To examine the effectiveness of an exercise program on quality of life (QOL), fatigue, sleep disturbances, exercise self-efficacy, exercise behavior, and exercise capacity in women with breast cancer.

Patients were randomly assigned to an exercise or usual care group. The exercise intervention was a six-week walking program based on modified exercise guidelines of the American Cancer Society and American College of Sports Medicine. This program included use of a heart rate ring monitor, pedometer, weekly telephone call, weekly meetings, and use of an exercise diary. Exercise was of low to moderate intensity (40%–60% maximum heart rate). In this program, patients performed weekly goal setting and were provided advice and information, and several specific strategies were described that were intended to boost self-efficacy. Patients were oriented to the exercise program prior to surgery, and exercise was begun within a few days after surgery. Data were collected at 24 hours prior to surgery and at 24 hours prior to the first cycle of chemotherapy, seven to 10 days after chemotherapy, and at the end of six weeks.

• Sixty-two patients were included.
• Mean age was 50.42 years (standard deviation = 9.64 years).
• All patients were female.
• All patients had stage I or II disease and were newly diagnosed.
• All patients had undergone mastectomy, 36% had at least a college education, 80.6% were married, and 51.4% were working full-time.

• Single site  
• Outpatient
• Taiwan

Patients were undergoing the active treatment phase of care.

The study used an experimental, longitudinal repeated measures design.

• Functional Assessment of Cancer Treatment – General and Fatigue scales (FACT-G, FACT-F) 
• Pittsburgh Sleep Quality Index (PSQI)
• Exercise Self-Efficacy Scale (EXSE)
• Godin Leisure-Time Exercise Questionnaire (GLTEQ)
• Six-minute walk test

The pattern of change in QOL over time showed significant consistent improvement among those in the exercise group compared to usual care controls (p < 0.001). Patterns of change in and overall sleep disturbance also showed significant improvement over time compared to controls (p < 0.006). The pattern of fatigue showed higher fatigue levels in the exercise group at all study time points. Average fatigue scores went from 40.5 to 45.8 at week 6 in the exercise group and from 40.1 to 40 with usual care. Patients in the exercise group had significantly better exercise self-efficacy (p ≤ 0.001) and higher levels of exercise behavior (p < 0.001) than those receiving usual care. Patients in the exercise group walked farther in the six-minute walk test than controls after the intervention (p ≤ 0.001).

Findings showed that a self-managed home exercise program, along with intervention strategies aimed at boosting self-efficacy, had a positive effect on QOL and exercise behavior among women newly diagnosed with breast cancer.

• The study had a small sample size, with less than 100 patients.
• It is not clear what type of relevant patient information and education was provided in the usual care group. 
• The duration of the study was relatively short at six weeks. 
• The sample was only very slightly underpowered.
• Lack of any blinding suggests the potential of bias.
• It is not clear if both patient groups received weekly telephone calls so that attentional control was provided. 
• The authors noted that there was a 30% contamination rate, with 30% of control group patients also exercising at least three times per week.

Findings of this study did not show a positive impact of a home-based exercise and self-efficacy interventions on fatigue in the first six weeks after surgery in newly diagnosed patients. However, over a longer period of time, patients in the exercise group did better. These findings suggest that nurses may need to educate patients that adherence to an exercise program may not show results in the short term and that effects may take some time to be felt. Nurses can educate and encourage patients to exercise at home and support activities to boost a patient's sense of efficacy may improve patient adherence to an exercise prescription.

To determine the effectiveness of the therapeutic transfusion strategy (bleeding occurred) versus the prophylactic strategy of platelet count of 10 x10⁹ at the morning blood draw in two defined groups

The primary end point of the study was to evaluate two groups of patients: patients with acute myeloid leukemia (AML) (group A, n = 190) versus patients who had received an autologous transplantation (group B, n = 201), comparing prophylactic platelet transfusion to therapeutic platelet transfusion. Group A consisted of a prophylactic group (n = 96) and a therapeutic group (n = 94). Group B also consisted of a prophylactic group (n = 98) and a therapeutic group (n = 94). Those in group A assigned to the prophylactic transfusion protocol were given one unit of platelets when the morning count was 10x10⁹ or lower one day after the end of induction therapy or consolidation. The protocol started on the day of stem cell transplantation in group B. The therapeutic groups received a transfusion only when a grade 2 or higher bleeding episode occurred. If bleeding continued, next steps, including further transfusions, were decided by the treating provider.

