Brain and Central Nervous System TumorsPhase 3NCT00666211
Opioid Titration Order Sheet or Standard Care in Treating Patients With Cancer Pain
A Phase 3 study testing educational intervention, Titrated pain management and questionnaire administration in people with Brain and Central Nervous System Tumors and Chronic Myeloproliferative Disorders, run by Vanderbilt-Ingram Cancer Center at 11 sites in United States.
Trial summary
RATIONALE: An Opioid Titration Order Sheet that allows healthcare providers to adjust the dose and schedule of pain medication may help improve pain treatment for patients with cancer. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Brain and Central Nervous System Tumors, Chronic Myeloproliferative Disorders, Leukemia
- What is being tested?
- educational intervention, Titrated pain management and questionnaire administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 11 sitesUnited States
- Study dates
- May 2005to May 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed carcinoma
- Cancer-related pain requiring fixed-dose opioid therapy
- Has received ≥ 1 week of fixed-dose opioid therapy AND meets any of the following criteria:
- Inadequate pain control as defined by the patient
- Requires 2 or more rescue doses per day
- Requires adjustments in pain regimen (either fixed or breakthrough dosing)
- No pain crisis that requires hospitalization or immediate anesthetic or neurosurgical intervention
- No predominantly neuropathic pain (e.g., peripheral neuropathy) as assessed by the treating physician
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- ANC > 1,500/mm³
- Platelet count > 100,000/mm³
- Serum bilirubin < 1.5 mg/dL
- Serum creatinine < 2.5 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Nutritional, pulmonary, and cardiac status must be considered adequate to tolerate the proposed study therapy
- Must be available for active follow-up
- No documented active psychiatric disorder (i.e., psychosis or major depression) that would preclude informed consent or the patient's ability to comply with study procedures
- No significant infection
- No concerns about compliance with medication regimens or medical follow-up
- No excessive alcohol use
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Concurrent chemotherapy or radiotherapy allowed
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Erlanger Health System
Chattanooga, Tennessee, 37403
Tennessee Plateau Oncology
Crossville, Tennessee, 38555
Jennie Stuart Medical Center
Hopkinsville, Kentucky, 44240
Center for Biomedical Research
Knoxville, Tennessee, 37909
The Jones Clinic
Memphis, Tennessee, 38138
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, 37064
Meharry Medical College
Nashville, Tennessee, 37208
Veterans Affairs Medical Center - Nashville
Nashville, Tennessee, 37212
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
Mitchell Memorial Cancer Center at Owensboro Medical Health System
Owensboro, Kentucky, 42303
About this study
Official title: Phase III Randomized Trial of an Opioid Titration Order Sheet Compared to Standard of Care in Patients With Cancer Related Pain.
RATIONALE: An Opioid Titration Order Sheet that allows healthcare providers to adjust the dose and schedule of pain medication may help improve pain treatment for patients with cancer. It is not yet known whether the use of an Opioid Titration Order Sheet is more effective than standard care in treating pain caused by cancer.
PURPOSE: This randomized phase III trial is studying an Opioid Titration Order Sheet to see how well it works compared with standard care in treating patients with cancer pain.
Read the detailed description
OBJECTIVES:
- To examine the effect of an opioid titration order sheet on pain outcomes.
- To examine the effect of an opioid titration order sheet on secondary outcomes of function, mood, and quality of life.
OUTLINE: This is a multicenter study. Participating centers are randomized to 1 of 2 treatment arms.
- Arm I (usual care): After completion of baseline assessments, patients undergo a standardized pain education program over approximately 15 minutes. The program consists of standard written materials about communicating pain to providers, opioids and side effect management, as well as a tailored discussion about patient concerns and specific information about prescribed opioid medications. Patients are also instructed in the use of the daily pain diary. Patients are then discharged from the clinic with instructions to contact the treating physician (through standard procedures) for problems with pain or side effects. The study staff conducts weekly telephone interviews to prevent changes in patient pain management practice. The treating physician continues to manage pain in their usual manner.
