Pain and Fatigue Management in Patients With Breast Cancer, Prostate Cancer, Colon Cancer, or Lung Cancer
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Purpose
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 | Intervention |
|---|---|
|
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 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Reducing Barriers to Pain and Fatigue Management |
- Quality of life [ Designated as safety issue: No ]
- Pain knowledge of patients and professionals [ Designated as safety issue: No ]
- Fatigue knowledge of patients and professionals [ Designated as safety issue: No ]
- Adherence to algorithm by patients, professionals, and system [ Designated as safety issue: No ]
- Satisfaction of patients and professionals [ Designated as safety issue: No ]
| Enrollment: | 470 |
| Study Start Date: | June 2005 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, California | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010-3000 | |
| Principal Investigator: | Betty Ferrell, PhD | Beckman Research Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Betty Ferrell, City of Hope Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00900835 History of Changes |
| Other Study ID Numbers: | 04140, R01CA115323, P30CA033572, CHNMC-04140, CDR0000628799 |
| Study First Received: | May 12, 2009 |
| Last Updated: | March 3, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by City of Hope Medical Center:
|
fatigue pain recurrent breast cancer stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer recurrent prostate cancer stage I prostate cancer stage II prostate cancer stage III prostate cancer stage IV prostate cancer |
recurrent colon cancer stage I colon cancer stage II colon cancer stage III colon cancer stage IV colon cancer extensive stage small cell lung cancer limited stage small cell lung cancer recurrent non-small cell lung cancer recurrent small cell lung cancer stage I non-small cell lung cancer stage II non-small cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Colonic Neoplasms Colorectal Neoplasms Fatigue Lung Neoplasms Prostatic Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases |
Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Signs and Symptoms Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013