NCT00950144

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 31, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

March 2, 2011

Status Verified

February 1, 2011

Enrollment Period

1.8 years

First QC Date

July 30, 2009

Last Update Submit

February 28, 2011

Conditions

Colorectal CancerDepressionFatigueLiver CancerPainPancreatic Cancer

Keywords

paindepressionfatiguestage III colon cancerstage IV colon cancerrecurrent colon cancerstage III rectal cancerstage IV rectal cancerrecurrent rectal cancerstage III pancreatic cancerstage IV pancreatic cancerrecurrent pancreatic canceradult primary hepatocellular carcinomaadvanced adult primary liver cancerlocalized unresectable adult primary liver cancerrecurrent adult primary liver cancer

Outcome Measures

Primary Outcomes (4)

  • 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

    At study entry

  • Pain and other symptoms, and their relationship to overall symptom distress

    At study entry

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

    At study entry

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

    At study entry

Interventions

medical chart reviewOTHER
questionnaire administrationOTHER
study of socioeconomic and demographic variablesOTHER
quality-of-life assessmentPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients receiving treatment at the City of Hope Medical Center.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsDepressionFatigueLiver NeoplasmsPainPancreatic NeoplasmsColonic NeoplasmsRectal NeoplasmsCarcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesBehavioral SymptomsBehaviorSigns and SymptomsPathological Conditions, Signs and SymptomsLiver DiseasesNeurologic ManifestationsEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Virginia Sun, RN, MSN

    City of Hope Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 30, 2009

First Posted

July 31, 2009

Study Start

December 1, 2008

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

March 2, 2011

Record last verified: 2011-02

Locations

US(1)