Radiation Oncology Patient Medical Physics Intervention Study

Not Applicable

Completed

• Conditions: Patient Satisfaction; Anxiety; Radiation Therapy

• 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

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