Communication Issues in Patient and Provider Discussions of Immunotherapy

NCT05873608 | Recruiting

• 5 other identifiers: IRB00091198NCI-2020-00828WINSHIP3293-16P01CA257906P30CA138292
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 2

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.

Conditions

Hematopoietic and Lymphoid System Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

Study Arms (2)

Interview

OTHER

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

Other: Interview; Other: Observation

Aim 4 tests an educational video

OTHER

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

Other: Educational video

Interventions

Educational video OTHER

Testing an educational video

Aim 4 tests an educational video

Interview OTHER

Participate in interview

Interview

Observation OTHER

Undergo observation

Also known as: Inspection, Visual Inspection

Interview

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Emory University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

Atlanta VA Medical Center

Decatur, Georgia, 30033, United States

RECRUITING

MeSH Terms

Interventions

Interviews as Topic; Observation; Watchful Waiting

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Methods; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Health Services Administration

Study Officials

• Rebecca Pentz, PhD

  Emory University Hospital/Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Pentz, PhD

CONTACT

404-778-5694; rpentz@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: For aim 4, each participant is assigned to watch a video and comprehension is tested using a pre and post method

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: May 24, 2023
• Study Start: October 6, 2016
• Primary Completion (Estimated): September 17, 2026
• Study Completion (Estimated): November 17, 2026
• Last Updated: April 10, 2025

Record last verified: 2025-04

Locations

US (2)