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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA116423-06 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose | Experimental | Low dose of the psychoeducational intervention (i.e., 8.0 hours with the intervention nurse over 10 weeks) |
|
| High dose | Experimental | High dose of the psychoeducational intervention (i.e., 12.3 hours with the intervention nurse over 10 weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRO-SELF PLUS Pain Management Program | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine A. Miaskowski, RN, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco Veterans Affairs Medical Center | San Francisco | California | 94121 | United States | ||
| UCSF Helen Diller Comprehensive Cancer Center |
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We recruited patients from October 2007 to December 2012 from oncology clinics in the San Francisco Bay area.
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Dose | Low dose of the psychoeducational intervention (i.e., 8.0 hours with the intervention nurse over 10 weeks) 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. |
| FG001 | High Dose | High dose of the psychoeducational intervention (i.e., 12.3 hours with the intervention nurse over 10 weeks) 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Dose | Low dose of the psychoeducational intervention (i.e., 8.0 hours with the intervention nurse over 10 weeks) 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | 95% Confidence Interval | units on a scale | 10 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Dose | Low dose of the psychoeducational intervention (i.e., 8.0 hours with the intervention nurse over 10 weeks) 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christine Miaskowski | University of California, San Francisco | 415-476-9407 | chris.miaskowski@nursing.ucsf.edu |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D010146 | Pain |
| D000072716 | Cancer Pain |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
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|
| San Francisco |
| California |
| 94143 |
| United States |
| BG001 | High Dose | High dose of the psychoeducational intervention (i.e., 12.3 hours with the intervention nurse over 10 weeks) 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | High Dose | High dose of the psychoeducational intervention (i.e., 12.3 hours with the intervention nurse over 10 weeks) 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. |
|
|
| Secondary | 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). | Posted | Mean | 95% Confidence Interval | units on a scale | 10 weeks |
|
|
|
| 0 |
| 92 |
| 0 |
| 92 |
| EG001 | High Dose | High dose of the psychoeducational intervention (i.e., 12.3 hours with the intervention nurse over 10 weeks) 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. | 0 | 93 | 0 | 93 |
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| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |