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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00950144
First received: July 30, 2009
Last updated: February 28, 2011
Last verified: February 2011

July 30, 2009
February 28, 2011
December 2008
October 2010   (final data collection date for primary outcome measure)
  • 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 ]
  • 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 [ Designated as safety issue: No ]
  • Pain and other symptoms, and their relationship to overall symptom distress [ Designated as safety issue: No ]
  • Overall quality of life (QOL) and its specific summary scales [ Designated as safety issue: No ]
  • Relationship among characteristics (i.e., sociodemographic, disease, health status) associated with illness perceptions, overall symptom distress, and QOL) [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00950144 on ClinicalTrials.gov Archive Site
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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

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Patients receiving treatment at the City of Hope Medical Center.

  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
123
October 2010
October 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00950144
08131, P30CA033572, CHNMC-08131, CDR0000632905
Yes
Virginia Sun, City of Hope Comprehensive Cancer Center
City of Hope Medical Center
National Cancer Institute (NCI)
Principal Investigator: Virginia Sun, RN, MSN Beckman Research Institute
City of Hope Medical Center
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP