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Opioid Titration Order Sheet or Standard Care in Treating Patients With Cancer Pain

Primary Purpose

Brain and Central Nervous System Tumors, Chronic Myeloproliferative Disorders, Leukemia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
educational intervention
Titrated pain management
questionnaire administration
Sponsored by
Vanderbilt-Ingram Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Brain and Central Nervous System Tumors focused on measuring 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

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jennie Stuart Medical Center
  • Mitchell Memorial Cancer Center at Owensboro Medical Health System
  • Erlanger Health System
  • Tennessee Plateau Oncology
  • Center for Biomedical Research
  • The Jones Clinic
  • Vanderbilt-Ingram Cancer Center - Cool Springs
  • Vanderbilt-Ingram Cancer Center at Franklin
  • Meharry Medical College
  • Veterans Affairs Medical Center - Nashville
  • Vanderbilt-Ingram Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care

Opioid Titration

Arm Description

Standard pain control drugs.

Pain will be Monitored and Medication Titrated

Outcomes

Primary Outcome Measures

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
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).
Pain Duration
Pain duration in hours 0 to 24

Secondary Outcome Measures

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.
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.
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.
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).

Full Information

First Posted
April 23, 2008
Last Updated
August 4, 2012
Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00666211
Brief Title
Opioid Titration Order Sheet or Standard Care in Treating Patients With Cancer Pain
Official Title
Phase III Randomized Trial of an Opioid Titration Order Sheet Compared to Standard of Care in Patients With Cancer Related Pain.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
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, 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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Standard pain control drugs.
Arm Title
Opioid Titration
Arm Type
Experimental
Arm Description
Pain will be Monitored and Medication Titrated
Intervention Type
Other
Intervention Name(s)
educational intervention
Intervention Description
Participants will be educated on pain management.
Intervention Type
Other
Intervention Name(s)
Titrated pain management
Intervention Description
Pain will be Monitored and Medication Titrated
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Description
Participants will be given questionnaires to complete.
Primary Outcome Measure Information:
Title
Pain Intensity
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
Time Frame
Baseline(Week 0) to week 8, Total time frame is 9 weeks.
Title
Pain-related Distress
Description
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).
Time Frame
Baseline(Week 0) to week 8, Total time frame is 9 weeks.
Title
Pain Duration
Description
Pain duration in hours 0 to 24
Time Frame
at 9 weeks
Secondary Outcome Measure Information:
Title
Ability to Engage in Activities of Daily Living (ADL)
Description
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.
Time Frame
Baseline(Week 0) to week 8, Total time frame is 9 weeks.
Title
Interference in Daily Life Due to Pain
Description
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.
Time Frame
9 weeks
Title
Mood Disturbance
Description
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.
Time Frame
9 weeks
Title
Quality of Life
Description
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).
Time Frame
9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Wells, DNSc, RN
Organizational Affiliation
Vanderbilt-Ingram Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jennie Stuart Medical Center
City
Hopkinsville
State/Province
Kentucky
ZIP/Postal Code
44240
Country
United States
Facility Name
Mitchell Memorial Cancer Center at Owensboro Medical Health System
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
Erlanger Health System
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Tennessee Plateau Oncology
City
Crossville
State/Province
Tennessee
ZIP/Postal Code
38555
Country
United States
Facility Name
Center for Biomedical Research
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
The Jones Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center - Cool Springs
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37064
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center at Franklin
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37064
Country
United States
Facility Name
Meharry Medical College
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37208
Country
United States
Facility Name
Veterans Affairs Medical Center - Nashville
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6838
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Opioid Titration Order Sheet or Standard Care in Treating Patients With Cancer Pain

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