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

Completed

• Conditions: Psychosocial Effects of Cancer and Its Treatment; Cognitive/Functional Effects; Lung Cancer; Prostate Cancer; Breast Cancer; Pain; Colorectal 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.

Study Timeline

• Study Start: 2006-03-14
• Study First Submitted: 2006-03-15
• Study First Submitted QC: 2006-03-15
• Study First Posted: 2006-03-17
• Primary Completion: 2008-03
• Study Completion: 2013-03-04
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-14
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2310

Inclusion Criteria

Not provided

Exclusion Criteria

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

John H. Stroger, Jr. Hospital of Cook County; 🇺🇸 Chicago, Illinois, United States

Evanston Hospital; 🇺🇸 Evanston, Illinois, United States

Elkhart General Hospital; 🇺🇸 Elkhart, Indiana, United States

Howard Community Hospital; 🇺🇸 Kokomo, 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

Memorial Hospital of South Bend; 🇺🇸 South Bend, Indiana, United States

Saint Joseph Regional Medical Center; 🇺🇸 South Bend, Indiana, United States

South Bend Clinic; 🇺🇸 South Bend, Indiana, United States

Scroll for more (22 remaining)