Gynecologic CancerPRO-GRONCT04753086
Patient Related Outcomes for Gynecologic Radiation Oncology
An observational study of Gynecologic Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Cancer
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 15 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with gynecologic cancer receiving radiation treatment at the University of North Carolina
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill, Department of Radiation Oncology
Chapel Hill, North Carolina, 27599
About this study
Official title: LCCC 2052: Patient Related Outcomes for Gynecologic Radiation Oncology (PRO-GRO)
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.
Read the 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.
- Conditions
- Gynecologic Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Gynecologic Cancer Pts | Gynecologic cancer patients being treated with radiation at UNC. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: First week of radiation to 6 weeks after completing radiation
Secondary outcomes (26)
Rate of survey completion at late timepoints
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
Measured: 6 months post-treatment to 2 years post-treatment
Late, persistent, substantial, treatment-related symptoms (LAPERS)
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.
Measured: 6 months post-treatment to 2 years post-treatment
Incidence of acute symptoms for all patients
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.
Measured: First week of radiation to 6 weeks after completing radiation
Prevalence of acute symptoms for all patients
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.
Measured: First week of radiation to 6 weeks after completing radiation
Time course of acute symptoms for all patients
We will evaluate the time course by creating a graphical representation of each symptom severity at each time point.
Measured: First week of radiation to 6 weeks after completing radiation
Incidence of late symptoms for all patients
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.
Measured: 6 months post-treatment to 2 years post-treatment
Prevalence of late symptoms for all patients
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.
Measured: 6 months post-treatment to 2 years post-treatment
Time course of late symptoms for all patients
We will evaluate the time course by creating a graphical representation of each symptom severity at each time point.
Measured: 6 months post-treatment to 2 years post-treatment
Incidence of acute symptoms for cervical cancer patients
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.
Measured: First week of radiation to 6 weeks after completing radiation
Prevalence of acute symptoms for cervical cancer patients
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.
Measured: First week of radiation to 6 weeks after completing radiation
Time course of acute symptoms for cervical cancer patients
We will evaluate the time course by creating a graphical representation of each symptom severity at each time point.
Measured: First week of radiation to 6 weeks after completing radiation
Incidence of late symptoms for cervical cancer patients
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.
Measured: 6 months post-treatment to 2 years post-treatment
Prevalence of late symptoms for cervical cancer patients
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.
Measured: 6 months post-treatment to 2 years post-treatment
Time course of late symptoms for cervical cancer patients
We will evaluate the time course by creating a graphical representation of each symptom severity at each time point.
Measured: 6 months post-treatment to 2 years post-treatment
Incidence of acute symptoms for endometrial cancer patients
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.
Measured: First week of radiation to 6 weeks after completing radiation
Prevalence of acute symptoms for endometrial cancer patients
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.
Measured: First week of radiation to 6 weeks after completing radiation
Time course of acute symptoms for endometrial cancer patients
We will evaluate the time course by creating a graphical representation of each symptom severity at each time point.
Measured: First week of radiation to 6 weeks after completing radiation
Incidence of late symptoms for endometrial cancer patients
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.
Measured: 6 months post-treatment to 2 years post-treatment
Prevalence of late symptoms for endometrial cancer patients
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.
Measured: 6 months post-treatment to 2 years post-treatment
Time course of late symptoms for endometrial cancer patients
We will evaluate the time course by creating a graphical representation of each symptom severity at each time point.
Measured: 6 months post-treatment to 2 years post-treatment
Incidence of acute symptoms for vulvar cancer patients
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.
Measured: First week of radiation to 6 weeks after completing radiation
Prevalence of acute symptoms for vulvar cancer patients
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.
Measured: First week of radiation to 6 weeks after completing radiation
Time course of acute symptoms for vulvar cancer patients
We will evaluate the time course by creating a graphical representation of each symptom severity at each time point.
Measured: First week of radiation to 6 weeks after completing radiation
Incidence of late symptoms for vulvar cancer patients
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.
Measured: 6 months post-treatment to 2 years post-treatment
Prevalence of late symptoms for vulvar cancer patients
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.
