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

NCT04266522 | Completed

• 2 other identifiers: 2019-104P30CA022453
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Neoplasm

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Patient treatment adherence

  4 months

Study Arms (2)

Arm I (printed materials)

ACTIVE COMPARATOR

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

Other: Informational Intervention; Other: Questionnaire Administration

Arm II (printed materials, physicist interaction)

EXPERIMENTAL

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; Other: Counseling; Other: Questionnaire Administration

Interventions

Informational Intervention OTHER

Receive printed materials

Arm I (printed materials); Arm II (printed materials, physicist interaction)

Counseling OTHER

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

Also known as: counseling, Counseling Intervention

Arm II (printed materials, physicist interaction)

Questionnaire Administration OTHER

Ancillary studies

Arm I (printed materials); Arm II (printed materials, physicist interaction)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• NONE

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Counseling

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jay Burmeister, PhD

  Barbara Ann Karmanos Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 12, 2020
• Study Start: January 16, 2020
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: October 7, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)