To evaluate a low-cost, patient-administered skin care regimen for minimizing skin toxicities in patients with head and neck cancer receiving chemoradiation

A skin care algorithm was created that included a radiation dermatitis assessment (subjective and objective data and pertinent medical history); a skin toxicity grading; and the management of skin toxicities based on patients' grades. Patients were given laminated cards with specific skin care instructions and were provided with verbal instructions. Teaching included: wash daily with mild soap (e.g., Dove) and warm water TID; be gentle (do not scrub); pat skin dry; apply Aveeno^® moisturizer to skin in treated area; do not apply lotions within four hours of radiation treatment; keep skin moist; keep well hydrated; maximize nutrition; provide loose clothing; avoid friction; and protect skin from sun (e.g., sunscreen with SPF 30 and lip balm with sunscreen). For skin toxicities of grade 2 or higher, a consult was made to a clinical nurse specialist with consideration for a consult to a burn clinic for alternative skin products. Data were collected at baseline and at weekly intervals. At least three clinicians reviewed and compared both the National Cancer Institute (NCI) grades and digital photographs to reach 100% inter-rater agreement.

• N = 100
• MEAN AGE = 57 years
• MALES: 87%, FEMALES: 13%
• KEY DISEASE CHARACTERISTICS: Patients with head and neck malignancies receiving concurrent chemoradiation
• OTHER KEY SAMPLE CHARACTERISTICS: Eligibility criteria included patient age of 21-years-old or older. The subjects were all English-speaking and had a mean of 15 years of education. 64% were married, 82% were Caucasian, 55% were former smokers, and 69% used ethanol at the time of the trial. Most subjects (90/100) received chemotherapy and/or biotherapy regimens, including carboplatin and paclitaxel (34%), carboplatin and etoposide (21%), and carboplatin (17%). Only 4% of the subjects received a carboplatin, paclitaxel, and panitumumab regimen. Most of the subjects (90/100) received radiation treatment regimens including photon (67%), proton (12%), and photon and proton (11%).

• SITE: Single-site  
• SETTING TYPE: Outpatient  
• LOCATION: Boston, MA

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Elder care 

Prospective, descriptive study design

Investigators developed a demographic data collection form and a weekly skin care diary. Skin grading was assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE v3.0) grading scale for dermatitis associated with chemoradiation.

The verbal instructions and laminated skin care instructions provided to the subjects in this study proved to be an affordable regimen to which patients could easily adhere. These interventions, combined with increased patient–provider interaction at weekly assessments, most likely contributed to the high level of adherence.

• Risk of bias (no control group) 
• Risk of bias (sample characteristics)
• Unintended interventions or applicable interventions that would influence results not described 
• Key sample group differences that could influence results
• Selective outcomes reporting
• Other limitations/explanation: Products were provided to patients free of charge; this may have increased patient adherence. Some patients reported using other moisturizing products, which may have influenced outcomes.

Nurses can promote positive patient outcomes through proactive patient education, the early initiation of a skin care regimen, and the ongoing reinforcement of skin care interventions that may be beneficial in minimizing skin toxicities. Empowering patients to become active participants in their care may also contribute to positive outcomes. It is within nursing scope-of-practice to provide educational cards to patients for education and to promote skin care during treatment.

To implement two psychological interventions to evaluate the effects of coping and communication-enhancing intervention (CCI) and supportive counseling (SC) on depressive symptoms.

Subjects were randomized into three groups based on Beck Depression Inventory (BDI) baseline score. CCI and SC groups consisted of six individual sessions of one-hour each plus one telephone session one week after the sixth individual session. There was a pre-intervention baseline questionnaire, and measures were repeated three times—at three months, six months, and nine months. Data were collected over six years, but each participant was involved for only the nine months of repeated measures.

• N = 353
• MEAN AGE = 55 years (SD = 11.4 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Diagnosed with primary gynecologic cancers
• OTHER KEY SAMPLE CHARACTERISTICS: Most of the women (89.5%) were white. More than 70% were married, and 49% were working full- or part-time. More than 52% held a college degree.

