Skip to main content
OpenTrials
Completed

NCT Number: NCT00950144

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Colorectal Cancer Adenocarcinoma Behavior Behavioral Symptoms Carcinoma Carcinoma, Hepatocellular Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Depression Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Fatigue Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Liver Cancer Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neurologic Manifestations Pain Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Pathological Conditions, Signs and Symptoms Rectal Diseases Rectal Neoplasms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

medical chart review

Other

Questionnaire Administration

Other

study of socioeconomic and demographic variables

Other

quality-of-life assessment

Procedure

Primary outcomes

  1. 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

  2. Pain and other symptoms, and their relationship to overall symptom distress

    Time frame: At study entry

  3. Overall quality of life (QOL) and its specific summary scales

    Time frame: At study entry

  4. Relationship among characteristics (i.e., sociodemographic, disease, health status) associated with illness perceptions, overall symptom distress, and QOL)

    Time frame: At study entry

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Illness Perception, Pain and Symptom Distress in Gastrointestinal Cancers

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jul 31, 2009
Registry last updated
Mar 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.