Improving Cancer Pain Management Through Self-Care

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.

Study Overview

• Status: Completed
• Conditions: Pain; Cancer
• Intervention / Treatment: Behavioral: PRO-SELF PLUS Pain Management Program

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.

• Study Type: Interventional
• Enrollment (Actual): 185
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94121
      • San Francisco Veterans Affairs Medical Center
    • San Francisco, California, United States, 94143
      • UCSF Helen Diller Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low dose; Low dose of the psychoeducational intervention (i.e., 8.0 hours with the intervention nurse over 10 weeks)	Behavioral: 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.
Experimental: High dose; High dose of the psychoeducational intervention (i.e., 12.3 hours with the intervention nurse over 10 weeks)	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	10 weeks

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Christine A. Miaskowski, RN, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: June 30, 2008
• First Submitted That Met QC Criteria: July 1, 2008
• First Posted (Estimate): July 2, 2008

Study Record Updates

• Last Update Posted (Estimate): May 5, 2016
• Last Update Submitted That Met QC Criteria: April 1, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: breast cancer; psychoeducational intervention; patient education; bone metastasis; cancer pain; nurse coaching
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Cancer Pain
• Other Study ID Numbers: Cancer Pain Management; R01CA116423-06 (U.S. NIH Grant/Contract)