Radiation Oncology Patient Medical Physics Intervention Study

Anxiety Clinical Trial

Official title:

Radiation Oncology Patient Medical Physics Intervention Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04362306
• Other study ID #: CTMS# 19-0182
• Status: Recruiting
• Phase: N/A
• Start date: March 3, 2020
• Est. completion date: August 2025

Study information

• Verified date: April 2024
• Source: The University of Texas Health Science Center at San Antonio
• Contact: Anna Laura Licon, BS
• Phone: 210-450-5545
• Email: liconal[@]livemail.uthscsa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This investigation is designed to be a two-arm, non-randomized prospective phase 2 study evaluating the impact of medical physicist patient intervention on the anxiety level and patient satisfaction of patients undergoing a course of radiation therapy. The goal is to demonstrate that these interventions will have a significantly positive impact on the overall well-being of the oncology patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: August 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >/= 18 years

• Patients receiving treatment in the outpatient setting.

• Patients with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0, 1, or 2.

Exclusion Criteria:

• Patients receiving a single fraction of treatment.

• History of Prior Radiation.

Related Conditions & MeSH terms

• Anxiety
• Patient Satisfaction
• Radiation Therapy

Intervention

Behavioral:
• Planned Intervention
Intervention with a member of the medical physics team to review the process of simulation, treatment planning, and subsequent treatment. This meeting will last approximately 15 minutes and at this time, the team member will explain that they are the primary resource for all the technical aspects related to the patient's treatment. Additionally, they will identify and address any concerns that patients or their caregivers have with radiation treatment and the patient will be shown the simulation infographic.
• No planned intervention
Anxiety and patient satisfaction questionnaires will be completed prior to CT simulation.

Locations

Country	Name	City	State
United States	Mays Cancer Center, UT Health San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety Inventory	The change in score from 6 questions in the validated short-form of the Spielberger State-Trait Anxiety Inventory (STAI).10 The mean medical physics intervention cohort anxiety score will be calculated at each of the 4 time points and compare to the same time points for the control cohort.	Baseline to last treatment (up to 9 weeks)
Primary	Patient Satisfaction	Change in mean Function Assessment of Chronic Illness Therapy Treatment Satisfaction Patient Satisfaction score for the control and intervention groups will be compared.	Baseline to last treatment (up to 9 weeks)
Secondary	Medical competency/health literacy of Spanish speaking patients	Analyze medical competency/health literacy through a one-time, 3-question medical competency questionnaire.	Prior to CT simulation