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

Depression Clinical Trial

Official title:

Illness Perception, Pain and Symptom Distress in Gastrointestinal Cancers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00950144
• Other study ID #: 08131
• Secondary ID: P30CA033572CHNMC
• Status: Completed
• Phase: N/A
• First received: July 30, 2009
• Last updated: February 28, 2011
• Start date: December 2008
• Est. completion date: October 2010

Study information

• Verified date: February 2011
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Cancer
• Depression
• Fatigue
• Liver Cancer
• Liver Neoplasms
• Pain
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Other:
• medical chart review

• questionnaire administration

• study of socioeconomic and demographic variables

Procedure:
• quality-of-life assessment

Locations

Country	Name	City	State
United States	City of Hope Comprehensive Cancer Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		At study entry	No
Primary	Pain and other symptoms, and their relationship to overall symptom distress		At study entry	No
Primary	Overall quality of life (QOL) and its specific summary scales		At study entry	No
Primary	Relationship among characteristics (i.e., sociodemographic, disease, health status) associated with illness perceptions, overall symptom distress, and QOL)		At study entry	No