Trial Outcomes & Findings for Improving Cancer Pain Management Through Self-Care (NCT NCT00708019)
NCT ID: NCT00708019
Last Updated: 2016-05-05
Results Overview
Average pain was measured using a 0 (no pain) to 10 (worst pain imaginable) numeric rating scale on a daily basis. Change in average pain intensity between the two intervention groups was evaluated from enrollment to the end of the study (i.e., 10 weeks).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
185 participants
Primary outcome timeframe
10 weeks
Results posted on
2016-05-05
Participant Flow
We recruited patients from October 2007 to December 2012 from oncology clinics in the San Francisco Bay area.
Participant milestones
| Measure |
Low Dose
Low dose of the psychoeducational intervention (i.e., 8.0 hours with the intervention nurse over 10 weeks)
PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls \[total time 12.3 hours\]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls \[8.0 hours\]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes.
|
High Dose
High dose of the psychoeducational intervention (i.e., 12.3 hours with the intervention nurse over 10 weeks)
PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls \[total time 12.3 hours\]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls \[8.0 hours\]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes.
|
|---|---|---|
|
Overall Study
STARTED
|
92
|
93
|
|
Overall Study
COMPLETED
|
77
|
78
|
|
Overall Study
NOT COMPLETED
|
15
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Cancer Pain Management Through Self-Care
Baseline characteristics by cohort
| Measure |
Low Dose
n=92 Participants
Low dose of the psychoeducational intervention (i.e., 8.0 hours with the intervention nurse over 10 weeks)
PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls \[total time 12.3 hours\]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls \[8.0 hours\]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes.
|
High Dose
n=93 Participants
High dose of the psychoeducational intervention (i.e., 12.3 hours with the intervention nurse over 10 weeks)
PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls \[total time 12.3 hours\]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls \[8.0 hours\]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes.
|
Total
n=185 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.01 years
STANDARD_DEVIATION 1.19 • n=5 Participants
|
59.29 years
STANDARD_DEVIATION 1.29 • n=7 Participants
|
59.15 years
STANDARD_DEVIATION 11.90 • n=5 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
92 participants
n=5 Participants
|
93 participants
n=7 Participants
|
185 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 weeksAverage pain was measured using a 0 (no pain) to 10 (worst pain imaginable) numeric rating scale on a daily basis. Change in average pain intensity between the two intervention groups was evaluated from enrollment to the end of the study (i.e., 10 weeks).
Outcome measures
| Measure |
Low Dose
n=92 Participants
Low dose of the psychoeducational intervention (i.e., 8.0 hours with the intervention nurse over 10 weeks)
PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls \[total time 12.3 hours\]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls \[8.0 hours\]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes.
|
High Dose
n=93 Participants
High dose of the psychoeducational intervention (i.e., 12.3 hours with the intervention nurse over 10 weeks)
PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls \[total time 12.3 hours\]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls \[8.0 hours\]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes.
|
|---|---|---|
|
Average Pain Intensity Score
|
1.192 units on a scale
Interval 0.452 to 1.932
|
1.304 units on a scale
Interval 0.54 to 2.069
|
SECONDARY outcome
Timeframe: 10 weeksWorst pain was measured using a 0 (no pain) to 10 (worst pain imaginable) numeric rating scale on a daily basis. Change in worst pain intensity between the two intervention groups was evaluated from enrollment to the end of the study (i.e., 10 weeks).
Outcome measures
| Measure |
Low Dose
n=92 Participants
Low dose of the psychoeducational intervention (i.e., 8.0 hours with the intervention nurse over 10 weeks)
PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls \[total time 12.3 hours\]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls \[8.0 hours\]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes.
|
High Dose
n=93 Participants
High dose of the psychoeducational intervention (i.e., 12.3 hours with the intervention nurse over 10 weeks)
PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls \[total time 12.3 hours\]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls \[8.0 hours\]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes.
|
|---|---|---|
|
Worst Pain Intensity Score
|
1.575 units on a scale
Interval 0.744 to 2.375
|
1.522 units on a scale
Interval 0.695 to 2.349
|
Adverse Events
Low Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Christine Miaskowski
University of California, San Francisco
Phone: 415-476-9407
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place