Studying Pain and Symptom Distress in Patients With Advanced Colon Cancer, Rectal Cancer, Pancreatic Cancer, or Liver Cancer
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|ClinicalTrials.gov Identifier: NCT00950144|
Recruitment Status : Completed
First Posted : July 31, 2009
Last Update Posted : March 2, 2011
RATIONALE: Studying a patient's understanding of his or her illness, pain, symptoms, and quality-of-life may help the study of advanced cancer and may help patients live more comfortably.
PURPOSE: This clinical trial is studying pain and symptom distress in patients with advanced colon cancer, rectal cancer, pancreatic cancer, or liver cancer.
|Condition or disease||Intervention/treatment|
|Colorectal Cancer Depression Fatigue Liver Cancer Pain Pancreatic Cancer||Other: medical chart review Other: questionnaire administration Other: study of socioeconomic and demographic variables Procedure: quality-of-life assessment|
- To describe illness perception as indicated in the five domains of the Common Sense Model (i.e., identity, cause, time line, consequences, controllability) and their relationship to symptom distress in patients with colon, rectal, pancreatic, or liver (i.e., hepatocellular carcinoma) cancer.
- To describe pain and other symptoms and their relationship to overall symptom distress in these patients.
- To describe overall quality of life (QOL) and its specific summary scales in these patients.
- To explore the relationship among characteristics (i.e., sociodemographic, disease, health status) associated with illness perceptions, overall symptom distress, and QOL in these patients.
OUTLINE: Patients undergo an empirical examination of illness perceptions as predictors of disease, specifically from the five domains in the Common Sense Model. Patients undergo an assessment of the relationship between influencing characteristics (i.e., sociodemographic), symptoms, and behavioral factors (i.e., illness perceptions, overall symptom distress, and quality of life). Patients complete questionnaires to evaluate demographics by the Sociodemographic, Disease, and Health Status Tool; illness perception by the Illness Perception Questionnaire-Revised (IPQ-R); symptoms and symptom distress by the Memorial Symptom Assessment Scale (MSAS) and Brief Pain Inventory; and quality of life by the SF-12. Patients also undergo a medical chart review and self-report on sociodemographic characteristics.
|Study Type :||Observational|
|Estimated Enrollment :||123 participants|
|Official Title:||Illness Perception, Pain and Symptom Distress in Gastrointestinal Cancers|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2010|
- Illness perception as indicated in the five domains of the Common Sense Model (i.e., identity, cause, time line, consequences, controllability) and their relationship to symptom distress [ Time Frame: At study entry ]
- Pain and other symptoms, and their relationship to overall symptom distress [ Time Frame: At study entry ]
- Overall quality of life (QOL) and its specific summary scales [ Time Frame: At study entry ]
- Relationship among characteristics (i.e., sociodemographic, disease, health status) associated with illness perceptions, overall symptom distress, and QOL) [ Time Frame: At study entry ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00950144
|United States, California|
|City of Hope Comprehensive Cancer Center|
|Duarte, California, United States, 91010-3000|
|Principal Investigator:||Virginia Sun, RN, MSN||City of Hope Comprehensive Cancer Center|