- Arm II (opioid titration order sheet): After completion of baseline assessments, patients undergo the standardized pain education program and are instructed in the use of the daily pain diary as described in arm I. The treating physician signs an Opioid Titration Order Sheet (OTOS) providing a baseline dose and schedule. The OTOS is faxed to study staff and verified. Patients are then discharged from the clinic with instructions to contact the research nurse for problems with pain or side effects. The treating physician also contacts the study staff if he/she is made aware of any problems pertaining to the patient's pain control. The research nurse, in consultation with study physician, manages pain according to the OTOS and manages opioid side effects using standing orders. Referral to the treating physician is made as needed.
Patients' pain is managed on study for 8 weeks in the absence of unacceptable toxicity, pain crisis, or new site of pain.
Patients complete a demographic questionnaire at baseline and other questionnaires at 2, 4, and 6 weeks (over the telephone) and at 8 weeks (at site or by telephone), including the Functional Assessment Screening Questionnaire (FASQ), the Brief Pain Inventory-Interference (PPI-I), The Profile of Mood States-Short Form (POMS-SF), and the Quality of life (FACT-G) questionnaire. Patients also complete a pain diary recording daily measures of pain dimensions, analgesic use (i.e., fixed dose opioids, rescue doses, and non-opioids), adjuvant medications, and side effects that prevented the patient from taking medications. Data in the pain diary is transcribed over the telephone on a weekly basis.
Clinical data, including the type of cancer, stage of disease, time since diagnosis, current treatment for cancer, type of pain, time since onset of pain, and time of first opioid prescription, as well as information regarding analgesics (opioid and non-opioid), adjuvant medications, and medications to manage side effects prescribed during the study is collected from patients' medical records. Anticancer and palliative treatment received during the study is monitored via treating physician records.
The physician charts are reviewed after study completion to determine whether pain, treatment, and response are adequately documented and treated. The documentation in the physician charts is compared to the documentation obtained by the study staff during the study.
- Conditions
- Brain and Central Nervous System Tumors, Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm
- Being tested
- educational intervention, Titrated pain management, questionnaire administration
- Keywords
- pain, unspecified adult solid tumor, protocol specific, accelerated phase chronic myelogenous leukemia, acute undifferentiated leukemia, adult acute lymphoblastic leukemia in remission, adult acute myeloid leukemia in remission, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), atypical chronic myeloid leukemia, BCR-ABL negative, blastic phase chronic myelogenous leukemia, chronic myelomonocytic leukemia, chronic phase chronic myelogenous leukemia, mast cell leukemia, meningeal chronic myelogenous leukemia, progressive hairy cell leukemia, initial treatment, prolymphocytic leukemia, recurrent adult acute lymphoblastic leukemia
- Medical subject headings
- Central Nervous System Neoplasms, Myeloproliferative Disorders, Leukemia, Lymphoma, Lymphoproliferative Disorders, Multiple Myeloma, Neoplasms, Plasma Cell, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational interventionOther
Participants will be educated on pain management.
Titrated pain managementOther
Pain will be Monitored and Medication Titrated
questionnaire administrationOther
Participants will be given questionnaires to complete.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Standard pain control drugs. Receives: Other: educational intervention; Other: questionnaire administration |
| Opioid Titration | Experimental | Pain will be Monitored and Medication Titrated Receives: Other: educational intervention; Other: Titrated pain management; Other: questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Patients in each arm will each have 9 measures: daily scores averaged over 1 week with baseline to week 8:
- Average daily pain intensity 0 (no pain) to 10 (worst) scale
- Worst daily pain intensity 0 (no pain) to 10 (worst) scale
Measured: Baseline(Week 0) to week 8, Total time frame is 9 weeks.
Pain-related Distress
Patients in each arm will each have 9 measures: daily scores averaged over 1 week with baseline to week 8. Pain-related distress scale is from 0 (no pain) to 10 (worst pain).
Measured: Baseline(Week 0) to week 8, Total time frame is 9 weeks.
Pain Duration
Pain duration in hours 0 to 24
Measured: at 9 weeks
Secondary outcomes (4)
Ability to Engage in Activities of Daily Living (ADL)
The Functional Assessment Screening Questionnaire (FASQ) scale is used, scored at baseline and at weeks 2, 4, 6, 8. The FASQ consists of 15 questions about ability to perform ADL with minimum score of 1 (easy to perform) to a maximum score of 5 (N/A, meaning someone else performs this activity for the patient or else the patient chooses not to do it). A summary mean score is generated with a minimum score of 1 and a maximum score of 5.
