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Studying Pain and Symptom Distress in Patients With Advanced Colon Cancer, Rectal Cancer, Pancreatic Cancer, or Liver Cancer

Illness Perception, Pain and Symptom Distress in Gastrointestinal Cancers

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00950144
Enrollment
123
Registered
2009-07-31
Start date
2008-12-31
Completion date
2010-10-31
Last updated
2011-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Depression, Fatigue, Liver Cancer, Pain, Pancreatic Cancer

Keywords

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

Brief summary

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.

Detailed description

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.

Interventions

OTHERmedical chart review
OTHERquestionnaire administration
OTHERstudy of socioeconomic and demographic variables
PROCEDUREquality-of-life assessment

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
City of Hope Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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 distressAt study entry
Pain and other symptoms, and their relationship to overall symptom distressAt study entry
Overall quality of life (QOL) and its specific summary scalesAt study entry
Relationship among characteristics (i.e., sociodemographic, disease, health status) associated with illness perceptions, overall symptom distress, and QOL)At study entry

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026