Radiation Oncology Patient Medical Physics Intervention Study

NCT04362306 | Completed

• 1 other identifier: CTMS# 19-0182
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Patient Satisfaction; Radiation Therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Medical competency/health literacy of Spanish speaking patients

  Prior to CT simulation

Study Arms (2)

Planned Intervention

EXPERIMENTAL

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

No Planned Intervention

ACTIVE COMPARATOR

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

Interventions

Planned Intervention BEHAVIORAL

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.

Planned Intervention

No planned intervention BEHAVIORAL

Anxiety and patient satisfaction questionnaires will be completed prior to CT simulation.

Also known as: Control group

No Planned Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients receiving a single fraction of treatment.
• History of Prior Radiation.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

Mays Cancer Center, UT Health San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Patient Satisfaction

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Mental Disorders; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Timothy Wagner, MD, MBA

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 24, 2020
• Study Start: March 3, 2020
• Primary Completion: June 28, 2024
• Study Completion: June 28, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)