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

Study Overview
=================
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.

Official Title
-----------------
Medical Physics Direct Patient Care Initiative - Communication Intervention Study Protocol

Conditions
-----------------
Malignant Neoplasm

Intervention / Treatment
-----------------
* Other: Informational Intervention
* Other: Counseling
* Other: Questionnaire Administration


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm I (printed materials)<br>Patients receive printed materials describing the technical aspects of their treatment. | Other: Informational Intervention<br>* Receive printed materials<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Arm II (printed materials, physicist interaction)<br>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. | Other: Informational Intervention<br>* Receive printed materials<br>Other: Counseling<br>* Receive direct physicist interactions to describe the technical aspects of the treatment<br>* Other names: counseling, Counseling Intervention;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient treatment adherence | Will be assessed using 2-sided unpaired t-test. | 4 months |