Skip to main content
OpenTrials
Completed

NCT Number: NCT04362306

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anxiety Anxiety Disorders Behavior Health Behavior Mental Disorders Patient Satisfaction Radiation Therapy Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mays Cancer Center, UT Health San Antonio

San Antonio, Texas, 78229, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

No planned intervention

Behavioral

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

Other names: Control group

Primary outcomes

  1. Anxiety Inventory

    Time frame: 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.

  2. Patient Satisfaction

    Time frame: 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.

Secondary outcomes

  1. Medical competency/health literacy of Spanish speaking patients

    Time frame: Prior to CT simulation

    Analyze medical competency/health literacy through a one-time, 3-question medical competency questionnaire.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Apr 24, 2020
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.