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Home > "P" Clinical Trials Conditions > Pain Control in Patients With Recurrent or Metastatic Breast or Prostate Cancer

Pain Control in Patients With Recurrent or Metastatic Breast or Prostate Cancer



Pain Control in Patients With Recurrent or Metastatic Breast or Prostate Cancer

For Condition: stage 4 breast cancer,recurrent breast cancer,stage 4 prostate cancer,recurrent prostate cancer,Pain
Status: Recruiting
Sponsor(s): Eastern Cooperative Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: An outpatient educational and behavioral skills training program may help patients with metastatic breast or prostate cancer live longer and more comfortably. PURPOSE: Randomizedpilot study to evaluate whether an outpatient educational and behavioral skills training program will improve pain control in patients who have metastatic or recurrent breast or prostate cancer.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol 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: - Not specified PATIENT CHARACTERISTICS: Age: - 18 and over Menopausal status: - Not specified Performance status: - ECOG 0-2 Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified 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 PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - Not specified Radiotherapy: - At least 28 days since prior palliative radiotherapy to major site(s) of pain Surgery: - Greater than 30 days since prior surgery
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
CharlesCleeland,  Study Chair,  M.D. Anderson Cancer Center

Westmead Hospital *Recruiting*
Westmead,  New South Wales,  2145
Australia
Recruiting Richard  Kefford 61-2-9845-6033

CCOP - Metro-Minnesota *Recruiting*
St. Louis Park,  Minnesota,  55416
United States
Recruiting Patrick  Flynn 952-993-15175

CCOP - Iowa Oncology Research Association *Recruiting*
Des Moines,  Iowa,  50309-1016
United States
Recruiting Roscoe  Morton 515-244-7586

Penn State Cancer Institute at Milton S. Hershey Medical Center *Recruiting*
Hershey,  Pennsylvania,  17033-0850
United States
Recruiting Witold  Rybka 717-531-1050

CCOP - Sioux Community Cancer Consortium *Recruiting*
Sioux Falls,  South Dakota,  57104
United States
Recruiting Loren  Tschetter 605-328-8044

Instituto de Enfermedades Neoplasicas *Recruiting*
Lima,  ,  34
Peru
Recruiting Carlos  Vallejos-Sologuren 51-14-499-137

CCOP - Northern New Jersey *Recruiting*
Hackensack,  New Jersey,  07601
United States
Recruiting Richard  Rosenbluth 201-996-5917

CCOP - Ochsner *Recruiting*
New Orleans,  Louisiana,  70121
United States
Recruiting Carl  Kardinal 504-842-3910

CCOP - Cedar Rapids Oncology Project *Recruiting*
Cedar Rapids,  Iowa,  52403-1206
United States
Recruiting Martin  Wiesenfeld 319-363-8303

CCOP - Carle Cancer Center *Recruiting*
Urbana,  Illinois,  61801
United States
Recruiting Kendrith  Rowland 217-383-4083

John Stoddard Cancer Center at Iowa Methodist Medical Center *Recruiting*
Des Moines,  Iowa,  50309
United States
Recruiting Roscoe  Morton 515-241-4245

CCOP - St. Vincent Hospital Cancer Center, Green Bay *Recruiting*
Green Bay,  Wisconsin,  54307-3453
United States
Recruiting Gerald  Bayer 920-433-8889

San Juan City Hospital *Recruiting*
San Juan,  ,  00936-7344
Puerto Rico
Recruiting Luis  Baez-Diaz 787-641-3693

Midlands Cancer Center at Midlands Community Hospital *Recruiting*
Papillion,  Nebraska,  68128-4157
United States
Recruiting James  Mailliard 402-593-3000

Iowa Lutheran Hospital *Recruiting*
Des Moines,  Iowa,  50316-2301
United States
Recruiting Roscoe  Morton 515-663-5612

Mercy Cancer Center at Mercy Medical Center-Des Moines *Recruiting*
Des Moines,  Iowa,  50314
United States
Recruiting Roscoe  Morton 515-247-3121

MBCCOP - University of New Mexico HSC *Recruiting*
Albuquerque,  New Mexico,  87131
United States
Recruiting Cynthia  Cathcart 505-272-5688

CCOP - MainLine Health *Recruiting*
Wynnewood,  Pennsylvania,  19096
United States
Recruiting Abigail  Silvers 610-645-2057


Additional Information:
Study ID Numbers:
  CDR0000064257;  ECOG-3Z93,NCI-P95-0068
Study Start Date: 
Record last reviewed: December 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002668

Other Stage 4 Breast Cancer Studies:
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3. BMS-247550 in Treating Women With Metastatic Breast Cancer

4. Drug Resistance Inhibition in Treating Patients With Recurrent or Metastatic Breast Cancer

5. Intravenous Interleukin-4 PE38KDEL Cytotoxin in Treating Patients With Recurrent or Metastatic Kidney Cancer, Non-Small Cell Lung Cancer, or Breast Cancer

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