Cancer Treatment Decision-making in the HIV Population: an Observational Study of Physician-patient Interactions
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/7/2019 |
| Start Date: | March 2019 |
| End Date: | November 30, 2023 |
| Contact: | Noelani Ho, BS |
| Email: | noelani.ho@duke.edu |
| Phone: | 919 6683726 |
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.
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.
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
