Trial Outcomes & Findings for Opioid Titration Order Sheet or Standard Care in Treating Patients With Cancer Pain (NCT NCT00666211)
NCT ID: NCT00666211
Last Updated: 2012-09-06
Results Overview
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
COMPLETED
PHASE3
98 participants
Baseline(Week 0) to week 8, Total time frame is 9 weeks.
2012-09-06
Participant Flow
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.
Participant milestones
| Measure |
Standard of Care
Standard pain control drugs.
|
Opioid Titration
Pain will be Monitored and Medication Titrated
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
56
|
|
Overall Study
COMPLETED
|
22
|
18
|
|
Overall Study
NOT COMPLETED
|
20
|
38
|
Reasons for withdrawal
| Measure |
Standard of Care
Standard pain control drugs.
|
Opioid Titration
Pain will be Monitored and Medication Titrated
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
10
|
13
|
|
Overall Study
went off medication, no more pain
|
1
|
0
|
|
Overall Study
patient non-compliant
|
6
|
6
|
|
Overall Study
disease progression
|
1
|
8
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
toxicity
|
0
|
2
|
|
Overall Study
hospital admission
|
0
|
5
|
|
Overall Study
Death
|
0
|
2
|
|
Overall Study
off tx for other complicating disease
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Opioid Titration Order Sheet or Standard Care in Treating Patients With Cancer Pain
Baseline characteristics by cohort
| Measure |
Standard of Care
n=42 Participants
Standard pain control drugs.
|
Opioid Titration
n=56 Participants
Pain will be Monitored and Medication Titrated
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age Continuous
|
55.6 years
STANDARD_DEVIATION 1 • n=5 Participants
|
56.4 years
STANDARD_DEVIATION 1 • n=7 Participants
|
56 years
STANDARD_DEVIATION 1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
56 participants
n=7 Participants
|
98 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Standard of Care
n=42 Participants
Standard pain control drugs.
|
Opioid Titration
n=56 Participants
Pain will be Monitored and Medication Titrated
|
|---|---|---|
|
Pain Intensity
Average Daily Pain Intensity
|
5.60 units on a scale
Standard Deviation 2.76
|
6.44 units on a scale
Standard Deviation 1.89
|
|
Pain Intensity
Worst Daily Pain Intensity
|
5.11 units on a scale
Standard Deviation 2.45
|
5.98 units on a scale
Standard Deviation 1.96
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Standard of Care
n=42 Participants
Standard pain control drugs.
|
Opioid Titration
n=56 Participants
Pain will be Monitored and Medication Titrated
|
|---|---|---|
|
Pain-related Distress
|
3.32 units on a scale
Standard Deviation 2.50
|
4.87 units on a scale
Standard Deviation 2.64
|
PRIMARY outcome
Timeframe: at 9 weeksPain duration in hours 0 to 24
Outcome measures
| Measure |
Standard of Care
n=42 Participants
Standard pain control drugs.
|
Opioid Titration
n=56 Participants
Pain will be Monitored and Medication Titrated
|
|---|---|---|
|
Pain Duration
|
8.40 hours
Standard Deviation 6.06
|
11.31 hours
Standard Deviation 7.78
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Standard of Care
n=42 Participants
Standard pain control drugs.
|
Opioid Titration
n=56 Participants
Pain will be Monitored and Medication Titrated
|
|---|---|---|
|
Ability to Engage in Activities of Daily Living (ADL)
Baseline
|
2.18 units on a scale
Standard Deviation 0.61
|
1.99 units on a scale
Standard Deviation 0.58
|
|
Ability to Engage in Activities of Daily Living (ADL)
Week 2
|
2.14 units on a scale
Standard Deviation 0.73
|
2.06 units on a scale
Standard Deviation 0.67
|
|
Ability to Engage in Activities of Daily Living (ADL)
Week 4
|
1.94 units on a scale
Standard Deviation 0.57
|
1.91 units on a scale
Standard Deviation 0.55
|
|
Ability to Engage in Activities of Daily Living (ADL)
Week 6
|
2.01 units on a scale
Standard Deviation 0.73
|
2.03 units on a scale
Standard Deviation 0.49
|
|
Ability to Engage in Activities of Daily Living (ADL)
Week 8
|
1.98 units on a scale
Standard Deviation 0.67
|
1.96 units on a scale
Standard Deviation 0.58
|
SECONDARY outcome
Timeframe: 9 weeksPatients 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.
