To compare partially supervised, structured exercise to standard of care for patients with advanced cancer. The primary outcome was general fatigue.

Patients were randomized into three groups. Group A received treatment as usual; participants in group B were taught a structured, individual sports program; and group C received additional ambulatory physiotherapeutical supervision. Exercises were defined based on expert consensus with physical therapists and physicians. Included as “possible exercises” into a catalog and a patient information sheet. For groups B and C, a physical therapist selected applicable exercises from this catalog. Patients were instructed to complete three sessions of endurance and two sessions of strength each week for 20-30 minutes per session. Patients were contacted at weeks 4 and 8, during which groups B and C could ask specific questions and adherence was encouraged. Patients were then followed up with in person at 12 and 24 weeks.

• N = 43   
• AGE = 52.38 years (consented group) 
• MALES: 58%, FEMALES: 42%
• CURRENT TREATMENT: Chemotherapy, radiation 
• KEY DISEASE CHARACTERISTICS: Curative and palliative treatment
• OTHER KEY SAMPLE CHARACTERISTICS: Hematologic, brain, gastrointestinal, lung, head and neck, testicle, and breast cancer, as well as sarcoma

• SITE: Single site   
• SETTING TYPE: Inpatient    
• LOCATION: University Hospital Carl Gustav Carus, Dresden

PHASE OF CARE: Active antitumor treatment

Randomized, controlled trial into three groups

• Multidimensional Fatigue Inventory-14 
• 6-minute walk test (6MWT)
• International Physical Activity Questionnaire Short-Form

No difference in general fatigue was observed. Significant difference was found with mental fatigue (p = 0.03). Over time, all groups experienced an increase in fitness, with group C experiencing the most improvement.

No effects on fatigue were seen.

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

This study did not find any effect of interventions. The study was underpowered to identify significant differences between groups.

Low level laser therapy (LLLT) using two different low level GaAIAs diode lasers was administered 650 nm to group I and 780 nm to group II compared to sham treatment in the placebo group (group III) beginning on the first day of conditioning and continuing through two days after HCT.

Assessors and patients were blinded; only the laser therapist knew the treatment type.

Powered for 22 subjects per group

70 patients were treated on protocol.

Group 1: n = 23
Group 2: n = 24
Group 3: n = 24


The median age was 44–48 years (range = 18–69 years).

Autologous versus allogeneic was 17% versus 82% in group I, 9% versus 90% in group 2, and 8% versus 92% in group III.
 

February-November 2001

Randomized, double-blind, placebo-controlled study of patients with HCT

Oral mucositis index OMI and VAS for pain

0, 4, 7, 11, 14, 18, 21
 

State mean OMI scores varied most at day 11. Scores approached significance (p = 0.06 not significant) when adjusted. Patient-specific average OMI scores for TBI were p = 0.03 (group I) and p = 0.23 (group II).

Two patients died with severe mucositis.
 

Patients in the placebo group appeared to have suffered more pain than patients in the laser treatment group, particularly group I.

The study demonstrated a tendency for LLLT to reduce severity of mucositis during the second week.

Pain data were incomplete; some patients were too ill to do VAS.

Although randomly assigned, TBI and busulfan/cytoxan were not equally distributed.

Small sample size

Set up as a prevention trial, so treatment only occurred through day 2.
 

To examine effectiveness of oral suspension posaconazole for antifungal prophylaxis

Consecutive patients were examined retrospectively. All received intensive-induction chemotherapy. All were given oral suspension posaconazole at 200 mg three times daily. All received antibacterial and antiviral prophylaxis. All infectious workups, empiric treatment, and second-line treatment were standard.

• N = 79
• MEDIAN AGE = 58 years
• AGE RANGE = 22–73 years
• MALES: 38.5%, FEMALES: 62.5%
• KEY DISEASE CHARACTERISTICS: All patients had acute myeloid leukemia; 40% were secondary due to prior therapy.

• SITE: Single site  
• SETTING TYPE: Not specified  
• LOCATION: Germany

• PHASE OF CARE: Transition phase after active treatment

• Retrospective

• Not applicable.

Seventy percent did not develop invasive fungal infection during AML induction chemotherapy. Twenty-one percent had possible infection, and one-third underwent empiric first-line antifungal treatment because of persistent fever of unknown origin or presence of pulmonary infiltrates. Fourteen patients with possible infection received either liposomal amphotericin B or caspofungin. Only those receiving caspofungin required second-line antifungal treatment.

