To investigate whether a communication skill training program for nurses would reduce psychological distress and improve coping among patients newly diagnosed with cancer

The communication skill training (CST) program involved two workshops, one at the start of the study and the other after three months. Workshops lasted six hours and were structured in a six-step approach (SPIKES) involving (1) setting up the interview, (2) assessing the patient’s perception of his or her illness, (3) obtaining a patient invitation to disclose information, (4) giving information and knowledge to the patient, (5) addressing the patient's emotion with empathic responses, and (6) strategy and summary. The program involved a large group meeting on theoretic content followed by small facilitated group work in which nurses worked through various scenarios using the SPIKES steps. Study patients were randomly assigned to be interviewed three times by nurses who attended the CST program (experimental group) or interviewed the same three times by nurses in the control group. Interviews were scheduled on the day of diagnosis, and one week and one month after diagnosis. Study measurements were done at one week after diagnosis (T1), one month after diagnosis (T2), and three months after (T3). Nurses were randomly assigned to either CST or usual care provision.

• The study reported on a sample of 89 patients, plus 8 nurse participants.
• Mean patient age in the experimental group was 61.4 ± 10.8 years; mean patient age in the control group was 60.9 ± 14.3 years.
• The sample was 56%–61% female and 39%–40% male.
• Patients had gastric, colorectal, and breast cancers.
• More than 90% of study patients had surgery, 76%–81% were married, 39%–44% were unemployed, and more than 50% in both groups had stage I disease.
• Nurse participants had a mean age of 40.8 ± 7.2 years, and mean years of experience as an oncology nurse of 17.2 ± 6.87.
• Inclusion criteria included patients who were newly diagnosed and informed of cancer in physician consultation, were older than age 18, and had disease that was not advanced and at an operable stage.
• Patients were excluded if they had a severe psychological problem as assessed by the physician.

• Single site
• Outpatient setting
• Japan

Patients were undergoing the diagnostic phase of care.

A randomized controlled trial design was used.

• Hospital Anxiety and Depression Scale (HADS)
• Mental Adjustment to Cancer Scale (MAC)

There was a significant different in HADS depression and total scores over time associated with group (p = 0.03). These scores declined over time in both groups; however, the decline was greater for the experimental group. There was no group interaction or for anxiety. There were no significant changes in any other HADS data. MAC score changes over time showed mixed results. The only consistent directional change in the experimental group, as compared to the control group, was in the area of fatalism, with decline over time in the experimental group and increase over time in the control group (p = 0.04).

CST appears to have a positive effect on psychological distress and some areas of coping for patients newly diagnosed with cancer.

• The study sample was small, with less than 100 participants.
• The study sample was purposefully homogeneous in terms of diagnoses, disease stage, and phase of care, and findings may not be applicable to other patient groups.
• Nurses in the study had extensive years of experience in cancer care. The CST described here may not have similar effects with nurses who are less experienced in general or in oncology care.
• The authors point out that results may have been influenced by the cultural attitude of Japanese patients and poor support systems that are seen to exist in Japan for newly diagnosed patients. These patients tend to not seek professional assistance, so the magnitude of differences in results may not be the same for other cultural groups in which professional support is more available or acceptable.
• There was no credible evaluation of actual communications between nurses and patients or between physicians and patients that may have also influenced findings. In addition to study nurses, nurses in charge who had not been trained were always present at physician consultations and were involved in patient support afterward. There is no way to tell if charge nurse interactions were different between groups, changed over time, or were influenced by interaction with CST-trained nurses.

Study findings support the idea that providing information, support, and empathic responses to patients can positively influence patient coping and emotional distress, and suggest that nurse training in communication skills of this nature can be useful. Further research in this area needs to demonstrate actual differences in communications between nurses and patients as a result of such training. It would be useful to see if such training can be beneficial in various groups of nurses based on differences in nursing education level and experience.

To determine whether an intervention could improve antiemetic guideline adherence and the control of chemotherapy-induced nausea and vomiting (CINV)

Evidence-based antiemetic medication information was provided as notification to physicians in a view format. The description of the intervention was not clear, and it was presumed that the notification was provided in some manner through the electronic medical record system. CINV control after the intervention was compared to CINV control in a cohort of patients treated prior to the intervention.

• N = 125 (64 in intervention group)
• MEAN AGE = 64.2 years
• MALES: 71%, FEMALES: 29%
• KEY DISEASE CHARACTERISTICS: All patients had colorectal cancer and were receiving moderately emetogenic chemotherapy.

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

• PHASE OF CARE: Active antitumor treatment

Cohort comparison

• Complete protection in the acute and delayed periods was defined as no vomiting and protection from nausea.