Outcome measures
| Measure |
Standard of Care
n=42 Participants
Standard pain control drugs.
|
Opioid Titration
n=56 Participants
Pain will be Monitored and Medication Titrated
|
|---|---|---|
|
Interference in Daily Life Due to Pain
Baseline
|
4.49 units on a scale
Standard Deviation 2.54
|
4.23 units on a scale
Standard Deviation 2.30
|
|
Interference in Daily Life Due to Pain
Week 2
|
4.25 units on a scale
Standard Deviation 2.89
|
4.12 units on a scale
Standard Deviation 2.26
|
|
Interference in Daily Life Due to Pain
Week 4
|
4.16 units on a scale
Standard Deviation 2.82
|
3.48 units on a scale
Standard Deviation 2.03
|
|
Interference in Daily Life Due to Pain
Week 6
|
3.78 units on a scale
Standard Deviation 2.99
|
3.16 units on a scale
Standard Deviation 2.21
|
|
Interference in Daily Life Due to Pain
Week 8
|
3.01 units on a scale
Standard Deviation 2.43
|
3.68 units on a scale
Standard Deviation 2.42
|
SECONDARY outcome
Timeframe: 9 weeksPatients 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.
Outcome measures
| Measure |
Standard of Care
n=42 Participants
Standard pain control drugs.
|
Opioid Titration
n=56 Participants
Pain will be Monitored and Medication Titrated
|
|---|---|---|
|
Mood Disturbance
Baseline
|
1.48 units on a scale
Standard Deviation 0.55
|
1.21 units on a scale
Standard Deviation 0.63
|
|
Mood Disturbance
Week 2
|
1.45 units on a scale
Standard Deviation 0.63
|
1.20 units on a scale
Standard Deviation 0.52
|
|
Mood Disturbance
Week 4
|
1.37 units on a scale
Standard Deviation 0.70
|
1.12 units on a scale
Standard Deviation 0.52
|
|
Mood Disturbance
Week 6
|
1.19 units on a scale
Standard Deviation 0.64
|
1.22 units on a scale
Standard Deviation 0.66
|
|
Mood Disturbance
Week 8
|
1.14 units on a scale
Standard Deviation 0.58
|
1.32 units on a scale
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: 9 weeksEach 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).
Outcome measures
| Measure |
Standard of Care
n=42 Participants
Standard pain control drugs.
|
Opioid Titration
n=56 Participants
Pain will be Monitored and Medication Titrated
|
|---|---|---|
|
Quality of Life
Emotional at baseline
|
2.55 scores on a scale
Standard Deviation 0.90
|
2.93 scores on a scale
Standard Deviation 0.69
|
|
Quality of Life
Emotional at week 8
|
2.88 scores on a scale
Standard Deviation 0.77
|
2.42 scores on a scale
Standard Deviation 0.83
|
|
Quality of Life
Functional well-being at baseline
|
1.81 scores on a scale
Standard Deviation 0.92
|
1.75 scores on a scale
Standard Deviation 0.82
|
|
Quality of Life
Physical at baseline
|
1.94 scores on a scale
Standard Deviation 0.83
|
2.11 scores on a scale
Standard Deviation 0.77
|
|
Quality of Life
Physical at week 8
|
2.18 scores on a scale
Standard Deviation 0.93
|
2.34 scores on a scale
Standard Deviation 0.86
|
|
Quality of Life
Social/family at baseline
|
3.02 scores on a scale
Standard Deviation 0.82
|
3.30 scores on a scale
Standard Deviation 0.77
|
|
Quality of Life
Social/family at week 8
|
3.03 scores on a scale
Standard Deviation 0.90
|
2.88 scores on a scale
Standard Deviation 0.92
|
|
Quality of Life
Functional well-being at week 8
|
1.88 scores on a scale
Standard Deviation 0.86
|
1.88 scores on a scale
Standard Deviation 0.78
|
Adverse Events
Standard of Care
Opioid Titration
Serious adverse events
| Measure |
Standard of Care
n=42 participants at risk
Standard pain control drugs.
