Pain and Fatigue Management in Patients With Breast Cancer, Prostate Cancer, Colon Cancer, or Lung Cancer

Reducing Barriers to Pain and Fatigue Management

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.

Study Overview

• Status: Completed
• Conditions: Pain; Breast Cancer; Fatigue; Colorectal Cancer; Lung Cancer; Prostate Cancer
• Intervention / Treatment: Other: questionnaire administration; Procedure: quality-of-life assessment; Other: educational intervention; Other: study of socioeconomic and demographic variables; Procedure: fatigue assessment and management; Procedure: assessment of therapy complications; Procedure: standard follow-up care

Detailed Description

OBJECTIVES:

• To test the effects of the Passport to Comfort (Passport) intervention at 1 and 3 months post-intervention by comparing baseline data to the high-intensity intervention.
• To test the effects of select demographic and disease/treatment variables on outcomes of the Passport model at 1 and 3 months post-intervention compared to pre-intervention.
• To examine perceived patient and professional satisfaction with the Passport model.
• To test the effects of the Passport intervention by comparing high-intensity to low-intensity.

OUTLINE: Patients are stratified according to cancer diagnosis (breast vs prostate vs colon vs lung), pain level (< 4 vs ≥ 4 on pain scale), and fatigue level (< 4 vs ≥ 4 on fatigue scale). Patients are assigned to 1 of 3 groups.

• Group 1 (enrolled during months 1-8): Patients undergo pain and fatigue assessment periodically by demographic and treatment data, Quality of life-Patient Tool, BQII, Piper Fatigue Scale, Pain and Fatigue Knowledge Tools, and Patient Satisfaction Tool. Patients receive usual care and undergo pain and fatigue evaluation with no algorithms or formal education. Research nurses conduct chart audits to identify professional and system barriers but receive no medical education, peer review, or feedback. Medical professionals undergo assessment periodically by a Demographic Data Tool, Pain and Fatigue Knowledge Tools, Chart Audit Tool, and Provider Satisfaction.
• Group 2 (enrolled during months 9-30): Patients and medical professionals are assessed periodically as in group 1. Patients undergo a high-intensity Passport intervention with algorithms based on National Comprehensive Cancer Network (NCCN) guidelines, pain and fatigue education once weekly for 4 weeks, and follow-up reinforcement phone calls every 2 weeks. Research nurses conduct chart audits of congruence between practice and guidelines, tape education sessions, and receive feedback from the principal investigator in the form of a Tape-Monitoring Checklist. Medical oncologists attend training on the use of the algorithms, peer review pain and fatigue management audit with feedback, and reinforce and apply content in clinical rounds.
• Group 3 (enrolled during months 34-57): Patients and medical professionals are assessed periodically as in group 1. Patients undergo a low-intensity Passport intervention as in group 2. Medical professionals conduct realistic implementation of the intervention into existing systems and procedures within the cancer center, less direct education and system intervention, and share group 2 experiences.

After completion of study intervention, patients are followed at 1 and 3 months.

• Study Type: Interventional
• Enrollment (Actual): 470
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010-3000
      • City of Hope Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: May 12, 2009
• First Submitted That Met QC Criteria: May 12, 2009
• First Posted (Estimate): May 13, 2009

Study Record Updates

• Last Update Posted (Estimate): March 7, 2011
• Last Update Submitted That Met QC Criteria: March 3, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: stage IV breast cancer; stage IIIA breast cancer; recurrent breast cancer; stage IIIB breast cancer; recurrent non-small cell lung cancer; extensive stage small cell lung cancer; recurrent small cell lung cancer; stage III prostate cancer; stage IV prostate cancer; recurrent prostate cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; pain; fatigue; stage IV colon cancer; recurrent colon cancer; stage I non-small cell lung cancer; stage II non-small cell lung cancer; stage III colon cancer; stage II breast cancer; stage IIIC breast cancer; stage I breast cancer; limited stage small cell lung cancer; stage I prostate cancer; stage II prostate cancer; stage II colon cancer; stage I colon cancer
• Additional Relevant MeSH Terms: Skin Diseases; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Breast Diseases; Prostatic Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Breast Neoplasms; Fatigue; Prostatic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 04140; P30CA033572 (U.S. NIH Grant/Contract); R01CA115323 (U.S. NIH Grant/Contract); CHNMC-04140; CDR0000628799 (Registry Identifier: NCI PDQ)