Hematopoietic and Lymphoid System NeoplasmNCT05873608
Communication Issues in Patient and Provider Discussions of Immunotherapy
A study testing Educational video, Interview and Observation in people with Hematopoietic and Lymphoid System Neoplasm and Malignant Solid Neoplasm, run by Emory University at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Educational video, Interview and Observation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Oct 2016to 17 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- AIMS 1-3: All patients and providers who may have a discussion about immunotherapy at the Winship Cancer Institute
- AIM 4: Any cancer patient
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Rebecca D. Pentz, PhD, 404-778-5694, rpentz@emory.edu
Margie Dixon, 404-778-4379, mddixon@emory.edu
- Recruiting
Atlanta VA Medical Center
Decatur, Georgia, 30033
Wayne B. Harris, MD, 404-728-7680, Wayne.Harris@va.gov
Margie Dixon, 404-778-4379, mddixon@emory.edu
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Being tested
- Educational video, Interview, Observation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational videoOther
Testing an educational video
InterviewOther
Participate in interview
ObservationOther
Also called Inspection, Visual Inspection
Undergo observation
| Study group | Role | What they receive |
|---|---|---|
| Interview | Other | Patients and providers undergo observation during a conversation about immunotherapy. Then participate in an interview over 20 minutes. Receives: 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 Receives: Other: Educational video |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start6 Oct 2016
- Primary completion17 Sep 2027 (estimated)
- Study completion17 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid System NeoplasmStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- For aim 4, each participant is assigned to watch a video and comprehension is tested using a pre and post method
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Rebecca D. Pentz, Emory University
- Investigators
- Rebecca Pentz, PhD, Principal investigator, Emory University Hospital/Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05873608
- Sponsor's protocol ID
- IRB00091198
- Other IDs
- NCI-2020-00828, IRB00091198, WINSHIP3293-16, P01CA257906, P30CA138292
- Status last verified
- Mar 2026
- First submitted
- 16 May 2023
- Last updated
- 6 Apr 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communication Issues in Patient/Provider Discussions of Immunotherapy
- ClinicalTrials.gov ID
- NCT05873608
- Acronym / sponsor ID
- IRB00091198
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 6 Oct 2016 (actual)
- Primary completion
- 17 Sep 2027 (estimated)
- Study completion
- 17 Nov 2027 (estimated)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- For aim 4, each participant is assigned to watch a video and comprehension is tested using a pre and post method
| Arm | Type | Receives |
|---|---|---|
| Interview | Other | Other: Interview, Other: ObservationPatients and providers undergo observation during a conversation about immunotherapy. Then participate in an interview over 20 minutes. |
| Aim 4 tests an educational video | Other | Other: Educational videoThe participants watch a video and their comprehension is tested in a pre and post methodology |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- AIMS 1-3: All patients and providers who may have a discussion about immunotherapy at the Winship Cancer Institute
- AIM 4: Any cancer patient
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational videoTesting an educational video | Other | Aim 4 tests an educational video |
| InterviewParticipate in interview | Other | Interview |
| ObservationAlso: Inspection, Visual InspectionUndergo observation | Other | Interview |
Primary outcome
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.
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.
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rebecca Pentz, PhD principal investigator
Emory University Hospital/Winship Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational video, Interview and Observation in people with Hematopoietic and Lymphoid System Neoplasm and Malignant Solid Neoplasm, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca Pentz, PhD (404-778-5694, rpentz@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Misestimations about the risks and benefits of immunotherapy resulting from media hype or other sources (time frame: Up to 4 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.