Duke University
Durham, North Carolina, United States
NCT Number: NCT01898481
The purpose of this pilot study is to test the feasibility of identifying and interviewing healthcare triads (patients, loved ones and oncologists) in a research study and evaluate the influences of patients' loved ones and oncologists on cancer treatment decision-making. the study team plans to explore concordance or discordance within the triad about the decisions, and also assess decisional conflict, regret and distress. Study methods involve interviewing a total of 75 patients, their loved ones and oncologists about past cancer treatment decisions. Analysis will consist mainly of qualitative content analysis. The investigators do not anticipate risk or safety issues beyond loss of confidentiality or minimal discomfort while discussing a cancer treatment decision.
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Notify Me18 year and older
All sexes
Observational
Durham, North Carolina, United States
The overall goal of this study is to evaluate the influences of oncologists and patients' loved ones on cancer treatment decision-making. The specific aims are:
AIM 1: Test the feasibility of identifying and interviewing health care triads (patients, loved ones, and oncologists) in a research study about treatment decisions.
AIM 2: Assess perceptions of the decision-making experience from the perspective of three parties within the health care triad (patients, loved ones, and oncologists) and examine the relationships among the triadic perspectives.
AIM 3: Explore concordance or discordance within the triad about cancer treatment decisions and assess decisional conflict, decisional regret, and distress.
This is an exploratory pilot study of 25 health care triads. Triads will include: (1) a patient diagnosed with advanced cancer, (2) a loved one, and (3) an oncology provider. In a few instances, the study team may interview more than one oncologist or loved one per patient.
In phase one of recruitment, oncologists will be recruited and enrolled. In phase two, the study team will recruit patients who receive care from at least one enrolled oncologist and at least one of the patient's friends or family members. While oncology providers may participate in the study with multiple patients and their loved ones, the patients will be unique to each triad.
Investigators anticipate enrolling two triads per week for a total of three months. They will utilize mainly qualitative methods, and specifically, content analysis, in this exploratory pilot study to (1) further hone and develop research questions and aims for a larger study with appropriate statistical power, (2) test the feasibility of recruiting health care triads in the oncology context, and (3) strengthen our study design, protocols and surveys. The investigators plan to use an iterative process of coding to allow for protocol and survey revisions, and in particular the inclusion of new probes, during the study. The codebook will include inductive and deductive codes related to the general decision making process, expectations and decisional outcomes, conflict and concordance between members of the triad, and other relevant topics. Two coders will review each interview and the team will review for themes and exemplars. The investigators plan to pilot three scales in this study that might be used in a larger future study.
Only the study team can determine whether someone qualifies for participation.
Oncologist Inclusion Criteria:
Patient Inclusion Criteria:
Loved One (friend/family) Inclusion Criteria:
Exclusion for all Subjects:
Time frame: three to four months after treatment decision
This outcome will be measured with an interviewer-administered survey.
Time frame: three to four months after treatment decision
This outcome will be measured with an interviewer-administered survey.
Duke University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.