To compare if individual psychosocial support for patients with breast cancer provided by oncology nurses specially trained in cognitive behavioral techniques was as effective as that given by psychologists or standard care.

Patients received individualized psychosocial support interventions using cognitive behavioral techniques, such as relaxation, distraction, activity scheduling, and ways to improve communication. The frequency of sessions varied based on patients' perceptions of need. Patients were randomized in blocks of nine into one of three alternatives:  60 received individual psychosocial support by a specially trained oncology nurse, 60 received it from a psychologist, and 59 received standard care. Outcomes measured were quality of life (QOL), fatigue, nausea, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties.

• The study was comprised of 179 consecutive patients with breast cancer about to start adjuvant treatment.
• Mean age was 55 years (range 23–87).

The study was conducted at the Department of Oncology, Uppsala University, Sweden.

Patients were undergoing the active treatment phase of care.

This was a prospective, randomized, quasiexperimental study using repeated measures at baseline and at one, three, and six months.

• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLC-C30)
• EORTC QLQ–Breast Cancer (EORTC QLQ-BR23)
• Hospital Anxiety and Depression Scale (HADS)
• Impact of Event Scale (IES)
• State Trait Anxiety Inventory–State (STAI-S)

The results revealed statistically significant group by time interactions for global QOL and health status, nausea and vomiting, and systemic therapy side effects. Intervention groups showed statistical differences on the insomnia, dyspnea, and financial difficulties EORTC subscales, in favor of one or both of the interventions.

• The number of sessions varied and was determined by the need and desire of individual patients.
• There was a need for special training to deliver the intervention.

Patients were randomized to two intervention groups:  Individual Psychosocial Support, provided by a trained oncology nurse (INS), and Individual Psychosocial Support, provided by a psychologist (IPS). Both interventions used the same techniques of relaxation, distraction, activity scheduling, and ways to improve communication. The number of sessions and time intervals between sessions varied according to the needs and desires of individual patients. Each session lasted 45 to 60 minutes, in which patients' problems were identified and developments were made to help manage these problems. Patients were provided with written and oral instructions on how to practice these strategies. Quality of life questionnaires were administered at baseline and at one, three, and six months.

• The study included 179 women with breast cancer about to start adjuvant treatment.
• Mean age was 55 years (range 23–87).
• Of the participants, 136 were married/cohabitant, and the majority (n = 130) were in stage T1.
• Most participants had received no preoperative chemotherapy.
• For postoperative treatment, most had received local radiation therapy only (n = 100), hormonal therapy (n = 88), or adjuvant polychemotherapy (n = 69).
• Patients were excluded if they had ongoing psychiatric illness, previous cancer diagnosis, or inability to speak and understand Swedish.

Department of Oncology, Uppsala University Hospital

Patients were undergoing the active treatment phase of care.

This was a prospective, randomized study.

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

Intervention groups had lower fatigue scores on the EORTC-QLQ-C30 at baseline, one month, and six months; these differences were minimal and not statistically significant.

• Twenty percent of the patients did not complete all three assessments.
• A significantly higher proportion of patients randomized to the INS group were diagnosed in stage N0 compared to the other groups. It is unclear whether this had a significant impact on the results.

To compare individual psychosocial support (cognitive behavioral therapy [CBT]) for patients with breast cancer provided by oncology nurses specially trained in psychologic techniques (INS), or the same support given by psychologists (IPS), versus standard care provided in Sweden.

Measures were done at one, three, and six months after inclusion in study.

The sample was comprised of 179 patients with breast cancer who were about to start adjuvant therapy.

A prospective, randomized study design was used.

• Hospital Anxiety and Depression Scale
• State-Trait Anxiety Inventory
• Impact of Event Scale (intrusion and avoidance subscales)

Results indicated that CBT offered by specially trained nurses is just as effective as CBT offered by psychologists. Statistically significant improvements in anxiety over time (p < 0.01) were shown between the INS and IPS groups versus the standard care group.

• No screening for psychological problems or treatment before inclusion into the study may flaw the results.
• Insufficient power of study may limit results.

To evaluate the effectiveness of oligon central venous catheters (CVC) and chlorhexidine biopatch to reduce CVC-related infections. Oligon catheters are impregnated with antimicrobial silver, platinum, and carbon.

Patients were randomized to receive either a standard polyurethane catheter, a standard catheter plus biopatch, or an oligon catheter. All catheters were triple lumen. Standard maximum barrier insertion techniques were used, and dressing change frequency was every three days with a transparent dressing. Those getting the biopatch had the biopatch changed with regular dressing changes. The primary study endpoint was catheter colonization. A decision to remove the catheter was made by individual physicians.

• N = 376; 465 in intention to treat analysis
• MEDIAN AGE = 59 years
• AGE RANGE = 32–73 years
• MALES: 69.7%, FEMALES: 30.3%
• CURRENT TREATMENT: Immunotherapy
• KEY DISEASE CHARACTERISTICS: Overall, 7% of the sample had cancer.
• OTHER KEY SAMPLE CHARACTERISTICS: 96% of patients were in the ICU for mechanical ventilation.

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

• Three-group randomized, controlled trial (RCT)

• Catheter colonization defined as 10³ or greater colony forming units ml of catheter tip
• Catheter-related infection (CRI) defined as positive colonization and clinical evidence of sepsis with the same organism and no other clinical site for infection
• Central line–associated bloodstream infection (CLABSI) defined as CRI plus one positive peripheral blood culture with the same organism as isolated from the catheter tip

There were no differences in catheter colonization rates, CRI, or CLABSI between groups. There were no differences between groups in number of catheter days, CLABSI incidence per 1,000 catheter days, or other factors potentially associated with development of CLABSI. Analysis showed that use of jugular or femoral insertion site and cancer diagnosis were significantly associated with development of catheter colonization (p < 0.05).

Findings did not support efficacy of BIOPATCH dressings or antimicrobial catheters for prevention of catheter-related colonization or infections.

• Risk of bias (no blinding)
• Risk of bias (sample characteristics)
• Key sample group differences that could influence results
• The study was underpowered. Patients receiving BIOPATCH dressing and impregnated catheters had significantly lower proportion of patients. No data regarding actual adherence to insertion and dressing change protocols existed.

Findings did not show efficacy of chlorhexidine-BIOPATCH CVC dressings or antimicrobial impregnated short-term catheters to prevent catheter colonization and related CVC-infection related outcomes.

To determine the effects of ginger on chemotherapy-induced nausea and vomiting (CINV) in women receiving adjuvant anthracycline for breast cancer

Patients were randomly assigned to control and treatment groups. Women in the intervention group consumed 500 mg of powdered ginger mixed with yogurt twice daily after an initial dose 30 minutes prior to chemotherapy. Both groups received triplet antiemetic therapy. Patients were followed for five days and were asked to record episodes of vomiting and retching and to evaluate their nausea using a numeric 10-point scale four times per day in a diary. The numeric scale also was used on the first day of chemotherapy to collect baseline data. Patient diaries were collected at the end of the five-day study period.

• N = 60  
• MEAN AGE = 48.5 years (range = 49–58 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All patients were receiving adjuvant anthracycline, were currently receiving triplet antiemetics, and experienced grade 3 or higher CINV during the previous cycle of chemotherapy.

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

• PHASE OF CARE: Active antitumor treatment

Randomized, controlled trial

• Numeric Rating Scale (NRS) for nausea
• Patient diary 

Nausea severity was significantly lower in the experimental group after the intervention on study days 2–5 (p = 0.0001). The number of vomiting episodes also was lower in the experimental group on some study days (p < 0.05).

The use of ginger as an adjuvant to triplet antiemetics among women receiving anthracycline-based chemotherapy resulted in lower acute and delayed nausea severity.

• Small sample (< 100)
• Risk of bias (no blinding)

Advances in antiemetic drugs have substantially improved the prevention and control vomiting in the acute and delayed phases of CINV. However, the prevention of nausea has been difficult to achieve. Findings from this study suggest that the use of ginger in combination with triplet antiemetics can be beneficial in reducing the severity of nausea.

