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


N/A
18 Years
N/A
Open (Enrolling)
Both
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


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.

Inclusion Criteria


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

Type of Study:

Observational

Study Design:

N/A

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

Authority:

United States: Federal Government

Study ID:

CDR0000462104

NCT ID:

NCT00303914

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

Name

Location

Hurley Medical CenterFlint, Michigan  48503
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
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
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
St. John Macomb HospitalWarren, Michigan  48093
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
Medical X-Ray Center, PCSioux Falls, South Dakota  57105
Avera Cancer InstituteSioux Falls, South Dakota  57105
Memorial Hospital of South BendSouth Bend, Indiana  46601
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Elkhart General HospitalElkhart, Indiana  46515
Howard Community HospitalKokomo, Indiana  46904
South Bend ClinicSouth Bend, Indiana  46617
Lakeland Regional Cancer Care Center - St. JosephSt. Joseph, Michigan  49085
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
Mercy Cancer Center at Mercy Medical Center - North IowaMason City, Iowa  50401
Evanston HospitalEvanston, Illinois  60201-1781
McFarland Clinic, PCAmes, Iowa  50010
Foote Memorial HospitalJackson, Michigan  49201
St. Mary Mercy HospitalLivonia, Michigan  48154
St. Joseph Mercy OaklandPontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy HospitalPort Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - SaginawSaginaw, Michigan  48601
John H. Stroger, Jr. Hospital of Cook CountyChicago, Illinois  60612-9985