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

June 14, 2023 updated by: Eastern Cooperative Oncology Group

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

2310

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611-3013
        • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
      • Chicago, Illinois, United States, 60612-3785
        • John H. Stroger, Jr. Hospital of Cook County
      • Evanston, Illinois, United States, 60201-1781
        • Evanston Hospital
    • Indiana
      • Elkhart, Indiana, United States, 46515
        • Elkhart General Hospital
      • Kokomo, Indiana, United States, 46904
        • Howard Community Hospital
      • La Porte, Indiana, United States, 46350
        • Center for Cancer Therapy at LaPorte Hospital and Health Services
      • South Bend, Indiana, United States, 46601
        • Memorial Hospital of South Bend
      • South Bend, Indiana, United States, 46601
        • CCOP - Northern Indiana CR Consortium
      • South Bend, Indiana, United States, 46617
        • Saint Joseph Regional Medical Center
      • South Bend, Indiana, United States, 46617
        • South Bend Clinic
    • Iowa
      • Ames, Iowa, United States, 50010
        • McFarland Clinic, PC
      • Mason City, Iowa, United States, 50401
        • Mercy Cancer Center at Mercy Medical Center - North Iowa
      • Sioux City, Iowa, United States, 51101
        • Siouxland Hematology-Oncology Associates, LLP
      • Sioux City, Iowa, United States, 51104
        • St. Luke's Regional Medical Center
      • Sioux City, Iowa, United States, 51104
        • Mercy Medical Center - Sioux City
    • Michigan
      • Ann Arbor, Michigan, United States, 48106-0995
        • Saint Joseph Mercy Cancer Center
      • Ann Arbor, Michigan, United States, 48106
        • CCOP - Michigan Cancer Research Consortium
      • Dearborn, Michigan, United States, 48123-2500
        • Oakwood Cancer Center at Oakwood Hospital and Medical Center
      • Flint, Michigan, United States, 48503
        • Hurley Medical Center
      • Flint, Michigan, United States, 48503
        • Genesys Hurley Cancer Institute
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Van Elslander Cancer Center at St. John Hospital and Medical Center
      • Jackson, Michigan, United States, 49201
        • Foote Memorial Hospital
      • Lansing, Michigan, United States, 48912-1811
        • Sparrow Regional Cancer Center
      • Livonia, Michigan, United States, 48154
        • St. Mary Mercy Hospital
      • Pontiac, Michigan, United States, 48341-2985
        • St. Joseph Mercy Oakland
      • Port Huron, Michigan, United States, 48060
        • Mercy Regional Cancer Center at Mercy Hospital
      • Saginaw, Michigan, United States, 48601
        • Seton Cancer Institute at Saint Mary's - Saginaw
      • Saint Joseph, Michigan, United States, 49085
        • Lakeland Regional Cancer Care Center - St. Joseph
      • Warren, Michigan, United States, 48093
        • St. John Macomb Hospital
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Cancer Institute
      • Sioux Falls, South Dakota, United States, 57105
        • Medical X-Ray Center, PC
      • Sioux Falls, South Dakota, United States, 57117-5039
        • Sanford Cancer Center at Sanford USD Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome 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

Secondary Outcome Measures

Outcome 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Cooperative Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Charles Cleeland, PhD, M.D. Anderson Cancer Center
  • Study Chair: Michael J. Fisch, MD, MPH, FACP, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2006

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 4, 2013

Study Registration Dates

First Submitted

March 15, 2006

First Submitted That Met QC Criteria

March 15, 2006

First Posted (Estimated)

March 17, 2006

Study Record Updates

Last Update Posted (Estimated)

June 16, 2023

Last Update Submitted That Met QC Criteria

June 14, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000462104
  • ECOG-E2Z02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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