To determine whether short-term and low-dose prednisolone reduces aromatase inhibitor (AI)–induced arthralgias in patients with breast cancer

Prednisolone 5 mg was administered to women once daily in the morning for one week.

• The study reported on a sample of 27 patients.
• Mean patient age was 62.8 years, with a range of 51–81 years.
• All patients were hormone receptor–positive women with breast cancer.
• Of the sample, 25 were taking anastrazole, and 2 were taking letrozole; 68% had finger pain, and 29% had knee joint pain.

• Multisite
• Outpatient setting
• Japan

Patients were undergoing active antitumor treatment.

The study was a prospective intervention clinical trial.

• Questionnaire for assessment of arthralgia symptoms (no mention of validation); symptoms were measured at one week, one month, and two months.
• A visual analog scale also was used to measure percentage of relief.

Joint symptoms improved in 67% of patients immediately after prednisolone, 63% continued to report relief at one month, and 52% at two months. Thirty percent of patients reported an improvement in daily life at one week and one month and 26% at two months.

Results suggest that a low dose of 5 mg of prednisolone given for one week at the initiation of AI therapy can relieve arthralgias in some patients.

• The study had a small sample, with less than 30 participants.     
• The study had baseline sample/group differences of import (two patients on letrozole and others on anastrozole).     
• The study had risk of bias due to no control group.
• Measurement/methods were not well described.  
• Measurement validity/reliability were questionable.
• Adverse effects were not delineated.

While this study suggests that AI-related pain can be reduced in patients with breast cancer using prednisolone, randomized controlled trials are needed that reflect longer follow-up and adverse event monitoring. Insufficient evidence exists to recommend practice implementation.

To provide a guideline for the use of antimicrobial prophylaxis for patients in an allogeneic bone marrow transplantation setting.

This was classified as a guideline of evidence-based medicine criteria.  The author used a table to rate available evidence-based articles about antimicrobial prophylaxis in allogeneic bone marrow transplant recipients.

• The phase of care was active treatment surrounding hematopoietic stem cell transplantation (HSCT).
  • Pre-engraftment occurred until day 30.
  • Post-engraftment occurred from days 30 to 100.
  • Late post-engraftment occurred after more than 100 days.

Evidence was rated using this table.   

Category, Grade                        Definition

Strength of Recommendation
A             Good evidence to support a recommendation for use (strongly recommended)
B             Moderate evidence to support a recommendation for use (generally recommended)   
C             Poor evidence to support a recommendation (optional)
D             Moderate evidence to support a recommendation against use (generally not recommended)
E             Good evidence to support a recommendation against use (never recommended)

Quality of Evidence
I                Evidence from at least one well-executed randomized, controlled trial
II               Evidence from at least one well-designed clinical trial without randomization; cohort or
                     case-controlled analytic studies (preferable from more than one center); multiple time-series    
                     studies; or dramatic results from uncontrolled experiments
III              Evidence from opinions of respected authorities based on clinical experience, descriptive
                      studies, or reports of expert committees.

Bacterial

Al:  Fluoroquinolones should be used for antibacterial prophylaxis.
BII:  Pneumococcus prophylaxis should be used for any patient with active chronic graft-versus-host disease and for the remainder of the patient's life following splenectomy.
BIII:  Patients already receiving Pneumocystis carinii pneumonia (PCP)-prophylaxis with trimethoprim/sulfamethoxazole (TMP-SMZ) should have additional prophylaxis based on the epidemiology for the area and patterns of resistance.
DI:  Anti-infectious prophylaxis with intravenous immunoglobulins should be used.