A high proportion of patients received consecutive antifungal treatment. Optimal protection against fungal infection in patients with AML undergoing induction chemotherapy is not clear.

• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment) 
• Measurement/methods not well described

Prevention of infection, and invasive fungal infection in particular, is a challenge in patients undergoing induction chemotherapy for AML. Findings from this retrospective review suggest that a high proportion of patients routinely given oral suspension posaconazole required additional treatment for possible invasive fungal infection. The authors noted that there is uncertain bioavailability of posaconazole given as oral suspension, suggesting that evaluation of various formulations is needed, and that this may not be the most effective approach for antifungal prophylaxis.

To assess differences between skin care with cream or powder formulations and protocols during radiation therapy

Twelve patients receiving radiation therapy to the head and neck region were randomly assigned to treat one side of the neck with cream and the contralateral side with powder. Highly detailed treatment regimens were defined, including cleaning and care for each type of skin problem that might be encountered. Care included a variety of topical treatments and dressings. All wound dressings and visible cream were removed before each radiation therapy session.

• The study sample (N = 12) was comprised of patients with cancer of the head and neck region.
• Eleven patients received adjuvant radiation therapy; eight patients received conventional fractionated radiation therapy up to  60 Gy, 2 up to 50, and all received 50–72 Gy.

The study took place at the University of Tuebingen in Germany.

The study used a quasi-experimental design.

• Objective and subjective assessment and photo documentation were performed at therapy onset and weekly during therapy.
• Skin dermatitis was scored weekly beginning with onset of therapy using a standard form based on skin toxicity scales.
• Patient questionnaires scored feeling of local warmth, tension, itch, pain, and general discomfort on a four-point scale
• Patient preference was considered.

Because of the small sample size, analysis was limited to description. No relevant differences were observed between the two treatment options according to the objective and subjective assessment criteria.

Onset and degree of acute skin reactions and differences in symptom relief between the two treatments could not be demonstrated.

• The sample size was small, with less than 30 participants.
• The trial was not strictly comparing cream and powder treatments (moist desquamation provided for dressings on the cream side and methyl violet solution and Bepanthen cream on the powder side). Complex protocol defined with use of many different treatments further complicates ability to draw any conclusions in the study.
• Validity and reliability of patient scoring was not noted.

The study evaluated a peer counseling program to improve sexual function, increase knowledge about reproductive health, and decrease menopausal symptoms and infertility-related distress for African American breast cancer survivors.

Participants were randomly assigned to immediate counseling or a three-month waitlist. Three peer counselors conducted a three-session intervention using a detailed workbook

The study enrolled  a convenience sample of 60 African American women MD Anderson Center.

The study used the Breast Cancer Prevention Trial Menopause Symptom Checklist.

Women had fewer problems with hot flashes with counseling. Knowledge of reproductive issues improved significantly from baseline to three-month follow-up (p < .0001), as did emotional distress (p < .0047), and menopause symptoms (p < .0128). Sexually dysfunctional women became less distressed (p < .0167).

This was a small convenience sample, and there was a short follow-up time (3 months). Hot flashes were not the primary focus of the study.

To determine if 70% ethanol catheter locks can prevent central line–associated bloodstream infections (CLABSI) in pediatric patients with cancer

Patients were randomised to receive either 70% ethanol or 100 IU/ml heparin locks. Locks were used only when needed, no more than weekly if not accessed, and at least every six weeks. Catheter insertion and care were done according to international guidelines. Patients were stratified according to type of catheter, port-a-cath or broviac type, and type of disease. Two hours after the lock solution was used, the catheter was flushed with saline and the CVC was closed with heparin.

• N = 237
• MEAN AGE = 8.8 years
• AGE RANGE = 1–18 years
• MALES: 57%, FEMALES: 43%
• OTHER KEY SAMPLE CHARACTERISTICS: 94% had single-lumen catheters. The majoirty of them (51%) were placed in the right jugular vein.

