Study of Symptoms Caused by Cancer and Cancer Therapy in Patients With Invasive Breast, Lung, Prostate, or Colorectal Cancer
- Conditions
- Psychosocial Effects of Cancer and Its TreatmentCognitive/Functional EffectsLung CancerProstate CancerBreast CancerPainColorectal Cancer
- Registration Number
- NCT00303914
- Lead Sponsor
- Eastern Cooperative Oncology Group
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2310
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 Compare treatment priority based on physical or psychological symptoms
Trial Locations
- Locations (32)
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
🇺🇸Chicago, Illinois, United States
Elkhart General Hospital
🇺🇸Elkhart, Indiana, United States
Saint Joseph Regional Medical Center
🇺🇸South Bend, Indiana, United States
South Bend Clinic
🇺🇸South Bend, Indiana, United States
Siouxland Hematology-Oncology Associates, LLP
🇺🇸Sioux City, Iowa, United States
Mercy Medical Center - Sioux City
🇺🇸Sioux City, Iowa, United States
St. Luke's Regional Medical Center
🇺🇸Sioux City, Iowa, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Sparrow Regional Cancer Center
🇺🇸Lansing, Michigan, United States
St. John Macomb Hospital
🇺🇸Warren, Michigan, United States
Genesys Hurley Cancer Institute
🇺🇸Flint, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
🇺🇸Grosse Pointe Woods, Michigan, United States
Lakeland Regional Cancer Care Center - St. Joseph
🇺🇸Saint Joseph, Michigan, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
🇺🇸Dearborn, Michigan, United States
Foote Memorial Hospital
🇺🇸Jackson, Michigan, United States
St. Mary Mercy Hospital
🇺🇸Livonia, Michigan, United States
St. Joseph Mercy Oakland
🇺🇸Pontiac, Michigan, United States
Evanston Hospital
🇺🇸Evanston, Illinois, United States
John H. Stroger, Jr. Hospital of Cook County
🇺🇸Chicago, Illinois, United States
Howard Community Hospital
🇺🇸Kokomo, Indiana, United States
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
🇺🇸La Porte, Indiana, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
McFarland Clinic, PC
🇺🇸Ames, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - North Iowa
🇺🇸Mason City, Iowa, United States
Mercy Regional Cancer Center at Mercy Hospital
🇺🇸Port Huron, Michigan, United States
Seton Cancer Institute at Saint Mary's - Saginaw
🇺🇸Saginaw, Michigan, United States
Medical X-Ray Center, PC
🇺🇸Sioux Falls, South Dakota, United States
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States
Sanford Cancer Center at Sanford USD Medical Center
🇺🇸Sioux Falls, South Dakota, United States
Saint Joseph Mercy Cancer Center
🇺🇸Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸Ann Arbor, Michigan, United States