Cytomegalovirus

Preventing Exposure

AIII:  All patients being considered for allogeneic stem cell transplant should have anti-cytomegalovirus (CMV) IgG-antibody testing.  This is recommended to establish the risk for reactivation (de novo infection).
BIII:  CMV-negative transplant candidates and patients should not share drinking cups or eating utensils that have been used by others.  If a patient who is CMV-negative is in a monogamous relationship, his/her partner is advised to be CMV-serotested. If his/her partner is positive or the patient is not in a monogamous relationship, condom use during sexual contact is recommended.
Al:  Transplant recipients who are CMV-seronegative should receive blood products from donors who have also tested negative. When blood banks lack CMV-negative donors, only leukocyte-depleted red cells and thrombocytes should be issued to this group.
DI:  CMV prophylaxis should use preparations of human immunoglobulin for CMV-negative matched related donors.

Preventing Disease and Reactivation

BIII:  For a CMV-positive recipient, most transplant physicians recommend a CMV-positive donor.
Al:  Any patient at risk for CMV disease should be screened for pp65 antigenemia or nucleic acid using real-time polymerase chain reaction (PCR) at least weekly after transplant from days 10 to 100.
Al:  Patients should begin pre-emptive therapy following one positive pp65 or two consecutive PCR results.  Pre-emptive therapy is advised for two weeks, followed by another two weeks of maintenance therapy.
AI:  In a pre-emptive setting, if the patient has resistance to ganciclovir, switching to foscarnet is recommended.
AI:  The recommendation for herpes simplex virus (HSV) reactivation in IgG-positive patients is acyclovir.  Acyclovir therapy should begin between the start of conditioning therapy and day 1 after the transplant and should continue until day 30 after stem cell transplantation.
Al:  The recommendation of drugs for prophylaxis or therapy of CMV are ganciclovir and foscarnet.  (Cidofovir has a BII recommendation.)
EI:  High-dose acyclovir and valacyclovir should be used to prevent CMV.
El:  Human immunoglobulins should be used for prophylaxis or therapy of CMV.

Herpes Simplex Virus

Preventing Exposure

AIII:  Serum tests for anti-HSV serostatus are mandatory.

Preventing Reactivation

AI:  Acyclovir should be used for standard reactivation prophylaxis, beginning between the start of conditioning therapy and day 1 posttransplant and continuing to day 30 following stem cell transplant.
CI:  Evidence is lacking for the use of acyclovir prophylaxis increased to 100 days or more.
BIII:  If repeated reactivation is present after 30 days of prophylaxis, continued therapy is recommended.
EIII:  Acyclovir is not recommended for continued HSV prophylaxis at times when gancyclovir or foscarnet is used for CMV therapy or prophylaxis because gancyclovir and foscarnet are effective against HSV in vitro.
CIII:  The effectiveness of valacyclovir and famciclovir in preventing HSV reactivation lacks the support of trials, but they are presumed effective.

Varicella-Zoster Virus

AIII:  All patients being considered for stem cell transplant should avoid contact with those suspected of active varicella-zoster virus (VZV) infection or reactivation.
BIII:  Those living with or in close contact with a transplant patient should be vaccinated before transplant.
AIII:  To prevent nosocomial spread, transplant patients with overt VZV disease are to be isolated until all lesions are crusted.
CIII:  Long-term acyclovir prophylaxis is not effective for prevention.

Epstein-Barr Virus

AIII:  Seronegative transplant candidates and patients with Epstein-Barr virus (EBV) should not share drinking cups or eating utensils that have been used by others.  If a patient negative for EBV is in a monogamous relationship, his/her partner is advised to be EBV-serotested.  If his/her partner is positive or the patient is not in a monogamous relationship, condom use during sexual contact is recommended.

Community Respiratory Virus

AIII:  Exposure prophylaxis is critical in avoiding respiratory syncytial virus, influenza, parainfluenza, and adenovirus.
BII:  Those living with or working on units with transplant patients should be vaccinated for influenza.
BIII:  Patients should receive a two-week course of amantadine or rimantadine for chemoprophylaxis if vaccination occurred during an influenza outbreak.

