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

Malignant Neoplasm Clinical Trial

Official title:

Medical Physics Direct Patient Care Initiative - Communication Intervention Study Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04266522
• Other study ID #: 2019-104
• Secondary ID: P30CA022453
• Status: Completed
• Phase: N/A
• Start date: January 16, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: October 2022
• Source: Barbara Ann Karmanos Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms

Intervention

Other:
• Informational Intervention
Receive printed materials
• Counseling
Receive direct physicist interactions to describe the technical aspects of the treatment
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Barbara Ann Karmanos Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety	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.	4 months
Primary	Distress	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.	4 months
Secondary	Patient treatment adherence	Will be assessed using 2-sided unpaired t-test.	4 months