study will provide insights into the symptom management of patients receiving external beam radiotherapy and brachytherapy.
Who should consider this trial
Good fit: Ideal candidates include English-speaking adults aged 18 and older who are receiving radiation treatment for gynecologic cancer at UNC.
Not a fit: Patients who are unable to read or speak English, currently incarcerated, pregnant, or have cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the management of symptoms in gynecologic cancer patients undergoing radiation therapy.
How similar studies have performed: Other studies have shown success in using patient-reported outcomes in similar contexts, but this specific focus on gynecologic cancer is less explored.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Chapel Hill, North Carolina
- University of North Carolina at Chapel Hill, Department of Radiation Oncology — Chapel Hill, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Ashley Weiner, M.D., Ph.D. — UNC Chapel Hill
- Study coordinator: Victoria Xu
- Email: victoria_xu@med.unc.edu
- Phone: 984-974-8744
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gynecologic Cancer