• SITE: Multi-site
• SETTING TYPE: Outpatient and home setting
• LOCATION: Northeastern United States

• PHASE OF CARE: Active treatment

• Stratified, randomized clinical trial with repeated measures

• BDI for depressive symptoms
• Six subscales of the COPE (The acronym was not defined.)
• Emotional Expressivity Questionnaire—general expressivity with three subscales: positive, emotion, and intimacy
• Emotional Processing Scale—cancer-related emotional expression. This is a four-item scale.
• Rosenberg Self-Esteem Inventory—a Guttman scale to measure self-acceptance

There were no significant differences in depressive symptoms in any group over time or at any point in time. Depressive symptoms declined in all groups over time. Compared with UC, people in the CCI group showed significant effect interventions on BDI (p = .037). There was a significant effect of the SC intervention on depressive symptoms compared with the UC condition (p = .0169). People in the CCI group also showed mixed results of association with the measures of COPE and emotional expression. The SC condition significantly was associated with higher levels of cancer-related emotional expression, emotional processing, positive reappraisal, and seeking instrumental support. Acceptance, positive reappraisal, self-esteem, cancer-related emotional expression, and expression of positive emotion significantly were related to depressive symptoms.

Neither of the treatments showed a significant impact on cancer-specific distress.

• Primarily white, well-educated, income-earning women were included in the study.
• Study participants were significantly younger and more likely to be married than were study refusers, and participants who completed more than one study survey were younger than participants who completed only one survey.
• These differences may have biased the results of this study.
• Many of the measures, such as self-esteem, were not cancer-specific.

This was a complex study but indicated a clearly positive impact of CCI and SC on depressive symptoms over time when compared to the UC group. A model depicting variables, mediators, and their strengths of association would help to clarify the actions, impacts, and interactions discovered in this study.

To compare the efficacy of two psychological interventions to the efficacy of usual care

The coping- and communication-enhancing intervention (CCI) involved challenging assumptions and talking about thoughts and feelings with others. Six hour-long individual sessions were supplemented with a final by-telephone booster session. Session content focused on enhancing coping, educating, and practicing skills; home practice assignments were included. Supportive counseling (SC) involved six hour-long sessions and a by-telephone booster. Rather than topic discussion, SC stressed reactions to cancer, support of existing coping behaviors, and autonomy. Usual care included routine social work consultations. Nineteen experienced therapists provided intervention. Participants were randomly assigned to CCI, SC, or usual care and were assessed preintervention and at three, six, and nine months.

The study included 353 women with primary gynecologic cancer who were in active treatment.

• Two comprehensive cancer centers and eight hospitals
• Three states in the United States

• Beck Depression Inventory
• Impact of Event Scale
• Emotional Expressiveness Questionnaire
• Cancer Rehabilitation Evaluation System subscale
• Modified Expectancy Rating Form
• A version of Borkovec and Nau’s evaluation of treatment credibility

For all patients, symptoms of depression decreased at first. For patients in CCI and SC, symptoms of depression remained relatively flat after six months, but in usual care they began to increase. Authors reported no significant difference between the interventions’ effects and no impact of either intervention on cancer-specific distress.

• The RCT was poorly designed, with a high rate of refusal and lack of survey completion.
• The sample was primarily Caucasian, young, and had ovarian cancer; this lack of diversity limits generalizability.
• Participants were paid $25 for each survey or session, a relatively high compensation.
• Different therapists were used for SC and CCI.