Measured: 6 months post-treatment to 2 years post-treatment
Time course of late symptoms for vulvar cancer patients
We will evaluate the time course by creating a graphical representation of each symptom severity at each time point.
Measured: 6 months post-treatment to 2 years post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start1 Jun 2022
- Primary completion1 Apr 2026
- Study completion15 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashley Weiner, M.D., Ph.D., Principal investigator, UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04753086
- Sponsor's protocol ID
- LCCC 2052
- Acronym
- PRO-GRO
- Status last verified
- May 2026
- First submitted
- 3 Feb 2021
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LCCC 2052: Patient Related Outcomes for Gynecologic Radiation Oncology (PRO-GRO)
- ClinicalTrials.gov ID
- NCT04753086
- Acronym / sponsor ID
- PRO-GRO / LCCC 2052
- Conditions
- Gynecologic Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 15 Feb 2028 (estimated)
- First posted
- 15 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gynecologic Cancer Pts | – | –Gynecologic cancer patients being treated with radiation at UNC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with gynecologic cancer receiving radiation treatment at the University of North Carolina
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
26 secondary outcomes
Rate of survey completion at late timepoints
Time frame: 6 months post-treatment to 2 years post-treatment
Late, persistent, substantial, treatment-related symptoms (LAPERS)
Time frame: 6 months post-treatment to 2 years post-treatment
Incidence of acute symptoms for all patients
Time frame: First week of radiation to 6 weeks after completing radiation
Prevalence of acute symptoms for all patients
Time frame: First week of radiation to 6 weeks after completing radiation
Time course of acute symptoms for all patients
Time frame: First week of radiation to 6 weeks after completing radiation
Incidence of late symptoms for all patients
Time frame: 6 months post-treatment to 2 years post-treatment
Prevalence of late symptoms for all patients
Time frame: 6 months post-treatment to 2 years post-treatment
Time course of late symptoms for all patients
Time frame: 6 months post-treatment to 2 years post-treatment
Incidence of acute symptoms for cervical cancer patients
Time frame: First week of radiation to 6 weeks after completing radiation
Prevalence of acute symptoms for cervical cancer patients
Time frame: First week of radiation to 6 weeks after completing radiation
Time course of acute symptoms for cervical cancer patients
Time frame: First week of radiation to 6 weeks after completing radiation
Incidence of late symptoms for cervical cancer patients
Time frame: 6 months post-treatment to 2 years post-treatment
Prevalence of late symptoms for cervical cancer patients
Time frame: 6 months post-treatment to 2 years post-treatment
Time course of late symptoms for cervical cancer patients
Time frame: 6 months post-treatment to 2 years post-treatment
Incidence of acute symptoms for endometrial cancer patients
Time frame: First week of radiation to 6 weeks after completing radiation
Prevalence of acute symptoms for endometrial cancer patients
Time frame: First week of radiation to 6 weeks after completing radiation
Time course of acute symptoms for endometrial cancer patients
Time frame: First week of radiation to 6 weeks after completing radiation
Incidence of late symptoms for endometrial cancer patients
Time frame: 6 months post-treatment to 2 years post-treatment
Prevalence of late symptoms for endometrial cancer patients
Time frame: 6 months post-treatment to 2 years post-treatment
Time course of late symptoms for endometrial cancer patients
Time frame: 6 months post-treatment to 2 years post-treatment
Incidence of acute symptoms for vulvar cancer patients
Time frame: First week of radiation to 6 weeks after completing radiation
Prevalence of acute symptoms for vulvar cancer patients
Time frame: First week of radiation to 6 weeks after completing radiation
Time course of acute symptoms for vulvar cancer patients
Time frame: First week of radiation to 6 weeks after completing radiation
Incidence of late symptoms for vulvar cancer patients
Time frame: 6 months post-treatment to 2 years post-treatment
Prevalence of late symptoms for vulvar cancer patients
Time frame: 6 months post-treatment to 2 years post-treatment
Time course of late symptoms for vulvar cancer patients
Time frame: 6 months post-treatment to 2 years post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashley Weiner, M.D., Ph.D. principal investigator
UNC Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gynecologic Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of survey completion at acute timepoints (time frame: First week of radiation to 6 weeks after completing radiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.