NCT Number: NCT00303914
Study of Symptoms Caused by Cancer and Cancer Therapy in Patients With Invasive Breast, Lung, Prostate, or Colorectal Cancer
RATIONALE: Questionnaires that assess symptoms caused by cancer and cancer therapy may help improve the ability to plan treatment for patients with invasive cancer to help them live longer and more comfortably.
PURPOSE: This clinical trial is studying symptoms caused by cancer and cancer therapy in patients with invasive breast, lung, prostate, or colorectal cancer.
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Notify MeKey information
Conditions
Age range
18 year–120 year
Sex eligibility
All sexes
Study type
Observational
Primary location
John H. Stroger, Jr. Hospital of Cook County, Chicago, Illinois, United States
About this study
OBJECTIVES:
Primary
- Determine the prevalence, severity, and interference due to physical and psychological symptoms experienced (over a 4 to 5 week period) by patients with invasive primary breast, lung, prostate, or colorectal cancer who are being followed on an outpatient basis at ECOG institutions.
Secondary
- Determine if the number of symptom-related interventions are related to the providers' perception of symptom severity.
- Determine whether physical symptoms are more commonly prioritized and treated compared to psychological symptoms.
- Determine the percentage of patients who experience a significant reduction in moderate-to-severe symptoms and characterize the determinants of symptom relief.
- Determine the focus and scope of interventions chosen by oncologists to improve the symptom control of patients seen in outpatient clinics.
OUTLINE: This is an open-label, multicenter study. Patients are stratified according to disease type, prevalence according to gender, race/ethnicity, age, and type of treatment.
Patients complete the M.D. Anderson Symptom Assessment Inventory and other questionnaires, rating the symptoms most frequently found in this patient group and how much these symptoms interfere with mood and activity-related domains, on day 1 and again between days 28-35.
At the same time points, a healthcare provider (treating physician, nurse, or physician assistant) completes the Revised Edmonton Staging System for Cancer Pain questionnaire, assessing the patient's cancer pain on the basis of mechanism of pain, incidental pain, psychological distress and addictive behavior, and cognitive function, for clinical prognosis on pain control.
PROJECTED ACCRUAL: A total of 2,310 patients and their physicians will be accrued for this study.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
DISEASE CHARACTERISTICS:
- Being seen in an outpatient setting at an ECOG-affiliated academic institution, a CGOP site, or a CCOP site
- In pretreatment, active treatment, or follow-up for their cancer
- Clinically diagnosed invasive cancer involving at least 1 of the following primary sites:
- Breast
- Lung
- Prostate
- Colorectal
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Male or female
- Menopausal status not specified
- Willing to complete a written survey between day 28 and day 35 after completion of the baseline assessment
- Able to read, write, and understand English
- No significantly impaired cognitive status which, in the opinion of the investigator, would hinder ability to provide responses
PRIOR CONCURRENT THERAPY:
- Not specified
Treatment and study plan
cognitive assessment
Procedurepsychosocial assessment and care
ProcedurePrimary outcomes
-
Prevalence, severity, and interference due to physical and psychological symptoms experienced by cancer patients as assessed by MD Anderson Symptom Inventory at baseline and days 28-35 following initial assessment
Secondary outcomes
-
Number of symptom-related interventions related to the providers perception of symptom severity as assessed by The Revised Edmonton Staging System for cancer pain (rESS) at baseline and days 28-35 following initial assessment
-
Compare treatment priority based on physical or psychological symptoms
-
Percentage of patients who experience a significant reduction in moderate-to-severe symptoms and characterize the determinants of symptom relief
-
Focus and scope of interventions chosen to improve symptom control
Sponsors and collaborators
Lead sponsor
Eastern Cooperative Oncology Group
Network
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
A Survey of Disease and Treatment-Related Symptoms in Patients With Invasive Cancer: Prevalence, Severity and Treatment
Important dates
- Study start
- 2006
- Primary completion
- 2008
- Study completion
- 2013
- First posted
- Mar 17, 2006
- Registry last updated
- Jun 18, 2023
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.
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