 |
Clinical Trial Questions?
|
|
|
Randomized Pilot Study to Evaluate Educational Intervention and Behavioral Skills Training for Pain Control in Patients With Recurrent or Metastatic Breast or Prostate Cancer
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information
Alternate Title
Pain Control in Patients With Recurrent or Metastatic Breast or Prostate Cancer
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| No phase specified | Educational/Counseling/Training | Closed | 18 and over | ECOG-3Z93
NCI-P95-0068, NCT00002668 |
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.
Entry Criteria Disease Characteristics:
- Recurrent or metastatic breast or prostate cancer
- "Pain worst" score of 4 or greater on the Brief Pain Inventory
- No prior enrollment on this study (patients treated during the run-in
period
are ineligible for randomization)
- Hormone receptor status:
Prior/Concurrent Therapy:
Biologic therapy: Chemotherapy: Endocrine therapy: Radiotherapy: - At least 28 days since prior palliative radiotherapy to major
site(s) of pain
Surgery: - Greater than 30 days since prior surgery
Patient Characteristics:
Age: Menopausal status: Performance status: Hematopoietic: Hepatic: Renal: Other: - No major psychiatric illness, including the following
DSM-III-R diagnoses:
- Bipolar disorder
- Schizophrenia
- Major depression
- Multiple personality disorder
- Psychotic disorder
- Dementia
- Outpatient status required
Expected Enrollment 96A total of 96 patients (48 per arm) will be accrued for this study. 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.
Trial Contact Information
Trial Lead Organizations Eastern Cooperative Oncology Group | | | | Charles Cleeland, PhD, Protocol chair | | | Ph: 713-745-3470; 800-392-1611 |
| |
| Registry Information | | | Official Title | | PATIENT SKILLS FOR CANCER PAIN CONTROL IN PATIENTS WITH METASTATIC BREAST OR PROSTATE CANCER | | | Trial Start Date | | 1995-10-04 | | | Registered in ClinicalTrials.gov | | NCT00002668 | | | Date Submitted to PDQ | | 1995-10-04 | | | Information Last Verified | | 2002-09-03 | | | NCI Grant/Contract Number | | CA21115 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
|
