Clinical trial NCT00582192: Seeking Informed Consent to Phase I Cancer Clinical Trials: Identifying Oncologists'Communication Styles
Official title: Seeking Informed Consent to Phase I Cancer Clinical Trials: Identifying Oncologists' Communication Styles
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Phase I trial
Oncologists' Communication Styles
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2007-12-28
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with certain types of cancers that are eligible for studies at Memorial Sloan-Kettering Cancer Center.

Brief summary: The purpose of this study is to examine doctor-patient communication about treatment options which may include an experimental, new treatment for cancer. What we learn from this study may help us to teach doctors better ways to talk to their patients.

Detailed description: Subjects will be cancer patients attending one of three outpatient clinics at Memorial Sloan-Kettering Cancer Center. Subjects will be recruited from the Melanoma/Sarcoma, GI and Genitourinary Oncology services. The patients of six oncologists across the three services will be approached. All patients of these six oncologists who are invited to participate in a Phase I clinical trial will be approached to participate in the study. Patients who consent to participate in this study will be included in the sample regardless of their trial decision.

Design and Analysis:

To gather information about the communication strategies used by oncologists to discuss trials, a qualitative analysis of audio recordings of consultations containing discussions of Phase I trials will be conducted. These consultations will be audio recorded and transcribed in full; analysis will proceed using the constant comparative method. Initially (and as is consistent with the qualitative method employed for this study), a small sample of 15 patients will be recruited. Once an exhaustive analysis of this original data set is complete a further set of 15 patients will be recruited and transcripts of these consultations analyzed. In order to identify any new themes, the themes that emerged from the new data set will be compared with those identified in the original data set. We anticipate that the study will be completed within one year of commencement.

Significance: Oncologists report that one of their most significant communication challenges is communicating effectively and ethically with their patients about joining a clinical trial. Communication skills training has demonstrated efficacy in assisting doctors in this difficult task, however, there is a paucity of research in this area and studies have been limited to the Phase II and III trial setting. There is some research evidence that suggests that different communication issues and challenges emerge in the Phase I versus the Phase II and III trial setting. The pilot research proposed in this protocol will: a) explore the types of communication currently used by oncologists when recruiting patients to clinical trials and b) develop a set of communication strategies that can be used to address gaps in doctor- patient communication in this difficult area.

Eligibility criteria: Inclusion Criteria:

* Patients at the outpatient oncology clinics of the six participating physicians (Drs Schwartz, Scher, Slovin, Tse, Shah \& Carvajal)
* Diagnosed with cancer
* Eligible for a Phase I trial
* Discussing participation in such a trial with their physician during their visit

Exclusion Criteria:

* Fewer than 18 years of age
* Not proficient in English
* Cognitively or physically impaired, rendering them incapable of providing informed consent to participate in the study

Primary outcomes:
measure: This study aims to use qualitative research methods to examine the pattern of communication strategies oncologists use to discuss Phase I clinical trials ith their patients.
timeFrame: This study will begin with your appointment with your doctor the day of registration and will end at the end of the visit that day.
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Richard Brown, PhD
role: PRINCIPAL_INVESTIGATOR
References: