Improving Cancer Pain Management Through Self-Care

This study is currently recruiting participants.
Verified by University of California, San Francisco, June 2008
First Received: June 30, 2008 Last Updated: May 30, 2013

Sponsor:
University of California, San Francisco
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00708019


Purpose
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.
 

Condition Intervention
Cancer Pain Behavioral: PRO-SELF PLUS Pain Management Program


Study Type: Interventional
Study Design: Allocation: Randomized
Control: Dose Comparison
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Official Title: Improving Cancer Pain Management Through Self-Care

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

  • average pain intensity score [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

  • worst pain intensity score [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Estimated Enrollment: 308
Study Start Date: December 2007
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
 
Arms Assigned Interventions

Low dose: Experimental Low dose of the psychoeducational intervention (i.e., 8.0 hours with the intervention nurse over 10 weeks) Intervention: Behavioral: PRO-SELF PLUS Pain Management Program

 

 

 

 

 

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.

 

 

 

High dose: Experimental High dose of the psychoeducational intervention (i.e., 12.3 hours with the intervention nurse over 10 weeks) Intervention: Behavioral: PRO-SELF PLUS Pain Management Program

 

 

 

 

 

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.

 

 

 


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
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

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
  • 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.
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