Radiation Oncology Patient Medical Physics Intervention Study

Sponsor
The University of Texas Health Science Center at San Antonio (Other)
Overall Status
Recruiting
CT.gov ID
NCT04362306
Collaborator
(none)
66
1
2
53
1.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Planned Intervention
  • Behavioral: No planned intervention
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Radiation Oncology Patient Medical Physics Intervention Study
Actual Study Start Date :
Mar 3, 2020
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Behavioral: 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.

Active Comparator: 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

Behavioral: No planned intervention
Anxiety and patient satisfaction questionnaires will be completed prior to CT simulation.
Other Names:
  • Control group
  • Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    Secondary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mays Cancer Center, UT Health San Antonio San Antonio Texas United States 78229

    Sponsors and Collaborators

    • The University of Texas Health Science Center at San Antonio

    Investigators

    • Principal Investigator: Timothy Wagner, MD, MBA, University of Texas

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The University of Texas Health Science Center at San Antonio
    ClinicalTrials.gov Identifier:
    NCT04362306
    Other Study ID Numbers:
    • CTMS# 19-0182
    First Posted:
    Apr 24, 2020
    Last Update Posted:
    Mar 31, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Mar 31, 2022