Yeasts

CIII:  Foods at risk for allowing fungi to colonize in the gastrointestinal (GI) tract should be restricted.
AIII:  Hand washing and disinfecting by personnel should be performed to prevent GI-colonizing fungi from reaching patients at risk.
Al:  It is recommended to take fluconazole 400 mg/day IV or orally  to prevent yeast infections in allogeneic stem cell recipients while they are neutropenic.  
BI:  One study found itraconazole superior to fluconazole but noted that GI side effects can limit oral use.
EII:  Itraconazole is not recommended for yeast prophylaxis because of interactions with metabolism of busulfan.   
EI:  Itraconazole is not recommended for yeast prophylaxis because of interactions with metabolism of cyclophosphamide.

Molds

AII:  Stem cell transplant candidates and patients must avoid construction, renovation, or other areas with dust exposure.
AII:  Use of air conditioning with high-efficiency particulate absorption filtration or laminar air flow in transplant units reduces mold spore presence in the air and mortality related to fungal invasion.
BIII:  Transplant patients should wear appropriate fitting masks when traveling through or to areas off the transplant unit.
BII:  No drug demonstrates effectiveness for the primary prophylaxis of aspergillosis following bone marrow transplant.      
DII:  Itraconazole capsules are limited based on low bioavailability.
AI:  For patients with acute leukemia, itraconazole solution reduced the incidence of invasive aspergillosis if plasma levels were greater than 500 ng/mL.
AIII:  Secondary prophylaxis with a drug having systemic effectiveness was recommended despite a lack of trial evidence.

Pneumocystis jiroveci (formerly Pneumocystis carinii)

BIII:  Stem cell recipients are not to have contact with patients with known PCP.
AII:  TMP-SMZ prophylaxis should be used for all allogeneic transplant patients beginning at engraftment until the completion of immunosuppressive therapy or when chronic graft-versus-host disease is resolved.  
AII:  Dapsone or aerosolized pentacarinate should be used when TMP-SMZ is contraindicated or when the patient does not tolerate it.  Higher breakthrough rates are noted with these alternate drugs.

Toxoplasmosis

AIII:  Allograft recipient candidates should be tested for Toxoplasma gondii antibodies to identify risk for reactivation.  Education should include ways to avoid exposure.
CIII:  Toxoplasma prophylaxis at the time of acute graft-versus-host disease or secondary prophylaxis following history of toxoplasmosis should be performed.

Food

BIII:  Foods with a risk of fungi, bacteria, or other contamination should be eliminated during and following stem cell transplant, and safer alternatives should be used (e.g., pasteurized cheese instead of unpasteurized cheese).

Vaccination After Stem Cell Transplant

AIII:  Immunity against specific pathogens should be analyzed one year after allogeneic transplant with reimmunization with inactivated vaccine or toxoids.

The article also states that stem cell transplant recipients are not to receive live-attenuated virus vaccination during the two years after transplant.  No rating was provided for this “strictly contraindicated” recommendation.

• Some clinical trials during the 1990s did not specify allograft recipients for inclusion, so patients undergoing allograft and autologous stem cell transplants may have been included.
• Placebo studies are rare for this area of study, so most trials compared an old medication with a new one.
• Advances in allogeneic stem cell transplantation over the past 15 years make comparisons of patients who received growth factor stimulation after transplant and those who did not, which is problematic.
   

Specific recommendations with strong evidence, AI and EI, should be included in nursing practice guidelines with recommendations for and against practice, respectively.  Other recommendations should not be included until higher evidence from trials can be demonstrated or included in the “Evidence Not Established” category. 

To investigate the feasibility and effects of a multimodal intervention for fatigue compared to home-based aerobic exercise

Individuals selected which intervention they wanted—home exercise or the multimodal intervention. The multimodal intervention included psychoeducation, including mindfulness-based techniques, sleep education regarding sleep hygiene, restriction and stimulus control, eurythmy therapy involving mind-body exercises, and medicine-oriented painting therapy. Those in the exercise group were asked to carry out 30-minute sessions three to five times weekly. Those in the multimodal group had 225 minutes of activity once weekly over 10 weeks, led by specialists in that therapy. Baseline and follow-up study measures were obtained within three weeks prior to starting the study and within three weeks after completion.