• SITE: Multi-site  
• SETTING TYPE: Not specified  
• LOCATION: Netherlands

• APPLICATIONS: Pediatrics

• Single-blind randomized, controlled trial

• Central line–associated bloodstream infection (CLABSI) defined as pathogen cultured from at least one blood culture and fever, chills, or hypotension and a common skin organism from at least two culture drawn on separate locations

The total number of catheter days were 20,916 in the ethanol group and 19,915 in the heparin group. In the ethanol group, 10% of patients developed a CLABSI, compared to 19% in the heparin group (hazard ratio [HR] = 0.52, p = 0.05). CLABSI incidence per catheter days was 0.77/1000 in the ethanol group and 1.46/1000 in the heparin group (p = 0.039); however, when corrected for type of catheter, there was no significant difference between groups. Patients with internalized catheters had significantly lower risk of CLABSI (HR = 0.22, p < 0.001). Survival curve analysis at 100 days showed lower CLABSI rate in the ethanol group (p = 0.038). There was no difference between groups in the number of positive blood cultures. There was no difference in hospital days related to infection. Patients in the ethanol group reported nausea, taste alteration, and dizziness during the time of infusion or lock flushing. A larger proportion of those in the ethanol group withdrew from the study (p = 0.031).

Although authors concluded that ethanol locks reduced CLABSI rate, there was no difference when analyzed according to type of catheter, whether indwelling or not. It appears that the type of catheter may be more important for CLABSI prevention.

• Key sample group differences that could influence results
• Measurement/methods not well described
• Subject withdrawals ≥ 10%  
• No information about proportion of study groups that had indwelling catheters
• There were high catheter days in the ethanol group.
• Timing of study measures was not provided.

Findings of this study are not conclusive regarding the efficacy of two-hour ethanol CVC locks, though results are somewhat promising. Further research is needed with clear differentiation of indwelling catheter versus broviac catheters in analysis. This study used a dwell time of two hours for the ethanol lock; the optimum dwell time is unclear.

STUDY PURPOSE: To investigate antibiotics or other lock treatments in comparison to a control intervention for the treatment of central venous catheter (CVC)-related infections in children with cancer

TYPE OF STUDY: Systematic review

DATABASES USED: CENTRAL (2011), MELINE/PubMed (1945–August 2011), and EMBASE/Ovid (1980–August 2011); reference lists from relevant articles and conference proceedings (SIOP, 2006–2010; American Society of Clinical Oncology, 2006–2010; Multinational Association of Supportive Care in Cancer, 2006–2011; American Society of Hematology, 2006–2010; and International Society on Thrombosis and Haemostasis, 2006–2011); and scanned ISRCTN for ongoing trials

KEYWORDS: See appendices attached.

INCLUSION CRITERIA: Randomized controlled trials (RCTs) and controlled clinical trials (CCTs) comparing one lock treatment with another, or with systemic antibiotics alone, to treat CVC-related infections in children with cancer; cohort studies also were included for adverse events.

EXCLUSION CRITERIA: Adults included in the analyses, studies focused on infection prevention, use of coated catheters, observational studies, no control comparisons, case report studies, and review studies

TOTAL REFERENCES RETRIEVED = 508

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Two review authors searched the databases and reviewed articles for inclusion criteria. Bias assessment was conducted, and if no agreement was reached, a third party was included in the assessment. Pooled analysis was conducted using Review Manager 5 when studies met methodologic quality and were comparable; otherwise, descriptive summaries were conducted. Comparisons included the creation of forest plots. The comprehensive search of multiple databases, meeting proceedings, and ongoing trials to elicit articles for the evaluation of RCTs, CCTs, and cohort studies was appropriate for this evaluation.

• FINAL NUMBER STUDIES INCLUDED = 12 (not all included in all of the analyses)
• SAMPLE RANGE ACROSS STUDIES = 23–68
• TOTAL PATIENTS INCLUDED IN REVIEW = 132
• KEY SAMPLE CHARACTERISTICS: Children with cancer (aged 0–18 years) who incurred a CVC-related infection

• PHASE OF CARE: Active antitumor treatment     
• APPLICATIONS: Pediatrics

No significant differences were found between the use of ethanol or urokinase lock treatments with systemic antibiotics and systemic antibiotics alone for the outcomes of number cured, number of recurrent CVC-related infections, days until first negative blood culture, number of early removal of CVCs, intensive care unit admissions, or sepsis.

No benefit of urokinase or ethanol lock in addition to systemic antibiotics was found.

• Small sample sizes
• Short follow-up time
• Some CVC malfunctioning was reported.
• No adverse events were reported in the cohort studies.
• No RCTs or CCTs that used antibiotic lock treatment alone were found in the literature.

No added benefit was found in the use of urokinase or ethanol lock treatment in addition to systemic antibiotics for the treatment of CVC-related infections in children undergoing treatment for cancer.

