Clinical trial NCT00303914: Study of Symptoms Caused by Cancer and Cancer Therapy in Patients With Invasive Breast, Lung, Prostate, or Colorectal Cancer
Official title: A Survey of Disease and Treatment-Related Symptoms in Patients With Invasive Cancer: Prevalence, Severity and Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Cognitive/Functional Effects
Colorectal Cancer
Lung Cancer
Pain
Prostate Cancer
Psychosocial Effects of Cancer and Its Treatment
Keywords: 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
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-03-17
Enrollment: 2310
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.

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.

Eligibility 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

Primary outcomes:
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
Secondary outcomes:
measure: 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
measure: Compare treatment priority based on physical or psychological symptoms
measure: Percentage of patients who experience a significant reduction in moderate-to-severe symptoms and characterize the determinants of symptom relief
measure: Focus and scope of interventions chosen to improve symptom control
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center at Northwestern University
state: Illinois
city: Chicago
country: United States
facility: John H. Stroger, Jr. Hospital of Cook County
state: Illinois
city: Evanston
country: United States
facility: Evanston Hospital
state: Illinois
city: Elkhart
country: United States
facility: Elkhart General Hospital
state: Indiana
city: Kokomo
country: United States
facility: Howard Community Hospital
state: Indiana
city: La Porte
country: United States
facility: Center for Cancer Therapy at LaPorte Hospital and Health Services
state: Indiana
city: South Bend
country: United States
facility: CCOP - Northern Indiana CR Consortium
state: Indiana
city: South Bend
country: United States
facility: Memorial Hospital of South Bend
state: Indiana
city: South Bend
country: United States
facility: Saint Joseph Regional Medical Center
state: Indiana
city: South Bend
country: United States
facility: South Bend Clinic
state: Indiana
city: Ames
country: United States
facility: McFarland Clinic, PC
state: Iowa
city: Mason City
country: United States
facility: Mercy Cancer Center at Mercy Medical Center - North Iowa
state: Iowa
city: Sioux City
country: United States
facility: Siouxland Hematology-Oncology Associates, LLP
state: Iowa
city: Sioux City
country: United States
facility: Mercy Medical Center - Sioux City
state: Iowa
city: Sioux City
country: United States
facility: St. Luke's Regional Medical Center
state: Iowa
city: Ann Arbor
country: United States
facility: Saint Joseph Mercy Cancer Center
state: Michigan
city: Ann Arbor
country: United States
facility: CCOP - Michigan Cancer Research Consortium
state: Michigan
city: Dearborn
country: United States
facility: Oakwood Cancer Center at Oakwood Hospital and Medical Center
state: Michigan
city: Flint
country: United States
facility: Genesys Hurley Cancer Institute
state: Michigan
city: Flint
country: United States
facility: Hurley Medical Center
state: Michigan
city: Grosse Pointe Woods
country: United States
facility: Van Elslander Cancer Center at St. John Hospital and Medical Center
state: Michigan
city: Jackson
country: United States
facility: Foote Memorial Hospital
state: Michigan
city: Lansing
country: United States
facility: Sparrow Regional Cancer Center
state: Michigan
city: Livonia
country: United States
facility: St. Mary Mercy Hospital
state: Michigan
city: Pontiac
country: United States
facility: St. Joseph Mercy Oakland
state: Michigan
city: Port Huron
country: United States
facility: Mercy Regional Cancer Center at Mercy Hospital
state: Michigan
city: Saginaw
country: United States
facility: Seton Cancer Institute at Saint Mary's - Saginaw
state: Michigan
city: Saint Joseph
country: United States
facility: Lakeland Regional Cancer Care Center - St. Joseph
state: Michigan
city: Warren
country: United States
facility: St. John Macomb Hospital
state: Michigan
city: Sioux Falls
country: United States
facility: Avera Cancer Institute
state: South Dakota
city: Sioux Falls
country: United States
facility: Medical X-Ray Center, PC
state: South Dakota
city: Sioux Falls
country: United States
facility: Sanford Cancer Center at Sanford USD Medical Center
state: South Dakota
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Michael J. Fisch, MD, MPH, FACP
role: STUDY_CHAIR
affiliation: M.D. Anderson Cancer Center
name: Charles Cleeland, PhD
References:
citation: 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.
citation: 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). [Abstract] J Clin Oncol 30 (Suppl 15): A-6076, 2012.
citation: 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.
citation: 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.
citation: 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.
citation: Zhao F, Chang VT, Cleeland C, Cleary JF, Mitchell EP, Wagner LI, Fisch MJ. Determinants of pain severity changes in ambulatory patients with cancer: an analysis from Eastern Cooperative Oncology Group trial E2Z02. J Clin Oncol. 2014 Feb 1;32(4):312-9. doi: 10.1200/JCO.2013.50.6071. Epub 2013 Dec 23.