Ignite Creation Date:
2025-12-24 @ 5:52 PM
Ignite Modification Date:
2025-12-30 @ 1:45 AM
Study NCT ID:
NCT00002668
Status:
TERMINATED
Last Update Posted:
2023-06-22
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain Control in Patients With Recurrent or Metastatic Breast or Prostate Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Study Overview
Official Title:
PATIENT SKILLS FOR CANCER PAIN CONTROL IN PATIENTS WITH METASTATIC BREAST OR PROSTATE CANCER
Status:
TERMINATED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE: An outpatient educational and behavioral skills training program may help patients with metastatic breast or prostate cancer live longer and more comfortably.
PURPOSE: This randomized clinical trial studies whether an outpatient educational and behavioral skills training program will improve pain control in patients who have metastatic or recurrent breast or prostate cancer.
PURPOSE: This randomized clinical trial studies whether an outpatient educational and behavioral skills training program will improve pain control in patients who have metastatic or recurrent breast or prostate cancer.
Detailed Description:
OBJECTIVES:
* Evaluate the feasibility of implementing an outpatient education and behavioral skills training program for pain control in a multi-institution setting.
* Evaluate whether patient education and behavioral skills training improve cancer pain control in patients with recurrent or metastatic breast or prostate cancer.
* Amend the protocol, with the approval of the Division of Cancer Prevention and Control, to a groupwide 3-arm study if analysis demonstrates feasibility and potential efficacy of the patient education and behavioral skills training program.
OUTLINE: This is a randomized study. Patients are stratified according to diagnosis (breast vs prostate cancer), initial "pain worst" score (4-6 vs 7 or higher), and participating institution. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive standard pain management.
* Arm II: Patients receive educational intervention (booklets, audiotapes, and videotapes) and behavioral skills training (including a schedule of practice relaxation sessions) in addition to standard pain management. Patients receive a follow-up phone call within 48-72 hours of intervention to review pain status.
Patients on both arms undergo pain and psychological assessments on days 1 and 15.
PROJECTED ACCRUAL: A total of 96 patients (48 per arm) will be accrued for this study.
* Evaluate the feasibility of implementing an outpatient education and behavioral skills training program for pain control in a multi-institution setting.
* Evaluate whether patient education and behavioral skills training improve cancer pain control in patients with recurrent or metastatic breast or prostate cancer.
* Amend the protocol, with the approval of the Division of Cancer Prevention and Control, to a groupwide 3-arm study if analysis demonstrates feasibility and potential efficacy of the patient education and behavioral skills training program.
OUTLINE: This is a randomized study. Patients are stratified according to diagnosis (breast vs prostate cancer), initial "pain worst" score (4-6 vs 7 or higher), and participating institution. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive standard pain management.
* Arm II: Patients receive educational intervention (booklets, audiotapes, and videotapes) and behavioral skills training (including a schedule of practice relaxation sessions) in addition to standard pain management. Patients receive a follow-up phone call within 48-72 hours of intervention to review pain status.
Patients on both arms undergo pain and psychological assessments on days 1 and 15.
PROJECTED ACCRUAL: A total of 96 patients (48 per arm) will be accrued for this study.
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 |
|---|---|---|---|---|
| U10CA021115 | NIH | None | https://reporter.nih.gov/quic… | View |
| ECOG-3Z93 | None | None | View | |
| NCI-P95-0068 | None | None | View |