To evaluate (a) the impact of an intimacy-enhancing therapy (IET) versus a usual care (UC) program on survivor and partner psychological outcomes, including distress, well-being, and relationship outcomes (relationship satisfaction and intimacy), (b) the impact of an IET on relationship communication, and (c) the role of preintervention levels of each outcome variable on post-IET intervention outcome variables  

Participants received assignment to either an IET or a UC group. The IET intervention consisted of  five 90-minute couple sessions delivered by a trained therapist. This person focused on improving couples’ ability to comfortably share their thoughts and feelings to promote mutual understanding and support for cancer concerns and to facilitate emotional intimacy. The IET program techniques evolved from cognitive-behavioral and behavioral marital therapy practice and other published communication skills interventions adapted for prostate cancer. Careful attention was made to ensuring treatment fidelity by videotaping sessions and using manuals to structure the intervention. UC group participants received standard clinic psychosocial care. The IET group received the same surveys following the fifth and final session of the IET (approximately two months post-baseline). The UC and IET participants who did not complete sessions received a second round of surveys eight weeks after baseline assessment.

• The sample (N = 71) included 34 participants in the UC group and 37 participants in the IET group.  
• Mean age of participants in both groups was 60 years (SD = 8.35).
• UC group males represented 34 (48%) survivors and no partners; IET group males represented 37 (52%) survivors and 2 (3%) partners.  
• UC group females represented no survivors and 34 (47%) partners; IET group females represented no survivors and 35 (49%) partners.
• Survivors had a diagnosis of stage 2 localized prostate cancer, an Eastern Cooperative Oncology Group score of 0, and mean time since diagnosis of eight months.
• The sample was white (86%), well educated (83% had completed high school or beyond), and married (95%), and had mean relationship length of 27 years. 

• Multisite
• Outpatient setting
• Memorial Sloan-Kettering Cancer Center and Fox Chase Cancer Center (northeastern United States)
   

• Transition phase after initial treatment
• Late effects and survivorship; localized prostate cancer

A pre/post-test pilot design was used.

• Mental Health Inventory: (a) Psychological Distress Scale assessed depressive and anxiety symptoms of patients and partners; coefficient alphas for patient survivors and partners exceeded 0.94 at baseline and second assessment, (b) Psychological Well-Being Scale assessed satisfaction with life, sense of future hopefulness, and feelings of calmness; coefficient alphas for patient survivors and partners exceeded 0.93 at both assessment times.    
• Impact of Events Scale: Measured severity of cancer-specific distress; coefficient alphas for both survivors and partners above 0.92 at both assessment times. 
• Cancer Concerns: Rated partner and survivor concerns about 10 cancer-related problems; the tool was developed for the study, and coefficient alphas exceeded 0.81 for both groups at both assessment times.
• Dyadic Adjustment Scale (DAS): Assessed relationship functioning, satisfaction, and distress; coefficient alphas exceeded 0.90 for both survivors and partners at both assessment times.
• Personal Assessment of Intimacy in Relationships: Assessed emotional closeness; coefficient alphas exceeded 0.82 for both groups at both assessment times.
• Self-Disclosure/Perceived Partner Disclosure: Assessed degree to which survivors and their partners disclosed thoughts, information, and feelings about cancer to each other and perceived partner responsiveness.
• Communications Pattern Questionnaire
   

Seventy-three percent of IET couples attended 80% or more of the sessions, but another 21.6% of the IET group did not attend any sessions following random assignment to the IET group. Treatment fidelity on 114 of 138 sessions averaged 87.4%. Intervention survivors and partners rated the sessions as “quite successful,” but only 72% of the intervention group reported completion of homework assignments as part of the IET program. With study attrition, an intent-to-treat statistical analysis approach was used.

There were no significant treatment effects for general distress, cancer-specific distress, and relationship intimacy for either survivors or partners. There were no significant treatment differences for relationship communication for either survivors or partners. IET effects were largely moderated by baseline couple relationship and psychosocial factors (individual distress). Survivors who had high levels of cancer concerns at baseline significantly reduced those concerns post-IET. Moderating effects of preintervention levels for self-disclosure and perceived partner disclosure and responsiveness resulted from the intervention. The IET program improved cancer-specific distress, low intimacy, martial satisfaction, and communication if a couple experienced problems in these areas before the intervention.  
 

