Cancer, Pain
Conditions
Keywords
cancer pain, bone metastasis, psychoeducational intervention, nurse coaching, patient education, breast cancer
Brief summary
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
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.
Interventions
BEHAVIORALPRO-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.
Sponsors
National Cancer Institute (NCI)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Pain Intensity Score | 10 weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Worst Pain Intensity Score | 10 weeks | 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). |
Countries
United States
Participant flow
Recruitment details
We recruited patients from October 2007 to December 2012 from oncology clinics in the San Francisco Bay area.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 92 |
| 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. | 93 |
| Total | 185 |
Baseline characteristics
| Characteristic | Low Dose | High Dose | Total |
|---|---|---|---|
| Age, Continuous | 59.01 years STANDARD_DEVIATION 1.19 | 59.29 years STANDARD_DEVIATION 1.29 | 59.15 years STANDARD_DEVIATION 11.9 |
| Region of Enrollment United States | 92 participants | 93 participants | 185 participants |
| Sex: Female, Male Female | 53 Participants | 51 Participants | 104 Participants |
| Sex: Female, Male Male | 39 Participants | 42 Participants | 81 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 92 | 0 / 93 |
| serious Total, serious adverse events | 0 / 92 | 0 / 93 |
Outcome results
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).
Time frame: 10 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Low Dose | Average Pain Intensity Score | 1.192 units on a scale |
| High Dose | Average Pain Intensity Score | 1.304 units on a scale |
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).
Time frame: 10 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Low Dose | Worst Pain Intensity Score | 1.575 units on a scale |
| High Dose | Worst Pain Intensity Score | 1.522 units on a scale |