Clinical trial NCT00950144: Studying Pain and Symptom Distress in Patients With Advanced Colon Cancer, Rectal Cancer, Pancreatic Cancer, or Liver Cancer
Official title: Illness Perception, Pain and Symptom Distress in Gastrointestinal Cancers
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-07-31
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving treatment at the City of Hope Medical Center.

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.

Eligibility 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

Primary outcomes:
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
timeFrame: At study entry
measure: Pain and other symptoms, and their relationship to overall symptom distress
timeFrame: At study entry
measure: Overall quality of life (QOL) and its specific summary scales
timeFrame: At study entry
measure: Relationship among characteristics (i.e., sociodemographic, disease, health status) associated with illness perceptions, overall symptom distress, and QOL)
timeFrame: At study entry
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center
state: California
Study officials:
affiliation: City of Hope Comprehensive Cancer Center
name: Virginia Sun, RN, MSN
role: PRINCIPAL_INVESTIGATOR
References: