Skip to content
Triangle logo TriangleGet started
← Study library

NCT00666211 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2012-09-06

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Pain Intensity

→

outcome · POSTED

Ability to Engage in Activities of Daily Living (ADL)

→

outcome · POSTED

Interference in Daily Life Due to Pain

→

outcome · POSTED

Mood Disturbance

→

outcome · POSTED

Quality of Life

→

outcome · POSTED

Pain-related Distress

→

outcome · POSTED

Pain Duration

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
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
healthy Volunteers
false
minimum Age
21 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Standard pain control drugs.
    intervention Names
    1. Other: educational intervention
    2. Other: questionnaire administration
    label
    Standard of Care
    type
    ACTIVE_COMPARATOR
  2. description
    Pain will be Monitored and Medication Titrated
    intervention Names
    1. Other: educational intervention
    2. Other: Titrated pain management
    3. Other: questionnaire administration
    label
    Opioid Titration
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Opioid Titration
    2. Standard of Care
    description
    Participants will be educated on pain management.
    name
    educational intervention
    type
    OTHER
  2. arm Group Labels
    1. Opioid Titration
    description
    Pain will be Monitored and Medication Titrated
    name
    Titrated pain management
    type
    OTHER
  3. arm Group Labels
    1. Opioid Titration
    2. Standard of Care
    description
    Participants will be given questionnaires to complete.
    name
    questionnaire administration
    type
    OTHER
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
SUPPORTIVE_CARE
Enrollment
count
98
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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
    measure
    Pain Intensity
    time Frame
    Baseline(Week 0) to week 8, Total time frame is 9 weeks.
  2. 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).
    measure
    Pain-related Distress
    time Frame
    Baseline(Week 0) to week 8, Total time frame is 9 weeks.
  3. description
    Pain duration in hours 0 to 24
    measure
    Pain Duration
    time Frame
    at 9 weeks
secondary Outcomes
  1. 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.
    measure
    Ability to Engage in Activities of Daily Living (ADL)
    time Frame
    Baseline(Week 0) to week 8, Total time frame is 9 weeks.
  2. 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.
    measure
    Interference in Daily Life Due to Pain
    time Frame
    9 weeks
  3. 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.
    measure
    Mood Disturbance
    time Frame
    9 weeks
  4. 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).
    measure
    Quality of Life
    time Frame
    9 weeks
Full 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.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-288500358c6d6b8ced62
      requested nct id
      NCT00666211
      primary nct id
      NCT00666211
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      cddcd4e3a59550bc78924062a298c359d8f811413f73f4a4461963aecf3790d6
      payload sha256
      125eacb27484d197d93bf9fc6a066b9f50ce748ff2ec8856e08cb51fec3218d9
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-288500358c6d6b8ced62
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00666211
      occurrences
      1. context exact
        NCT00666211
        end
        11
        exact text
        NCT00666211
        start
        0
      offset unit
      unicode_code_points
      query cond
      Juvenile Myelomonocytic Leukemia
      query disease state id
      ds-juvenile-myelomonocytic-leukemia
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-juvenile-myelomonocytic-leukemia-000.json
      source file sha256
      cddcd4e3a59550bc78924062a298c359d8f811413f73f4a4461963aecf3790d6
      source json pointer
      /studies/68/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      efabce8d4f12762ac6ac810ff7b6f65af2c015e27783e1e32ceb3562f9a81bab
    2. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-8c06b518b3b067a208cf
      requested nct id
      NCT00666211
      primary nct id
      NCT00666211
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      a6089e8b15d43633ec778b2a5c464ada1207289beea2ae90de3e4bbe04b32186
      payload sha256
      80d0cfb626dcc15eab70f8aac93eaf0c86378aa2c8a7da23b6f7a7399d17a0e0
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-8c06b518b3b067a208cf
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00666211
      occurrences
      1. context exact
        NCT00666211
        end
        11
        exact text
        NCT00666211
        start
        0
      offset unit
      unicode_code_points
      query cond
      Acute Undifferentiated Leukemia
      query disease state id
