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

18 Years
Open (Enrolling)
Breast Cancer, Cognitive/Functional Effects, Colorectal Cancer, Lung Cancer, Pain, Prostate Cancer, Psychosocial Effects of Cancer and Its Treatment

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Trial Information

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



- 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.


- 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

Inclusion Criteria


- 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

- Breast

- Lung

- Prostate

- Colorectal

- Hormone receptor status not specified


- 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


- Not specified

Type of Study:


Study Design:


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

Principal Investigator

Michael J. Fisch, MD, MPH, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Federal Government

Study ID:




Start Date:

April 2006

Completion Date:

Related Keywords:

  • Breast Cancer
  • Cognitive/Functional Effects
  • Colorectal Cancer
  • Lung Cancer
  • Pain
  • Prostate Cancer
  • Psychosocial Effects of Cancer and Its Treatment
  • 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 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
  • 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
  • Breast Neoplasms
  • Colorectal Neoplasms
  • Lung Neoplasms
  • Prostatic Neoplasms



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Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
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Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
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CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
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Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
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Howard Community HospitalKokomo, Indiana  46904
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McFarland Clinic, PCAmes, Iowa  50010
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St. Joseph Mercy OaklandPontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy HospitalPort Huron, Michigan  48060
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