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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00002668




Registration number
NCT00002668
Ethics application status
Date submitted
1/11/1999
Date registered
27/01/2003
Date last updated
22/06/2023

Titles & IDs
Public title
Pain Control in Patients With Recurrent or Metastatic Breast or Prostate Cancer
Scientific title
PATIENT SKILLS FOR CANCER PAIN CONTROL IN PATIENTS WITH METASTATIC BREAST OR PROSTATE CANCER
Secondary ID [1] 0 0
U10CA021115
Secondary ID [2] 0 0
CDR0000064257
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Pain 0 0
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Active comparator: Observation - Standard pain management interventions usually given by hospital staff

Experimental: Educational Intervention and Behavioral Skills Training - Patients participated in a program including video presentations, written materials, and coaching in behavioral skills to improve pain control (not to reduce analgesic use).
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in pain assessed using the Brief Pain Inventory
Timepoint [1] 0 0
Assessed over 15 days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
120 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/02/1996
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/1998
Sample size
Target
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois
Country [2] 0 0
United States of America
State/province [2] 0 0
Iowa
Country [3] 0 0
United States of America
State/province [3] 0 0
Louisiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Minnesota
Country [5] 0 0
United States of America
State/province [5] 0 0
Nebraska
Country [6] 0 0
United States of America
State/province [6] 0 0
New Jersey
Country [7] 0 0
United States of America
State/province [7] 0 0
New Mexico
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
South Dakota
Country [10] 0 0
United States of America
State/province [10] 0 0
Wisconsin
Country [11] 0 0
Peru
State/province [11] 0 0
Lima
Country [12] 0 0
Puerto Rico
State/province [12] 0 0
San Juan

Funding & Sponsors
Primary sponsor type
Other
Name
Eastern Cooperative Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00002668
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Charles Cleeland, PhD
Address 0 0
M.D. Anderson Cancer Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00002668