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Active, Not Recruiting

NCT Number: NCT04753086

Patient Related Outcomes for Gynecologic Radiation Oncology

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Gynecologic Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

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

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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

  1. Rate of survey completion at late timepoints

    Time frame: 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

  2. Late, persistent, substantial, treatment-related symptoms (LAPERS)

    Time frame: 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.

  3. Incidence of acute symptoms for all patients

    Time frame: 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.

  4. Prevalence of acute symptoms for all patients

    Time frame: 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.

  5. Time course of acute symptoms for all patients

    Time frame: 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.

  6. Incidence of late symptoms for all patients

    Time frame: 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.

  7. Prevalence of late symptoms for all patients

    Time frame: 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.

  8. Time course of late symptoms for all patients

    Time frame: 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.

  9. Incidence of acute symptoms for cervical cancer patients

    Time frame: 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.

  10. Prevalence of acute symptoms for cervical cancer patients

    Time frame: 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.

  11. Time course of acute symptoms for cervical cancer patients

    Time frame: 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.

  12. Incidence of late symptoms for cervical cancer patients

    Time frame: 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.

  13. Prevalence of late symptoms for cervical cancer patients

    Time frame: 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.

  14. Time course of late symptoms for cervical cancer patients

    Time frame: 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.

  15. Incidence of acute symptoms for endometrial cancer patients

    Time frame: 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.

  16. Prevalence of acute symptoms for endometrial cancer patients

    Time frame: 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.

  17. Time course of acute symptoms for endometrial cancer patients

    Time frame: 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.

  18. Incidence of late symptoms for endometrial cancer patients

    Time frame: 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.

  19. Prevalence of late symptoms for endometrial cancer patients

    Time frame: 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.

  20. Time course of late symptoms for endometrial cancer patients

    Time frame: 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.

  21. Incidence of acute symptoms for vulvar cancer patients

    Time frame: 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.

  22. Prevalence of acute symptoms for vulvar cancer patients

    Time frame: 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.

  23. Time course of acute symptoms for vulvar cancer patients

    Time frame: 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.

  24. Incidence of late symptoms for vulvar cancer patients

    Time frame: 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.

  25. Prevalence of late symptoms for vulvar cancer patients

    Time frame: 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.

  26. Time course of late symptoms for vulvar cancer patients

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Registry information

Official study title

LCCC 2052: Patient Related Outcomes for Gynecologic Radiation Oncology (PRO-GRO)

Acronym: PRO-GRO

Important dates

Study start
2022
Primary completion
2026
Study completion
2028
First posted
Feb 15, 2021
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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