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 percent of patients in the intervention group, pain intensity scores did not decrease by >30 percent and 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. Lay summary - This study will test two different doses of an educational intervention to improve cancer pain management. In addition, the study will determine if the changes in pain management behaviors that the patients and their family caregivers learn continue to be used once the intervention stops.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
5R01CA116423-04
Application #
7686759
Study Section
Special Emphasis Panel (ZRG1-HOP-V (02))
Program Officer
O'Mara, Ann M
Project Start
2006-09-27
Project End
2012-07-31
Budget Start
2009-08-01
Budget End
2010-07-31
Support Year
4
Fiscal Year
2009
Total Cost
$1,208,489
Indirect Cost
Name
University of California San Francisco
Department
Other Health Professions
Type
Schools of Nursing
DUNS #
094878337
City
San Francisco
State
CA
Country
United States
Zip Code
94143
Viet, Chi T; Dang, Dongmin; Aouizerat, Bradley E et al. (2017) OPRM1 Methylation Contributes to Opioid Tolerance in Cancer Patients. J Pain 18:1046-1059
Schumacher, Karen L; Plano Clark, Vicki L; West, Claudia M et al. (2014) Pain medication management processes used by oncology outpatients and family caregivers part II: home and lifestyle contexts. J Pain Symptom Manage 48:784-96
Schumacher, Karen L; Plano Clark, Vicki L; West, Claudia M et al. (2014) Pain medication management processes used by oncology outpatients and family caregivers part I: health systems contexts. J Pain Symptom Manage 48:770-83
Gilbertson-White, Stephanie; Aouizerat, Bradley E; Jahan, Thierry et al. (2012) Determination of cutpoints for low and high number of symptoms in patients with advanced cancer. J Palliat Med 15:1027-36
Esther Kim, Jung-Eun; Dodd, Marylin J; Aouizerat, Bradley E et al. (2009) A review of the prevalence and impact of multiple symptoms in oncology patients. J Pain Symptom Manage 37:715-36