To investigate the benefits of a group nurse-led intervention on psychological morbidity, unmet needs, treatment-related concerns, and quality of life in men with prostate cancer receiving radiotherapy with curative intent

This phase-III, randomized trial assessed the relative benefits of a tailored, group consultation intervention for men receiving curative intent radiotherapy for prostate cancer compared to the best supportive care. The aim was to communicate information about diagnosis, treatment, and side effects, and coaching in self-management. Content and discussion were based on expressed needs and concerns. It included four group consultation sessions and one individual consultation completed by uro-oncology nurse specialists. Survey assessments occurred before treatment, at the end of treatment, and six months postcompletion of treatment. Sessions were tape recorded, and random selections were used to evaluate intervention fidelity.

• N = 165 included in analysis of primary outcome   
• MEAN AGE = 67.2 years (intervention), 67.6 years (usual care group)
• MALES: 100%  
• CURRENT TREATMENT: Radiation
• KEY DISEASE CHARACTERISTICS: Low risk prostate cancer for both groups (about 11%), intermediate risk (prostate cancer control group) (42.3%), prostate cancer risk intervention group (41.1%), high risk prostate cancer (about 47% for both groups) 
• OTHER KEY SAMPLE CHARACTERISTICS: A little less than 80% were married, 82% were from urban areas, about 78% had previous treatment (e.g., prostatectomy, ADT). Included patients aged 18 years or older with prostate cancer

• SITE: Multi-site   
• SETTING TYPE: Outpatient    
• LOCATION: Australia

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

Phase-III, two-arm cluster, randomized, controlled trial

• Hospital Depression and Anxiety Scale (HADS)
• Cancer Treatment Scale (CaTS)
• The Short-Form Supportive Care Needs survey questionnaire (SCNS-SF34-R)
• Expanded Prostate Cancer Index Composite (EPIC-26)

A higher consent rate existed at one site, but no other statistically significant differences in patient characteristics existed between the two groups. One hundred thirteen (out of 165) participants attended all sessions in the intervention group (p = 0.02). Mixed models analysis indicated that group consultations were statistically more beneficial on depressive symptoms (p = 0.009) and procedural concerns relating to cancer treatment (p = 0.049). Ninety-two percent completed surveys at all three time points. Descriptive analysis showed a slight reduction in depressive symptoms in the intervention group between baseline and the end of radiotherapy; the control (usual care) group reported an increase in these symptoms during the same time period. The difference between groups persisted six months post radiotherapy, although between groups, differences in mean changes was substantially reduced. No significant difference existed in rate of change in anxiety between the intervention group and the usual care group noted from the HADS. Descriptive analysis indicated a reduction in anxious symptoms in both groups at the follow-up assessments. Differences in mean changes from baseline to six months post-radiation also occurred, as it did with depressive symptoms.

Nurse-led group consultations may help address patient education, particularly among men who are experiencing depression.

• Findings not generalizable
• Participants had a baseline high level of baseline functioning.

Nurses must realize the importance of patient education and their role in counseling patients experiencing depression not only during treatment but following treatment as part of survivorship care.

Primary aim: To evaluate effect of an educational DVD about chemotherapy on pretreatment anxiety, self-efficacy, unmet informational needs, and satisfaction with information received

Secondary aim: To determine if effects differ between those who perceived treatment to be curative rather than palliative

Control group patients received usual care and completed questionnaires before beginning their treatment. Experimental group patients were recruited at a later time. They were given a copy of the DVD to take home to watch, several days before their first treatment. They then completed questionnaires on the first day of chemotherapy treatment. The DVD focused on preparation for chemotherapy and self-management of side effects, including nausea and vomiting, constipation, diarrhea, mucositis, fever and infection, hair loss, infertility, and effects on sexuality and intimacy. Content was evidence-based, derived from a systematic review of the literature to support recommended self-care approaches. Most content was delivered by cancer survivors who also discussed their experiences and the self-care strategies they used to manage side effects. An oncologist and oncology nurse presented medical and nursing information. The DVD was 25 minutes long and had been previously pilot tested. Usual care education consisted of a brief description of the procedure and side effects provided by the patient’s oncologist and a 30-minute education session with a chemotherapy nurse. Analysis was done within curative and palliative care patient groupings.

• The study reported on a sample of 100 patients.
• Mean patient age among curative cases was 54 years, and among palliative cases was 56.88 years.
• The sample was 52% male and 48% female.
• A variety of cancer diagnoses were represented. The most common types were head and neck, lung, gynecologic, gastrointestinal, and breast cancers.
• A majority of the sample was employed full- or part-time, and patients were essentially equally distributed across educational levels from less than high school completion to university completion.
• The majority of patients were married.
• All patients had not previously received chemotherapy treatment.

