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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00582192
• Other study ID #: 07-096
• Status: Completed
• Phase: N/A
• First received: December 21, 2007
• Last updated: April 30, 2009
• Start date: July 2007
• Est. completion date: April 2009

Study information

• Verified date: April 2009
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Consult visit
Your appointment with your doctor will be audio taped. The research team will listen to the tape(s) and type them up. The team will then look for patterns in the discussions between patients and doctors. They will use this information to see if the discussions can be improved.

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		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.	No

External Links

•   Memorial Sloan-Kettering Cancer Center