Opioid Titration Order Sheet or Standard Care in Treating Patients With Cancer Pain
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Phase 3 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Standard of Care Standard pain control drugs. |
Other: educational intervention
Participants will be educated on pain management.
Other: questionnaire administration
Participants will be given questionnaires to complete.
|
| Experimental: Opioid Titration Pain will be Monitored and Medication Titrated |
Other: educational intervention
Participants will be educated on pain management.
Other: Titrated pain management
Pain will be Monitored and Medication Titrated
Other: questionnaire administration
Participants will be given questionnaires to complete.
|
Outcome Measures
Primary Outcome Measures
- Pain Intensity [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: 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 [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 [at 9 weeks]
Pain duration in hours 0 to 24
Secondary Outcome Measures
- Ability to Engage in Activities of Daily Living (ADL) [Baseline(Week 0) to week 8, Total time frame is 9 weeks.]
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 [9 weeks]
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 [9 weeks]
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 [9 weeks]
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).
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Jennie Stuart Medical Center | Hopkinsville | Kentucky | United States | 44240 |
| 2 | Mitchell Memorial Cancer Center at Owensboro Medical Health System | Owensboro | Kentucky | United States | 42303 |
| 3 | Erlanger Health System | Chattanooga | Tennessee | United States | 37403 |
| 4 | Tennessee Plateau Oncology | Crossville | Tennessee | United States | 38555 |
| 5 | Center for Biomedical Research | Knoxville | Tennessee | United States | 37909 |
| 6 | The Jones Clinic | Memphis | Tennessee | United States | 38138 |
| 7 | Vanderbilt-Ingram Cancer Center - Cool Springs | Nashville | Tennessee | United States | 37064 |
| 8 | Vanderbilt-Ingram Cancer Center at Franklin | Nashville | Tennessee | United States | 37064 |
| 9 | Meharry Medical College | Nashville | Tennessee | United States | 37208 |
| 10 | Veterans Affairs Medical Center - Nashville | Nashville | Tennessee | United States | 37212 |
| 11 | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | United States | 37232-6838 |
Sponsors and Collaborators
- Vanderbilt-Ingram Cancer Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Nancy Wells, DNSc, RN, Vanderbilt-Ingram Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VICC SUPP 0424
- P30CA068485
- VU-VICC-SUPP-0424
- VU-VICC-040410
Study Results
Participant Flow
| Recruitment Details | This study opened to accrual May 2005 through May 2010. Although 99 patients were consented one was determined ineligible, thus only 98 went on study. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Standard of Care | Opioid Titration |
|---|---|---|
| Arm/Group Description | Standard pain control drugs. | Pain will be Monitored and Medication Titrated |
| Period Title: Overall Study | ||
| STARTED | 42 | 56 |
| COMPLETED | 22 | 18 |
| NOT COMPLETED | 20 | 38 |
Baseline Characteristics
| Arm/Group Title | Standard of Care | Opioid Titration | Total |
|---|---|---|---|
| Arm/Group Description | Standard pain control drugs. | Pain will be Monitored and Medication Titrated | Total of all reporting groups |
