Communication Issues in Patient and Provider Discussions of Immunotherapy

Communication Issues in Patient/Provider Discussions of Immunotherapy

This trials studies communication issues in patient and provider discussions about immunotherapy. The goal of this study is to describe where patients have heard about immunotherapy, what the participants understand about it, how physicians and other healthcare workers describe immunotherapy, and how educational videos may support patient knowledge about immunotherapy.

Study Overview

• Status: Recruiting
• Conditions: Malignant Solid Neoplasm; Hematopoietic and Lymphoid System Neoplasm
• Intervention / Treatment: Other: Interview; Other: Observation; Other: Educational video

Detailed Description

PRIMARY OBJECTIVES:

I. To identify misestimations about the risks and benefits of immunotherapy resulting from media hype or other sources and assess if these misestimations persist post-provider conversation about immunotherapy.

II. To qualitatively describe patient reported misunderstandings and to assess patient understanding of technical terms and metaphors used in the immunotherapy conversation.

III. To identify provider and patient preferences for information to be communicated about immunotherapy.

IV. Develop videos that describe immunotherapy and test their efficacy in improving understanding using pre and post methodology.

OUTLINE:

Patients and their providers undergo observation during a conversation about immunotherapy. Then participate in an interview over 20 minutes. Understanding of educational videos is then tested.

• Study Type: Interventional
• Enrollment (Estimated): 125
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rebecca Pentz, PhD; Phone Number: 404-778-5694; Email: rpentz@emory.edu

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University Hospital/Winship Cancer Institute
      • Contact: Rebecca D. Pentz, PhD; Phone Number: 404-778-5694; Email: rpentz@emory.edu
      • Contact: Margie Dixon; Phone Number: 404-778-4379; Email: mddixon@emory.edu
      • Principal Investigator: Rebecca D. Pentz, PhD
    • Decatur, Georgia, United States, 30033
      • Recruiting
      • Atlanta VA Medical Center
      • Contact: Margie Dixon; Phone Number: 404-778-4379; Email: mddixon@emory.edu
      • Contact: Wayne B. Harris, MD; Phone Number: 404-728-7680; Email: Wayne.Harris@va.gov
      • Principal Investigator: Wayne B. Harris, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• AIMS 1-3: All patients and providers who may have a discussion about immunotherapy at the Winship Cancer Institute
• AIM 4: Any cancer patient

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Aim 4 tests an educational video; The participants watch a video and their comprehension is tested in a pre and post methodology	Other: Educational video; Testing an educational video
Other: Interview; Patients and providers undergo observation during a conversation about immunotherapy. Then participate in an interview over 20 minutes.	Other: Interview; Participate in interview; Other: Observation; Undergo observation; Other Names: Inspection; Visual Inspection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Misestimations about the risks and benefits of immunotherapy resulting from media hype or other sources	Will use descriptive statistics to summarize the demographic characteristics and responses to the interviews. Will audio-record and transcribe the provider conversation for immunotherapy and the pre- and post-provider conversation interviews. The transcripts will be qualitatively coded using multi-level semantic analysis in MAXQDA. Pre-determined codes will include a list of potential benefits of immunotherapy, any patient estimation of the potential for benefit, any side effect and risk mentioned and any estimation of its frequency. Because there is no data on the frequency of misestimations due to media hype, no quantitative analysis is planned.	Up to 4 years
Provider and patient preferences for information to be communicated about immunotherapy	The frequencies of each item of information identified by providers and patients will be determined. A combined list of the most frequently mentioned items of information to be included and a discussion of immunotherapy will be compiled.	Up to 4 years
Correct definition rates (pre- versus post-video)	Before-video and after-video correct definition rates will be calculated, along with 95% exact binomial confidence intervals using the Clopper-Pearson method. Before and after paired rates will be compared using an exact McNemar's test. Subset analyses will be performed for gender, age group (=< 55, > 55), and education level (high school graduate or less, some college or more).	Up to 4 years
Qualitatively describe patient reported misunderstandings	During the observed conversation, the ethics team member will note any technical term or metaphor used. The patient will then be asked if each term and metaphor is understood. The open ended questions about misunderstanding, technical terms and metaphors used, and patients' understanding of each term will be qualitatively coded using multi-level semantic analysis in MAXQDA. Frequency of misunderstood terms and misunderstood metaphors will be calculated.	Up to 4 years

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Rebecca Pentz, PhD, Emory University Hospital/Winship Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2016
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: May 16, 2023
• First Submitted That Met QC Criteria: May 16, 2023
• First Posted (Actual): May 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: IRB00091198; P30CA138292 (U.S. NIH Grant/Contract); NCI-2020-00828 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); WINSHIP3293-16 (Other Identifier: Emory University Hospital/Winship Cancer Institute); P01CA257906 (U.S. NIH Grant/Contract)