To evaluate the effectiveness of prophylactic tetracycline on afatinib-induced skin toxicities

Afatinib was given after disease progression with chemotherapy. Patients receiving afatinib were randomly assigned to receive general dermatological recommendations (control group) or 250 mg tetracycline every 12 hours in addition to general recommendations. All were receiving 40 mg afatanib every day until disease progression or toxicity. Dosage of afatinib was reduced to 30 mg daily for grade 3 or prolonged grade 2 toxicity. General recommendations provided to all patients were brief baths with lukewarm water, use of sunscreen, emollient creams, hypoallergenic soap, and fingernail care. Study assessments were conducted at baseline, week 2, and week 4 by a blinded assessor.

• N = 90
• MEAN AGE = 57 
• MALES: 26.7%, FEMALES: 73.3%
• KEY DISEASE CHARACTERISTICS: All had lung cancer.

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

PHASE OF CARE: Active antitumor treatment

• Single-blind, randomized, controlled trial

• National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)

Most common toxicities were rash (65.6%), pruritus,(42.2%), mucositis (41.1%), paronychia (33.3%), skin fissures (24.4%), folliculitis (24.4%), and trichomegaly (22.2%). No grade 5 toxicities existed. Rash incidence was 75.5% in the control group versus 55.5% in the tetracycline group (relative risk [RR] = 0.4, p = 0.046), and rash severity of grade 2 or higher was 15.6% in the tetracycline group compared to 35.6% among controls (RR = 0.35, p = 0.03). Incidence of paronychia was lower in the tetracycline group, but group differences were not statistically significant. No other differences existed between groups in skin effects, and no differences existed between groups in the proportion of patients who required afatinib dose reductions. Most patients developed maximum rash intensity between weeks 1 and 4 of treatment. No relationship existed between rash incidence or severity and general disease outcomes.

Prophylactic tetracycline was effective in reducing the incidence and severity of rashes associated with afatinib use.

• Small sample (< 100)

Very limited evidence exists for effective interventions to prevent or treat skin toxicities associated with epidermal growth factor receptor inhibitor (EGFRI) administration. Although the use of antibiotics has been suggested, currently little research demonstrates their efficacy. This study begins to fill that evidence gap, showing that tetracycline can be effective in reducing the incidence and severity of skin toxicity. This is a relatively low-cost and generally safe intervention to reduce adverse skin effects in patients receiving EGFRIs.

To evaluate the efficacy of low level laser therapy (LLLT) for the prevention and treatment of radiotherapy-induced oral mucositis in patients with oral cancer

Patients with primary oral cancer were randomized to the laser group or a control group. All patients had oral prophylaxis before starting radiation therapy, and all had the same oral care during treatment. All patients were evaluated daily for pain severity, functional impairment, and oral mucositis. The clinical exams were performed by a single examiner. All the laser treatments were administered by one operator. The treatment consisted of use of a laser scanner for the first eight days followed by treatment to six areas on the right and left sides of the oral cavity for 25 days.

• The study reported on 24 patients, ages 55–59 years old.
• The sample was 50% female and 50% male.
• Patients were newly diagnosed with primary oral cancer limited to the oral cavity
• Patients received 66 Gy in 33 fractions, 5 days per week for 6.5 weeks. No patients experiencing treatment delays were included in the study.

This was a single site, inpatient and outpatient study conducted at Kasturba Medical College of Manipal University in Karnataka, India.

This was a randomized controlled trial.

• A numeric rating scale was used to measure severity of oral pain.
• To evaluate patient need for supplemental analgesics, the World Health Organization (WHO) analgesic ladder, date of initiation, and  duration of analgesic use were recorded.
• Functional impairment was recorded.
• A scale was used to assess severity of dysphagia.
• Mucositis severity was assessed daily by one examiner using the Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer (RTOG/EORTC) scoring system.

