Radiation Oncology Patient Medical Physics Intervention Study

Not Applicable

Completed

• Conditions: Patient Satisfaction; Anxiety; Radiation Therapy
• Interventions: Behavioral: Planned Intervention; Behavioral: No planned intervention

• Registration Number: NCT04362306
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-03
• Study First Submitted: 2020-04-14
• Study First Submitted QC: 2020-04-23
• Study First Posted: 2020-04-24
• Primary Completion: 2024-06-28
• Study Completion: 2024-06-28
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Planned Intervention	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.
No Planned Intervention	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

Primary Outcome Measures

Name	Time	Method
Patient Satisfaction	Baseline to last treatment (up to 9 weeks)	Change in mean Function Assessment of Chronic Illness Therapy Treatment Satisfaction Patient Satisfaction score for the control and intervention groups will be compared.
Anxiety Inventory	Baseline to last treatment (up to 9 weeks)	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.

Secondary Outcome Measures

Name	Time	Method
Medical competency/health literacy of Spanish speaking patients	Prior to CT simulation	Analyze medical competency/health literacy through a one-time, 3-question medical competency questionnaire.

Trial Locations

Locations (1)

Mays Cancer Center, UT Health San Antonio; 🇺🇸 San Antonio, Texas, United States