• N = 391   
• AGE = Group A: 16–80 years, Group B: 16–68 years
• MALES: 216, FEMALES: 175
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: AML or autologous peripheral stem cell transplantation for hematologic cancers
• OTHER KEY SAMPLE CHARACTERISTICS: Patients were excluded from Group B if they had pulmonary or cerebral lesions. Patients who were refractory to platelets or had a previous major bleed or plasmatic coagulopathy were also excluded.

• SITE: Multi-site   
• SETTING TYPE: Inpatient    
• LOCATION: Germany

PHASE OF CARE: Active antitumor treatment

Multicenter, open-label randomized trial of patients with hematologic malignancies

In the prophylactic group, the morning platelet level was the determining factor to transfuse or not. In the therapeutic group, platelets were administered if a patient's bleeding was defined as a grade 2 or higher according to the World Health Organization criteria.

A significant result of p < 0.0001 in the reduction of platelets transfused in the therapeutic group was noted. The therapeutic group had a higher risk of grade 2 bleeding, which consisted mainly of petechial bleeding or purpura of the skin. The group with AML showed a significant result of p < 0.0001 in a grade 4 bleeding risk of 37% compared to the transplantation group of 18%.

This study revealed that the therapeutic strategy for patients receiving autologous stem cell transplantation would be safe and could become the standard of care with platelet transfusion limitation. The standard of care for patients with AML should remain the standard with prophylactic platelet transfusion because of the risk for increased bleeding.

There was only a 78% protocol compliance rate on the therapeutic group. The study was not powered to prove a significant difference in grade 4 bleeding events or lethal events.

Therapeutic platelet transfusions for patients receiving transplanations could become standard practice, given the hardship to maintain a continued platelet inventory, and decrease the risk of alloimmunization. Nurses need to remain vigilant in assessing and monitoring for increased bleeding. Education would be a necessity to ensure that early identification of potential bleeding is assessed.

To review the literature on nonpharmacologic supportive strategies to enhance quality of life (QOL) among patients with breast cancer experiencing cancer-related fatigue.

Databases searched were MEDLINE and CINAHL (2000–2010).

Search keywords were breast cancer patient, oncology patient, fatigue, cancer-related fatigue, quality of life, health-related quality of life, physical activity, and exercise.

Studies were included in the review if they 

• Were randomized, controlled trials or quasiexperimental designs
• Investigated nonpharmacological supportive strategies
• Had cancer-related fatigue and/or QOL as an outcome measure.

Eighty-nine articles were identified, of which 28 met the inclusion criteria. No method of quality rating of the studies was described.

• Twenty-eight studies including 2,164 patients were included.
• Sample sizes among studies ranged from 11 to 377 patients.
• All studies were performed in patients with breast cancer at various phases of care and receiving various types of treatment or after treatment.

Supervised exercise was used in eight studies.  Four of these showed that exercise significantly improved QOL and reduced fatigue.  Two studies showed that supervised exercise improved QOL but not fatigue; they had noted study limitations and intervention contamination. One large multi-site study showed that supervised aerobic exercise improved self-esteem, fitness, etc., but had no significant effect on QOL, depression, anxiety, or fatigue

Home-based exercise was used in six studies.  All of these confirmed a positive effect of participation in exercise on fatigue.  Fatigue levels either decreased, or those who exercised had significantly less increase in fatigue over time.

Telephone-based encouragement in activity was used in one study (25 patients).  At 12 weeks, there were significant increases in activity, QOL, and fatigue.