The IET had a marginally significant (p = 0.08) main effect on survivor well-being and improved overall outcomes for couples with fewer personal and relationship resources. Couples with more resources (e.g., higher educational level, stronger marital ties) experienced no improvement from the IET program.

• The sample was small, with less than 100 participants.
• The sample was predominately Caucasian, heterosexual, and well educated.
• Drop-out rate was high following randomization to the treatment group.

Interventions such as the IET may prove valuable for couples challenged by treatment and outcomes of prostate cancer treatment. As members of the healthcare team, nurses have an obligation to assess prostate cancer survivors about their overall coping skills, learning, and relationship needs to offer patient- and couple-centered interventions to improve the quality of their relationships and adjustment to living with prostate cancer.

The intervention was a couple-focused support group intervention (90-minute group session over six weeks). The intervention consisted of enhanced support exchanges and coping skills between women with cancer and their partners. One group received the intervention and one group received usual care, which included social work consultations for all women and referral to a psychiatrist or psychologist if indicated. Assessments occurred initially, after the first group session, at the end of group session 6, and at six months for follow-up.

• The study reported on a sample of 238 women with early-stage breast cancer who had undergone surgery within the past six months and their partners.
• Patients had primarily ductal cancer (in situ, stage I, II, or IIIa), with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Patients were married or living with a significant other.
• Patients and partners were at least 18 years of age, able to give informed consent, and English speaking.

A longitudinal, randomized controlled trial design was used.

• Mental Health Inventory-18 (MHI-18) – anxiety subscale
• Impact of Event Scale
• Partner Unsupportive Behavior Scale
• Cancer Rehabilitation Evaluation System (CARES) – functional status subscale
• Expectancy Rating Form (modified) given after group session 1
• Borkovec and Naus’ Scale (expanded version) administered after group session 6
• Survey assessing use of psychosocial care
• Information on stage, treatment, and ECOG symptom ratings (obtained from medical chart; ECOG rating done by the patient’s physician)

Analysis evaluated subgroups of data using growth curves models approach with three-step procedure. For first step, time was considered the only explanatory variable. For second step, demographic, medical, site, treatment, and psychological covariates were examined. Third step examined moderator effects by crossing the intervention group main effect with time and the proposed mean-centered moderators. All multiple mean comparisons were adjusted with Tukey.

Women attending sessions reported significantly less distress and anxiety levels than did women receiving usual care or those who dropped out of the intervention (p = 0.0171). Findings suggest that women who rated their partners as more unsupportive and those who had greater physical impairment had an increased response to the intervention compared to women in the control group. Thirty-five percent dropped out of the intervention. Results via ITT analysis: First step (time) indicated significant decline in anxiety over time ([t344] = -2.21, p = 0.0280) and significant differences among participants both in preintervention anxiety (z = 8.02, p < 0.0001) and in the rates at which anxiety changed over time (z = 2.38, p = 0.0085). Second and third steps steps indicated that interactions involving the intervention group were not significant for anxiety. Effect sizes of intervention were small, ranging from 0.2 to 0.7.

Effect sizes were relatively small (0.2–0.7).

To evaluate the effectiveness of strategies to prevent ​palmar-plantar erythrodysesthesia (PPE) incidence, including regional cooling, behavioral rules, and lower-dose pegylated liposomal doxorubicin (PLD), in patients with gynecologic malignancies.

PLD doses ranged from 30 to 50 mg/m² every 21 to 28 days. All patients received premedication with oral dexamethasone 8 mg (12 hours before PLD) and pyridoxine 300 mg PO daily. All patients were advised to follow strict behavioral rules: keep skin well hydrated, avoid sunlight, minimize trauma to the hands and feet, avoid contact with warm water, and avoid hot foods and liquids. Patients who were enrolled from 2001 to December 2003 were in the non–regional cooling group (n = 25), whereas patients who were enrolled from January 2004 to 2006 were in the regional cooling group (n = 28). Patients received regional cooling (application of ice packs around wrists and ankles) and icicles during PLD infusion.

