NCT00900835

Brief Summary

RATIONALE: Collecting information over time about patients' and health care providers' understanding of pain and fatigue and providing education about pain and fatigue management may improve quality of life. PURPOSE: This clinical trial is studying pain and fatigue management in patients with breast cancer, prostate cancer, colon cancer, or lung cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
470

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Jun 2005

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 13, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

March 7, 2011

Status Verified

March 1, 2011

Enrollment Period

4.3 years

First QC Date

May 12, 2009

Last Update Submit

March 3, 2011

Conditions

Breast CancerColorectal CancerFatigueLung CancerPainProstate Cancer

Keywords

fatiguepainrecurrent breast cancerstage I breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancerrecurrent prostate cancerstage I prostate cancerstage II prostate cancerstage III prostate cancerstage IV prostate cancerrecurrent colon cancerstage I colon cancerstage II colon cancerstage III colon cancerstage IV colon cancerextensive stage small cell lung cancerlimited stage small cell lung cancerrecurrent non-small cell lung cancerrecurrent small cell lung cancerstage I non-small cell lung cancerstage II non-small cell lung cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancerstage IV non-small cell lung cancer

Outcome Measures

Primary Outcomes (5)

  • Quality of life

  • Pain knowledge of patients and professionals

  • Fatigue knowledge of patients and professionals

  • Adherence to algorithm by patients, professionals, and system

  • Satisfaction of patients and professionals

Interventions

educational interventionOTHER
questionnaire administrationOTHER
study of socioeconomic and demographic variablesOTHER
assessment of therapy complicationsPROCEDURE
fatigue assessment and managementPROCEDURE
quality-of-life assessmentPROCEDURE
standard follow-up carePROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of breast, prostate, colon, or lung cancer (any stage) * Diagnosed ≥ 1 month before study entry * Reports pain and/or fatigue intensity ≥ 4 on a scale of 0-10 * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Menopausal status not specified * Life expectancy ≥ 6 months * Able to read and understand English PRIOR CONCURRENT THERAPY: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsColorectal NeoplasmsFatigueLung NeoplasmsPainProstatic NeoplasmsColonic NeoplasmsCarcinoma, Non-Small-Cell LungSmall Cell Lung Carcinoma

Interventions

Early Intervention, EducationalTherapeutics

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesNeurologic ManifestationsGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Betty Ferrell, PhD

    City of Hope Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 12, 2009

First Posted

May 13, 2009

Study Start

June 1, 2005

Primary Completion

September 1, 2009

Study Completion

August 1, 2010

Last Updated

March 7, 2011

Record last verified: 2011-03

Locations

US(1)