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Seeking Informed Consent to Phase I Cancer Clinical Trials: Identifying Oncologists' Communication Styles

18 Years
Not Enrolling

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Trial Information

Seeking Informed Consent to Phase I Cancer Clinical Trials: Identifying Oncologists' Communication Styles

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.

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

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome 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.

Outcome Time Frame:

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.

Safety Issue:


Principal Investigator

Richard Brown, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

July 2007

Completion Date:

April 2009

Related Keywords:

  • Cancer
  • Phase I trial
  • Oncologists' Communication Styles



Memorial Sloan-Kettering Cancer Center New York, New York  10021