NCT00507351

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2006

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

August 1, 2012

Status Verified

July 1, 2012

Enrollment Period

3 years

First QC Date

July 24, 2007

Last Update Submit

July 31, 2012

Conditions

Breast CancerColorectal CancerLung CancerProstate Cancer

Keywords

Breast CancerColorectal CancerLung CancerProstate CancerPain ManagementQuestionnaireSurvey

Outcome Measures

Primary Outcomes (1)

  • Pain and symptom data across multiple institutions

    Survey data collection taking 30 minutes, collecation accomplished at multiple sites over 3 years

Study Arms (1)

Cancer Pain Management

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

Behavioral: Questionnaire

Interventions

QuestionnaireBEHAVIORAL

3 questionnaires that will take 20 minutes total to complete.

Also known as: Survey
Cancer Pain Management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Receiving chemotherapy in preparation for a bone marrow or stem cell transplant
  • Received a bone marrow or stem cell transplant
  • Age 17 or younger
  • Receiving weekly chemotherapy.
  • Receiving hormonal therapy alone.
  • Receiving radiation or chemoradiation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

Methodist Hospital

Houston, Texas, 77030, United States

Location

Michael E. DeBakey Veterans Administration Medical Center

Houston, Texas, 77030, United States

Location

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Breast NeoplasmsColorectal NeoplasmsLung NeoplasmsProstatic NeoplasmsAgnosia

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Anita Broxson, RN

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2007

First Posted

July 26, 2007

Study Start

July 1, 2006

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

August 1, 2012

Record last verified: 2012-07

Locations

US(4)