Pain and Fatigue Management in Patients With Breast Cancer, Prostate Cancer, Colon Cancer, or Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00900835|
Recruitment Status : Completed
First Posted : May 13, 2009
Last Update Posted : March 7, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Colorectal Cancer Fatigue Lung Cancer Pain Prostate Cancer||Other: educational intervention Other: questionnaire administration Other: study of socioeconomic and demographic variables Procedure: assessment of therapy complications Procedure: fatigue assessment and management Procedure: quality-of-life assessment Procedure: standard follow-up care||Not Applicable|
- 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 (Clinical Trial)|
|Actual Enrollment :||470 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Reducing Barriers to Pain and Fatigue Management|
|Study Start Date :||June 2005|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||August 2010|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00900835
|United States, California|
|City of Hope Comprehensive Cancer Center|
|Duarte, California, United States, 91010-3000|
|Principal Investigator:||Betty Ferrell, PhD||City of Hope Comprehensive Cancer Center|