Colorectal CancerNCT00950144
Studying Pain and Symptom Distress in Patients With Advanced Colon Cancer, Rectal Cancer, Pancreatic Cancer, or Liver Cancer
An observational study of Colorectal Cancer and Depression, run by City of Hope Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Depression, Fatigue
- What is being tested?
- medical chart review, questionnaire administration and study of socioeconomic and demographic variables
- Type of treatment
- Surgery or procedure
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Oct 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
About this study
Official title: Illness Perception, Pain and Symptom Distress in Gastrointestinal Cancers
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.
- Conditions
- Colorectal Cancer, Depression, Fatigue, Liver Cancer, Pain, Pancreatic Cancer
- Being tested
- medical chart review, questionnaire administration, study of socioeconomic and demographic variables, quality-of-life assessment
- 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
- Medical subject headings
- Colorectal Neoplasms, Depression, Fatigue, Liver Neoplasms, Pain, Pancreatic Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical chart reviewOther
questionnaire administrationOther
study of socioeconomic and demographic variablesOther
quality-of-life assessmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At study entry
Pain and other symptoms, and their relationship to overall symptom distress
Measured: At study entry
Overall quality of life (QOL) and its specific summary scales
Measured: At study entry
Relationship among characteristics (i.e., sociodemographic, disease, health status) associated with illness perceptions, overall symptom distress, and QOL)
Measured: At study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2009 (estimated)
- Study startDec 2008
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 123 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Virginia Sun, RN, MSN, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00950144
- Sponsor's protocol ID
- 08131
- Other IDs
- P30CA033572, CHNMC-08131, CDR0000632905
- Status last verified
- Feb 2011
- First submitted
- 30 Jul 2009
- Last updated
- 2 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Illness Perception, Pain and Symptom Distress in Gastrointestinal Cancers
- ClinicalTrials.gov ID
- NCT00950144
- Acronym / sponsor ID
- 08131
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 31 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving treatment at the City of Hope Medical Center.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| medical chart review | Other | – |
| questionnaire administration | Other | – |
| study of socioeconomic and demographic variables | Other | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
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
Pain and other symptoms, and their relationship to overall symptom distress
Time frame: At study entry
Overall quality of life (QOL) and its specific summary scales
Time frame: At study entry
Relationship among characteristics (i.e., sociodemographic, disease, health status) associated with illness perceptions, overall symptom distress, and QOL)
Time frame: At study entry
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Virginia Sun, RN, MSN principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Depression, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: At study entry). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2011.