• N = 28 
• MEAN AGE = 57 years
• MALES: 0.5%, FEMALES: 99.5%
• KEY DISEASE CHARACTERISTICS: All had breast cancer. On average, patients were three years out from initial diagnosis and treatment.
• OTHER KEY SAMPLE CHARACTERISTICS: Approximately half were employed. All had a fatigue score of at least four and had fatigue for at least six months.

• SITE: Single site 
• SETTING TYPE: Outpatient 
• LOCATION: Germany

• PHASE OF CARE: Late effects and survivorship

• Observational two-group pilot study

• Cancer Fatigue Scale (CFS-D) (scale of affective, physical, and cognitive fatigue)
• Pittsburgh Sleep Quality Index (PSQI)
• Satisfaction with intervention on five-point Likert scale

Those in the multimodal group showed a significant reduction in physical fatigue (p = .0342, mean change = -2.1). Those in the multimodal group had a significant improvement in global sleep quality (p = .041, mean change = -2.0).

A multicomponent intervention was seen to be feasible and had a positive impact on rating of physical fatigue and global sleep quality.

• Small sample (< 30)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Risk of bias (no appropriate attentional control condition)
• Other limitations/explanation: Adherence to home-based exercise is not known.

A holistic multicomponent approach to manage patient fatigue and sleep disruption may have greater benefit than interventions that only incorporate exercise. Further research is needed to determine what type and intervention components are most effective.

The study assessed the effects of tibolone versus placebo in postmenopausal women receiving tamoxifen, measuring effects on hot flashes, endometrium, and serum lipid and lipoproteins.

Women were randomized to receive 20 mg/day tamoxifen plus 2.5 mg/day tibolone or placebo.

Seventy (70) post-menopausal women less than or equal to 75 years of age (mean age: 58. I years) with Stage IIB or less started on tamoxifen postoperatively. Sixty-seven (67) patients completed the study. I

• Inclusion criteria:
  • Post-menopausal women less than or equal to 75 years of age with newly diagnosed Stage Ilb or lower breast cancer
  • Surgical treatment with conservative therapy or modified radical mastectomy
  • Receiving tamoxifen therapy
  • Last menstrual period one year or more before the diagnosis of breast cancer
  • Serum estradiol concentration of less than or equal to 30 pg/mL
• Exclusion criteria:
  • Other malignancies; prior hysterectomy or bilateral oophorectomy; endometrial hyperplasia/adenocarcinoma; cervical smear result showing moderate dysplasia or worse
  • Cardiovascular, cerebrovascular, or thromboembolic disorders
  • Uterine bleeding of unknown cause; severe liver disorders 
  • Drug or alcohol abuse in the previous 12 months
  • Requirement for cancer therapy (other than tamoxifen therapy and radiotherapy)
  • Nedication that may affect the metabolism of tibolone
  • Use of steroids or tamoxifen in the six weeks prior to the study
  • Hormonal implants at any time

This was an outpatient, multicenter trial.

The trial was a double-blind, randomized, placebo-controlled, multicenter, pilot study.

The trial's primary end point was frequency and severity of hot flashes at three months. Daily hot flash diaries were used to assess frequency and severity of hot flashes. The Landgren scale assessed intensity of hot flashes and sweats. Patients completed a questionnaire to assess interference of hot flashes and sweats with everyday life. Endometrial biopsies were taken at 6 and 12 months. Monthly diaries assessed the incidence of bleeding or spotting throughout the study. Serum lipid profiles were assessed.

Daily diaries showed no change in the daily number of hot flashes with either tibolone or placebo (p = 0.219) after three months. There was a significant reduction in the severity of hot flashes with tibolone verses placebo (-0.4 versus 0.2, p = 0.031). The Landgren scale showed a mean change in the number of hot flashes of –0.6 with tibolone and +1.1 with placebo after 12 months (p = 0.022). Endometrial biopsies were normal and vaginal bleeding similar in both groups. Significant decrease in triglycerides ( 23% versus 1.4%) and HDL (12% versus 19%) with tibolone versus placebo after 12 months were noted.