      ds-acute-undifferentiated-leukemia
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-acute-undifferentiated-leukemia-000.json
      source file sha256
      a6089e8b15d43633ec778b2a5c464ada1207289beea2ae90de3e4bbe04b32186
      source json pointer
      /studies/25/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      efabce8d4f12762ac6ac810ff7b6f65af2c015e27783e1e32ceb3562f9a81bab
    3. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-a19488426dabb908f996
      requested nct id
      NCT00666211
      primary nct id
      NCT00666211
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      1f6ffef8d557bd3ff6e7738a80f73b58dddfc3fab889f2661577c6dd238f078c
      payload sha256
      fb6543ceaab8b9bbcd710e3bc701cacfe5dcfae3c51134006559238e4e678064
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-a19488426dabb908f996
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00666211
      occurrences
      1. context exact
        NCT00666211
        end
        11
        exact text
        NCT00666211
        start
        0
      offset unit
      unicode_code_points
      query cond
      Infant Acute Undifferentiated Leukemia
      query disease state id
      ds-infant-acute-undifferentiated-leukemia
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-infant-acute-undifferentiated-leukemia-000.json
      source file sha256
      1f6ffef8d557bd3ff6e7738a80f73b58dddfc3fab889f2661577c6dd238f078c
      source json pointer
      /studies/15/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      efabce8d4f12762ac6ac810ff7b6f65af2c015e27783e1e32ceb3562f9a81bab
    4. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-a8ecd4cef79dccd06cd4
      requested nct id
      NCT00666211
      primary nct id
      NCT00666211
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      5133d5efc2041fb2554b035b378f2db0c15cad34dada88cd170d20b9c4e7432a
      payload sha256
      b4fdfeafd3e1e6551c53c943eeecae44d9d0fe99db923d86486899caef62967b
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-a8ecd4cef79dccd06cd4
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00666211
      occurrences
      1. context exact
        NCT00666211
        end
        11
        exact text
        NCT00666211
        start
        0
      offset unit
      unicode_code_points
      query cond
      Primary Central Nervous System Lymphoma
      query disease state id
      ds-primary-central-nervous-system-lymphoma
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-primary-central-nervous-system-lymphoma-000.json
      source file sha256
      5133d5efc2041fb2554b035b378f2db0c15cad34dada88cd170d20b9c4e7432a
      source json pointer
      /studies/29/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      efabce8d4f12762ac6ac810ff7b6f65af2c015e27783e1e32ceb3562f9a81bab
    5. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-cdde32acbb6e82d05afe
      requested nct id
      NCT00666211
      primary nct id
      NCT00666211
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      payload sha256
      de8424b0d6847ab139ee0cdc7f128fe15480486eeef94ce861e5628686d6cdac
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-cdde32acbb6e82d05afe
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00666211
      occurrences
      1. context exact
        NCT00666211
        end
        11
        exact text
        NCT00666211
        start
        0
      offset unit
      unicode_code_points
      query cond
      Plasma Cell Neoplasms
      query disease state id
      ds-plasma-cell-neoplasms
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      source json pointer
      /studies/494/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      efabce8d4f12762ac6ac810ff7b6f65af2c015e27783e1e32ceb3562f9a81bab
    6. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-fd2ef342ae545239279e
      requested nct id
      NCT00666211
      primary nct id
      NCT00666211
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      8b9a346048372591e3ee0de631ceead25528dc1d384a69971d454af93b26921d
      payload sha256
      f2d1fe79da46c23c4999138e8c8eca2a2806a9fb06a069e9d90e9febf8ffe609
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-fd2ef342ae545239279e
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00666211
      occurrences
      1. context exact
        NCT00666211
        end
        11
        exact text
        NCT00666211
        start
        0
      offset unit
      unicode_code_points
      query cond
      Hairy Cell Leukemia
      query disease state id
      ds-hairy-cell-leukemia
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-hairy-cell-leukemia-000.json
      source file sha256
      8b9a346048372591e3ee0de631ceead25528dc1d384a69971d454af93b26921d
      source json pointer
      /studies/21/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      efabce8d4f12762ac6ac810ff7b6f65af2c015e27783e1e32ceb3562f9a81bab

    Preserved source evidence · Not medical advice