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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00303914
• Other study ID #: CDR0000462104
• Secondary ID: ECOG-E2Z02
• Status: Completed
• Start date: March 14, 2006
• Est. completion date: March 4, 2013

Study information

• Verified date: June 2023
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2310
• Est. completion date: March 4, 2013
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• assessment of therapy complications

• cognitive assessment

• psychosocial assessment and care

Locations

Country	Name	City	State
United States	McFarland Clinic, PC	Ames	Iowa
United States	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan
United States	Saint Joseph Mercy Cancer Center	Ann Arbor	Michigan
United States	John H. Stroger, Jr. Hospital of Cook County	Chicago	Illinois
United States	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois
United States	Oakwood Cancer Center at Oakwood Hospital and Medical Center	Dearborn	Michigan
United States	Elkhart General Hospital	Elkhart	Indiana
United States	Evanston Hospital	Evanston	Illinois
United States	Genesys Hurley Cancer Institute	Flint	Michigan
United States	Hurley Medical Center	Flint	Michigan
United States	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan
United States	Foote Memorial Hospital	Jackson	Michigan
United States	Howard Community Hospital	Kokomo	Indiana
United States	Center for Cancer Therapy at LaPorte Hospital and Health Services	La Porte	Indiana
United States	Sparrow Regional Cancer Center	Lansing	Michigan
United States	St. Mary Mercy Hospital	Livonia	Michigan
United States	Mercy Cancer Center at Mercy Medical Center - North Iowa	Mason City	Iowa
United States	St. Joseph Mercy Oakland	Pontiac	Michigan
United States	Mercy Regional Cancer Center at Mercy Hospital	Port Huron	Michigan
United States	Seton Cancer Institute at Saint Mary's - Saginaw	Saginaw	Michigan
United States	Lakeland Regional Cancer Care Center - St. Joseph	Saint Joseph	Michigan
United States	Mercy Medical Center - Sioux City	Sioux City	Iowa
United States	Siouxland Hematology-Oncology Associates, LLP	Sioux City	Iowa
United States	St. Luke's Regional Medical Center	Sioux City	Iowa
United States	Avera Cancer Institute	Sioux Falls	South Dakota
United States	Medical X-Ray Center, PC	Sioux Falls	South Dakota
United States	Sanford Cancer Center at Sanford USD Medical Center	Sioux Falls	South Dakota
United States	CCOP - Northern Indiana CR Consortium	South Bend	Indiana
United States	Memorial Hospital of South Bend	South Bend	Indiana
United States	Saint Joseph Regional Medical Center	South Bend	Indiana
United States	South Bend Clinic	South Bend	Indiana
United States	St. John Macomb Hospital	Warren	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Eastern Cooperative Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (5)

Hamann HA, Lee J, Schiller JH, et al.: Clinician perceptions of care difficulty and quality of life for lung cancer patients: results from the ECOG SOAPP study (E2Z02). [Abstract] J Clin Oncol 28 (Suppl 15): A-9102, 2010.

Manola J, Zhao F, Miller AH, et al.: Patterns of antidepressant use in cancer patients (pts): An analysis from SOAPP (ECOG E2Z02: Symptom Outcomes and Practice Patterns). [Abstract] J Clin Oncol 30 (Suppl 15): A-9016, 2012.

Tevaarwerk A, Lee J, Sesto MC, et al.: Predictors of employment (empl) outcomes in outpatients (pts) with common solid tumors: A secondary analysis from E2Z02 (ECOG's SOAPP study). [Abstract] J Clin Oncol 28 (Suppl 15): A-9118, 2010.

Wagner LI, Zickl L, Smith ML, et al.: Prospective assessment of symptom burden among cancer survivors with common solid tumors: results from ECOG trial E2Z02. [Abstract] J Clin Oncol 29 (Suppl 15): A-9137, 2011.

Zhao F, Wagner LI, Pirl WF, et al.: Racial disparities in depressive symptom prevalence and selective serotonin reuptake inhibitor (SSRI) utilization in cancer patients: An analysis from ECOG E2Z02: Symptom Outcomes and Practice Patterns (SOAPP). [Abstrac

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Compare treatment priority based on physical or psychological symptoms
Secondary	Percentage of patients who experience a significant reduction in moderate-to-severe symptoms and characterize the determinants of symptom relief
Secondary	Focus and scope of interventions chosen to improve symptom control