Medical Physics Direct Patient Care for the Improvement of Patient Understanding of Care

Not Applicable

Completed

• Conditions: Malignant Neoplasm
• Interventions: Other: Informational Intervention; Other: Questionnaire Administration; Other: Counseling

• Registration Number: NCT04266522
• Lead Sponsor: Barbara Ann Karmanos Cancer Institute

Brief Summary

This phase II trial studies how well medical physics direct patient care works in improving patients' understanding of their cancer treatment. Providing direct physicist-patient interactions and answering patients' questions about their cancer treatment may help patients to understand the care and therefore reduce anxiety and distress during treatment.

Detailed Description

PRIMARY OBJECTIVE:

I. To evaluate whether the Medical Physics Direct Patient Care Initiative (MPDPCI) improves anxiety/distress.

SECONDARY OBJECTIVE:

II. To assess whether the MPDPCI improves patient treatment adherence and overall satisfaction.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive printed materials describing the technical aspects of their treatment.

ARM II: Patients receive printed materials as in Arm I. Patients also receive a minimum of 2 direct physicist interactions to describe the technical aspects of their treatment either immediately prior to or immediately after treatment simulation.

Study Timeline

• Study Start: 2020-01-16
• Study First Submitted: 2020-02-10
• Study First Submitted QC: 2020-02-10
• Study First Posted: 2020-02-12
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-06
• Last Update Posted: 2022-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Medical physicists will be eligible if they care for patients within the Gershenson Radiation Oncology Center within the Karmanos Cancer Institute and have completed the patient communication training
• Are able to read and write in English
• Are scheduled for curative radiation therapy at the Gershenson Radiation Oncology Center

Exclusion Criteria

• NONE

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (printed materials)	Informational Intervention	Patients receive printed materials describing the technical aspects of their treatment.
Arm II (printed materials, physicist interaction)	Informational Intervention	Patients receive printed materials as in Arm I. Patients also receive a minimum of 2 direct physicist interactions to describe the technical aspects of their treatment either immediately prior to or immediately after treatment simulation.
Arm I (printed materials)	Questionnaire Administration	Patients receive printed materials describing the technical aspects of their treatment.
Arm II (printed materials, physicist interaction)	Counseling	Patients receive printed materials as in Arm I. Patients also receive a minimum of 2 direct physicist interactions to describe the technical aspects of their treatment either immediately prior to or immediately after treatment simulation.
Arm II (printed materials, physicist interaction)	Questionnaire Administration	Patients receive printed materials as in Arm I. Patients also receive a minimum of 2 direct physicist interactions to describe the technical aspects of their treatment either immediately prior to or immediately after treatment simulation.

Primary Outcome Measures

Name	Time	Method
Anxiety	4 months	Will be assessed using linear mixed-effects models. These objectives will be evaluated based on the difference between groups across three time points (i.e., group-effect) using the baseline corrected measurements. Each patient will be considered as random-effects along with the repeated measurements at three time points. The repeated measurements at three time points will be handled by autocorrelated residuals within groups.
Distress	4 months	Will be assessed using linear mixed-effects models. These objectives will be evaluated based on the difference between groups across three time points (i.e., group-effect) using the baseline corrected measurements. Each patient will be considered as random-effects along with the repeated measurements at three time points. The repeated measurements at three time points will be handled by autocorrelated residuals within groups.

Secondary Outcome Measures

Name	Time	Method
Patient treatment adherence	4 months	Will be assessed using 2-sided unpaired t-test.

Trial Locations

Locations (1)

Barbara Ann Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States