Clinical Trials

MainTitle

Cancer Treatment Decision-making in the HIV Population: an Observational Study of Physician-patient Interactions

This study is currently recruiting participants. (see Contacts and Locations)

Verified February 2019 by Duke University

Sponsor
Duke University

Collaborator
National Cancer Institute (NCI)

Information provided by (Responsible Party)
Duke University
ClinicalTrials.gov Identifier
NCT03721796

First received: October 24, 2018
Last updated: June 6, 2019
Last Verified: February 2019
History of Changes
Purpose

Purpose

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.

Condition Intervention
Newly Diagnosed Cancer Patients Who Are HIV Positive and Their Treating Oncologist

Other : Audio recording of initial consultation and debriefing interviews.

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cancer Treatment Decision-making in the HIV Population: an Observational Study of Physician-patient Interactions

Further study details as provided by Duke University:

Primary Outcome Measures

  • 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.

Estimated Enrollment: 50
Study Start Date: May 26, 2019
Estimated Study Completion Date: November 30, 2023
Estimated Primary Completion Date: November 30, 2023 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Arm 1 Physician/APP
Surgical, medical, and radiation oncologists and/or Advanced Practice Provider (APP)
Other: 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.

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.
Other: 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.

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  
Sampling Method: Non-Probability Sample  

Study Population

Oncologists Newly diagnosed cancer patients

Criteria

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03721796

Contacts

Contact:   Noelani Ho, BS 919 6683726 noelani.ho@duke.edu
Contact:   Joan Cahill, BNS OCN CCRP 9196 683726

Locations

United States, North Carolina
Duke Cancer Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Joan Cahill, BNS OCN CCRP    919-668-3726

Sponsors and Collaborators

Duke University
National Cancer Institute (NCI)

Investigators

Principal Investigator: Gita Suneja, MD PhD Duke University
More Information

More Information


Responsible Party: Duke University  
ClinicalTrials.gov Identifier: NCT03721796   History of Changes  
Other Study ID Numbers: Pro00101102  
  CA228631  
Study First Received: October 24, 2018  
Last Updated: June 6, 2019  
Individual Participant Data    
Plan to Share IPD: No  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Additional relevant MeSH terms:
HIV Seropositivity

ClinicalTrials.gov processed this data on August 16, 2019
This information is provided by ClinicalTrials.gov.