The study was limited by its small sample size with less than 100 participants.

The effect of tibolone on recurrence of breast cancer is unknown.

To investigate the short- and long-term effects of classical massage therapy on cytokine responses and the Th1/Th2 ratio, depression, mood, and perceived stress in patients with primary breast cancer; to evaluate the relevance of classical massage therapy in the context of oncologic care  

Authors randomized 34 women into two groups. The massage group received a 30-minute classical massage twice per week for five weeks. The control group received standard medical care only. Time points in the study were before intervention, at the end of the five-week intervention period, and at six weeks after the intervention. At these time points, participants completed several measurement instruments, and investigators took blood samples to determine cytokine concentrations and the Th1/Th2 ratio.

• The sample was composed of 29 participants.
• Mean age of patients in the massage group was 59.5 years; in the control group, 59.9 years.
• Because participants were patients with breast cancer, the assumption is that 100% of participants were female.
• The tumor size of all participants was less than or equal to T2; nodal state, less than or equal to N2. The time since disease onset was less than four years before the study. Participants had completed surgery, chemotherapy, and/or radiation therapy at least three months prior to the beginning of the study.
   

Unspecified

• Phase of care: long-term follow-up
• Clinical applications: late effects and survivorship

Randomized controlled trial

• Perceived Stress Questionnaire (PSQ), to assess the subjective experience of stressful situations on the cognitive and emotional level. Authors used a 20-item German version of the PSQ, a version consisting of four subscales: worries, tension, demands, and joy. These are rated with a four-point Likert scale and subscale values are transformed into scores 0–100. High scores correspond to high levels of stress.    
• Patient Health Questionnaire (PHQ), to screen, diagnose, and evaluate the severity of different psychiatric diseases. Depression score is derived from nine items, and the sum of the scores varies 0–27. The higher the score, the more severe the depression.    
• Berlin Mood Questionnaire, or Berliner Stimmungsfragebogen (BSF), a self-report of mood developed on the basis of the Profile of Mood States (POMS). The 30-item BSF measures six mood states and rates each on a five-point scale. Authors used BSF scales of anxious depression and elevated mood.
• BD Cytometric Bead Array (CBA) kit to measure cytokine concentrations.
   

• Authors noted no significant sociodemographic or clinical differences between participants in the massage group and those in the control group.
• At five weeks, immediately after massage, depression and anxious depression decreased significantly, compared to depression and anxious depression in the control group (p = 0.005, effect size (ES) = 1.39 in PHQ scores).
• Stress and elevated mood did not change significantly after massage therapy.
• Changes of cytokine concentrations and Th1/Th2 ratio were insignificant, although authors noted a slight shift toward Th1 in the massage group over time.

Massage therapy is an efficient treatment for reducing depression in breast cancer patients. Insignificant results concerning immunologic parameters, stress, and mood indicate that further research is needed to determine psychological and immunologic changes associated with massage therapy.

• The study had a small sample size, with fewer than 30 participants.
• The study had a risk of bias due to no attentional control condition.
• Improvement of psychometric parameters may differ with massage therapist.
• Cytokine levels may fluctuate or increase coincident with immunologic processes, such as infections or chronic diseases.
• Authors do not make clear whether, at the five-week time point, measures were taken immediately after the massage. Timing could influence results.
• Authors stated that effect size for depression was 1.39 on a 100-point scale, but they did not state how effect size was calculated.

Massage therapy may be an effective intervention to offer to patients who struggle with depression. Additional studies should evaluate the effectivenss of this intervention as well as its effect on immunologic parameters, stress, and mood.

