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CompletedNCT00950144Updated Mar 2, 2011

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

An observational study in Colorectal Cancer, Depression and Fatigue, sponsored by City of Hope Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-03-02.

Sponsored by City of Hope Medical Center · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
123
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's planned enrollment of 123 is below the median of 200 across 620 observational studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

City of Hope Medical Center is the lead sponsor of 670 studies on the registry; 181 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 12 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients receiving treatment at the City of Hope Medical Center.

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
123 participants (estimated)

Interventions

  • Othermedical chart review
  • Otherquestionnaire administration
  • Otherstudy of socioeconomic and demographic variables
  • Procedurequality-of-life assessment
06

What researchers measure

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

07

Study locations

1 site
  • City of Hope Comprehensive Cancer Center
    Duarte, California 91010-3000, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 2, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00950144
Lead sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
First posted
Jul 31, 2009
Start date
Dec 2008
Primary completion
Oct 2010
Completion
Oct 2010
Last update
Mar 2, 2011

Study contacts

Virginia Sun, RN, MSN
principal investigator · City of Hope Comprehensive Cancer Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.

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