| Overall Participants | 42 | 56 | 98 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
33
78.6%
|
49
87.5%
|
82
83.7%
|
| >=65 years |
9
21.4%
|
7
12.5%
|
16
16.3%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
55.6
(1)
|
56.4
(1)
|
56
(1)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
19
45.2%
|
20
35.7%
|
39
39.8%
|
| Male |
23
54.8%
|
36
64.3%
|
59
60.2%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
42
100%
|
56
100%
|
98
100%
|
Outcome Measures
| 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Standard of Care | Opioid Titration |
|---|---|---|
| Arm/Group Description | Standard pain control drugs. | Pain will be Monitored and Medication Titrated |
| Measure Participants | 42 | 56 |
| Average Daily Pain Intensity |
5.60
(2.76)
|
6.44
(1.89)
|
| Worst Daily Pain Intensity |
5.11
(2.45)
|
5.98
(1.96)
|
| 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Standard of Care | Opioid Titration |
|---|---|---|
| Arm/Group Description | Standard pain control drugs. | Pain will be Monitored and Medication Titrated |
| Measure Participants | 42 | 56 |
| Baseline |
2.18
(0.61)
|
1.99
(0.58)
|
| Week 2 |
2.14
(0.73)
|
2.06
(0.67)
|
| Week 4 |
1.94
(0.57)
|
1.91
(0.55)
|
| Week 6 |
2.01
(0.73)
|
2.03
(0.49)
|
| Week 8 |
1.98
(0.67)
|
1.96
(0.58)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Standard of Care | Opioid Titration |
|---|---|---|
| Arm/Group Description | Standard pain control drugs. | Pain will be Monitored and Medication Titrated |
| Measure Participants | 42 | 56 |
| Baseline |
4.49
(2.54)
|
4.23
(2.30)
|
| Week 2 |
4.25
(2.89)
|
4.12
(2.26)
|
| Week 4 |
4.16
(2.82)
|
3.48
(2.03)
|
| Week 6 |
3.78
(2.99)
|
3.16
(2.21)
|
| Week 8 |
3.01
(2.43)
|
3.68
(2.42)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Standard of Care | Opioid Titration |
|---|---|---|
| Arm/Group Description | Standard pain control drugs. | Pain will be Monitored and Medication Titrated |
| Measure Participants | 42 | 56 |
| Baseline |
1.48
(0.55)
|
1.21
(0.63)
|
| Week 2 |
1.45
(0.63)
|
1.20
(0.52)
|
| Week 4 |
1.37
(0.70)
|
1.12
(0.52)
|
| Week 6 |
1.19
(0.64)
|
1.22
(0.66)
|
| Week 8 |
1.14
(0.58)
|
1.32
(0.70)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Standard of Care | Opioid Titration |
|---|---|---|
| Arm/Group Description | Standard pain control drugs. | Pain will be Monitored and Medication Titrated |
| Measure Participants | 42 | 56 |
| Physical at baseline |
1.94
(0.83)
|
2.11
(0.77)
|
| Physical at week 8 |
2.18
(0.93)
|
2.34
(0.86)
|
| Social/family at baseline |
3.02
(0.82)
|
3.30
(0.77)
|
| Social/family at week 8 |
3.03
(0.90)
|
2.88
(0.92)
|
| Emotional at baseline |
2.55
(0.90)
|
2.93
(0.69)
|
| Emotional at week 8 |
2.88
(0.77)
|
2.42
(0.83)
|
| Functional well-being at baseline |
1.81
(0.92)
|
1.75
(0.82)
|
| Functional well-being at week 8 |
1.88
(0.86)
|
1.88
(0.78)
|
| 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Standard of Care | Opioid Titration |
|---|---|---|
| Arm/Group Description | Standard pain control drugs. | Pain will be Monitored and Medication Titrated |
| Measure Participants | 42 | 56 |
| Mean (Standard Deviation) [units on a scale] |
3.32
(2.50)
|
4.87
(2.64)
|
| Title | Pain Duration |
|---|---|
| Description | Pain duration in hours 0 to 24 |
| Time Frame | at 9 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Standard of Care | Opioid Titration |
|---|---|---|
| Arm/Group Description | Standard pain control drugs. | Pain will be Monitored and Medication Titrated |
| Measure Participants | 42 | 56 |
