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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 Cancer-Related Problem/Condition Colorectal Cancer Lung Cancer Pain Prostate Cancer |
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:
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: | May 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00303914 History of Changes |
Health Authority: | Unspecified |
pain psychosocial effects/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 |