Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002668
Status:
TERMINATED
Last Update Posted:
2023-06-22
First Post:
1999-11-01
Brief Title:
Pain Control in Patients With Recurrent or Metastatic Breast or Prostate Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
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:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-P95-0068 | US NIH GrantContract | None | httpsreporternihgovquickSearchU10CA021115 |
| U10CA021115 | NIH | None | None |
| ECOG-3Z93 | None | None | None |