• The study reported on a sample of patients who received PLD as a single therapy (n = 33), PLD plus carboplatin (n = 17), or PLD plus paclitaxel (n = 3).
• All patients were women with gynecologic cancers (N = 53).

Obstetrical/Gynecological Department at San Raffaele Hospital in Milan, Italy

This was a prospective, observational, single-center, nonrandomized study.

Skin toxicity was graded according to National Cancer Institute (NCI) and Gynecologic Oncology Group (GOG) criteria.

The incidence of PPE was significantly higher in the non–regional cooling group (n = 9, 36%) compared to the regional cooling group (n = 2, 7%; p = 0.0097).

Multivariant analysis revealed the use of a regional cooling protocol and lower PLD dosage were significant factors in reducing the onset and incidence of PPE. The authors estimated the probability of developing PPE in a patient who receives 30 to 35 mg/m² of PLD and follows the regional cooling protocol is 1.42%. Conversely, a patient who does not adapt this regional cooling protocol and receives 40 to 50 mg/m² of PLD every three weeks has a 60.41% estimated probability of developing PPE.

• The sample size was small.
• This was a prospective, observational, nonrandomized study. Efficacy needs to be proven in a controlled and randomized study.
• A combination of interventions was used in this study. All patients were given oral dexamethasone and oral pyridoxine as premedication. Therefore, determining the effectiveness of the individual interventions is difficult.

To evaluate the effectiveness of strategies to prevent ​palmar-plantar erythrodysesthesia (PPE) incidence, including regional cooling, behavioral rules, and lower-dose pegylated liposomal doxorubicin (PLD), in patients with gynecologic malignancies.

PLD doses ranged from 30 to 50 mg/m² every 21 to 28 days. All patients received premedication with oral dexamethasone 8 mg (12 hours before PLD) and pyridoxine 300 mg PO daily. All patients were advised to follow strict behavioral rules: keep skin well hydrated, avoid sunlight, minimize trauma to the hands and feet, avoid contact with warm water, and avoid hot foods and liquids. Patients who were enrolled from 2001 to December 2003 were in the non–regional cooling group (n = 25), whereas patients who were enrolled from January 2004 to 2006 were in the regional cooling group (n = 28). Patients received regional cooling (application of ice packs around wrists and ankles) and icicles during PLD infusion.

• The study reported on a sample of patients who received PLD as a single therapy (n = 33), PLD plus carboplatin (n = 17), or PLD plus paclitaxel (n = 3).
• All patients were women with gynecologic cancers (N = 53).

Obstetrical/Gynecological Department at San Raffaele Hospital in Milan, Italy

This was a prospective, observational, single-center, nonrandomized study.

Skin toxicity was graded according to National Cancer Institute (NCI) and Gynecologic Oncology Group (GOG) criteria.

The incidence of PPE was significantly higher in the non–regional cooling group (n = 9, 36%) compared to the regional cooling group (n = 2, 7%; p = 0.0097).

Multivariant analysis revealed the use of a regional cooling protocol and lower PLD dosage were significant factors in reducing the onset and incidence of PPE. The authors estimated the probability of developing PPE in a patient who receives 30 to 35 mg/m² of PLD and follows the regional cooling protocol is 1.42%. Conversely, a patient who does not adapt this regional cooling protocol and receives 40 to 50 mg/m² of PLD every three weeks has a 60.41% estimated probability of developing PPE.

• The sample size was small.
• This was a prospective, observational, nonrandomized study. Efficacy needs to be proven in a controlled and randomized study.
• A combination of interventions was used in this study. All patients were given oral dexamethasone and oral pyridoxine as premedication. Therefore, determining the effectiveness of the individual interventions is difficult.

The purpose of the study was to compare the efficacy and toxicity of oral voriconazole to IV low-dose amphotericin B in pediatric patients with acute leukemia.   

