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
  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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Ambulatory Cancer Pain Management: A Feasibility Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: July 2006
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cancer Pain Management
Patients receiving chemotherapy for breast, colon, lung, or prostate cancer.
Behavioral: Questionnaire
3 questionnaires that will take 20 minutes total to complete.
Other Name: Survey

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 M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00507351     History of Changes
Other Study ID Numbers: 2005-0841
Study First Received: July 24, 2007
Last Updated: July 31, 2012
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

Additional relevant MeSH terms:
Breast Neoplasms
Colorectal Neoplasms
Lung Neoplasms
Prostatic Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014