A Survey of Disease and Treatment-Related Symptoms in Patients With Invasive Cancer: Prevalence, Severity and Treatment
18 Years
N/A
Both
Breast Cancer, Cognitive/Functional Effects, Colorectal Cancer, Lung Cancer, Pain, Prostate Cancer, Psychosocial Effects of Cancer and Its Treatment
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 Center | Flint, Michigan 48503 |
| Mercy Medical Center - Sioux City | Sioux City, Iowa 51104 |
| Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa 51101 |
| St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
| Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
| Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan 48123-2500 |
| Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
| Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
| St. John Macomb Hospital | Warren, Michigan 48093 |
| Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls, South Dakota 57117-5039 |
| Medical X-Ray Center, PC | Sioux Falls, South Dakota 57105 |
| Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
| Memorial Hospital of South Bend | South Bend, Indiana 46601 |
| CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
| Saint Joseph Regional Medical Center | South Bend, Indiana 46617 |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
| Elkhart General Hospital | Elkhart, Indiana 46515 |
| Howard Community Hospital | Kokomo, Indiana 46904 |
| South Bend Clinic | South Bend, Indiana 46617 |
| Lakeland Regional Cancer Care Center - St. Joseph | St. Joseph, Michigan 49085 |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
| Mercy Cancer Center at Mercy Medical Center - North Iowa | Mason City, Iowa 50401 |
| Evanston Hospital | Evanston, Illinois 60201-1781 |
| McFarland Clinic, PC | Ames, Iowa 50010 |
| Foote Memorial Hospital | Jackson, Michigan 49201 |
| St. Mary Mercy Hospital | Livonia, Michigan 48154 |
| St. Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
| Mercy Regional Cancer Center at Mercy Hospital | Port Huron, Michigan 48060 |
| Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw, Michigan 48601 |
| John H. Stroger, Jr. Hospital of Cook County | Chicago, Illinois 60612-9985 |
