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

Sponsor

Eastern Cooperative Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00303914

Collaborator

National Cancer Institute (NCI) (NIH)

2,310

Enrollment

Locations

83.1

Actual Duration (Months)

72.2

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Cognitive/Functional Effects Colorectal Cancer Lung Cancer Pain Prostate Cancer Psychosocial Effects of Cancer and Its Treatment	Procedure: assessment of therapy complications Procedure: cognitive assessment Procedure: psychosocial assessment and care

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 Design

Study Type:

Observational

Anticipated Enrollment :

2310 participants

Official Title:

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

Actual Study Start Date :

Apr 1, 2006

Actual Primary Completion Date :

Mar 1, 2008

Actual Study Completion Date :

Mar 4, 2013

Outcome Measures

Primary Outcome Measures

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

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois	United States	60611-3013
2	John H. Stroger, Jr. Hospital of Cook County	Chicago	Illinois	United States	60612-3785
3	Evanston Hospital	Evanston	Illinois	United States	60201-1781
4	Elkhart General Hospital	Elkhart	Indiana	United States	46515
5	Howard Community Hospital	Kokomo	Indiana	United States	46904
6	Center for Cancer Therapy at LaPorte Hospital and Health Services	La Porte	Indiana	United States	46350
7	CCOP - Northern Indiana CR Consortium	South Bend	Indiana	United States	46601
8	Memorial Hospital of South Bend	South Bend	Indiana	United States	46601
9	Saint Joseph Regional Medical Center	South Bend	Indiana	United States	46617
10	South Bend Clinic	South Bend	Indiana	United States	46617
11	McFarland Clinic, PC	Ames	Iowa	United States	50010
12	Mercy Cancer Center at Mercy Medical Center - North Iowa	Mason City	Iowa	United States	50401
13	Siouxland Hematology-Oncology Associates, LLP	Sioux City	Iowa	United States	51101
14	Mercy Medical Center - Sioux City	Sioux City	Iowa	United States	51104
15	St. Luke's Regional Medical Center	Sioux City	Iowa	United States	51104
16	Saint Joseph Mercy Cancer Center	Ann Arbor	Michigan	United States	48106-0995
17	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan	United States	48106
18	Oakwood Cancer Center at Oakwood Hospital and Medical Center	Dearborn	Michigan	United States	48123-2500
19	Genesys Hurley Cancer Institute	Flint	Michigan	United States	48503
20	Hurley Medical Center	Flint	Michigan	United States	48503
21	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan	United States	48236
22	Foote Memorial Hospital	Jackson	Michigan	United States	49201
23	Sparrow Regional Cancer Center	Lansing	Michigan	United States	48912-1811
24	St. Mary Mercy Hospital	Livonia	Michigan	United States	48154
25	St. Joseph Mercy Oakland	Pontiac	Michigan	United States	48341-2985
26	Mercy Regional Cancer Center at Mercy Hospital	Port Huron	Michigan	United States	48060
27	Seton Cancer Institute at Saint Mary's - Saginaw	Saginaw	Michigan	United States	48601
28	Lakeland Regional Cancer Care Center - St. Joseph	Saint Joseph	Michigan	United States	49085
29	St. John Macomb Hospital	Warren	Michigan	United States	48093
30	Avera Cancer Institute	Sioux Falls	South Dakota	United States	57105
31	Medical X-Ray Center, PC	Sioux Falls	South Dakota	United States	57105
32	Sanford Cancer Center at Sanford USD Medical Center	Sioux Falls	South Dakota	United States	57117-5039