The dosage of oxaliplatin or irinotecan was higher in the intervention group (p < 0.01). In the observational group, adherence to guidelines was 100% in the acute phase and 6.6% in the delayed phase. Nonadherence was caused by the lack of a prescription of dexamethasone on days 2 and 3. After the intervention, adherence to the administration of dexamethasone was 89%. In the intervention group, the complete protection rate was 20% higher after the intervention (p < 0.05), but adherence during the acute phase dropped and was significantly lower in the intervention group (p < 0.01). The incidence of leukopenia was higher in the intervention group (42.2% versus 23%, p = 0.024). There were no other differences in toxicity.

The intervention used in this study had mixed results in terms of adherence to CINV antiemetic guidelines and control of CINV in acute and delayed phases.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Key sample group differences that could influence results
• Measurement validity/reliability questionable
• Other limitations/explanation: The intervention group was significantly older. The exact intervention was not well described. The definition and method of measurement of CINV outcomes were not well described.

In this study, an organizational intervention had mixed results in improving adherence to antiemetic guidelines and patient CINV outcomes. The findings were limited by the lack of detail regarding the specific intervention used, but it appears to have been a notification in the medical record with no other action. Organizational initiatives to improve practice are not all created equally, and such studies need to provide sufficient detail about the actual intervention to determine if approaches that are effective in creating practice changes and improvements in patient outcomes.

To evaluate the effectiveness of probiotic supplementation for the prevention and treatment of radiation-induced diarrhea

Databases searched were PubMed, EMBASE, Cochrane Library, Google Scholar, and online clinical trials registers (Cochrane Central Register of Conrolled Trials, metaRegister of Controlled Trials, National Institutes of Health) until January 2009. Other relevant trials were identified from the reference list of selected articles. Abstracts presented up to 2008 at the United European Gastroenterology Week meetings, American Society for Therapeutic Radiology and Oncology Annual Meetings, and American Gastroenterological Association Digestive Disease Week were searched manually.

Search keywords were diarrhea, probiotics, radiotherapy, radiation therapy, Lactobacilli, Bifidobacteria, Enterococci, VSL no. 3, pelvic tumors, and abdominal tumors.

Studies were included in the review if they were randomized, controlled trials with at least two parallel groups that evaluated the effectiveness of probiotic supplementation to prevent or treat radiation-induced diarrhea.

Studies were excluded if they were review articles, involved nonradiation-induced diarrhea, or covered radiation-induced gastrointestinal (GI) symptoms other than diarrhea.

The abstracts of 58 articles were reviewed. Fifty evaluated the effects of probiotic supplementation for conditions other than radiation therapy and were eliminated. Of the remaining eight, three were duplicate reports and one studied radiation-induced chronic bowel discomfort rather than diarrhea.

The remaining four studies were selected for this review. Three were randomized controlled trials evaluating probiotic supplementation for the prevention of radiation-induced diarrhea, and one trial evaluated probiotic supplementation for the treatment of radiation-induced diarrhea.

Three studies evaluated the use of probiotic supplementation to prevent radiation-induced diarrhea. A total of 632 individuals initially were randomized to the studies; the final sample sizes were 21, 85, and 482. The study using probiotic supplementation to treat radiation-induced diarrhea had a sample size of 205 patients, with 102 receiving the intervention and 103 receiving a placebo.

• Probiotic supplementation was well-tolerated in the prevention and treatment trials.
• The three trials addressing probiotic supplementation for the prevention of radiation-induced diarrhea did not collectively show significant differences between the intervention and control groups.
• The study addressing treatment also did not show significant differences between the intervention and placebo groups.

The few available studies on the use of probiotics to prevent or treat radiation-induced diarrhea do not allow for firm conclusions to be drawn regarding the benefits of this intervention.

The studies included in the systematic review and meta-analysis used different single strains and different doses of probiotics.

More studies using preparations containing several strains of probiotics and studies looking at comparisons between different probiotics are needed.

To determine the effectiveness of topical rectal beclomethasone dipropionate (BDP) in the prevention of rectal proctopathy, which can lead to rectal bleeding, in patients undergoing radiation therapy for prostate cancer

The treatment arm consisted of a 3 mg BDP enema each evening before radiotherapy treatments and two 3 mg BDP suppositories (one in the morning and one in the evening daily) over four weeks. The placebo arm consisted of an identical looking enema and suppository given at the same intervals without medication. Time points for clinical evaluation were before radiotherapy, one month after completion of the treatment, and every three months thereafter. Time points for endoscopic evaluation were before treatment, at three months, and at 12 months postradiotherapy. The patients self-administered the treatment, and they were asked to hold the medication in for as long as they could and return the unused materials at the end of the study to assess compliance.

