Newly Diagnosed Cancer Patients Who Are HIV Positive and Their Treating OncologistNCT03721796
Cancer Treatment Decision-making in the HIV Population: an Observational Study of Physician-patient Interactions
An observational study of Newly Diagnosed Cancer Patients Who Are HIV Positive and Their Treating Oncologist, run by Duke University at 1 site in United States.
Trial summary
This is a prospective, qualitative study consisting of observation and audio recording of the initial physician-patient consultations in newly diagnosed cancer patients occurring at the Duke University Medical Center (DUMC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Newly Diagnosed Cancer Patients Who Are HIV Positive and Their Treating Oncologist
- What is being tested?
- Audio recording of initial consultation and debriefing interviews.
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2019to 16 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Oncologists Newly diagnosed cancer patients
Patient Inclusion Criteria:
- Adults 18 years or older
- First diagnosis of primary cancer
- Pre-existing diagnosis of HIV
- Signed and dated informed consent
Physician Inclusion Criteria:
- Must be a practicing medical, radiation or surgical oncologist or APP at Duke Health.
- Signed and dated informed consent
Patient Exclusion Criteria:
- Non-English speaking
- Prior diagnosis of cancer
Physician/APP Exclusion Criteria:
-None applicable
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective, qualitative study consisting of observation and audio recording of the initial physician-patient consultations in newly diagnosed cancer patients occurring at the Duke University Medical Center (DUMC). Semi-structured debriefing interviews with participating oncologists and patients will follow the initial encounter.
Read the detailed description
The purpose of this research study is to examine oncologist and patients communication and how patient participation in shared decision-making may impact cancer treatment. Patients who are HIV positive and newly diagnosed with cancer and their treating oncologist may voluntarily participate in this study. The study team will record and observe the initial consultation visit between the patient and treating oncologist. Typically, at this visit, specific treatment options for a new cancer are reviewed in detail. Semi-structured debriefing interviews with participating oncologists and patients will follow the initial encounter.
Patient interviews will occur in person or by telephone within 72 hours of the initial consultation. Oncologists will be interviewed in person within one week following the clinical interaction. Clinical interactions at the initial consultation visit and interviews with oncologists will be audio recorded and transcribed. Interviews will be conducted over 45-60 minutes and will be semi-structured with open-ended questions to allow the interviewee to direct the flow of the conversation. A research assistant trained in qualitative research methods will administer interviews.
There are two to three visits: one visit to complete the informed consent process, the recording of the initial consultation visit, and lastly a debriefing interview visit. The debriefing interview may be conducted in person or over the phone.
The following instruments and question probes will assess three main areas of decision-making:
- Physician Rationale for Decision-Making: In debriefing interviews with physicians, research staff will ask how they arrived at their treatment recommendation and what alternatives they entertained. The extent to which medical comorbidities (including HIV) influenced treatment decision-making and what additional information would have been useful in arriving at the treatment recommendation will be assesssed. We will ask physicians what challenges they encountered in communicating treatment options to the patient, how patient preferences influenced treatment recommendations, and their assessment of how likely the patient is to pursue cancer treatment.
- Strength of Physician Treatment Recommendations: The Physician Recommendation Coding System (PhyReCS) is a validated tool to measure the strength of physician recommendations using direct observation of clinical encounters.64 It is a global, 5-point scale ranging from -2 (strong recommendation against treatment) to +2 (strong recommendation for treatment) that captures how physicians portrayed treatment options during the entirety of the clinical appointment. The PhyReCS addresses major limitations with prior physician decision-making research by having the flexibility to capture multiple nuanced recommendations, for example, patients with early stage breast cancer choosing whether to receive breast-conserving therapy (lumpectomy plus radiation) or mastectomy.
- Patient Preferences: In debriefing interviews with patients, we will elicit beliefs and preferences regarding cancer treatment (e.g. self-efficacy, fear of toxicity, financial hardship, challenges with dual management of co-morbidities and cancer, family support. We will ask patients about their understanding of risks, benefits, and alternatives to treatment and their satisfaction with communication regarding cancer management and outcomes. Patients will be asked if they plan to pursue cancer treatment and if so, which elements of physician communication were most influential.
Patient treatment choice will be determined via chart review 6 months after the initial recorded appointment. We will measure concordance between physician recommendation, strength of the physician recommendation (PhyReCS), and patient treatment choice.
