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

Medical Physics Direct Patient Care Initiative - Communication Intervention Study Protocol

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04266522

Enrollment

Registered

2020-02-12

Start date

2020-01-16

Completion date

2021-09-30

Last updated

2022-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Neoplasm

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.

Interventions

OTHERInformational Intervention

Receive printed materials

OTHERCounseling

Receive direct physicist interactions to describe the technical aspects of the treatment

OTHERQuestionnaire Administration

Ancillary studies

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026