Overview

This trial is active, not recruiting.

Conditions breast cancer, cognitive/functional effects, colorectal cancer, lung cancer, pain, prostate cancer, psychosocial effects of cancer and its treatment
Treatments assessment of therapy complications, cognitive assessment, psychosocial assessment and care
Sponsor Eastern Cooperative Oncology Group
Collaborator National Cancer Institute (NCI)
Start date April 2006
Trial size 2310 participants
Trial identifier NCT00303914, CDR0000462104, ECOG-E2Z02

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.

United States No locations recruiting
Other Countries No locations recruiting

Primary Outcomes

Measure
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
time frame:

Secondary Outcomes

Measure
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
time frame:
Compare treatment priority based on physical or psychological symptoms
time frame:
Percentage of patients who experience a significant reduction in moderate-to-severe symptoms and characterize the determinants of symptom relief
time frame:
Focus and scope of interventions chosen to improve symptom control
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Survey of Disease and Treatment-Related Symptoms in Patients With Invasive Cancer: Prevalence, Severity and Treatment
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2012.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).