Know Cancer

or
forgot password

PATIENT SKILLS FOR CANCER PAIN CONTROL IN PATIENTS WITH METASTATIC BREAST OR PROSTATE CANCER


N/A
18 Years
N/A
Not Enrolling
Both
Breast Cancer, Pain, Prostate Cancer

Thank you

Trial Information

PATIENT SKILLS FOR CANCER PAIN CONTROL IN PATIENTS WITH METASTATIC BREAST OR PROSTATE CANCER


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

Change in pain assessed using the Brief Pain Inventory

Outcome Description:

Change in worst pain from baseline to day 15

Outcome Time Frame:

Assessed over 15 days

Safety Issue:

No

Principal Investigator

Charles Cleeland, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000064257

NCT ID:

NCT00002668

Start Date:

October 1995

Completion Date:

September 1998

Related Keywords:

  • Breast Cancer
  • Pain
  • Prostate Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • stage IV prostate cancer
  • recurrent prostate cancer
  • pain
  • Breast Neoplasms
  • Prostatic Neoplasms

Name

Location

CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - Northern New JerseyHackensack, New Jersey  07601
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
CCOP - OchsnerNew Orleans, Louisiana  70121
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico  87131
CCOP - St. Vincent Hospital Cancer Center, Green BayGreen Bay, Wisconsin  54301
Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
Mercy Cancer Center at Mercy Medical Center-Des MoinesDes Moines, Iowa  50314
Midlands Cancer Center at Midlands Community HospitalPapillion, Nebraska  68128-4157