To determine whether centralized telephone-based care management cued by automated symptom monitoring can improve depression and pain in patients with cancer

In this study, called the Indiana Cancer Pain and Depression Trial, centralized telecare management was conducted by a nurse-physician specialist team that worked in concert with automated home-based symptom monitoring. The means of monitoring was interactive voice recording or Internet. A nurse care manager assessed symptom response and medication adherence, provided pain- and depression-specific education, and made treatment adjustments according to evidence-based guidelines. Intervention patients received scheduled calls (at baseline, at 1 week, and at 4 and 12 weeks) and received calls when automated monitoring indicated problems in symptom management. Control group received usual care. Data were collected at baseline and at months 1, 3, 6, and 12.

• The sample was composed of 405 patients, 202 in the intervention group and 203 in the control group.
• Mean patient age in the intervention group was 58.7 years (SD = 11 years); in the control group, 59 years (SD = 10.6 years).
• In the intervention group, 63% of patients were female and 37% were male. In the control group, 72% were female and 28% were male.
• The sample included diverse cancer types (more than 20% of patients had breast cancer) and various disease stages. Patients had to have depression, pain, or both to be eligible. Depression was defined by a score equal or greater than 10 on the Patient Health Questionnaire-9; cancer pain, by a worst-pain score equal or greater than 6 on the Brief Pain Inventory (BPI). Baseline demographic and clinical characteristics between groups were balanced.

• Multisite
• Outpatient
• Sixteen community-based urban and rural oncology practices in Indiana

Randomized controlled trial

• Twenty-item Hopkins Symptom Checklist (HSCL-20), to measure depression severity
• BPI, to measure pain severity 
• Single-item scale, 0–10, to measure overall quality of life
• SF-12 Health Survey, to measure physical and mental components
• Generalized Anxiety Disorder questionnaire, to measure anxiety
• Somatic Symptom Scale, to measure physical-symptom burden

• Over the 12 months of the trial, of the 274 patients with pain, the 137 patients in the intervention group had greater decreases in pain severity (≥ 30% decrease), as measured by the BPI (as a continuous severity score or as a categorical pain responder), than did the 137 patients in the usual care group (p < 0.001 for both groups).
• Over the 12 months of the trial, of the 309 patients with depression, the 154 patients in the intervention group had greater decreases in depression (≥ 50% decrease), as measured by the HSCL-20 (as a continuous severity score or as a categorical depression responder), than did the 155 patients in the usual care group (p < 0.001).
• The standardized effect size for between-group differences at 3 and 12 months was 0.67 (95% CI 0.33–1.02) and 0.39 (95% CI 0.01–0.77) for pain and 0.42 (95% CI 0.16–0.69) and 0.41 (95% CI 0.08–0.72) for depression.
• The intervention group had better outcomes in several health-related quality-of-life domains: mental health, vitality, anxiety, and physical-symptom burden.

This study showed that centralized telecare management with automated symptom monitoring may be a feasible approach for geographically dispersed urban and rural oncology practices. This approach may be effective in improving the pain and depression of cancer patients.

Lack of control of the type of cancer treatment and of the time lapse since treatment might have affected study findings.

Cost will be involved in training the care manager and in the hiring of trained personnel. The cost-effectiveness of the collaborative care model needs to be further examined. Findings suggest that telecare management used with automatic systems cued by patient problems can be an effective approach.

To determine whether centralized telephone-based care management and automated symptom monitoring can reduce depression and pain in patients with cancer

Participants in the intervention group received centralized telecare management, conducted by a nurse-physician specialist team, and automated home-based symptom monitoring by means of interactive voice recording or Internet. The control group received usual care. Data were collected at baseline and at months 1, 3, 6, and 12.

• The sample was composed of 405 participants, 202 in the intervention group and 203 in the control group.
• In the intervention group, mean patient age was 58.7 years (SD = 11.0). In the control group, mean patient age was 59 years (SD = 10.6 years).
• Most participants, more than 60%, were female.
• The sample included cancers of diverse types and stages.
• To be eligible, patients had to have depression, pain, or both as defined by a score of at least 10 on the Patient Health Questionnaire-9 (PQ-9) or a score of at least 6 on the Brief Pain Inventory (BPI).

