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Ambulatory Cancer Pain Management: A Feasibility Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00507351
First received: July 24, 2007
Last updated: July 31, 2012
Last verified: July 2012

July 24, 2007
July 31, 2012
July 2006
July 2009   (final data collection date for primary outcome measure)
Pain and symptom data across multiple institutions [ Time Frame: Survey data collection taking 30 minutes, collecation accomplished at multiple sites over 3 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00507351 on ClinicalTrials.gov Archive Site
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Ambulatory Cancer Pain Management: A Feasibility Study
Ambulatory Cancer Pain Management: A Feasibility Study

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
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Non-Probability Sample

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

  • Breast Cancer
  • Colorectal Cancer
  • Lung Cancer
  • Prostate Cancer
Behavioral: Questionnaire
3 questionnaires that will take 20 minutes total to complete.
Other Name: Survey
Cancer Pain Management
Patients receiving chemotherapy for breast, colon, lung, or prostate cancer.
Intervention: Behavioral: Questionnaire
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
July 2009
July 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00507351
2005-0841
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Not Provided
Principal Investigator: Anita Broxson, RN M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP