Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-29 @ 12:59 AM
Study NCT ID:
NCT00900835
Status:
COMPLETED
Last Update Posted:
2011-03-07
First Post:
2009-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain and Fatigue Management in Patients With Breast Cancer, Prostate Cancer, Colon Cancer, or Lung Cancer
Sponsor:
City of Hope Medical Center
Organization:
Study Overview
Official Title:
Reducing Barriers to Pain and Fatigue Management
Status:
COMPLETED
Status Verified Date:
2011-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
PURPOSE: This clinical trial is studying pain and fatigue management in patients with breast cancer, prostate cancer, colon cancer, or lung cancer.
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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01CA115323 | NIH | None | https://reporter.nih.gov/quic… | View |
| P30CA033572 | NIH | None | https://reporter.nih.gov/quic… | View |
| CHNMC-04140 | None | None | View | |
| CDR0000628799 | REGISTRY | NCI PDQ | View |