Patient Related Outcomes for Gynecologic Radiation Oncology

NCT ID: NCT04753086

Last Updated: 2026-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-01

Study Completion Date

2028-02-15

Brief Summary

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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

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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

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Gynecologic Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Gynecologic Cancer Pts

Gynecologic cancer patients being treated with radiation at UNC.

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ashley Weiner, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

UNC Chapel Hill

Locations

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

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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LCCC 2052

Identifier Type: -

Identifier Source: org_study_id

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