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

Eastern Cooperative Oncology Group

Status: Terminated

Conditions: Breast Cancer; Prostate Cancer; Pain

Treatments: Behavioral: Educational Intervention and Behavioral Skills Training; Behavioral: Observation

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00002668

NCI-P95-0068

ECOG-3Z93

CDR0000064257

U10CA021115 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

Observation

Active Comparator group

Description:

Standard pain management interventions usually given by hospital staff

Treatment:

Behavioral: Observation

Educational Intervention and Behavioral Skills Training

Experimental group

Description:

Patients participated in a program including video presentations, written materials, and coaching in behavioral skills to improve pain control (not to reduce analgesic use).

Treatment:

Behavioral: Educational Intervention and Behavioral Skills Training