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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00303914 |
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.
Condition | Intervention |
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Breast Cancer Cognitive/Functional Effects Colorectal Cancer Lung Cancer Pain Prostate Cancer Psychosocial Effects of Cancer and Its Treatment |
Procedure: assessment of therapy complications Procedure: cognitive assessment Procedure: psychosocial assessment and care |
Study Type: | Observational |
Official Title: | A Survey of Disease and Treatment-Related Symptoms in Patients With Invasive Cancer: Prevalence, Severity and Treatment |
Estimated Enrollment: | 2310 |
Study Start Date: | April 2006 |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Being seen in an outpatient setting at an ECOG-affiliated academic institution, a CGOP site, or a CCOP site
Clinically diagnosed invasive cancer involving at least 1 of the following primary sites:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Illinois | |
Evanston Hospital | |
Evanston, Illinois, United States, 60201-1781 | |
John H. Stroger, Jr. Hospital of Cook County | |
Chicago, Illinois, United States, 60612-3785 | |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |
Chicago, Illinois, United States, 60611-3013 | |
United States, Indiana | |
CCOP - Northern Indiana CR Consortium | |
South Bend, Indiana, United States, 46601 | |
Memorial Hospital of South Bend | |
South Bend, Indiana, United States, 46601 | |
Elkhart General Hospital | |
Elkhart, Indiana, United States, 46515 | |
Howard Community Hospital | |
Kokomo, Indiana, United States, 46904 | |
Center for Cancer Therapy at LaPorte Hospital and Health Services | |
La Porte, Indiana, United States, 46350 | |
Saint Joseph Regional Medical Center | |
South Bend, Indiana, United States, 46617 | |
South Bend Clinic | |
South Bend, Indiana, United States, 46617 | |
United States, Iowa | |
McFarland Clinic, PC | |
Ames, Iowa, United States, 50010 | |
Mercy Cancer Center at Mercy Medical Center - North Iowa | |
Mason City, Iowa, United States, 50401 | |
Mercy Medical Center - Sioux City | |
Sioux City, Iowa, United States, 51104 | |
Siouxland Hematology-Oncology Associates, LLP | |
Sioux City, Iowa, United States, 51101 | |
St. Luke's Regional Medical Center | |
Sioux City, Iowa, United States, 51104 | |
United States, Michigan | |
CCOP - Michigan Cancer Research Consortium | |
Ann Arbor, Michigan, United States, 48106 | |
Foote Memorial Hospital | |
Jackson, Michigan, United States, 49201 | |
Genesys Hurley Cancer Institute | |
Flint, Michigan, United States, 48503 | |
Hurley Medical Center | |
Flint, Michigan, United States, 48503 | |
Lakeland Regional Cancer Care Center - St. Joseph | |
St. Joseph, Michigan, United States, 49085 | |
Seton Cancer Institute at Saint Mary's - Saginaw | |
Saginaw, Michigan, United States, 48601 | |
Oakwood Cancer Center at Oakwood Hospital and Medical Center | |
Dearborn, Michigan, United States, 48123-2500 | |
Saint Joseph Mercy Cancer Center | |
Ann Arbor, Michigan, United States, 48106-0995 | |
Mercy Regional Cancer Center at Mercy Hospital | |
Port Huron, Michigan, United States, 48060 | |
Sparrow Regional Cancer Center | |
Lansing, Michigan, United States, 48912-1811 | |
St. John Macomb Hospital | |
Warren, Michigan, United States, 48093 | |
St. Joseph Mercy Oakland | |
Pontiac, Michigan, United States, 48341-2985 | |
St. Mary Mercy Hospital | |
Livonia, Michigan, United States, 48154 | |
Van Elslander Cancer Center at St. John Hospital and Medical Center | |
Grosse Pointe Woods, Michigan, United States, 48236 | |
United States, South Dakota | |
Avera Cancer Institute | |
Sioux Falls, South Dakota, United States, 57105 | |
Medical X-Ray Center, PC | |
Sioux Falls, South Dakota, United States, 57105 | |
Sanford Cancer Center at Sanford USD Medical Center | |
Sioux Falls, South Dakota, United States, 57117-5039 |
Study Chair: | Michael J. Fisch, MD, MPH, FACP | M.D. Anderson Cancer Center |
Investigator: | Charles Cleeland, PhD | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000462104, ECOG-E2Z02 |
Study First Received: | March 15, 2006 |
Last Updated: | August 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00303914 History of Changes |
Health Authority: | United States: Federal Government |
pain psychosocial effects of cancer and its treatment cognitive/functional effects recurrent breast cancer stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer recurrent colon cancer stage I colon cancer stage II colon cancer stage III colon cancer stage IV colon cancer |
recurrent rectal cancer stage I rectal cancer stage II rectal cancer stage III rectal cancer stage IV rectal cancer extensive stage small cell lung cancer limited stage small cell lung cancer recurrent small cell lung cancer recurrent non-small cell lung cancer stage I non-small cell lung cancer stage II non-small cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer recurrent prostate cancer |
Thoracic Neoplasms Prostatic Diseases Genital Neoplasms, Male Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Urogenital Neoplasms Pain Breast Cancer, Male Rectal Diseases Respiratory Tract Diseases Lung Neoplasms Breast Diseases Digestive System Neoplasms Skin Diseases |
Rectal Neoplasm Breast Neoplasms Genital Diseases, Male Intestinal Diseases Recurrence Intestinal Neoplasms Carcinoma, Small Cell Rectal Cancer Digestive System Diseases Breast Neoplasms, Male Lung Diseases Non-small Cell Lung Cancer Gastrointestinal Neoplasms Carcinoid Tumor Carcinoma, Non-Small-Cell Lung |
Thoracic Neoplasms Respiratory Tract Neoplasms Digestive System Neoplasms Prostatic Diseases Genital Neoplasms, Male Skin Diseases Gastrointestinal Diseases Colonic Diseases Breast Neoplasms Urogenital Neoplasms Genital Diseases, Male Intestinal Diseases |
Rectal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Respiratory Tract Diseases Lung Neoplasms Lung Diseases Gastrointestinal Neoplasms Prostatic Neoplasms Colorectal Neoplasms Breast Diseases |