Breast CancerNCT00002668
Pain Control in Patients With Recurrent or Metastatic Breast or Prostate Cancer
A study testing Observation and Educational Intervention and Behavioral Skills Training in people with Breast Cancer and Pain, run by Eastern Cooperative Oncology Group at 18 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Breast Cancer, Pain, Prostate Cancer
- What is being tested?
- Observation and Educational Intervention and Behavioral Skills Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 18 sitesin 4 countries
- Study dates
- 14 Feb 1996to Sep 1998
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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 locations and contacts
18 sites in 4 countries.
18 sites in 4 countries
United States15 sites
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, 87131
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, 50309
Mercy Cancer Center at Mercy Medical Center-Des Moines
Des Moines, Iowa, 50314
Iowa Lutheran Hospital
Des Moines, Iowa, 50316-2301
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 54307-3453
CCOP - Northern New Jersey
Hackensack, New Jersey, 07601
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
CCOP - Ochsner
New Orleans, Louisiana, 70121
Midlands Cancer Center at Midlands Community Hospital
Papillion, Nebraska, 68128-4157
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096
About this study
Official title: PATIENT SKILLS FOR CANCER PAIN CONTROL IN PATIENTS WITH METASTATIC BREAST OR PROSTATE CANCER
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.
Read the detailed 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.
- Conditions
- Breast Cancer, Pain, Prostate Cancer
- Being tested
- Observation, Educational Intervention and Behavioral Skills Training
- Keywords
- stage IV breast cancer, recurrent breast cancer, stage IV prostate cancer, recurrent prostate cancer, pain
- Medical subject headings
- Breast Neoplasms, Pain, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationBehavioural
Educational Intervention and Behavioral Skills TrainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Observation | Active comparator | Standard pain management interventions usually given by hospital staff Receives: Behavioral: Observation |
| Educational Intervention and Behavioral Skills Training | Experimental | Patients participated in a program including video presentations, written materials, and coaching in behavioral skills to improve pain control (not to reduce analgesic use). Receives: Behavioral: Educational Intervention and Behavioral Skills Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain assessed using the Brief Pain Inventory
Change in worst pain from baseline to day 15
Measured: Assessed over 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study start14 Feb 1996
- Primary completionSep 1998
- Study completionSep 1998
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Cooperative Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Charles Cleeland, PhD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002668
- Sponsor's protocol ID
- CDR0000064257
- Other IDs
- U10CA021115, ECOG-3Z93, NCI-P95-0068
- Status last verified
- Jun 2023
- First submitted
- 1 Nov 1999
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PATIENT SKILLS FOR CANCER PAIN CONTROL IN PATIENTS WITH METASTATIC BREAST OR PROSTATE CANCER
- ClinicalTrials.gov ID
- NCT00002668
- Acronym / sponsor ID
- CDR0000064257
- Conditions
- Breast Cancer, Pain, Prostate Cancer
- Keywords
- stage IV breast cancer, recurrent breast cancer, stage IV prostate cancer, recurrent prostate cancer, pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Eastern Cooperative Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 14 Feb 1996 (actual)
- Primary completion
- Sep 1998 (actual)
- Study completion
- Sep 1998 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observation | Active comparator | Behavioral: ObservationStandard pain management interventions usually given by hospital staff |
| Educational Intervention and Behavioral Skills Training | Experimental | Behavioral: Educational Intervention and Behavioral Skills TrainingPatients participated in a program including video presentations, written materials, and coaching in behavioral skills to improve pain control (not to reduce analgesic use). |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation | Behavioural | Observation |
| Educational Intervention and Behavioral Skills Training | Behavioural | Educational Intervention and Behavioral Skills Training |
Primary outcome
Change in pain assessed using the Brief Pain Inventory
Time frame: Assessed over 15 days
Change in worst pain from baseline to day 15
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Cleeland, PhD study chair
M.D. Anderson Cancer Center
18 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Observation and Educational Intervention and Behavioral Skills Training in people with Breast Cancer and Pain, run by Eastern Cooperative Oncology Group at 18 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Australia, Peru, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain assessed using the Brief Pain Inventory (time frame: Assessed over 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.