- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00711672
Study of the Therapeutic Use of Language in Patients With Metastatic Colorectal Cancer
June 2, 2015 updated by: Hematology and Oncology Associates of NE Pennsylvania
Critical Negotiations: Narrative Agreement, Negotiation, and Register Use in Encounters Between Patients With Metastatic Colorectal Carcinoma and Their Oncologists
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
5
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Dunmore, Pennsylvania, United States, 18512
- Hematology and Oncology Associates of Northeastern Pennsylvania, PC
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with metastatic colorectal carcinoma and their physicians at a large community cancer center in Northeastern Pennsylvania.
Description
Inclusion Criteria:
- Patients and Physicians at Hematology and Oncology Associates of NE Pennsylvania
- Patients must have metastatic (stage IV) colorectal carcinoma
- Patients must be on treatment for their disease
- Patients must be scheduled for re-staging CT scans
- Patients must be older than 18 years old
Exclusion Criteria:
- Patients with a diagnosis other than metastatic colorectal carcinoma
- Patients not receiving active treatment or not having re-staging CT scans
- Patients younger than 18 years old
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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1
Medical Oncologists treating patients with metastatic colorectal cancer
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2
Patients with metastatic colorectal cancer receiving re-staging CT scans
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Correlation of degree of "narrative agreement" with validated quality of life measures
Time Frame: 6-8 weeks
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6-8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Christian S Adonizio, MD, Hematology and Oncology Associates of NE Pennsylvania
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Agha, A. (2007). Language and Social Relations. Studies in the Social and Cultural Foundations of Language. Cambridge, Cambridge University Press. 24: 242-244.
- Ainsworth-Vaughn, N. (1998). Claiming Power in Doctor-Patient Talk. New York, Oxford University Press.
- Austin, J.L. (1975) How to do things with Words. Ed. J.O. Urmson and Marina Sbisa. Cambridge, MA, Harvard University Press.
- Briggs, C. (1986) Learning How to Ask:A sociolinguistic appraisal of the role of the interview in social science research. Cambridge, Cambridge University Press.
- Cassel EJ. The nature of suffering and the goals of medicine. N Engl J Med. 1982 Mar 18;306(11):639-45. doi: 10.1056/NEJM198203183061104.
- Cassell, E. J. (1991). The Nature of Suffering and the Goals of Medicine. New York, Oxford University Press: 37-43.
- Charon, R. (2006). Narrative Medicine: Honoring the Stories of Illness. New York, Oxford.
- Csordas, T. J. ed. (1994). Embodiment and experience: The existential ground of culture and self. Cambridge Studies in Medical Anthropology. Cambridge: Cambridge University Press.
- Gee, J.P. (2005) An Introduction to Discourse Analysis: Theory and Method, 2nd ed. New York, Routledge.
- Eggly S. Physician-patient co-construction of illness narratives in the medical interview. Health Commun. 2002;14(3):339-60. doi: 10.1207/S15327027HC1403_3.
- Ferrell BR, Dow KH, Grant M. Measurement of the quality of life in cancer survivors. Qual Life Res. 1995 Dec;4(6):523-31. doi: 10.1007/BF00634747.
- Foucault, M. (1994). The Birth of the Clinic: An Archaeology of Medical Perception. New York, NY, Vintage Books.
- Frank, A. W. (1995). The Wounded Storyteller: Body, Illness, and Ethics. Chicago, Chicago University Press.
- Goffman, E. (1963) Stigma: Notes on the Management of Spoiled Identity. Englewood Cliffs, Prentice Hall.
- Good, B. J. (1994). Medicine, Rationality, and Experience: an anthropological perspective. Cambridge, Cambridge University Press.
- Laderman, C. and M, Roseman eds (1996) The Performance of Healing. London, Routledge.
- Linde, C. (1993) Life Stories: The Creation of Coherence. New York, Oxford University Press.
- Lock, M. and N. Scheper-Hughes (1996). A Critical-Interpretive Approach in Medical Anthropology: Rituals and Routines of Discipline and Dissent. Medical Anthropology: Contemporary Theory and Method. C. F. Sargent and T. M. Johnson. Westport, CT, Praeger Publishers: 47.
- Lyotard, J.-F. (1984). The Postmodern Condition: A Report on Knowledge. Minneapolis, University of Minnesota Press.
- Mattingly, C. (1998). Healing dramas and clinical plots: the narrative structure of experience. Cambridge, Cambridge University Press
- Mehan, H. (1996). The Construction of an LD student: A case study in the politics of Representation. Natural Histories of Discourse. M. Silverstein and G. Urban. Chicago, The University of Chicago Press: 253-276.
- Mishler, E. G. (1984). The Discourse of Medicine: Dialectics of Medical Interviews. Norwood, NJ, Ablex Publishing Corporation.
- National Cancer Institute (2007). "NCI Community Cancer Centers Program Pilot 2007-2010." from http://ncccp.cancer.gov/Media/FactSheet.htm.
- Riessman, Catherine Kohler. (1993) Narrative Analysis. Newbury Park, Sage University Paperback
- Ross, N. (2004). Culture and Cognition: Implications for Theory and Method. Thousand Oaks, CA, Sage
- Sontag, S. (2002). Illness as Metaphor and AIDS and Its Metaphors. New York, Penguin Books.
- The University of Texas--M.D.Anderson Cancer Center. (1999) "MDASI, M.D. Anderson Symptom Inventory Core Items", University of Texas.
- Webb, M. (1999). The Good Death: The New American Search to Reshape the End of Life. New York, Bantam.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
October 1, 2009
Study Completion (Actual)
October 1, 2009
Study Registration Dates
First Submitted
July 7, 2008
First Submitted That Met QC Criteria
July 7, 2008
First Posted (Estimate)
July 9, 2008
Study Record Updates
Last Update Posted (Estimate)
June 3, 2015
Last Update Submitted That Met QC Criteria
June 2, 2015
Last Verified
June 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 808231
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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