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Phase III Randomized Trial of an Opioid Titration Order Sheet Compared to Standard of Care in Patients With Cancer Related Pain.


Phase 3
21 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors, Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms, Pain, Precancerous Condition, Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

Phase III Randomized Trial of an Opioid Titration Order Sheet Compared to Standard of Care in Patients With Cancer Related Pain.


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Pain Intensity

Outcome Description:

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

Outcome Time Frame:

Baseline(Week 0) to week 8, Total time frame is 9 weeks.

Safety Issue:

No

Principal Investigator

Nancy Wells, DNSc, RN

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

VICC SUPP 0424

NCT ID:

NCT00666211

Start Date:

May 2005

Completion Date:

May 2010

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Chronic Myeloproliferative Disorders
  • Leukemia
  • Lymphoma
  • Lymphoproliferative Disorder
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Neoplasms
  • Pain
  • Precancerous Condition
  • Unspecified Adult Solid Tumor, Protocol Specific
  • 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
  • recurrent adult acute myeloid leukemia
  • recurrent adult T-cell leukemia/lymphoma
  • refractory chronic lymphocytic leukemia
  • refractory hairy cell leukemia
  • relapsing chronic myelogenous leukemia
  • secondary acute myeloid leukemia
  • stage I adult T-cell leukemia/lymphoma
  • stage I chronic lymphocytic leukemia
  • stage II adult T-cell leukemia/lymphoma
  • stage II chronic lymphocytic leukemia
  • stage III adult T-cell leukemia/lymphoma
  • stage III chronic lymphocytic leukemia
  • stage IV adult T-cell leukemia/lymphoma
  • stage IV chronic lymphocytic leukemia
  • T-cell large granular lymphocyte leukemia
  • stage I adult Hodgkin lymphoma
  • stage II adult Hodgkin lymphoma
  • stage III adult Hodgkin lymphoma
  • stage IV adult Hodgkin lymphoma
  • anaplastic large cell lymphoma
  • angioimmunoblastic T-cell lymphoma
  • cutaneous B-cell non-Hodgkin lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • stage I cutaneous T-cell non-Hodgkin lymphoma
  • stage II cutaneous T-cell non-Hodgkin lymphoma
  • stage III cutaneous T-cell non-Hodgkin lymphoma
  • stage IV cutaneous T-cell non-Hodgkin lymphoma
  • recurrent mycosis fungoides/Sezary syndrome
  • stage I mycosis fungoides/Sezary syndrome
  • stage II mycosis fungoides/Sezary syndrome
  • stage III mycosis fungoides/Sezary syndrome
  • stage IV mycosis fungoides/Sezary syndrome
  • adult grade III lymphomatoid granulomatosis
  • adult nasal type extranodal NK/T-cell lymphoma
  • Waldenstrom macroglobulinemia
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • contiguous stage II adult Burkitt lymphoma
  • contiguous stage II adult diffuse large cell lymphoma
  • contiguous stage II adult diffuse mixed cell lymphoma
  • contiguous stage II adult diffuse small cleaved cell lymphoma
  • contiguous stage II adult immunoblastic large cell lymphoma
  • contiguous stage II adult lymphoblastic lymphoma
  • contiguous stage II grade 1 follicular lymphoma
  • contiguous stage II grade 2 follicular lymphoma
  • contiguous stage II grade 3 follicular lymphoma
  • contiguous stage II mantle cell lymphoma
  • contiguous stage II marginal zone lymphoma
  • stage I adult Burkitt lymphoma
  • stage I adult diffuse large cell lymphoma
  • stage I adult diffuse mixed cell lymphoma
  • stage I adult diffuse small cleaved cell lymphoma
  • stage I adult immunoblastic large cell lymphoma
  • stage I adult lymphoblastic lymphoma
  • stage I grade 1 follicular lymphoma
  • stage I grade 2 follicular lymphoma
  • stage I grade 3 follicular lymphoma
  • stage I mantle cell lymphoma
  • stage I marginal zone lymphoma
  • stage I small lymphocytic lymphoma
  • noncontiguous stage II adult Burkitt lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult diffuse mixed cell lymphoma
  • noncontiguous stage II adult diffuse small cleaved cell lymphoma
  • noncontiguous stage II adult immunoblastic large cell lymphoma
  • noncontiguous stage II adult lymphoblastic lymphoma
  • noncontiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • noncontiguous stage II marginal zone lymphoma
  • noncontiguous stage II small lymphocytic lymphoma
  • stage III adult Burkitt lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage III mantle cell lymphoma
  • stage III marginal zone lymphoma
  • stage III small lymphocytic lymphoma
  • stage IV adult Burkitt lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV mantle cell lymphoma
  • stage IV marginal zone lymphoma
  • stage IV small lymphocytic lymphoma
  • recurrent adult Burkitt lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult grade III lymphomatoid granulomatosis
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent mantle cell lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • intraocular lymphoma
  • primary central nervous system non-Hodgkin lymphoma
  • primary central nervous system Hodgkin lymphoma
  • post-transplant lymphoproliferative disorder
  • chronic eosinophilic leukemia
  • chronic neutrophilic leukemia
  • primary myelofibrosis
  • essential thrombocythemia
  • polycythemia vera
  • extramedullary plasmacytoma
  • isolated plasmacytoma of bone
  • monoclonal gammopathy of undetermined significance
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • primary systemic amyloidosis
  • refractory multiple myeloma
  • de novo myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • myelodysplastic/myeloproliferative neoplasm, unclassifiable
  • recurrent adult Hodgkin lymphoma
  • Neoplasms
  • Leukemia
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoproliferative Disorders
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Nervous System Neoplasms
  • Precancerous Conditions
  • Lymphoma, Large-Cell, Immunoblastic
  • Central Nervous System Neoplasms
  • Myelodysplastic-Myeloproliferative Diseases

Name

Location

Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Veterans Affairs Medical Center - NashvilleNashville, Tennessee  37212
Center for Biomedical ResearchKnoxville, Tennessee  37909
Meharry Medical CollegeNashville, Tennessee  37208-3599
Mitchell Memorial Cancer Center at Owensboro Medical Health SystemOwensboro, Kentucky  42303
Erlanger Health SystemChattanooga, Tennessee  37403
The Jones ClinicGermantown, Tennessee  38138
Vanderbilt-Ingram Cancer Center - Cool SpringsNashville, Tennessee  37064
Vanderbilt-Ingram Cancer Center at FranklinNashville, Tennessee  37064
Jennie Stuart Medical CenterHopkinsville, Kentucky  42240
Tennessee Plateau OncologyCrossville, Tennessee  38555