Study of the Therapeutic Use of Language in Patients With Metastatic Colorectal Cancer
| Tracking Information | |||||
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| First Received Date ICMJE | July 7, 2008 | ||||
| Last Updated Date | June 10, 2011 | ||||
| Start Date ICMJE | July 2008 | ||||
| Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Correlation of degree of "narrative agreement" with validated quality of life measures [ Time Frame: 6-8 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00711672 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study of the Therapeutic Use of Language in Patients With Metastatic Colorectal Cancer | ||||
| Official Title ICMJE | Critical Negotiations: Narrative Agreement, Negotiation, and Register Use in Encounters Between Patients With Metastatic Colorectal Carcinoma and Their Oncologists | ||||
| Brief Summary | The purpose of this study is to determine if the degree of agreement between patients and their physicians regarding the "story" of the illness correlates with improved patient symptom control and quality of life. Another goal of the study is to examine the actual language used by patients and physicians in a specific clinical situation. |
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| Detailed Description | The purpose of this study is to investigate the co-created therapeutic narrative in scheduled office visits between adult patients with metastatic colorectal carcinoma and their medical oncologists in a community practice setting. The study will focus on the negotiation of the illness narrative and the semiotic (primarily linguistic) tools employed. The study will involve patients from a large community cancer center from Northeastern Pennsylvania (this center sees about 3,000 new patients each year). About 85% of patients with cancer in the United States are treated in this type of setting (National Cancer Institute, 2007), and so many results from this population are applicable to most cancer patients in the United States. The location of this study makes it very different from the majority of medical anthropological studies that are usually performed in urban academic medical centers or in sites outside of the United States or Western Europe. Although community cancer centers are the location of most of the treatment of patients with cancer in the United States, there are few to no studies published studying this patient population. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients with metastatic colorectal carcinoma and their physicians at a large community cancer center in Northeastern Pennsylvania. |
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| Condition ICMJE | Colorectal Cancer | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 5 | ||||
| Completion Date | October 2009 | ||||
| Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00711672 | ||||
| Other Study ID Numbers ICMJE | 808231 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Christian S Adonizio MD, Hematology and Oncology Associates of Northeastern Pennsylvania, PC | ||||
| Study Sponsor ICMJE | Hematology and Oncology Associates of NE Pennsylvania | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Hematology and Oncology Associates of NE Pennsylvania | ||||
| Verification Date | June 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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