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

Breast Cancer Clinical Trial

Official title:

Reducing Barriers to Pain and Fatigue Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00900835
• Other study ID #: 04140
• Secondary ID: R01CA115323P30CA
• Status: Completed
• Phase: N/A
• First received: May 12, 2009
• Last updated: March 3, 2011
• Start date: June 2005
• Est. completion date: August 2010

Study information

• Verified date: March 2011
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 470
• Est. completion date: August 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Colorectal Cancer
• Fatigue
• Lung Cancer
• Lung Neoplasms
• Pain
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• educational intervention

• questionnaire administration

• study of socioeconomic and demographic variables

Procedure:
• assessment of therapy complications

• fatigue assessment and management

• quality-of-life assessment

• standard follow-up care

Locations

Country	Name	City	State
United States	City of Hope Comprehensive Cancer Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life			No
Primary	Pain knowledge of patients and professionals			No
Primary	Fatigue knowledge of patients and professionals			No
Primary	Adherence to algorithm by patients, professionals, and system			No
Primary	Satisfaction of patients and professionals			No