One study used print materials and step pedometers along with physical activity recommendations.  Those who received all three of these strategies had improved QOL and fatigue.

Education and counseling was used in five studies. Mixed results were seen across studies, with a positive effect on fatigue that was significant in three of these studies. 

Sleep therapy was examined in three studies.  Two of these demonstrated a significant positive effect on fatigue with cognitive behavioral therapy and insomnia treatment.  One large study using cognitive behavioral therapy showed improvement in sleep quality but no effect on fatigue.

Other interventions were yoga in one study, tai chi in one study, and physical therapy in one study.  Yoga was associated with an improvement in fatigue, and physical therapy was also associated with improvement, although this was only studied in 11 patients.

This review generally showed that supervised exercise and supervised exercise and other strategies to promote exercise can reduce cancer-related fatigue and improve QOL in women with breast cancer.  Findings were limited by several studies with small sample sizes and variations in the phases of care in which the interventions were provided. There was insufficient evidence to draw conclusions about the complementary therapies included.

• Studies of supervised education demonstrated mixed results.
• Several studies had small samples or other limitations.
• Application should be used cautiously.

Based on current evidence, exercise, educational counseling, and sleep therapy appear to be helpful methods to improve QOL and reduce fatigue. Because of methodological limitations of many of these previous studies, further well-designed research is needed to confirm these conclusions.

To test the hypothesis that prophylactic granulocyte macrophage–colony-stimulating factor (GM-CSF) decreases invasive fungal disease (IFD) in patients with neutropenia receiving allogeneic hematopoietic cell transplantation (HCT)

Patients were randomly assigned to receive GM-CSF, GCSF, or a combination of GM-CSF and GCSF. Administration was begun on day 5 after transplantation and continued until neutrophil recovery (ANC > 1.5 x 10⁹ for two days). If ANC declined within five days after stopping the CSF, CSF was resumed until neutrophil recovery again. All received antibiotic prophylaxis with levofloxacin and antifungal prophylaxis with oral fluconazole. Patients were followed for the study for 100 days post transplantation.

• N = 183   
• MEAN AGE = 31.76 years
• AGE RANGE = 13–60 years
• MALES: 72.1%, FEMALES: 27.9%

• SITE: Multi-site    
• LOCATION: China

PHASE OF CARE: Transition phase after active treatment

• Randomized, prospective, open-label, three-group trial

• IFD was determined as proven, probable, or possible according to the European Organization for Research and Treatment of Cancer (EORTC) and the National Institute of Allergy and Infectious Diseases (NIAID) Myoses Study Group (MSG)
• Invasive Aspergillus was diagnosed according to the Infectious Diseases of Society of America's guidelines

No significant differences existed between groups in the prevalence of proven and probable IFD from molds or yeasts overall. In the G-CSF only group, 11.6% had IFD attributable death, compared to one patient in each of the other study groups (p = 0.008). In multivariate analysis to include potential confounders, risk of death was 4.496 times higher (95% confidence interval [CI] [2.5, 8.1]) in patients with proven or probable IFD compared to those without IFD. Those receiving only G-CSF had a significantly higher 100-day mortality rate (p = 0.037). All infection-related mortality was lowest in the GM-CSF group (p = 0.011).

The findings showed that GM-CSF was more effective than G-CSF in the prevention of infection, fungal disease, and infection-related mortality at 100 days in patients undergoing allogeneic hematopoietic cell transplantation (HCT).

• Risk of bias (no blinding)

This study suggests that the use of GM-CSF versus G-CSF is more effective for infection prevention in patients undergoing allogeneic HCT with neutropenia. The effective use of colony-stimulating factors has been shown to reduce infection and IFD-related mortality in at-risk patients.

