Improving Cancer Pain Management Through Self-Care

Study Overview
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Brief Summary
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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
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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.

Official Title
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Improving Cancer Pain Management Through Self-Care

Conditions
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Cancer, Pain

Intervention / Treatment
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* Behavioral: PRO-SELF PLUS Pain Management Program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose<br>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<br>* 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.<br>|
| Experimental: High dose<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer pain, bone metastasis, psychoeducational intervention, nurse coaching, patient education, breast cancer