• Multisite
• Outpatient
• Indiana, United States

Random controlled trial with double blinding, with stratified randomization by symptom type (pain only, depression only, or both pain and depression)

• Twenty-item Hopkins Symptom Checklist (HSCL-20), to measure severity of depression
• Brief Pain Inventory (BPI), to measure severity of pain
• A single-item 0–10 scale, to measure overall quality of life
• SF-12, to provide physical-component and mental-component summary scores
• Generalized Anxiety Disorder Scale, to measure anxiety
• Somatic Symptom Scale, to measure physical-symptom burden

• The number of patients with pain was 274. Over the 12 months of the trial, the 137 patients in the intervention group had greater improvements in pain severity, as measured by BPI scores, than did the 137 patients in the usual-care group (p < 0.001).
• The number of patients with depression was 309. Over the 12 months of the trial, the 154 patients in the intervention group had greater improvements in HSCL-20 scores than did the 155 patients in the usual-care group (p < 0.001). The HSCL-20 scores of the intervention group decreased at least 50%.
• The standardized effect size for between-group differences, at 3 and 12 months, was 0.67 and 0.39, repectively, for pain and 0.42 and 0.41, respectively, for depression.
• Compared to the usual-care group, the intervention group had better outcomes in several health-related quality-of-life domains.

The intervention may be effective at reducing pain and depression. The intervention proved to be a feasible care approach for geographically dispersed urban and rural oncology practices.

Lack of control over type of cancer treatment and over the time lapse since treatment might have affected study findings.

Cost will be involved in training the care manager and in hiring trained personnel. The cost-effectiveness of the collaborative care model needs to be further examined. Studies show mixed results regarding effect of by-telephone patient management; further work in this area is warranted. Use of technology may be a viable approach to ongoing patient support.

The intervention was a self-administered stress management training (SSMT) program for patients treated with radiation therapy. The usual care only (UCO) intervention included the usual psychosocial care typically provided at the institution where patients were receiving treatment. Participants in the SSMT program met individually with a nurse for approximately five minutes to receive instructional materials and explanations. The instructional materials consisted of a 15-minute prerecorded videotape, a 12-page booklet, and a 35-minute prerecorded audiotape titled “Active Relaxation,” which taught paced breathing, active relaxation, and positive thinking with guided imagery instructions. Data were collected at baseline and weeks 1, 2, and 3.

• The study reported on a sample of 310 patients prior to starting treatment with radiation.
• The UCO group had 156 patients, and the SSMT group had 154 patients.

Multiple centers in South Florida

A randomized controlled trial design was used.

• Mental Component Summary score of the Medical Outcomes Study–short form (SF-36)
• Center for Epidemiologic Studies–Depression Scale (CES-D)
• State-Trait Anxiety Inventory (STAI)–state anxiety
• Statistical analyses repeated measures using SAS PROC MIXED based on unstructured covariance matrix model assumption
• The models used for analysis included the baseline measures as covariates: the effects of treatment alone, time alone, the interaction of treatment with time, the quadratic effect of time, and the quadratic effect of treatment and time.

SSMT is effective only in those patients receiving radiotherapy with initially higher levels of psychological distress at baseline.

Special training needs include the creation of the SSMT tool (instructional materials, video tables, and audiotapes).

Intervention requires screening for psychological distress.

To update the 1999 American Society of Clinical Oncology (ASCO) guideline for antiemetics in oncology 

The update committee reviewed studies identified through a literature search.

Databases searched were MEDLINE, the National Library of Medicine, and the Cochrane Collaboration Library (1998-Feb. 2006).

Studies were included if they were phase II and III randomized, controlled trials.

The search identified the following studies.

• Systematic reviews and meta-analysis on neurokinin 1 (NK1) receptor antagonists in the prevention of chemotherapy-induced nausea and vomiting (CINV) related to high-dose chemotherapy
• A meta-analysis of randomized trials assessing the efficacy of dexamethasone in controlling CINV
• Three systematic reviews and meta-analyses of 5-hydroxytryptamine 3 (5-HT₃) receptor antagonists

Additional materials provided to the committee were

• Two additional systematic reviews available prepublication from the Cancer Care Ontario Program in Evidence-Based Care
• Consensus statements and guidelines from Multinational Association of Supportive Care in Cancer (MASCC).