- Being tested
- Audio recording of initial consultation and debriefing interviews.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audio recording of initial consultation and debriefing interviews.Other
Semi-structured debriefing interviews with participating oncologists and HIV-infected newly diagnosed cancer patients will follow the initial encounter. Interviews will be conducted over 45-60 minutes and will be semi-structured with open-ended questions to allow the interviewee to direct the flow of the conversation.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 Physician/APP | Surgical, medical, and radiation oncologists and/or Advanced Practice Provider (APP) Receives: Other: Audio recording of initial consultation and debriefing interviews. | |
| Arm 2 Patients | For each participating oncologist, we will may enroll up to three adult cancer patients presenting for consultation, since certain disease sites have a higher incidence in the HIV population. Receives: Other: Audio recording of initial consultation and debriefing interviews. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of concordance between physician recommendation and patient treatment decision using the The Physician Recommendation Coding System ( PhyReCS) tool.
The Physician Recommendation Coding System (PhyReCS) is a validated tool to measure the strength of physician recommendations using direct observation of clinical encounters. It is a global, 5-point scale ranging from -2 (strong recommendation against treatment) to +2 (strong recommendation for treatment) that captures how physicians portrayed treatment options during the entirety of the clinical appointment. The PhyReCS addresses major limitations with prior physician decision-making research by having the flexibility to capture multiple nuanced recommendations, for example, patients with early stage breast cancer choosing whether to receive breast-conserving therapy (lumpectomy plus radiation) or mastectomy.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start26 May 2019
- Primary completion16 Mar 2020
- Study completion16 Mar 2020
Why it stopped: study design changed due to COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Newly Diagnosed Cancer Patients Who Are HIV Positive and Their Treating OncologistStudies of the same condition, open and under way.
- More trials run by Duke 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Gita Suneja, MD PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03721796
- Sponsor's protocol ID
- Pro00101102
- Other IDs
- CA228631
- Status last verified
- Aug 2023
- First submitted
- 24 Oct 2018
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Henry V, Stephens MJ, Galyean P, Young J, Zickmund S, Knettel BA, Bartlett J, Watt MH, Pollak KI, Ubel PA, Fagerlin A, Suneja G. Improving Cancer Care for People Living With HIV: A Qualitative Study of Provider Knowledge, Attitudes, and Practice. Int J Radiat Oncol Biol Phys. 2023 May 1;116(1):60-67. doi: 10.1016/j.ijrobp.2023.01.045. Epub 2023 Jan 29.
PubMed 36724857
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Treatment Decision-making in the HIV Population: an Observational Study of Physician-patient Interactions
- ClinicalTrials.gov ID
- NCT03721796
- Acronym / sponsor ID
- Pro00101102
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: study design changed due to COVID-19
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 26 May 2019 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 16 Mar 2020 (actual)
- First posted
- 26 Oct 2018 (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 is a prospective, qualitative study consisting of observation and audio recording of the initial physician-patient consultations in newly diagnosed cancer patients occurring at the Duke University Medical Center (DUMC). Semi-structured debriefing interviews with participating oncologists and patients will follow the initial encounter.
Detailed description
The purpose of this research study is to examine oncologist and patients communication and how patient participation in shared decision-making may impact cancer treatment. Patients who are HIV positive and newly diagnosed with cancer and their treating oncologist may voluntarily participate in this study. The study team will record and observe the initial consultation visit between the patient and treating oncologist. Typically, at this visit, specific treatment options for a new cancer are reviewed in detail. Semi-structured debriefing interviews with participating oncologists and patients will follow the initial encounter.
Patient interviews will occur in person or by telephone within 72 hours of the initial consultation. Oncologists will be interviewed in person within one week following the clinical interaction. Clinical interactions at the initial consultation visit and interviews with oncologists will be audio recorded and transcribed. Interviews will be conducted over 45-60 minutes and will be semi-structured with open-ended questions to allow the interviewee to direct the flow of the conversation. A research assistant trained in qualitative research methods will administer interviews.
There are two to three visits: one visit to complete the informed consent process, the recording of the initial consultation visit, and lastly a debriefing interview visit. The debriefing interview may be conducted in person or over the phone.
