Improving Cancer Pain Management Through Self-Care
Primary Purpose
Cancer, Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PRO-SELF PLUS Pain Management Program
Sponsored by
About this trial
This is an interventional supportive care trial for Cancer focused on measuring cancer pain, bone metastasis, psychoeducational intervention, nurse coaching, patient education, breast cancer
Eligibility Criteria
Inclusion Criteria:
- adult oncology outpatients (> 18 years of age)
- able to read, write, and understand English
- agree to participate and give informed consent
- have a KPS Score of > 50
- have an average pain intensity score of > 3.0 on a 0 to 10 NRS
- have radiographic evidence of bone metastasis
- visceral or somatic pain
- have a life expectancy of at least 6 months
- are receiving outpatient treatment for cancer (not AIDS-related) with any single or combination therapy, and have a telephone line
Exclusion Criteria:
- A documented previous or current psychiatric disorder or if at the time of recruitment they are receiving hospice care in order not to interfere with the pain management program provided by hospice.
Sites / Locations
- San Francisco Veterans Affairs Medical Center
- UCSF Helen Diller Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Low dose
High dose
Arm Description
Low dose of the psychoeducational intervention (i.e., 8.0 hours with the intervention nurse over 10 weeks)
High dose of the psychoeducational intervention (i.e., 12.3 hours with the intervention nurse over 10 weeks)
Outcomes
Primary Outcome Measures
Average Pain Intensity Score
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).
Secondary Outcome Measures
Worst Pain Intensity Score
Worst 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).
Full Information
NCT ID
NCT00708019
First Posted
June 30, 2008
Last Updated
April 1, 2016
Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00708019
Brief Title
Improving Cancer Pain Management Through Self-Care
Official Title
Improving Cancer Pain Management Through Self-Care
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will test two different doses of a psychoeducational intervention to improve cancer pain management. In addition, the study will determine if the changes in pain management behaviors that the patients and family caregivers learn continue to be used when the intervention stops. It is hypothesized that patients and family caregivers who receive the high dose intervention will have a greater decrease in pain intensity scores.
Detailed Description
Recent work from our research group demonstrated that the use of a 6-week psychoeducational intervention, called the PRO-SELF Pain Control Program, compared to standard care, resulted in clinically and statistically significant improvements in pain management in a sample of oncology outpatients with bone metastasis. While the overall effects of the intervention were significant, for approximately 70% of patients in the intervention group pain intensity scores did not decrease by > 30% and that worst pain intensity scores remained at or above 4 at the end of the intervention. Therefore, as a logical extension of this study, we propose a randomized clinical trial (RCT) that will test the effectiveness of two different doses of the revised PRO-SELF Pain Control Program [i.e., PRO-SELF PLUS-HIGH and PRO-SELF PLUS-LOW] on pain intensity and analgesic prescriptions. In addition, the sustainability of the two doses of the intervention will be evaluated. Adult oncology outpatients with pain from bone metastasis will be recruited, stratified by site and by whether or not they participate alone or with a family caregiver, and randomized to one of the doses of the intervention. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Pain
Keywords
cancer pain, bone metastasis, psychoeducational intervention, nurse coaching, patient education, breast cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
185 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low dose
Arm Type
Experimental
Arm Description
Low dose of the psychoeducational intervention (i.e., 8.0 hours with the intervention nurse over 10 weeks)
Arm Title
High dose
Arm Type
Experimental
Arm Description
High dose of the psychoeducational intervention (i.e., 12.3 hours with the intervention nurse over 10 weeks)
Intervention Type
Behavioral
Intervention Name(s)
PRO-SELF PLUS Pain Management Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Average Pain Intensity Score
Description
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).
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Worst Pain Intensity Score
Description
Worst 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).
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult oncology outpatients (> 18 years of age)
able to read, write, and understand English
agree to participate and give informed consent
have a KPS Score of > 50
have an average pain intensity score of > 3.0 on a 0 to 10 NRS
have radiographic evidence of bone metastasis
visceral or somatic pain
have a life expectancy of at least 6 months
are receiving outpatient treatment for cancer (not AIDS-related) with any single or combination therapy, and have a telephone line
Exclusion Criteria:
A documented previous or current psychiatric disorder or if at the time of recruitment they are receiving hospice care in order not to interfere with the pain management program provided by hospice.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine A. Miaskowski, RN, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco Veterans Affairs Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
UCSF Helen Diller Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
12. IPD Sharing Statement
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Improving Cancer Pain Management Through Self-Care
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