Oral variconazole was administered at a dose of 6 mg/kg per dose for initial two doses followed by 4 mg/kg per dose twice daily one hour before meals. Low-dose IV amphotericin B was administered at a dose of 0.5 mg/kg per day three times a week. Before administration of amphotericin B all patients received diphehydramine IV and oral paracetamol as premedication and saline hydration post infusion. Systemic antifungals were not allowed for use before patients underwent the trial. Complete blood count, liver function tests, and renal function tests were done at least twice weekly until seven days after completion or failure.

• The sample consisted of 100 patients aged 15 years or younger. 
• Males were 75% of the sample, females were 25%
• Key disease characteristics included acute myeloid and acute lymphoblastic leukemias.
• Before induction chemotherapy, patients were eligible if they had no pneumonia on chest radiograph and no systemic antifungal therapy within seven days of randomization. Febrile patients who were hemodynamicaly stable with a normal chest radiograph also were included in the study.

• Single site
• Inpatient
• New Dehli, India
   

• The phase of care was active treatment
• The application was pediatrics.
   

Randomized, non-stratified, open-label, single-institution pilot study.

• EORTC/MSG criteria for definition and classification of proven, probable, and possible invasive fungal infection.    
• Hepatic toxicity was defined as liver function test values greater than 5 times the upper limit of normal.
• Renal toxicity is defined as creatinine greater than 2 mg/dl.
   

The overall probable, proven, and possible fungal infections were 5% in the study.  In the voriconazole arm, 28% had failure of prophylaxis compared to 34% failure rate in the amphotericin B arm. No differences were noted between groups in proven, probable, and possible fungal infections. Those receiving the voriconazole had significantly less toxicity, with 6% of patients in variconazole arm having any serious adverse event (SAE)  compared to 31% in the amphotericin B arm (hypokalemia) (p < 0.001). With the amphotericin B arm, 50% had infusion reactions.

 Oral voriconazole seemed to be comparable with amphotericin B, with less toxicity and more convenience.

• The empirical dose of varicanozole is an extrapolation of adult dose.
• The authors did not perform pharmacokinetics of the patients to show whether the empirical dose of variconazole administered was efficacious or not.
• There was no blinding in the study, with inherent risk of bias.

Potential increased need for patient and caregiver education regarding oral medication administration. Continued research in comparable efficacy of antifungal agents will be helpful in order to select effective agents that are least toxic, practical, and cost effective.

To investigate whether any association exists between hemoglobin (Hgb) levels and functional capacity, cognitive impairment, and comorbidities in older adult patients with lung cancer who were treated with chemotherapy

Patients were evaluated prior to the initiation of chemotherapy (baseline) and before each subsequent cycle (after 21 days) for quality of life, mental capacity, functional status, depression, and comorbidities.

• The study reported on a sample of 42 patients with a median age of 76.6 years (± 4.8 years).
• Participants were 73.8% male and 26.2% female.
• The patients were included if they were more than 70 years old and had a confirmed diagnosis of lung cancer for which they were undergoing chemotherapy. 
• Patients were excluded if they had symptomatic brain metastases, preexisting major neurologic or psychiatric problems, or a history of substance abuse.

• Single site
• Rome, Italy

A descriptive prospective study design was used.

• MMSE—global cognitive function
• Comprehensive Geriatric Assessment (CGA)—a multidimensional, interdisciplinary diagnostic process to determine the medical, psychological, and functional capabilities of a frail older person. Includes
  • Activities of Daily Living (ADL)—scores ranging between 0–8 were used to assess functional status for self-care activities.
  • Instrumental Activities of Daily Living (IADL)—scores ranging between 0–8 were used to assess functional status for higher level activities.
  • Geriatric Depression Scale (GDS)—15-item questionnaire
  • Mini Nutritional Assessment (MNA)
• Cumulative Illness Rating Scale-Geriatric (CIRS-G)—assesses the number and severity of comorbid conditions
• Quality of life (QOL)/fatigue outcomes were measured by a visual analogue scale (VAS)