Pain increased gradually and was the greatest at the end of seven weeks. The laser group had a statistically significant lower level of pain than did the control group (p < 0.03). In week 3, the laser group had grade I functional impairment, while the control group progressed to grade II and III functional impairment, with one individual having grade IV impairment. Overall, the laser group had lower mucositis severity than the control group (p = 0.033).

Prophylactic laser therapy during radiation therapy can reduce the severity of mucositis, as well as the severity of functional impairment and pain.

• The control group had a small sample size of fewer than 30 patients.
• The article did not state what the control group procedure involved (e.g., sham treatment).

This form of laser therapy is effective in the prevention of severe mucositis, but it is very high tech and requires special equipment and highly trained personnel.

The primary objective was to find which interventions, if any, were effective in preventing central venous catheter (CVC)-related infections in children with cancer. The secondary objective was to examine the effectiveness of each intervention in the subgroups of (a) implanted venous external catheters, (b) hematologic versus nonhematologic malignancies, and (c) in those receiving hematopoietic stem cell transplantation (HSCT) versus no HSCT.

Databases searched were the Cochrane Central Register of Controlled Trials (2008), MEDLINE (January 1950–January 2009), EMBASE (January 1980–January 2009), and CINAHL (January 1982–March 2009), as were reference lists from relevant articles and international conference proceedings (2004–2008).

Reviews examined were randomized, controlled trials and quasi-randomized, controlled trials of children (younger than 18 years) with cancer who had long-term tunneled CVCs with a CVC infection-prevention intervention other than anticoagulants, systemic antibiotics, and antibiotic lock techniques versus no intervention, placebo, or other intervention to prevent CVC-related infections.

Studies with interventions to treat other catheter-related complications were excluded.

Twenty-eight total references were retrieved.

For dichotomous outcomes, risk ratio and 95% confidence interval (CI) were used to express the estimate of effect; for continuous outcomes, weighted mean differences, standard deviation (SD), and 95% CI were used to summarize the data for each group; and for rare events, rate ratio as a summary statistic and meta-analysis of rate ratios via a generic inverse-variance approach were used.  

The initial total search yielded 876 citations, 216 of which were duplicates. From this, 28 full-text articles were reviewed and three were kept for final analysis. The overall study quality was low.

• After all exclusions, three studies (with 793 participants) were examined.
• Sample range across studies was 103 to 577 patients.
• Patients younger than 22 years with hematologic and nonhematologic malignancies, and one study with HSCT recipients, who had long-term internal or external CVCs were included. Interventions were monthly flushes of 3 mL of prophylactic urokinase-heparin (total doses of 5,000 IU of urokinase) versus heparin alone (total doses of 300 units of heparin); two weekly catheter flushes with urokinase alone (5,000 IU/mL) versus heparin alone (100 units per mL); and transparent catheter dressing changes every 15 days versus every four days (HSCT study).

• Patients were undergoing the active treatment phase of care.
• The study has clinical applicability for pediatrics.

Meta-analysis for the comparison of catheter flushing with urokinase (with or without heparin) versus heparin alone demonstrated an effect on the catheter-associated infection (CAI) rate with the rate ratio of CAI rate = 0.72 (95% CI [0.12, 4.41]) with use of urokinase in adults. One study reviewed reported an incidence of CAI of 2.6 per 1,000 CVC days with urokinase and 3.9 per 1,000 CVC days with heparin (p = 0.04). Studies involving different frequencies of dressing changes were difficult to analyze because adherence to every 14-day change was very low.

There were fewer CAIs with urokinase flushes, with or without heparin versus heparin alone, suggesting that urokinase use in catheter flushes may be beneficial. These findings are limited by the wide CI in findings and the fact that how CAI was defined for this systematic review was not described. No firm conclusions can be drawn from this review regarding urokinase, but the results suggest that further research in this area is warranted, although the difference between the groups was not statistically significant. There were no differences between groups who received dressing changes every 15 days versus every four days regarding the premature removal of the catheter due to infection. Catheter-related infections were not evaluated in the dressing change study, and adherence to the dressing change intervention was poor.

