Radiation Oncology Patient Medical Physics Intervention Study

NCT ID: NCT04362306

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-03

Study Completion Date

2024-06-28

Brief Summary

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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

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Conditions

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Anxiety Patient Satisfaction Radiation Therapy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Planned Intervention

Intervention Type 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.

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

Group Type ACTIVE_COMPARATOR

No planned intervention

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

No planned intervention

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Control group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Timothy Wagner, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

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Mays Cancer Center, UT Health San Antonio

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CTMS# 19-0182

Identifier Type: -

Identifier Source: org_study_id