|
Opioid Titration
n=56 participants at risk
Pain will be Monitored and Medication Titrated
|
|---|---|---|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
0.00%
0/42
|
1.8%
1/56 • Number of events 1
|
|
General disorders
Pain - Throat/pharynx/larynx - odynophagia
|
0.00%
0/42
|
1.8%
1/56 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/42
|
1.8%
1/56 • Number of events 1
|
|
General disorders
Death not associated with CTCAE term
|
0.00%
0/42
|
1.8%
1/56 • Number of events 1
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/42
|
1.8%
1/56 • Number of events 1
|
|
Infections and infestations
infection with normal ANC
|
0.00%
0/42
|
1.8%
1/56 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/42
|
1.8%
1/56 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
0.00%
0/42
|
1.8%
1/56 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
extremity-lower gait
|
0.00%
0/42
|
1.8%
1/56 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis/stomatisis
|
0.00%
0/42
|
3.6%
2/56 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
aspiration
|
0.00%
0/42
|
1.8%
1/56 • Number of events 1
|
|
Blood and lymphatic system disorders
neutrapenia
|
0.00%
0/42
|
1.8%
1/56 • Number of events 1
|
|
Blood and lymphatic system disorders
hyponatremia
|
0.00%
0/42
|
1.8%
1/56 • Number of events 1
|
|
Investigations
weight loss
|
0.00%
0/42
|
1.8%
1/56 • Number of events 1
|
|
Gastrointestinal disorders
dysphagia
|
0.00%
0/42
|
1.8%
1/56 • Number of events 1
|
|
General disorders
fatigue
|
0.00%
0/42
|
1.8%
1/56 • Number of events 1
|
|
Psychiatric disorders
confusion
|
0.00%
0/42
|
1.8%
1/56 • Number of events 1
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/42
|
1.8%
1/56 • Number of events 1
|
|
Infections and infestations
Infection with unknown ANC
|
0.00%
0/42
|
1.8%
1/56 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
fracture
|
2.4%
1/42 • Number of events 1
|
0.00%
0/56
|
Other adverse events
| Measure |
Standard of Care
n=42 participants at risk
Standard pain control drugs.
|
Opioid Titration
n=56 participants at risk
Pain will be Monitored and Medication Titrated
|
|---|---|---|
|
Nervous system disorders
drowsiness, somnolence
|
9.5%
4/42 • Number of events 13
|
3.6%
2/56 • Number of events 9
|
|
Psychiatric disorders
confusion
|
4.8%
2/42 • Number of events 4
|
1.8%
1/56 • Number of events 12
|
|
Psychiatric disorders
anorexia
|
4.8%
2/42 • Number of events 15
|
0.00%
0/56
|
|
Skin and subcutaneous tissue disorders
bruising
|
4.8%
2/42 • Number of events 2
|
0.00%
0/56
|
|
Cardiac disorders
cardiac arrhythmia
|
4.8%
2/42 • Number of events 2
|
1.8%
1/56 • Number of events 3
|
|
Gastrointestinal disorders
constipation
|
2.4%
1/42 • Number of events 8
|
7.1%
4/56 • Number of events 41
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
4.8%
2/42 • Number of events 5
|
3.6%
2/56 • Number of events 13
|
|
Nervous system disorders
dysphagia
|
0.00%
0/42
|
7.1%
4/56 • Number of events 33
|
|
General disorders
edema
|
0.00%
0/42
|
7.1%
4/56 • Number of events 14
|
|
General disorders
fatigue
|
0.00%
0/42
|
14.3%
8/56 • Number of events 46
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/42
|
10.7%
6/56 • Number of events 50
|
|
Nervous system disorders
neuropathy
|
2.4%
1/42 • Number of events 2
|
5.4%
3/56 • Number of events 11
|
|
Musculoskeletal and connective tissue disorders
pain, extremity
|
7.1%
3/42 • Number of events 10
|
0.00%
0/56
|
|
Nervous system disorders
dysgeusia
|
4.8%
2/42 • Number of events 7
|
0.00%
0/56
|
|
Nervous system disorders
Dysarthria
|
7.1%
3/42 • Number of events 18
|
0.00%
0/56
|
Additional Information
Nancy Wells, Director of Nursing Research Patient Care Svcs
Vanderbilt-Ingram Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place