Clinical trial NCT00708019: Improving Cancer Pain Management Through Self-Care
Official title: Improving Cancer Pain Management Through Self-Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Pain
Keywords: cancer pain
bone metastasis
psychoeducational intervention
nurse coaching
patient education
breast cancer
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-07-02
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Average Pain Intensity Score
timeFrame: 10 weeks
Secondary outcomes:
measure: Worst Pain Intensity Score
timeFrame: 10 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco Veterans Affairs Medical Center
state: California
city: San Francisco
country: United States
facility: UCSF Helen Diller Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Christine A. Miaskowski, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References: