Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Ambulatory Cancer Pain Management: A Feasibility Study
This study is ongoing, but not recruiting participants.
Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00507351
  Purpose

The primary purpose of this study is to examine the feasibility of collecting pain and other symptom data in outpatient treatment centers across multiple institutions in the Texas Medical Center (TMC). We will also examine the prevalence and severity of cancer-related pain and begin to identify other commonly reported symptoms in outpatient settings. Factors that interfere with management of pain will also be examined. Additionally, the study will explore patient satisfaction with pain management and pain education in outpatient settings. The specific aims of this study include:

Primary Objective:

-Explore the feasibility of a collaborative effort by oncology nurses to collect pain and symptom data across multiple institutions that care for ambulatory cancer patients in the TMC.

Secondary Objectives:

  • Describe the prevalence and severity of pain and other symptoms in persons with breast, colorectal, lung, or prostate cancer who are receiving chemotherapy in the outpatient setting.
  • Describe factors that interfere with adequate pain management in these patients.
  • Examine patient satisfaction with pain management and patient education about pain management.

Condition Intervention
Breast Cancer
Colorectal Cancer
Lung Cancer
Prostate Cancer
Behavioral: Questionnaire

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Colorectal Cancer Lung Cancer Prostate Cancer
U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, Prospective
Official Title: Ambulatory Cancer Pain Management: A Feasibility Study

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • The primary goal of this psychosocial research study is for nurses to look at the process for collecting information from patients in the Texas Medical Center. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To identify pain and/or other symptoms experienced, any factors that may interfere with managing the pain, and about education received about managing pain. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 125
Study Start Date: July 2006
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Patients receiving chemotherapy for breast, colon, lung, or prostate cancer.
Behavioral: Questionnaire
3 questionnaires that will take 20 minutes total to complete.

Detailed Description:

You will be asked to complete 3 questionnaires that will take a total of about 20 minutes to complete. Your name or medical record number will not appear on the questionnaires. You will be assigned a study subject code number. The study chair will keep a file that links your name to the code.

The first questionnaire will ask for basic demographic information (such as gender, ethnicity, and education) and your current chemotherapy and pain medications. If you cannot remember the names of these medications, researchers will locate them in your M. D. Anderson medical record.

The second questionnaire asks you to rate your pain and a variety of symptoms (for example, fatigue and nausea).

The last questionnaire includes 3 sections. The first section asks about your beliefs about pain and its treatment. The second part asks for your opinion about your pain management and about the education you have received about pain management. On the last page, you will be asked to use a picture of the outline of a body to show the researchers where you have pain.

Once you have completed these questionnaires, you will be considered off-study.

This is an investigational study. Up to 125 patients will take part in this study. Up to 35 will be enrolled at M. D. Anderson.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients receiving chemotherapy for breast, colon, lung, or prostate cancer.

Criteria

Inclusion Criteria:

  1. Diagnosis of breast, colorectal, lung, or prostate cancer (any histological type).
  2. Currently undergoing chemotherapy.
  3. Age 18 or older.
  4. Able to read, write, and speak English.
  5. Able to understand the purpose of this study.
  6. Must be a patient at one of the four participating institutions.
  7. Must be receiving the 2nd, 3rd, or 4th cycle of chemotherapy.

Exclusion Criteria:

  1. Receiving chemotherapy in preparation for a bone marrow or stem cell transplant
  2. Received a bone marrow or stem cell transplant
  3. Age 17 or younger
  4. Receiving weekly chemotherapy.
  5. Receiving hormonal therapy alone.
  6. Receiving radiation or chemoradiation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00507351

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Michael E. DeBakey Veterans Administration Medical Center
Houston, Texas, United States, 77030
Methodist Hospital
Houston, Texas, United States, 77030
Memorial Hermann Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Anita Broxson, RN U.T.M.D. Anderson Cancer Center
  More Information

MD Anderson Cancer Center website  This link exits the ClinicalTrials.gov site

Responsible Party: U.T.M.D. Anderson Cancer Center ( Anita Broxson, RN/Program Director )
Study ID Numbers: 2005-0841
Study First Received: July 24, 2007
Last Updated: December 17, 2008
ClinicalTrials.gov Identifier: NCT00507351  
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer
Colorectal Cancer
Lung Cancer
Prostate Cancer
Pain Management
Questionnaire
Survey

Study placed in the following topic categories:
Thoracic Neoplasms
Digestive System Neoplasms
Prostatic Diseases
Genital Neoplasms, Male
Skin Diseases
Gastrointestinal Diseases
Colonic Diseases
Breast Neoplasms
Urogenital Neoplasms
Pain
Genital Diseases, Male
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Digestive System Diseases
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Gastrointestinal Neoplasms
Prostatic Neoplasms
Colorectal Neoplasms
Breast Diseases

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009