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Pain Control in Patients With Recurrent or Metastatic Breast or Prostate Cancer Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Pain Control in Patients With Recurrent or Metastatic Breast or Prostate Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Pain Control in Patients With Recurrent or Metastatic Breast or Prostate Cancer Clinical research trials and Pain Control in Patients With Recurrent or Metastatic Breast or Prostate Cancer medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Pain Control in Patients With Recurrent or Metastatic Breast or Prostate Cancer. Pain Control in Patients With Recurrent or Metastatic Breast or Prostate Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Pain Control in Patients With Recurrent or Metastatic Breast or Prostate Cancer clinical trial. Participants frequently get the best healthcare available for their Pain Control in Patients With Recurrent or Metastatic Breast or Prostate Cancer condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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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 Pain Studies:
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2. Paclitaxel or Docetaxel in Treating Women With Advanced Breast Cancer
3. Chemotherapy in Treating Women With Metastatic Breast Cancer
4. Allogeneic Peripheral Stem Cell Transplantation After Antithymocyte Globulin, High-Dose Melphalan, and Fludarabine in Treating Women With Metastatic Adenocarcinoma of the Breast
5. Letrozole With or Without CCI-779 in Treating Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer
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Pain Control in Patients With Recurrent or Metastatic Breast or Prostate Cancer
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