To examine effects of live music therapy on quality-of-life indicators, medications administered, and length of stay in patients undergoing brain surgery

Patients were met 30–45 minutes prior to surgery in the outpatient surgery check-in area, inpatient room, or preoperative holding area and completed baseline study measures. Patients in the experimental group received 20–30 minutes of patient-preferred live music and completed postintervention measures prior to surgery. Those in the experimental group received the music intervention each subsequent day of hospital stay, and completed both pre- and postintervention measures. Patients, family members, and visitors could participate by singing, playing rhythm instruments, or listening. Techniques included lyric analysis, songwriting, progressive muscle relaxation, and guided imagery. Control group patients also completed study measures postoperatively and daily during their hospital stay.

• The study reported on a sample of 27 patients.
• Median patient age was 48 years, with a range of 8–73 years.
• The sample was 55.6% female and 44.4% male.
• Diagnoses included aneurysm, meningioma, neuralgia, malignant neoplasm, osteoma, angioma, intracranial abscess, and metastatic cancer to the brain.
• Surgical procedures varied according to patient situation.

• Single site
• Inpatient setting
• Florida

Patients were undergoing the active treatment phase of care.

A randomized controlled trial design was used.

• Visual analog scale for mood, pain, relaxation, stress, and perception of hospitalization
• Total milligrams of vicodin and morphine
• Medications for nausea
• Hospital length of stay

There were no significant differences between groups for anxiety, mood, pain, perception of hospitalization, relaxation, or stress. There were no differences between groups for medications used. There was no significant difference between groups for length of stay.

Results do not support an effect of live music therapy on anxiety, pain, medication use, or length of hospital stay in patients undergoing brain surgery.

• The study had a small sample, with less than 30 patients.
• The study design lacked an attentional control.
• The practicality of providing such an intervention preoperatively in a check-in area or preoperative holding area is questionable, and the authors did state that many of these interventions were interrupted. Sessions during hospital stay were also interrupted for various aspects of care.
• Range of age was very broad, and no other demographic information about patients was provided.

This study does not demonstrate effectiveness of music therapy in hospitalized patients undergoing brain surgery. Practical application of this type of intervention in most acute inpatient settings and perioperative settings is questionable.

To evaluate the success of additional professional team member weekly home visits, beyond support provided via specialist palliative care, on carer distress, burden, quality of life, satisfaction with care, and bereavement outcome

Carers were randomly assigned to either a control group (usual care = specialist palliative care team help and support in the home and clinic) or an intervention group (usual care plus a trained carer advisor who privately met with the carer to deliver advice and support outside the home and address domains of carer need each week over a six-week period). Carers completed mailed questionnaires (three instruments at 4, 9, and 12 weeks after randomization to group). Brief, semistructured interviews with carers at the final assessment time provided information about acceptability and satisfaction with the intervention.

• The sample was comprised of 271 carers (80% female and 20% male).
• Mean age of carers was 56.3 years (range = 16–92 years).
• All patients of carers received regular care at one of three cancer networks employing seven specialist palliative care teams.
• Carers scored above a threshold of 5/6 on the General Health Questionnaire (GHQ-28).
• Most carers were white (86%), and 64% were married or were partners with the patient.
• Approximately 30% of carers had a college education.

• Multisite/other setting
• London, England

An experimental design with generalized linear latent and mixed models (GLLAMM) approaches was used, as well as repeated measures with a brief intervention.

• General Health Quesionniare–28 (GHS-28): Assessed carer psychological distress*
• Carer Strain Index: Assessed baseline carer burden and at 4, 9, and 12 weeks*
• Carer Quality of Life Index: Assessed baseline carer quality of life and at 4, 9, and 12 weeks*
• Eastern Cooperative Oncology Group (ECOG): Assessed baseline patient physical performance status

* No reliability or validity data were given in the article with study use; references appear to address this area.

About 30% of carers in both the control and intervention groups decreased their GHS-28 scores to show less stress at each assessment point in the study. Mean GHS-28 scores dropped at 4- and 9-week assessment times but then increased by the 12-week assessment. The intervention group appeared to experience greater but statistically nonsignificant improvement in GHS-28 scores as compared to the usual care control group. GLLAMM, used to more specifically analyze the influence of the intervention on GHS scores, did not show any significant interaction effects of time and treatment. By the end of the study, 40% of patients had died. Carers noted the emotional support provided by the trained advisor as most beneficial, 20% noted that the intervention came “too late” to help, and almost 30% noted that more advisor sessions would have been helpful.