• Single site
• Outpatient setting
• Melbourne, Australia

Patients were undergoing the active treatment phase of care.

The study used a prospective quasi-experimental design with use of historical controls.

• Hospital Anxiety and Depression Scale (HADS)
• Cancer Behavior Inventory (CBI)–version 2: 33-item scale used to measure self-efficacy
• Supportive Care Needs Survey (SCNS)–short form: 31 items to assess unmet needs
• Satisfaction with information assessed with four questions on a five-point Likert scale developed for this study

There were no differences in anxiety or depression scores between usual care and intervention groups. Those who watched the DVD rated themselves as more confident about seeking social support than the usual care group (p = 0.044). There were no differences between groups in any supportive care needs that were unmet. Both curative and palliative patients reported having more psychological needs than any other type of care, and reported sexuality as the least needed area. Those in the intervention group were more satisfied with information they had received (p = 0.026) compared to the control group. There were significant differences between self-perceived curative and palliative patients in confidence for maintaining activity (p = 0.028), stress management (p = 0.044), coping with side effects (p = 0.002), maintaining a positive attitude (p = 0.008), managing emotions (p = 0.005), and seeking social support (p = 0.012).

The intervention appeared to have an influence on aspects of self-efficacy and satisfaction with information received. There were no findings to support an effect on anxiety or depression prior to chemotherapy.

• The study did not have an appropriate control group.
• A convenience sample was used.
• The sample size was not sufficiently powered to detect differences in measured outcomes.
• It is not clear how much information provided in the DVD differed from that provided in usual care by chemotherapy nurses and the oncologist.
• While the DVD was a different format, differences in content were not clear. It was also not clear from the report if intervention patients received the DVD in addition to usual care, or instead of usual care.

Prechemotherapy education is an important part of nursing management of these patients, but there is little evidence to guide the timing, content, format, and style of this type of education. Additional research in this area will be helpful to guide nursing practice. The use of adjuncts to direct face-to-face patient teaching and support by nurses may be helpful in the face of workforce shortages and increasing shifts of patient care to suggest that provision of basic information and orientation to the setting are not sufficient approaches to impact feelings of anxiety. Further study of such approaches can be helpful to determine how to best meet patient needs.

To test the hypothesis that presurgical distress would be lower in a group that received hypnosis compared to an attentional control group

On the day of surgery, participants completed data collection instruments prior to study interventions and 15 minutes postintervention. Both the hypnosis and control interventions were standardized to last for 15 minutes. The hypnosis intervention included debunking common misconceptions, giving the patient an opportunity to ask questions, and presentation of a scripted relaxation-based induction, guided imagery, deepening, and surgery-specific suggestions for decreasing pain, nausea, and distress. Patients in the control group spent an equal amount of time with study personnel in sessions of empathic listening and supportive remarks from study personnel. All personnel providing interventions were clinical psychologists with advanced training in use of hypnosis in the medical setting.

• The study reported on a sample of 90 female patients.
• Mean patient age was 45.7 years (range = 19–77).
• All patients were scheduled for excisional biopsy. Almost all patients did not have previous breast cancer; 22.2% had previous excisional biopsy.
• Of the sample, 64% were Caucasian, and 68.7% had a college or graduate degree.

• Single site
• Outpatient setting
• New York

Patients were undergoing the diagnostic phase of care.

A single-blind, randomized controlled trial design was used.

• Profile of Mood States–short version (POMS)
• Visual analog scale (VAS) for depressed mood, emotional upset, and level of relaxation – 100 mm

Patients in the hypnosis group demonstrated significantly lower general upset (d = 0.85, p < 0.001), depressed mood (d = 0.67, p < 0.002), and anxiety (d = 0.85, p < 0.001), and higher relaxation (d = 0.76, p < 0.001) on VAS and POMS scores.

Findings demonstrate that a brief hypnosis intervention reduced symptoms of depression and anxiety and increased relaxation prior to excisional breast biopsy.

The study had a small sample, with less than 100 participants.

Hypnosis can be an effective intervention to reduce distress prior to breast biopsy. Additional research to determine longer-term effects on post-biopsy patient symptoms is warranted. This intervention was accomplished in 15 minutes, suggesting that hypnosis can be a practical intervention in the clinical setting. This type of intervention does require specific expertise.