Improving Cancer Pain Management Through Self-Care

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00708019
First received: June 30, 2008
Last updated: May 30, 2013
Last verified: May 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Improving Cancer Pain Management Through Self-Care

Resource links provided by NLM:


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 ]

Enrollment: 222
Study Start Date: December 2007
Estimated Study Completion Date: April 2014
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00708019

Locations
United States, California
UCSF Helen Diller Comprehensive Cancer Center
San Francisco, California, United States, 94143
San Francisco Veterans Affairs Medical Center
San Francisco, California, United States
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Christine A. Miaskowski, RN, PhD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00708019     History of Changes
Other Study ID Numbers: Cancer Pain Management, R01 CA116423
Study First Received: June 30, 2008
Last Updated: May 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
cancer pain
bone metastasis
psychoeducational intervention
nurse coaching
patient education
breast cancer

ClinicalTrials.gov processed this record on April 15, 2014