The following instruments and question probes will assess three main areas of decision-making:
- Physician Rationale for Decision-Making: In debriefing interviews with physicians, research staff will ask how they arrived at their treatment recommendation and what alternatives they entertained. The extent to which medical comorbidities (including HIV) influenced treatment decision-making and what additional information would have been useful in arriving at the treatment recommendation will be assesssed. We will ask physicians what challenges they encountered in communicating treatment options to the patient, how patient preferences influenced treatment recommendations, and their assessment of how likely the patient is to pursue cancer treatment.
- Strength of Physician Treatment Recommendations: The Physician Recommendation Coding System (PhyReCS) is a validated tool to measure the strength of physician recommendations using direct observation of clinical encounters.64 It is a global, 5-point scale ranging from -2 (strong recommendation against treatment) to +2 (strong recommendation for treatment) that captures how physicians portrayed treatment options during the entirety of the clinical appointment. The PhyReCS addresses major limitations with prior physician decision-making research by having the flexibility to capture multiple nuanced recommendations, for example, patients with early stage breast cancer choosing whether to receive breast-conserving therapy (lumpectomy plus radiation) or mastectomy.
- Patient Preferences: In debriefing interviews with patients, we will elicit beliefs and preferences regarding cancer treatment (e.g. self-efficacy, fear of toxicity, financial hardship, challenges with dual management of co-morbidities and cancer, family support. We will ask patients about their understanding of risks, benefits, and alternatives to treatment and their satisfaction with communication regarding cancer management and outcomes. Patients will be asked if they plan to pursue cancer treatment and if so, which elements of physician communication were most influential.
Patient treatment choice will be determined via chart review 6 months after the initial recorded appointment. We will measure concordance between physician recommendation, strength of the physician recommendation (PhyReCS), and patient treatment choice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 Physician/APP | – | Other: Audio recording of initial consultation and debriefing interviews.Surgical, medical, and radiation oncologists and/or Advanced Practice Provider (APP) |
| Arm 2 Patients | – | Other: Audio recording of initial consultation and debriefing interviews.For each participating oncologist, we will may enroll up to three adult cancer patients presenting for consultation, since certain disease sites have a higher incidence in the HIV population. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Oncologists Newly diagnosed cancer patients
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 |
|---|---|---|
| Audio recording of initial consultation and debriefing interviews.Semi-structured debriefing interviews with participating oncologists and HIV-infected newly diagnosed cancer patients will follow the initial encounter. Interviews will be conducted over 45-60 minutes and will be semi-structured with open-ended questions to allow the interviewee to direct the flow of the conversation. | Other | Arm 1 Physician/APP, Arm 2 Patients |
Primary outcome
Percentage of concordance between physician recommendation and patient treatment decision using the The Physician Recommendation Coding System ( PhyReCS) tool.
Time frame: 3 years
The Physician Recommendation Coding System (PhyReCS) is a validated tool to measure the strength of physician recommendations using direct observation of clinical encounters. It is a global, 5-point scale ranging from -2 (strong recommendation against treatment) to +2 (strong recommendation for treatment) that captures how physicians portrayed treatment options during the entirety of the clinical appointment. The PhyReCS addresses major limitations with prior physician decision-making research by having the flexibility to capture multiple nuanced recommendations, for example, patients with early stage breast cancer choosing whether to receive breast-conserving therapy (lumpectomy plus radiation) or mastectomy.
Results and safety
The study was stopped early (reason given: study design changed due to COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Results publication: PubMed 36724857Henry V, Stephens MJ, Galyean P, Young J, Zickmund S, Knettel BA, Bartlett J, Watt MH, Pollak KI, Ubel PA, Fagerlin A, Suneja G. Improving Cancer Care for People Living With HIV: A Qualitative Study of Provider Knowledge, Attitudes, and Practice. Int J Radiat Oncol Biol Phys. 2023 May 1;116(1):60-67. doi: 10.1016/j.ijrobp.2023.01.045. Epub 2023 Jan 29.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Gita Suneja, MD PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Newly Diagnosed Cancer Patients Who Are HIV Positive and Their Treating Oncologist, run by Duke University at 1 site 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?
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: stopped early, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: study design changed due to COVID-19). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of concordance between physician recommendation and patient treatment decision using the The Physician Recommendation Coding System ( PhyReCS) tool. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03721796, which also lists 1 linked publication.
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 21 Aug 2023; AzTrials last refreshed its copy on 7 Nov 2026.