This study offers insight into the difficulties of collecting data on an intervention with carers who assume responsibility for a patient receiving palliative care due to a diagnosis of cancer. The fact that more 60% of carers scored above the threshold on the GHS-28 at baseline indicates that many carers show strain and would benefit from professional help during the cancer end-of-life journey. Results of this study did not show significant effects of the intervention, although a percentage of subjects identified that the intervention was helpful. It is not clear how different this intervention was from the usual care, which was provided by clinicians specialized in palliative care.

It is not clear whether the three instruments used in this study accurately assessed the variables of interest due to absence of information on the instruments in the article. For example, the authors wished to measure burden but used an instrument to measure strain. One must ask if these terms are conceptually equivalent to support use of the Carer Strain instrument to meet the aims of this study.

It is not clear whether each carer in the intervention received a tailored six-week program or whether all carers in that group received “all domains of care” (p. 143). It also is not clear how the intervention changed when it was delivered outside the home and perhaps in a carer’s workplace where distractions and lower privacy might exist (influences on external validity of study). The lack of specificity about differences between usual care (specialist palliative care teams) and the carer advisor intervention leads one to understand study findings of no significant effect with the brief intervention. One wonders if the use of ECOG scores obtained on patients could have predicted inclusion of carers who would have had a greater chance of concluding the study with a viable family member.

Additional investigation of effective interdisciplinary interventions to improve the quality of life of carers engaged with end-of-life care must be completed to uncover needs of carers during that vulnerable time, and to determine the most appropriate timing of such interventions This study indicated that carer quality of life deteriorated over the 12 weeks of the study despite a professionally trained carer advisor. The authors added valuable information about ways to refine their intervention to be useful in future studies. Continued search for evidence-based components of an intervention, optimal frequency and intensity (as well as sites for delivering it), and assessments throughout the intervention to determine its effectiveness will help support improved care for carers who commit to others despite their own grief.

To test the effects of art-making classes to reduce anxiety and stress among caregivers of patients with cancer

Art-making classes were offered as one part of an already established art program. The class involved with the research began with discussion of the study. Study participants completed self-report instruments and provided a saliva sample for cortisol testing. The art-making class was given over a two-hour period, and repeat questionnaires and saliva testing were done at the end of the session. Classes were delivered twice weekly by volunteer art interventionists in a residential facility. A variety of art-making projects were used in classes. Research team members attended each class and documented field notes during each session. Interventionists were trained in processes of caregiver experiences based on the end-of-life phase of experiential theory.

• The sample was comprised of 69 caregivers (80% female, 20% male).
• Mean caregiver age was 48 ± 14.47 (range = 18–81 years).
• Disease types of patients were not stated.
• Participants included Hispanics, Caucasians, Carribean Islanders, and individuals from other cultures.
• Of the sample, 75% were the primary caregiver of the patient, 41% had provided care for six months to one year, and 56% had high school formal education or less.

• Single site
• Other setting
• Miami, Florida, United States

• Late effects and survivorship
• Palliative care

A pretest/post-test quasi-experimental design was used.

• Beck Anxiety Inventory
• Salivary cortisol
• Field notes of participant comments

Anxiety measures showed a significant reduction in scores of the Beck Anxiety Inventory after the session, with preintervention of 7.28 ± 6.8 and postscore of 2.49 ± 4.5 (p < 0.01). No significant changes in cortisol level were reported. Field notes indicated that participants shared efforts, offered suggestions to each other, and became better acquainted. Numerous subjects refused to give samples for salivary cortisol.

Art-making classes appeared to produce a short-term reduction in anxiety level among caregivers of patients with cancer.