• The combination of 5-HT₃ receptor antagonist, dexamethasone, and aprepitant is recommended before highly emetogenic chemotherapy (HEC). This combination is recommended for patients receiving an anthracycline and cychlophosphamide. At equivalent doses for the prevention of acute emesis, 5-HT₃ receptor antagonists have equivalent safety and efficacy. 
• For patients receiving HEC, antiemetic agents of lower therapeutic index are not an appropriate first choice. Agents with lower therapeutic index should be used in patients who are unable to take to a 5-HT₃ receptor antagonist, dexamethasone, and aprepitant because of allergy or side effects or for whom these agents have been ineffective.
• For patients receiving moderately emetogenic chemotherapy (MEC), a combination of a 5-HT₃ receptor antagonist and dexamethasone is recommended.
• In patients receiving cisplatin and all other agents of high emetic risk, the combination of aprepitant and dexamethasone is recommended for the prevention of delayed emesis.
• The combination of a 5-HT₃ receptor antagonist and dexamethasone is no longer a recommendation for the prevention of delayed emesis after HEC.
• The recommendation to lower the dose of dexamethasone when administered as an antiemetic with aprepitant does not apply to corticosteroids for anticancer therapy.

To compare, in clinical practice, the effect and safety of a new matrix fentanyl patch (Fentanyl Improved Transdermal [FIT]) patch) to oral and other transdermal opioid treatment

Patients were randomly assigned to either FIT patch or standard opioid treatment via oral or transdermal route. Morphine was the only rescue medication allowed. Patients could receive radiotherapy and chemotherapy as well as nonpharmacologic and pharmacologic pain management therapies. Patients randomized to FIT therapy switched from existing regimens to FIT therapy by means of standard conversion ratios. Patients had an initial screening visit and four additional visits. Each evening each patient assessed his or her pain and recorded the pain rating in a diary. Adverse events were monitored in follow-up visits through the 30-day trial period and for one week longer. Patients assessed adverse events on a four-point scale and recorded the rating.

• The sample of patients who completed the trial was composed of 170 patients.
• In the FIT group, mean patient age was 63.1 years (SD = 11.04 years). In the control arm, mean patient age was 61.3 years (SD = 11.66 years).
• Of all patients, 40% were female and 60% were male.
• Overall, 11% of patients randomized were opioid naive.
• Authors did not report cancer diagnoses. All patients had a baseline Karnofsky performance score of 50 or higher.

• Multisite
• Outpatient
• Seven European countries

Randomized open-label parallel-group design

• Numeric rating scale (0–10), to measure pain intensity
• Four-point scale to rate adverse events, including constipation, nausea, sleep disturbance, and daytime drowsiness

• There was no significant difference between groups regarding pain intensity ratings.
• Subgroup analysis revealed no differences based on concomitant chemotherapy or radiotherapy or on subgroup analysis based on nocioceptive versus neuropathic pain.
• Between groups, there were no significant differences in the prevalence or severity of adverse effects.
• Authors observed no new or unexpected adverse drug reactions.

Results showed no differences, in terms of pain management or adverse effects, between the new transdermal patch and standard transdermal or oral opioid treatment. Findings suggest that the new type of patch is safe and, in terms of efficacy, similar to standard treatments.

• The study has a risk of bias due to no appropriate control group.
• Authors provided no analysis of other medications or approaches used for pain management. (These were not controlled in the study.) Authors did not report analysis of morphine use for breakthrough pain.
• Patients' diaries were the source of adverse events and pain intensity scores. Note, however, that authors stated that patients' records regarding rescue medication, for example, could not have been accurate. If patients' records were inaccurate, the study should have provided objective or observer scoring.

Transdermal fentanyl, delivered by means of conventional patch or FIT patch, is an effective means of controlling cancer pain.