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NCT Number: NCT04266522

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

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.

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Key information

Conditions

Malignant Neoplasm Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Informational intervention

Other

Receive printed materials

Counseling

Other

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

Other names: counseling, Counseling Intervention

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Anxiety

    Time frame: 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.

  2. Distress

    Time frame: 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 outcomes

  1. Patient treatment adherence

    Time frame: 4 months

    Will be assessed using 2-sided unpaired t-test.

Sponsors and collaborators

Lead sponsor

Barbara Ann Karmanos Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Medical Physics Direct Patient Care Initiative - Communication Intervention Study Protocol

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 12, 2020
Registry last updated
Oct 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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