Patient Related Outcomes for Gynecologic Radiation Oncology

NCT04753086 | Active Not Recruiting DMC

• 1 other identifier: LCCC 2052
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (26)

• Rate of survey completion at late timepoints

  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

• Time course of acute symptoms for all patients

  First week of radiation to 6 weeks after completing radiation

Study Arms (1)

Gynecologic Cancer Pts

Gynecologic cancer patients being treated with radiation at UNC.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with gynecologic cancer receiving radiation treatment at the University of North Carolina

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

University of North Carolina at Chapel Hill, Department of Radiation Oncology

Chapel Hill, North Carolina, 27599, United States

Location

Study Officials

• Ashley Weiner, M.D., Ph.D.

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 15, 2021
• Study Start: June 1, 2022
• Primary Completion: April 1, 2026
• Study Completion (Estimated): February 15, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-05

Locations

US (1)