• The sample was small, with less than 100 participants.
• Risk of bias existed due to no control group, no binding, no random assignment, and no appropriate attentional control condition.
• Measurement validity and reliability are questionable.*
• Other/*explanation: Cortisol levels can be expected to vary according to time of day. No information is available about the time of specimen collection in the study, and it is not known whether all patients had art-making sessions at the same time of day. Pre- and postanxiety inventory measures showed high variability, suggesting that mean scores may not be representative of the group. No information is available about how many sessions people attended. Sessions were also attended by individuals who were not part of the study or who had refused to provide consent for participation. Although numerous subjects refused to give salivary samples, the authors did not say how many refused or discuss relevant missing data. The authors noted lack of funds for creative approaches used. It is not clear if changes in anxiety were truly due to the use of art in these sessions, or the support group type of interactions that occurred among participants.

Findings suggest that participation in art making may reduce anxiety among caregivers momentarily, and group participation can provide an avenue for supportive caregiver interactions.

To test hypotheses that family caregivers would experience reduced stress and anxiety and have increased positive emotions from an art-making intervention

Art-making supplies were taken to patients’ bedsides or to the outpatient chemotherapy site to show patients and caregivers items that could be made. Caregivers decided on one or more activities that they could do with or without the patients’ involvement. Caregivers were given supplies and shown how to complete the activity. The artist–nurse intervention team then left the area and returned to monitor progress and offer assistance every 15–30 minutes. Participants completed study questionnaires prior to and immediately after the intervention.

• The sample was comprised of 40 family caregivers.
• Mean caregiver age was 51.43 ± 15.38 years.
• Of the sample, 78% were the primary caregivers for the patients, 75% were women, and most were spouses.
• Most caregivers had provided care for six months or less.

• Single site 
• Multiple settings
• Florida, United States

Mutliple phases of care

A pretest/post-test quasi-experimental design was used.

• Mini Profile of Mood States (miniPOMS)
• Beck Anxiety Inventory
• Derogatis Affects Balance Scale

The presession stress score mean was 13.27 ± 6, and the postscore was 9.85 ± 5.84 (p < 0.001). Cohen’s d calculation on stress scores was d = 0.44, suggesting a large effect size. Postintervention anxiety scores declined but were not reported to be statistically significant. Significantly more positive emotions were reported in the post-test evaluation  (p < 0.001). It was noted that individuals who participated in the hospital inpatient units had multiple interruptions.

Involvement in art making was associated with reduction in stress and increased positive emotions immediately after the involvement. Participation at the bedside in the inpatient area was complicated by multiple interruptions.

• The sample was small, with less than 100 participants.
• Risk of bias existed due to no control group, no binding, no random assignment, and no appropriate attentional control condition.
• Whether the nature of art making itself, or any type of distracting activity, was responsible for the changes seen is not clear.

Involvement in art making may be helpful for short-term stress reduction in caregivers of patients with cancer. Further well-designed research in this area is needed to evaluate this approach.

The purpose of the study was to demonstrate bioequivalence of two different filgrastim products.

Patients were randomized to receive one of the two types of filgrastim at the same dose and schedule. Treatment was 5 mcg subcutaneously daily on day 2 of chemotherapy in each cycle, and continued until absolute neutrophil count (ANC) was greater than 3 x 10⁹/L or treatment had been given for 14 days.

• 276 participants were studied.
• Mean age was 49.8 years (SD = 8.88)
• All were female
• All had breast cancer at various stages and were receiving chemotherapy with doxorubicin and docetaxel.
• Patients did not have any radiotherapy within six weeks of study entry, or prior chemotherapy within four weeks.
   

37 European outpatient centers in various countries

Mutliple phases of care

Randomized, double-blind phase III

• Duration of severe neutropenia for each chemotherapy cycle defined as ANC less than 0.5 x 10⁹/L
• Time to ANC recovery (greater than 3 x 10⁹/L)
• Incidence of febrile neutropenia (ANC less than 0.5 x 10⁹/L and temp 38.5ºC or higher)
• Incidence of documented infection
• NCI CTCAE [v.3.0]
   

Incidence of severe neutropenia was 77.6% in one group and 68.2% in the other, with no statistically significant difference. Duration of severe neutropenia across groups in cycle 1 ranged from 1.3 –1.6 days on average, and was lower in both groups in subsequent cycles. There were no differences in outcomes between the two. Those receiving Hospira filgrastim had a slightly higher incidence of  bone pain than Amgen filgrastim; however, overall prevalence of skeletal pain was similar in both groups.

