Study of Symptoms Caused by Cancer and Cancer Therapy in Patients With Invasive Breast, Lung, Prostate, or Colorectal Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Survey of Disease and Treatment-Related Symptoms in Patients With Invasive Cancer: Prevalence, Severity and Treatment

Conditions
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Breast Cancer, Cognitive/Functional Effects, Colorectal Cancer, Lung Cancer, Pain, Prostate Cancer, Psychosocial Effects of Cancer and Its Treatment

Intervention / Treatment
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* Procedure: assessment of therapy complications
* Procedure: cognitive assessment
* Procedure: psychosocial assessment and care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: assessment of therapy complications|nan|
|Procedure: cognitive assessment|nan|
|Procedure: psychosocial assessment and care|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I colon cancer, 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 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, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer, male breast cancer, pulmonary carcinoid tumor