Measured: Baseline(Week 0) to week 8, Total time frame is 9 weeks.
Interference in Daily Life Due to Pain
Patients in each arm will each have 5 measures on the Brief Pain Inventory (BPI) scale: baseline + weeks 2, 4, 6, 8. The BPI consists of 7 questions about interference of pain in daily life, answered on a scale of 0 (does not interfere) to 10 (completely interferes). The summary score is the average from the 7 questions, with higher score indicating greater interference due to pain.
Measured: 9 weeks
Mood Disturbance
Patients in each arm will each have 5 measures on the Profile of Mood States-Short Form (POMS-SF): baseline + weeks 2, 4, 6, 8. The POMS-SF consists of 37 questions, querying 6 mood states (anxiety, depression, anger, confusion, fatigue, and vigor), with responses on a scale from 0 (not at all) to 4 (extremely). To generate a summary score, questions on vigor state are first recoded to reverse the scale, so that higher summary scores consistently indicate greater mood disturbance.
Measured: 9 weeks
Quality of Life
Each patient in each arm is scored on the Functional Assessment of Cancer Therapy-General (FACT-G) at baseline + week 8 with 4 related sub-scales (physical, social/family, emotional, functional well-being. To generate sub-scale scores, physical and emotional items are reverse coded \& items are then summed, such that higher values indicate better quality of life. Thus, each sub-scale score ranges from 0 (not at all, worse outcome) to 4 (very much, better outcome) with a minimum total score of 0 (worst quality of life) to a maximum of 16 (good quality of life).
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2008 (estimated)
- Study startMay 2005
- Primary completionJan 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Brain and Central Nervous System TumorsStudies 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Nancy Wells, Vanderbilt-Ingram Cancer Center
- Investigators
- Nancy Wells, DNSc, RN, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00666211
- Sponsor's protocol ID
- VICC SUPP 0424
- Other IDs
- P30CA068485, VU-VICC-SUPP-0424, VU-VICC-040410
- Status last verified
- Aug 2012
- First submitted
- 23 Apr 2008
- Last updated
- 6 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized Trial of an Opioid Titration Order Sheet Compared to Standard of Care in Patients With Cancer Related Pain.
- ClinicalTrials.gov ID
- NCT00666211
- Acronym / sponsor ID
- VICC SUPP 0424
- Conditions
- Brain and Central Nervous System Tumors, Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm
- Keywords
- pain, unspecified adult solid tumor, protocol specific, accelerated phase chronic myelogenous leukemia, acute undifferentiated leukemia, adult acute lymphoblastic leukemia in remission, adult acute myeloid leukemia in remission, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2005
- Primary completion
- Jan 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 24 Apr 2008 (estimated)
- Results
- Posted 6 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: An Opioid Titration Order Sheet that allows healthcare providers to adjust the dose and schedule of pain medication may help improve pain treatment for patients with cancer. It is not yet known whether the use of an Opioid Titration Order Sheet is more effective than standard care in treating pain caused by cancer.
PURPOSE: This randomized phase III trial is studying an Opioid Titration Order Sheet to see how well it works compared with standard care in treating patients with cancer pain.
Detailed description
OBJECTIVES:
- To examine the effect of an opioid titration order sheet on pain outcomes.
- To examine the effect of an opioid titration order sheet on secondary outcomes of function, mood, and quality of life.
OUTLINE: This is a multicenter study. Participating centers are randomized to 1 of 2 treatment arms.
- Arm I (usual care): After completion of baseline assessments, patients undergo a standardized pain education program over approximately 15 minutes. The program consists of standard written materials about communicating pain to providers, opioids and side effect management, as well as a tailored discussion about patient concerns and specific information about prescribed opioid medications. Patients are also instructed in the use of the daily pain diary. Patients are then discharged from the clinic with instructions to contact the treating physician (through standard procedures) for problems with pain or side effects. The study staff conducts weekly telephone interviews to prevent changes in patient pain management practice. The treating physician continues to manage pain in their usual manner.