The results highlight need for clear and consistent outcomes definitions to further the research in this area.

Databases searched were AMED, EMBASE, MEDLINE, and PubMed via the Ovid platform and CINAHL via EBSCO.

Search keywords were oncology, chemotherapy, radiotherapy, strength training, aerobic exercise, walking program, physical activity, and fatigue.

Studies were included if they reported 

• An acute or rehab hospital setting
• A controlled trial
• An outcome measure of fatigue
• Sufficient exercise intensity to have a physiologic effect.

Studies were excluded if they reported additional diversional interventions.

Initially, 2,954 studies were retrieved. After exclusions, there was a final set of five studies. The PEDro scale was applied for evaluation of study quality.

• The final five trials included 269 patients with various cancer types.
• Sample sizes ranged from 22 to 104 patients.

• Overall study quality was low, with scores being an average of 4.6 out of 10 possible points.
• Four trials were included in the meta-analysis. Findings for fatigue showed a standardized mean difference of -0.22 (95% confidence interval [-0.62, 0.08]; p = 0.13).
• The most common fatigue measures were the Brief Fatigue Inventory (BFI) and visual analog scale (VAS).
• All interventions involved aerobic exercise.
• There were no between-group effects seen for other symptoms analyzed.

This review showed no significant effect of aerobic exercise interventions for fatigue outcomes in hospitalized patients with cancer. As this study only included hospitalized patients, the findings may not be applicable in other patient groups.

The study was limited by the small number of included trials, with most having small sample sizes.

Effectiveness of exercise for fatigue may vary greatly depending on the phase of care and time in the cancer disease trajectory at which the intervention is provided. Lack of significant positive findings here may be related to the timing of the intervention with all patients in acute or rehabilitation hospitals.

To test the effectiveness of a brief intervention using a cognitive and behaviorally oriented approach on symptoms of fatigue.

Patients were randomly assigned to the intervention or usual care control group. The intervention included three individual face-to-face, sixty-minute sessions that coincided with chemotherapy treatment schedules. These were aimed at clarifying meanings, setting goals, educating patients about cancer-related fatigue, developing and discussing coping strategies, and cognitive restructuring. Sessions were audiotaped to ensure treatment fidelity. Study assessments were performed at baseline (cycle three of chemotherapy), the end of treatment, four weeks after the end of treatment, and nine months after study entry.

• In total, 50 patients (40% male, 60% female) were included.  
• Mean age was 59.1 years (standard deviation = 11.5 years).
• Colorectal cancers were the most common. Multiple other tumor types were included
• Of the patients, 80% had stage III or IV disease, and 76% had at least one other comorbid condition.

• Single site 
• Outpatient 
• United Kingdom

Patients were undergoing the active antitumor treatment phase of care.

The study was a randomized, controlled trial.

• 100-mm visual analog scale (VAS) for global fatigue
• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
• Fatigue outcome measure designed for the study
• Multidimensional Fatigue Inventory (MFI)
• Hospital Anxiety and Depression Scale (HADS)

VAS fatigue scores were significantly lower in the experimental group at Time 2, end of treatment (p = 0.03), but not at any other time point. EORTC physical functioning scores were higher in the experimental group at the end of treatment (p = 0.001) and at four weeks after treatment ended (p = 0.02). There was an overall trend over time favoring the experimental group; however, the trend was not significant and was smaller when data were controlled for medical conditions and HADS scores. No data for the nine-month time after treatment were provided.

Findings suggest that a cognitive-behavioral approach intervention can be beneficial in reducing fatigue during the short term after cancer treatment.

• The study had a small sample size, with less than 100 participants.
• The study had risks of bias due to no blinding and no appropriate attentional control condition.
• Subject withdrawals were 10% or greater. 

Findings suggest that cognitive-behavioral approach interventions to restructure thinking, set goals and coping strategies, and improve self-efficacy may be helpful in reducing fatigue immediately after chemotherapy treatment. This evidence is not strong, given the study limitations here, but the findings are potentially promising.