Radiation Oncology Patient Medical Physics Intervention Study

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.

Study Overview

• Status: Recruiting
• Conditions: Anxiety; Patient Satisfaction; Radiation Therapy
• Intervention / Treatment: Behavioral: Planned Intervention; Behavioral: No planned intervention

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna Laura Licon, BS; Phone Number: 210-450-5545; Email: liconal@livemail.uthscsa.edu
• Study Contact Backup: Name: Carol Jenkins, RN; Phone Number: Jenkins; Email: jenkinsca@uthscsa.edu

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • Mays Cancer Center, UT Health San Antonio
      • Contact: Carol Jenkins, RN, MSN; Phone Number: 210-450-5924; Email: jenkinsca@uthscsa.edu
      • Principal Investigator: Timothy Wagner, MD, MBA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Planned Intervention; Patients will be scheduled for CT (computed tomography ) simulation for radiation treatment planning. Prior to simulation, patients will be asked to complete anxiety and patient satisfaction questionnaires. Following completion of the questionnaires, each patient will receive the first 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. The patient will then be asked to complete a second set of anxiety and patient satisfaction questionnaires and will then undergo the planned simulation.	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.
Active Comparator: No Planned Intervention; After patients are enrolled into this study, they will be scheduled for CT simulation for radiation treatment planning. Prior to simulation, patients will receive anxiety and patient satisfaction questionnaires to complete	Behavioral: No planned intervention; Anxiety and patient satisfaction questionnaires will be completed prior to CT simulation.; Other Names: Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Investigators: Principal Investigator: Timothy Wagner, MD, MBA, University of Texas

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2020
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: April 14, 2020
• First Submitted That Met QC Criteria: April 23, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CTMS# 19-0182

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No