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Clinical Trials/NCT05873608
NCT05873608
Recruiting
Not Applicable

Communication Issues in Patient/Provider Discussions of Immunotherapy

Emory University3 sites in 1 country125 target enrollmentOctober 6, 2016

Overview

Phase
Not Applicable
Intervention
Interview
Conditions
Hematopoietic and Lymphoid System Neoplasm
Sponsor
Emory University
Enrollment
125
Locations
3
Primary Endpoint
Misestimations about the risks and benefits of immunotherapy resulting from media hype or other sources
Status
Recruiting
Last Updated
26 days ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
October 6, 2016
End Date
November 17, 2027
Last Updated
26 days ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rebecca D. Pentz

Principal Investigator

Emory University

Eligibility Criteria

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

Exclusion Criteria

  • Not provided

Arms & Interventions

Interview

Patients and providers undergo observation during a conversation about immunotherapy. Then participate in an interview over 20 minutes.

Intervention: Interview

Interview

Patients and providers undergo observation during a conversation about immunotherapy. Then participate in an interview over 20 minutes.

Intervention: Observation

Aim 4 tests an educational video

The participants watch a video and their comprehension is tested in a pre and post methodology

Intervention: Educational video

Outcomes

Primary Outcomes

Misestimations about the risks and benefits of immunotherapy resulting from media hype or other sources

Time Frame: Up to 4 years

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.

Correct definition rates (pre- versus post-video)

Time Frame: Up to 4 years

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).

Qualitatively describe patient reported misunderstandings

Time Frame: Up to 4 years

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.

Provider and patient preferences for information to be communicated about immunotherapy

Time Frame: Up to 4 years

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.

Study Sites (3)

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