Studying Pain and Symptom Distress in Patients With Advanced Colon Cancer, Rectal Cancer, Pancreatic Cancer, or Liver Cancer
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Purpose
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 | Intervention |
|---|---|
|
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 |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Illness Perception, Pain and Symptom Distress in Gastrointestinal Cancers |
- 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 ] [ Designated as safety issue: No ]
- Pain and other symptoms, and their relationship to overall symptom distress [ Time Frame: At study entry ] [ Designated as safety issue: No ]
- Overall quality of life (QOL) and its specific summary scales [ Time Frame: At study entry ] [ Designated as safety issue: No ]
- Relationship among characteristics (i.e., sociodemographic, disease, health status) associated with illness perceptions, overall symptom distress, and QOL) [ Time Frame: At study entry ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 123 |
| Study Start Date: | December 2008 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients receiving treatment at the City of Hope Medical Center.
DISEASE CHARACTERISTICS:
Histologically confirmed colon, rectal, pancreatic, or liver (i.e., hepatocellular carcinoma) cancer
- Stage III or IV colon, rectal, or pancreatic cancer
- Child-Pugh class B or C hepatocellular carcinoma
PATIENT CHARACTERISTICS:
- Able to read English
- Able to provide written informed consent and complete questionnaire packet
PRIOR CONCURRENT THERAPY:
- Any treatment modality (e.g., chemotherapy, radiotherapy, surgery) allowed
Contacts and Locations| United States, California | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010-3000 | |
| Principal Investigator: | Virginia Sun, RN, MSN | Beckman Research Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Virginia Sun, City of Hope Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00950144 History of Changes |
| Other Study ID Numbers: | 08131, P30CA033572, CHNMC-08131, CDR0000632905 |
| Study First Received: | July 30, 2009 |
| Last Updated: | February 28, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by City of Hope Medical Center:
|
pain depression fatigue stage III colon cancer stage IV colon cancer recurrent colon cancer stage III rectal cancer stage IV rectal cancer |
recurrent rectal cancer stage III pancreatic cancer stage IV pancreatic cancer recurrent pancreatic cancer adult primary hepatocellular carcinoma advanced adult primary liver cancer localized unresectable adult primary liver cancer recurrent adult primary liver cancer |
Additional relevant MeSH terms:
|
Colonic Neoplasms Rectal Neoplasms Colorectal Neoplasms Depression Depressive Disorder Fatigue Liver Neoplasms Pancreatic Neoplasms Gastrointestinal Neoplasms Intestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Behavioral Symptoms Mood Disorders Mental Disorders Signs and Symptoms Liver Diseases Endocrine Gland Neoplasms Pancreatic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013