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Radiation Oncology Patient Medical Physics Intervention Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04362306
Recruitment Status : Suspended (Temporarily suspended due to pandemic)
First Posted : April 24, 2020
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Anxiety Patient Satisfaction Radiation Therapy Behavioral: Planned Intervention Behavioral: No planned intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 3, 2020
Estimated Primary Completion Date : March 3, 2022
Estimated Study Completion Date : March 3, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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 Name: Control group




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04362306


Locations
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United States, Texas
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
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Principal Investigator: Timothy Wagner, MD, MBA University of Texas
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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: April 24, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No