| Mean (Standard Deviation) [hours] |
8.40
(6.06)
|
11.31
(7.78)
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Standard of Care | Opioid Titration | ||
| Arm/Group Description | Standard pain control drugs. | Pain will be Monitored and Medication Titrated | ||
All Cause Mortality |
||||
| Standard of Care | Opioid Titration | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Standard of Care | Opioid Titration | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/42 (2.4%) | 8/56 (14.3%) | ||
| Blood and lymphatic system disorders | ||||
| neutrapenia | 0/42 (0%) | 0 | 1/56 (1.8%) | 1 |
| hyponatremia | 0/42 (0%) | 0 | 1/56 (1.8%) | 1 |
| Cardiac disorders | ||||
| Ventricular arrhythmia | 0/42 (0%) | 0 | 1/56 (1.8%) | 1 |
| Gastrointestinal disorders | ||||
| nausea | 0/42 (0%) | 0 | 1/56 (1.8%) | 1 |
| Mucositis/stomatisis | 0/42 (0%) | 0 | 2/56 (3.6%) | 2 |
| dysphagia | 0/42 (0%) | 0 | 1/56 (1.8%) | 1 |
| General disorders | ||||
| Pain - Throat/pharynx/larynx - odynophagia | 0/42 (0%) | 0 | 1/56 (1.8%) | 1 |
| Death not associated with CTCAE term | 0/42 (0%) | 0 | 1/56 (1.8%) | 1 |
| fatigue | 0/42 (0%) | 0 | 1/56 (1.8%) | 1 |
| Infections and infestations | ||||
| infection with normal ANC | 0/42 (0%) | 0 | 1/56 (1.8%) | 1 |
| Infection with unknown ANC | 0/42 (0%) | 0 | 1/56 (1.8%) | 1 |
| Investigations | ||||
| weight loss | 0/42 (0%) | 0 | 1/56 (1.8%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Pain - Back | 0/42 (0%) | 0 | 1/56 (1.8%) | 1 |
| extremity-lower gait | 0/42 (0%) | 0 | 1/56 (1.8%) | 1 |
| fracture | 1/42 (2.4%) | 1 | 0/56 (0%) | 0 |
| Nervous system disorders | ||||
| Somnolence/depressed level of consciousness | 0/42 (0%) | 0 | 1/56 (1.8%) | 1 |
| Psychiatric disorders | ||||
| confusion | 0/42 (0%) | 0 | 1/56 (1.8%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Pleural effusion | 0/42 (0%) | 0 | 1/56 (1.8%) | 1 |
| Dyspnea (shortness of breath) | 0/42 (0%) | 0 | 1/56 (1.8%) | 1 |
| aspiration | 0/42 (0%) | 0 | 1/56 (1.8%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| Standard of Care | Opioid Titration | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 13/42 (31%) | 27/56 (48.2%) | ||
| Cardiac disorders | ||||
| cardiac arrhythmia | 2/42 (4.8%) | 2 | 1/56 (1.8%) | 3 |
| Gastrointestinal disorders | ||||
| constipation | 1/42 (2.4%) | 8 | 4/56 (7.1%) | 41 |
| nausea | 0/42 (0%) | 0 | 6/56 (10.7%) | 50 |
| General disorders | ||||
| edema | 0/42 (0%) | 0 | 4/56 (7.1%) | 14 |
| fatigue | 0/42 (0%) | 0 | 8/56 (14.3%) | 46 |
| Musculoskeletal and connective tissue disorders | ||||
| pain, extremity | 3/42 (7.1%) | 10 | 0/56 (0%) | 0 |
| Nervous system disorders | ||||
| drowsiness, somnolence | 4/42 (9.5%) | 13 | 2/56 (3.6%) | 9 |
| dysphagia | 0/42 (0%) | 0 | 4/56 (7.1%) | 33 |
| neuropathy | 1/42 (2.4%) | 2 | 3/56 (5.4%) | 11 |
| dysgeusia | 2/42 (4.8%) | 7 | 0/56 (0%) | 0 |
| Dysarthria | 3/42 (7.1%) | 18 | 0/56 (0%) | 0 |
| Psychiatric disorders | ||||
| confusion | 2/42 (4.8%) | 4 | 1/56 (1.8%) | 12 |
| anorexia | 2/42 (4.8%) | 15 | 0/56 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| cough | 2/42 (4.8%) | 5 | 2/56 (3.6%) | 13 |
| Skin and subcutaneous tissue disorders | ||||
| bruising | 2/42 (4.8%) | 2 | 0/56 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Nancy Wells, Director of Nursing Research Patient Care Svcs |
|---|---|
| Organization | Vanderbilt-Ingram Cancer Center |
| Phone | 615-322-6184 |
| nancy.wells@vanderbilt.edu |
- VICC SUPP 0424
- P30CA068485
- VU-VICC-SUPP-0424
- VU-VICC-040410