Hgb level was significantly correlated with cognitive function at baseline prior to chemotherapy (r = 0.61, p < 0.002), as well as after one (r = 0.48, p < 0.002) and two cycles (r = 0.60, p < 0.002) of chemotherapy. A significant association was discovered between the change in Hgb levels and cognitive capacity as defined by the MMSE after the first (r = 0.48, p < 0.002) and second cycle (r = 0.60, p < 0.002) of chemotherapy. Significant associations were found between Hgb levels and VAS, CIRS-G, ADL, IADL assessments, and GDS at baseline and GDS at baseline and after one and two cycles of chemotherapy (p < 0.05). The strength of these correlations varied. Change in Hgb level was associated with the change in all above parameters with the exception of IADL, which was not significant.

Although the study was not designed to demonstrate a clinical benefit of erythropoietin on cognitive function during treatment, the authors noted that 14 patients who received erythropoietin during the first two cycles of chemotherapy experienced increases in the Hgb level and CGA indexes whereas patients who did not receive erythropoietin had a lowering of the Hgb levels and worsening of their CGA scores.

• The study had a small sample size for multiple chemotherapy regimens and variability in stage of disease.
• The study included patients with brain metastases as long as they were not “symptomatic.” 
• The study was not designed to specifically evaluate the effect of erythropoietin on cognitive function in patients with cancer.
• MMSE is not sensitive enough to detect subtle cognitive changes.
• There was a lack of alternate forms for repeated administration of MMSE.
• Other factors such as performance status, chemotherapy regimen, and response to chemotherapy may have interacted with Hgb level and other examined variables.

To assess whether the use of pregabalin in combined therapy provides better health outcomes in patients with cancer-related neuropathic pain

This study was a post hoc analysis of data from a previous epidemiologic study of clinical prevalence and analgesic management of neuropathic pain. Patients who received pregabalin versus those who did not were compared. Analgesic management was done at the individual physician’s discretion. Patients had a baseline visit and a final visit at eight weeks. In the initial study, patients were not randomized to different treatment, and numerous other interventions for analgesia were done.

• The study reported on a sample of 273 patients.
• Mean patient age was 62 years.
• The sample was 55.6% male and 44.4% female.
• Breast, lung, and genitourinary cancers were most prevalent.
• All patients were receiving radiation therapy.

• Multisite
• Outpatient setting
• Spain

Patients were undergoing active antitumor treatment.

The study was a post hoc analysis of data from a previous epidemiologic study.

• Brief Pain Inventory
• Hospital Anxiety and Depression Scale
• Medical Outcomes Sleep Scale
• Short-Form Health Survey (SF-12)

The most frequent cause of neuropathic pain was the tumor itself, and cisplatin was the most frequently used chemotherapeutic agent. Fentanyl patches were used more frequently in the pregabalin group. Pain intensity improved in all patients at eight weeks, but improved more with pregabalin (change = 0, 9 points, p = 0.0084). Depression and anxiety decreased significantly in both groups. Physical component and mental component scores on the SF-12 improved in all patients, but improved more in those on pregabalin. When data were adjusted for age and sex, differences from baseline scores were less than 1. There were significant differences in groups in other medications used, numbers of analgesic interventions, and amount of radiation therapy treatment.

It is difficult to draw any firm conclusions regarding efficacy of pregabalin from this study due to the differences in multiple other variables between study groups that could also affect the outcome measures used here. Changes from baseline measures seen at eight weeks were significant, but very small, raising the question of the clinical significance of results.

• The study had baseline sample/group differences of import.
• The study had risk of bias due to no control group, no blinding, no random assignment, and sample characteristics.
• There were substantial differences in treatments used, as well as disease factors between groups compared here.

No firm conclusions can be drawn from these results due to study limitations. Findings aim to show that use of pregabalin for neuropathic pain improves symptoms and  health outcomes. Differences from baseline reported here were small, suggesting lack of meaningful differences from a clinical perspective. Results point to the need for nurses to recognize the difference between statistical and clinical significance in evaluating intervention effects.