- Arm II (opioid titration order sheet): After completion of baseline assessments, patients undergo the standardized pain education program and are instructed in the use of the daily pain diary as described in arm I. The treating physician signs an Opioid Titration Order Sheet (OTOS) providing a baseline dose and schedule. The OTOS is faxed to study staff and verified. Patients are then discharged from the clinic with instructions to contact the research nurse for problems with pain or side effects. The treating physician also contacts the study staff if he/she is made aware of any problems pertaining to the patient's pain control. The research nurse, in consultation with study physician, manages pain according to the OTOS and manages opioid side effects using standing orders. Referral to the treating physician is made as needed.
Patients' pain is managed on study for 8 weeks in the absence of unacceptable toxicity, pain crisis, or new site of pain.
Patients complete a demographic questionnaire at baseline and other questionnaires at 2, 4, and 6 weeks (over the telephone) and at 8 weeks (at site or by telephone), including the Functional Assessment Screening Questionnaire (FASQ), the Brief Pain Inventory-Interference (PPI-I), The Profile of Mood States-Short Form (POMS-SF), and the Quality of life (FACT-G) questionnaire. Patients also complete a pain diary recording daily measures of pain dimensions, analgesic use (i.e., fixed dose opioids, rescue doses, and non-opioids), adjuvant medications, and side effects that prevented the patient from taking medications. Data in the pain diary is transcribed over the telephone on a weekly basis.
Clinical data, including the type of cancer, stage of disease, time since diagnosis, current treatment for cancer, type of pain, time since onset of pain, and time of first opioid prescription, as well as information regarding analgesics (opioid and non-opioid), adjuvant medications, and medications to manage side effects prescribed during the study is collected from patients' medical records. Anticancer and palliative treatment received during the study is monitored via treating physician records.
The physician charts are reviewed after study completion to determine whether pain, treatment, and response are adequately documented and treated. The documentation in the physician charts is compared to the documentation obtained by the study staff during the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Other: educational intervention, Other: questionnaire administrationStandard pain control drugs. |
| Opioid Titration | Experimental | Other: educational intervention, Other: Titrated pain management, Other: questionnaire administrationPain will be Monitored and Medication Titrated |
Who may qualify
- Ages
- 21 years and older
- 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 |
|---|---|---|
| educational interventionParticipants will be educated on pain management. | Other | Opioid Titration, Standard of Care |
| Titrated pain managementPain will be Monitored and Medication Titrated | Other | Opioid Titration |
| questionnaire administrationParticipants will be given questionnaires to complete. | Other | Opioid Titration, Standard of Care |
Primary outcome
Pain Intensity
Time frame: Baseline(Week 0) to week 8, Total time frame is 9 weeks.
Patients in each arm will each have 9 measures: daily scores averaged over 1 week with baseline to week 8: 1. Average daily pain intensity 0 (no pain) to 10 (worst) scale 2. Worst daily pain intensity 0 (no pain) to 10 (worst) scale
Pain-related Distress
Time frame: Baseline(Week 0) to week 8, Total time frame is 9 weeks.
Patients in each arm will each have 9 measures: daily scores averaged over 1 week with baseline to week 8. Pain-related distress scale is from 0 (no pain) to 10 (worst pain).
Pain Duration
Time frame: at 9 weeks
Pain duration in hours 0 to 24
4 secondary outcomes
Ability to Engage in Activities of Daily Living (ADL)
Time frame: Baseline(Week 0) to week 8, Total time frame is 9 weeks.
Interference in Daily Life Due to Pain
Time frame: 9 weeks
Mood Disturbance
Time frame: 9 weeks
Quality of Life
Time frame: 9 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Nancy Wells, DNSc, RN principal investigator
Vanderbilt-Ingram Cancer Center
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing educational intervention, Titrated pain management and questionnaire administration in people with Brain and Central Nervous System Tumors and Chronic Myeloproliferative Disorders, run by Vanderbilt-Ingram Cancer Center at 11 sites in United States.
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: finished, as of the sponsor's last update on 6 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain Intensity (time frame: Baseline(Week 0) to week 8, Total time frame is 9 weeks.). The study lists 3 primary outcomes in all. 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 6 Sep 2012.