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
  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

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • 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)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients receiving treatment at the City of Hope Medical Center.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00950144

Locations
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Sponsors and Collaborators
City of Hope Medical Center
Investigators
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:
Colorectal Neoplasms
Depression
Depressive Disorder
Fatigue
Liver Neoplasms
Pancreatic Neoplasms
Behavioral Symptoms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Liver Diseases
Mental Disorders
Mood Disorders
Neoplasms
Neoplasms by Site
Pancreatic Diseases
Rectal Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014