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

Primary Purpose

Breast Cancer, Cognitive/Functional Effects, Colorectal Cancer

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
assessment of therapy complications
cognitive assessment
psychosocial assessment and care
Sponsored by
Eastern Cooperative Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Breast Cancer focused on measuring 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

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
  • John H. Stroger, Jr. Hospital of Cook County
  • Evanston Hospital
  • Elkhart General Hospital
  • Howard Community Hospital
  • Center for Cancer Therapy at LaPorte Hospital and Health Services
  • CCOP - Northern Indiana CR Consortium
  • Memorial Hospital of South Bend
  • Saint Joseph Regional Medical Center
  • South Bend Clinic
  • McFarland Clinic, PC
  • Mercy Cancer Center at Mercy Medical Center - North Iowa
  • Siouxland Hematology-Oncology Associates, LLP
  • Mercy Medical Center - Sioux City
  • St. Luke's Regional Medical Center
  • Saint Joseph Mercy Cancer Center
  • CCOP - Michigan Cancer Research Consortium
  • Oakwood Cancer Center at Oakwood Hospital and Medical Center
  • Genesys Hurley Cancer Institute
  • Hurley Medical Center
  • Van Elslander Cancer Center at St. John Hospital and Medical Center
  • Foote Memorial Hospital
  • Sparrow Regional Cancer Center
  • St. Mary Mercy Hospital
  • St. Joseph Mercy Oakland
  • Mercy Regional Cancer Center at Mercy Hospital
  • Seton Cancer Institute at Saint Mary's - Saginaw
  • Lakeland Regional Cancer Care Center - St. Joseph
  • St. John Macomb Hospital
  • Avera Cancer Institute
  • Medical X-Ray Center, PC
  • Sanford Cancer Center at Sanford USD Medical Center

Outcomes

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

Full Information

First Posted
March 15, 2006
Last Updated
June 14, 2023
Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00303914
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 14, 2006 (Actual)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 4, 2013 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Enrollment
2310 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
assessment of therapy complications
Intervention Type
Procedure
Intervention Name(s)
cognitive assessment
Intervention Type
Procedure
Intervention Name(s)
psychosocial assessment and care
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
Compare treatment priority based on physical or psychological symptoms
Title
Percentage of patients who experience a significant reduction in moderate-to-severe symptoms and characterize the determinants of symptom relief
Title
Focus and scope of interventions chosen to improve symptom control

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J. Fisch, MD, MPH, FACP
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Charles Cleeland, PhD
Organizational Affiliation
M.D. Anderson Cancer Center
Facility Information:
Facility Name
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3013
Country
United States
Facility Name
John H. Stroger, Jr. Hospital of Cook County
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-3785
Country
United States
Facility Name
Evanston Hospital
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201-1781
Country
United States
Facility Name
Elkhart General Hospital
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46515
Country
United States
Facility Name
Howard Community Hospital
City
Kokomo
State/Province
Indiana
ZIP/Postal Code
46904
Country
United States
Facility Name
Center for Cancer Therapy at LaPorte Hospital and Health Services
City
La Porte
State/Province
Indiana
ZIP/Postal Code
46350
Country
United States
Facility Name
CCOP - Northern Indiana CR Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Memorial Hospital of South Bend
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Saint Joseph Regional Medical Center
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
South Bend Clinic
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
McFarland Clinic, PC
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
Mercy Cancer Center at Mercy Medical Center - North Iowa
City
Mason City
State/Province
Iowa
ZIP/Postal Code
50401
Country
United States
Facility Name
Siouxland Hematology-Oncology Associates, LLP
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101
Country
United States
Facility Name
Mercy Medical Center - Sioux City
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51104
Country
United States
Facility Name
St. Luke's Regional Medical Center
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51104
Country
United States
Facility Name
Saint Joseph Mercy Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106-0995
Country
United States
Facility Name
CCOP - Michigan Cancer Research Consortium
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Oakwood Cancer Center at Oakwood Hospital and Medical Center
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48123-2500
Country
United States
Facility Name
Genesys Hurley Cancer Institute
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Van Elslander Cancer Center at St. John Hospital and Medical Center
City
Grosse Pointe Woods
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Foote Memorial Hospital
City
Jackson
State/Province
Michigan
ZIP/Postal Code
49201
Country
United States
Facility Name
Sparrow Regional Cancer Center
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912-1811
Country
United States
Facility Name
St. Mary Mercy Hospital
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48154
Country
United States
Facility Name
St. Joseph Mercy Oakland
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341-2985
Country
United States
Facility Name
Mercy Regional Cancer Center at Mercy Hospital
City
Port Huron
State/Province
Michigan
ZIP/Postal Code
48060
Country
United States
Facility Name
Seton Cancer Institute at Saint Mary's - Saginaw
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
Country
United States
Facility Name
Lakeland Regional Cancer Care Center - St. Joseph
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
St. John Macomb Hospital
City
Warren
State/Province
Michigan
ZIP/Postal Code
48093
Country
United States
Facility Name
Avera Cancer Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Medical X-Ray Center, PC
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Sanford Cancer Center at Sanford USD Medical Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117-5039
Country
United States

12. IPD Sharing Statement

Citations:
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.
Results Reference
result
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.
Results Reference
result
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.
Results Reference
result
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.
Results Reference
result
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.
Results Reference
result
PubMed Identifier
24366929
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.
Results Reference
derived

Learn more about this trial

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

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