Communication Issues in Patient and Provider Discussions of Immunotherapy

Sponsor
Emory University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05873608
Collaborator
National Cancer Institute (NCI) (NIH)
125
2
2
101.7
62.5
0.6

Study Details

Study Description

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 they understand about it, how physicians and other healthcare workers describe immunotherapy, and how educational videos may support patient knowledge about immunotherapy.

Condition or Disease Intervention/Treatment Phase
  • Other: Educational video
  • Other: Interview
  • Other: Observation
N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. 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.

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

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

  4. 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. They then participate in an interview over 20 minutes. Understanding of educational videos is then tested

Study Design

Study Type:
Interventional
Anticipated Enrollment :
125 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
For aim 4, each participant is assigned to watch a video and comprehension is tested using a pre and post methodFor aim 4, each participant is assigned to watch a video and comprehension is tested using a pre and post method
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Communication Issues in Patient/Provider Discussions of Immunotherapy
Actual Study Start Date :
Oct 6, 2016
Anticipated Primary Completion Date :
Mar 27, 2024
Anticipated Study Completion Date :
Mar 27, 2025

Arms and Interventions

Arm Intervention/Treatment
Other: Interview

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

Other: Interview
Participate in interview

Other: Observation
Undergo observation
Other Names:
  • Inspection
  • Visual Inspection
  • 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

    Outcome Measures

    Primary Outcome Measures

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

    2. Qualitatively describe patient reported misunderstandings [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 they understand each term and metaphor. 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.

    3. Provider and patient preferences for information to be communicated about immunotherapy [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.

    4. Correct definition rates (pre- versus post-video) [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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Emory University Hospital/Winship Cancer Institute Atlanta Georgia United States 30322
    2 Atlanta VA Medical Center Decatur Georgia United States 30033

    Sponsors and Collaborators

    • Emory University
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Rebecca Pentz, PhD, Emory University Hospital/Winship Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rebecca D. Pentz, Principal Investigator, Emory University
    ClinicalTrials.gov Identifier:
    NCT05873608
    Other Study ID Numbers:
    • IRB00091198
    • NCI-2020-00828
    • IRB00091198
    • WINSHIP3293-16
    • P01CA257906
    • P30CA138292
    First Posted:
    May 24, 2023
    Last Update Posted:
    May 24, 2023
    Last Verified:
    May 1, 2023
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 24, 2023