ACTIVE_NOT_RECRUITING

PROs Following Low-dose Irradiation for Osteoarthritis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this observational registry study is to collect data related to patient reported outcomes (pain, function, quality of life, toxicity) in osteoarthritis (OA) patients receiving standard of care radiation therapy (RT).

Official Title

Patient Reported Outcomes Following Low-dose Irradiation for Osteoarthritis (PRO-LO): A Single-arm Prospective Registry

Quick Facts

Study Start:2023-05-31

Study Completion:2030-08-29

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05705947

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Willing and able to provide informed consent * Established diagnosis of OA of at least 1 joint * Inadequately controlled pain due to OA despite attempts with 2 or more other treatment modalities and Visual Analogue Pain Score of 4 or greater. * Will undergo radiation as part of their standard of care for OA. * At least 55 years old * Ability to read and speak English.	* Any woman who is pregnant or has reason to believe she is pregnant (the possibility of pregnancy has to be excluded by negative urine ß-HCG results, obtained within 2 weeks of CT simulation for radiation planning, or on the basis of patient history, e.g.: tubal ligation, hysterectomy or a minimum of 1 year without menses). * Estimated life expectancy less than 6 months. * Radiation treatment for shoulder OA * Patient weight greater than 550lbs

Inclusion Criteria

Exclusion Criteria

* Willing and able to provide informed consent
* Established diagnosis of OA of at least 1 joint
* Inadequately controlled pain due to OA despite attempts with 2 or more other treatment modalities and Visual Analogue Pain Score of 4 or greater.
* Will undergo radiation as part of their standard of care for OA.
* At least 55 years old
* Ability to read and speak English.

* Any woman who is pregnant or has reason to believe she is pregnant (the possibility of pregnancy has to be excluded by negative urine ß-HCG results, obtained within 2 weeks of CT simulation for radiation planning, or on the basis of patient history, e.g.: tubal ligation, hysterectomy or a minimum of 1 year without menses).
* Estimated life expectancy less than 6 months.
* Radiation treatment for shoulder OA
* Patient weight greater than 550lbs

Contacts and Locations

Principal Investigator

Theodore Yanagihara, MD, PhD

PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Study Locations (Sites)

UNC Chapel Hill

Chapel Hill, North Carolina, 27514

United States

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

Theodore Yanagihara, MD, PhD, PRINCIPAL_INVESTIGATOR, University of North Carolina, Chapel Hill

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-31

Study Completion Date2030-08-29

Study Record Updates

Study Start Date2023-05-31

Study Completion Date2030-08-29

Terms related to this study

Keywords Provided by Researchers

Osteoarthritis
radiation therapy

Additional Relevant MeSH Terms

Osteoarthritis