One limitation of this study was that the analysis for pain was underpowered due to the fewer than expected number of patients who met the criterion for pain intensity. A significant effect on pain over time may have demonstrated if the sample size of 55 per group had been achieved.
A second limitation is that this study was implemented at one national comprehensive cancer center outpatient setting located in Southern California where patients commonly are referred for treatment and second opinions, usually late in the course of their treatment and disease process. As a consequence, the findings may not be generalizable to other geographic areas or inpatient settings, or to other populations, such as newly diagnosed patients with early stage disease, survivors without evidence of disease, or patients with other types of malignancies. Although ethnic minorities were represented in this study, due to the small sample size we were unable to determine statistical differences by ethnicity.
Another limitation is the heterogeneity of sample population with four different cancer diagnoses. This strategy limited the number of participants accrued into each diagnosis group, which in turn prohibited generalizations of study results due to the smaller sample size in each diagnosis group.
The “Passport to Comfort” intervention is one of the first reported trials to utilize the NCCN supportive care guidelines to reduce barriers to pain and fatigue management in ambulatory care cancer patients. Study findings show that the model was effective in reducing patient barriers as well as increasing knowledge about pain and fatigue management. The literature has consistently documented that patients play a key role in the undertreatment of pain.9,10
Patients are reluctant to report their pain for reasons including fear of side effects, fatalism about the possibility of achieving pain control, fear of distracting physicians from treating cancer, and belief that pain is indicative of progressive disease.7
In this study, the “Passport” intervention was effective in improving patient’s beliefs on common and pervasive pain barriers, such as fear of addiction, tolerance, and beliefs that side effects of pain medications are difficult to control. Furthermore, these statistically significant improvements were observed immediately post-intervention as well as sustained over time.
Findings in the pain literature also suggest that strategies in reducing barriers to pain management require attention to knowledge as well as attitudes about pain.47-49
In this study, the intervention was effective in improving overall patient knowledge about pain assessment and management. Overall knowledge scores were increased for items such as opioids leading to addiction, beliefs that side effects from pain medications cannot be controlled, and that the need to increase medication dose is a sign of addiction. However, study findings suggest that some lack of knowledge persisted for patients in the intervention group, and these included the belief that pain can only be managed with pharmacologic agents. A potential explanation for this finding may be related to healthcare professionals’ lack of knowledge in non-pharmacologic management of pain, which have been shown to be effective in the pain literature.16,20
Findings from this study show that the “Passport” intervention was effective in decreasing sensory fatigue ratings, and this positive effect was immediate and sustained over time. In this study, the intervention was successful in improving perceptions of fatigue barriers. Common beliefs such as inevitability of fatigue, lack of effective treatment for fatigue, the lower priority given to managing fatigue, and concerns of being a complainer when reporting fatigue were all improved for the intervention group. In terms of patients’ fatigue knowledge, both the intervention and usual care group demonstrated high levels of knowledge. However, misconceptions persisted on the relationship between exercise and energy use and staying in bed when tired. This finding suggests that patients are more likely to utilize inactivity as a strategy to manage fatigue. This perception underscores the lack of translation of the strong empirical evidence of the benefits of physical activity on fatigue into usual practice and patient education.50-53
Over the past decade, several studies have demonstrated that it is possible to overcome patient barriers to pain and fatigue management.49,54
These model programs have emphasized patient teaching interventions including the use of pain and fatigue assessment tools, strategies to dispel misconceptions, and patient coaching regarding the reporting and documenting of their symptoms. Most of these interventions were successful in reducing barriers to symptom management that are persists in clinical practice settings. The “Passport” intervention is unique in aspects including the translation of the NCCN pain and fatigue guidelines into an educational intervention for reducing misconceptions and increasing patient knowledge and the incorporation of a design to integrate the intervention into usual care. These unique characteristics of the intervention will aid in the translation of the model into actual clinical settings so that it can be maintained after project conclusion.