 The results of this study showed that these two different preparations of filgrastim are bioevquivalent.

• Risk of bias (sample characteristics)
• The sample was almost 98% Caucasians. 
• Those receiving Hospira filgrastim who had more bone pain, also had a higher prevalence of bone metastases at baseline. It is not clear if these may have been related.

 This study was designed purely to demonstrate bioequivalence of these two filgrastim products.

To assess the safety and efficacy of long-term repeated dosing of osmotic extended-release oral delivery system (OROS) hydromorphone used to relieve chronic pain

A patient who entered this study after completing a comparative dose-conversion study with OROS hydromorphone continued taking OROS hydromorphone at his or her stable dose. This study also included patients who had participated in a comparison of hydromorphone immediate release (IR) and OROS hydromorphone. These patients began the OROS hydromorphone study by taking 50%–100% of their established dose; dose adjustments were allowed after a minimum of two days. Dose adjustments were usually in 8 mg increments. The target duration of treatment was at least one year. Adverse events were assessed monthly, and physical exams were conducted and vital signs assessed every three months.

• Of all patients in the study, 106 completed the study (388 had enrolled, and 72.7% withdrew). The study sponsor terminated 80 patients (28.4%) from the study because of a decreasing supply of study medication.
• Mean patient age was 50 years. Age range was 27–91 years.
• Of all patients, 50.8% were female and 49.2% were male.
• Patients in the study were adults, with chronic cancer pain or chronic pain unrelated to malignancies, who were receiving stable doses of OROS hydromorphone equal to at least 8 mg/day. Approximately 20% of the initial sample had cancer-related pain.

• Multisite
• Outpatient
• 56 centers in the United States and Canada

Multicenter open-label extension trial

• Brief Pain Inventory (BPI), patient ratings on a 0–10 scale (0 = no pain, 10 = worst pain imaginable)
• Pain relief as measured by the patient on a 0%–100% scale
• Scale measuring extent to which pain interfered with physical activity or social functioning (0 = no interference, 10 = complete interference)
• Global ratings, by patient and investigator, of overall medication effectiveness (1 = poor, 2 = fair, 3 = good, 4 = very good, 5 = excellent

BPI ratings of worst pain, least pain, and average pain were essentially stable throughout the study. Median daily dose of study medication increased from 32 mg at baseline to 40 mg at month 3 and 48 mg at months 6, 9, and 12. The most frequently reported adverse events were nausea (which 24% of patients experienced) and constipation (which 19.3% of patients experienced). The side-effect profile was similar to that of other sustained-release opioids. Most side effects usually resolved over time, although constipation was did not resolve. Laxatives can manage constipation effectively.

Authors concluded that the benefits of OROS hydromorphone were maintained when daily administration was continued. Once-daily OROS hydromorphone appeared to be safe and effective in controlling moderate to severe chronic pain.

• Only 20% of patients in the study had cancer-related pain upon study entry. Authors did not specify the number of patients with cancer-related pain who completed the study and were included in analysis. Given the relatively small number of patients with cancer-related pain, the degree to which overall findings are generalizable to the oncology patient population is unclear.
• The study had risks of bias due to no blinding and no comparison group. 
• Authors did not discuss rescue medication or breakthrough pain.

Of patients who entered the study, 52.3% experienced a treatment-related event. (The side effects experienced by anyone who entered the study and who took at least one dose of OROS hydromorphone were reported.) Therefore, the tolerability of OROS hydromorphone, used long term, appears limited. The single dose required for pain management may be advantageous for patients who must consume multiple oral medications.