Improving Cancer Pain Management Through Self-Care
18 Years
N/A
Both
Cancer, Pain
Trial Information
Improving Cancer Pain Management Through Self-Care
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
average pain intensity score
Outcome Time Frame:
10 weeks
Safety Issue:
No
Principal Investigator
Christine A. Miaskowski, RN, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of California, San Francisco
Authority:
United States: Institutional Review Board
Study ID:
Cancer Pain Management
NCT ID:
NCT00708019
Start Date:
December 2007
Completion Date:
April 2014
Related Keywords:
- Cancer
- Pain
- cancer pain
- bone metastasis
- psychoeducational intervention
- nurse coaching
- patient education
- breast cancer
Name | Location |
|---|---|
| UCSF Helen Diller Comprehensive Cancer Center | San Francisco, California 94143 |
| San Francisco Veterans Affairs Medical Center | San Francisco, California |
