Colorectal CancerNCT00711672
Study of the Therapeutic Use of Language in Patients With Metastatic Colorectal Cancer
An observational study of Colorectal Cancer, run by Hematology and Oncology Associates of NE Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Oct 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with metastatic colorectal carcinoma and their physicians at a large community cancer center in Northeastern Pennsylvania.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hematology and Oncology Associates of Northeastern Pennsylvania, PC
Dunmore, Pennsylvania, 18512
About this study
Official title: 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.
Read the 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.
- Conditions
- Colorectal Cancer
- Keywords
- Personal Communication, Doctor Patient Relations, Narrative Medicine
- Medical subject headings
- Colorectal Neoplasms, Communication, Narrative Medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Medical Oncologists treating patients with metastatic colorectal cancer | |
| 2 | Patients with metastatic colorectal cancer receiving re-staging CT scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of degree of "narrative agreement" with validated quality of life measures
Measured: 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hematology and Oncology Associates of NE Pennsylvania
- Sponsor type
- University, hospital or other
- Investigators
- Christian S Adonizio, MD, Principal investigator, Hematology and Oncology Associates of NE Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00711672
- Sponsor's protocol ID
- 808231
- Status last verified
- Jun 2011
- First submitted
- 7 Jul 2008
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 7057823Cassell, 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.
PubMed 12186492Ferrell 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.
PubMed 8556012Foucault, 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Critical Negotiations: Narrative Agreement, Negotiation, and Register Use in Encounters Between Patients With Metastatic Colorectal Carcinoma and Their Oncologists
- ClinicalTrials.gov ID
- NCT00711672
- Acronym / sponsor ID
- 808231
- Conditions
- Colorectal Cancer
- Keywords
- Personal Communication, Doctor Patient Relations, Narrative Medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Hematology and Oncology Associates of NE PennsylvaniaUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 9 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Medical Oncologists treating patients with metastatic colorectal cancer |
| 2 | – | –Patients with metastatic colorectal cancer receiving re-staging CT scans |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic colorectal carcinoma and their physicians at a large community cancer center in Northeastern Pennsylvania.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation of degree of "narrative agreement" with validated quality of life measures
Time frame: 6-8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
- BackgroundAgha, A. (2007). Language and Social Relations. Studies in the Social and Cultural Foundations of Language. Cambridge, Cambridge University Press. 24: 242-244.
- BackgroundAinsworth-Vaughn, N. (1998). Claiming Power in Doctor-Patient Talk. New York, Oxford University Press.
- BackgroundAustin, J.L. (1975) How to do things with Words. Ed. J.O. Urmson and Marina Sbisa. Cambridge, MA, Harvard University Press.
- BackgroundBriggs, C. (1986) Learning How to Ask:A sociolinguistic appraisal of the role of the interview in social science research. Cambridge, Cambridge University Press.
- Background: PubMed 7057823Cassel 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.
- BackgroundCassell, E. J. (1991). The Nature of Suffering and the Goals of Medicine. New York, Oxford University Press: 37-43.
- BackgroundCharon, R. (2006). Narrative Medicine: Honoring the Stories of Illness. New York, Oxford.
- BackgroundCsordas, T. J. ed. (1994). Embodiment and experience: The existential ground of culture and self. Cambridge Studies in Medical Anthropology. Cambridge: Cambridge University Press.
- BackgroundGee, J.P. (2005) An Introduction to Discourse Analysis: Theory and Method, 2nd ed. New York, Routledge.
- Background: PubMed 12186492Eggly S. Physician-patient co-construction of illness narratives in the medical interview. Health Commun. 2002;14(3):339-60. doi: 10.1207/S15327027HC1403_3.
- Background: PubMed 8556012Ferrell 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.
- BackgroundFoucault, M. (1994). The Birth of the Clinic: An Archaeology of Medical Perception. New York, NY, Vintage Books.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian S Adonizio, MD principal investigator
Hematology and Oncology Associates of NE Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Hematology and Oncology Associates of NE Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of degree of "narrative agreement" with validated quality of life measures (time frame: 6-8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00711672, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2015.