Communication Issues in Patient and Provider Discussions of Immunotherapy

Malignant Solid Neoplasm Clinical Trial

Official title:

Communication Issues in Patient/Provider Discussions of Immunotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05873608
• Other study ID #: IRB00091198
• Secondary ID: NCI-2020-00828IR
• Status: Recruiting
• Phase: N/A
• Start date: October 6, 2016
• Est. completion date: August 1, 2025

Study information

• Verified date: April 2024
• Source: Emory University
• Contact: Rebecca Pentz, PhD
• Phone: 404-778-5694
• Email: rpentz[@]emory.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: August 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hematopoietic and Lymphoid System Neoplasm
• Malignant Solid Neoplasm
• Neoplasms

Intervention

Other:
• Educational video
Testing an educational video
• Interview
Participate in interview
• Observation
Undergo observation

Locations

Country	Name	City	State
United States	Emory University Hospital/Winship Cancer Institute	Atlanta	Georgia
United States	Atlanta VA Medical Center	Decatur	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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