• N = 110  
• AGE = Not collected
• MALES: 100%         
• KEY DISEASE CHARACTERISTICS: Prostate cancer 
• OTHER KEY SAMPLE CHARACTERISTICS: N/A

• SITE: Single-site
• SETTING TYPE: Not specified  
• LOCATION: S.Orsola-Malpighi University Hospital in Italy

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

Double-blind, placebo-controlled, randomized trial

• The endoscopic evaluation consisted of a flexible sigmoidoscopy procedure. The findings were measured using World Organisation of Digestive Endoscopy language and were evaluated using the Vienna Rectoscopy Score (VRS).
• Simple Clinical Colitis Activity Index (SCCAI)
• Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer acute and late toxicity scales (RTOG/EORTC)
• Inflammatory Bowel Disease Questionnaire quality of life Index (IBDQ)

With respect to bleeding rate, the BDP group showed a statistically significant lower amount of blood in stools (OR = 0.38; 95% CI 0.17–0.86). The patients in the BDP arm showed a later onset of blood in stools overall (p = 0.032). The quality of life IBDQ score was significantly lower in patients randomized to BDP who reported rectal bleeding (p < 0.001). Severe hemorrhagic proctopathy, defined as anemia with a drop in hemoglobin of at least 1.5 g/dL, was found in 10 patients (four in the BDP group and six in the placebo group).

The BDP therapy arm of this study seemed to fair better with respect to bleeding risk postradiation and the prevention of some of the mucosal changes that lead to significant complications. It does not seem to affect other quality of life issues like continence and diarrhea. Changing the formulation of the BDP and/or its frequency of usage may improve outcomes for patients. Since the treatment did not cause harm to patients, it seems to be a good recommendation for patients to try.

It would be best for nurses to train patients on the usage of BDP during and following radiation therapy. A nursing study to evaluate methods of application and quality of life for patients would be the next step to further improve this research.

To evaluate the safety, feasibility, and acceptability of the Optimal-Lymph-Flow™ program for patients with breast cancer and to evaluate its benefit when introduced presurgically

The Optimal-Lymph-Flow™ (OLF) program is a patient self-care program designed to reduce the development of lymphedema through specific exercises and behaviors to improve lymph flow and reduce or maintain body mass index (BMI). Participants were recruited preoperatively and followed prospectively for 12 months after surgery. Trained nurses provided each participant with the study intervention through a 30-minute face-to-face meeting. Participants were trained in various exercise techniques and then did a return demonstration (shoulder, breathing, and pumping exercises). They also were instructed in a nutrition-balanced and portion-appropriate diet to maintain preoperative BMI. Participants’ limb volume was measured with a Perometer, and BMI was measured with bioimpedance presurgery, two to four weeks after surgery, and at 6–12 months. Any patient with a limb volume measurement ≥ 10% was referred for complete decongestive therapy. If a 5% increase in limb volume occurred, patients were instructed to increase OLF activities, and limb volume was rechecked a few weeks later.

• N = 140
• AVERAGE AGE = 56 years (SD = 11.8 years, range = 25–84 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: First-time diagnosis of breast cancer (stages 1–3)
• OTHER KEY SAMPLE CHARACTERISTICS: Women aged greater than 21 years and scheduled for surgical treatment including lumpectomy, mastectomy, sentinel lymph node biopsy, or axillary lymph node dissection; excluded stage 4 breast cancer, preexisting lymphedema, patients with a history of breast cancer, and bilateral breast cancer

• SITE: Single site    
• SETTING TYPE: Other  
• LOCATION: New York, United States

• PHASE OF CARE: Multiple phases of care

Prospective, longitudinal, quasi-experimental design with repeated measures

• The safety of the OLF program was assessed by asking participants if the program created any discomfort or injury at each follow-up visit.
• The feasibility of the program was evaluated in terms of intervention delivery time by the trained nurses.
• The acceptability of the program was assessed by asking the participants if the program helped the them to (a) understand how to reduce the risk of lymphedema, (b) reduce the fear and anxiety of developing lymphedema, and (c) develop a plan to reduce the risk of lymphedema.
• Lymph volume changes were measured by an infrared Perometer, and BMI was measured by a bioimpedance device.

One-hundred and thirty-four participants completed the study. At each follow-up visit, no participants reported injury or discomfort associated with the OLF program, making it safe. It took about 30 minutes for the trained nurses to deliver the program, making it feasible. Greater than 90% of the patients reported that the OLF program helped them reduce their fear and anxiety of developing lymphedema, making it acceptable.

The majority (97%) of patients maintained or improved their preoperative limb volumes and BMIs at the study endpoint of 12 months following surgery.

All four women who experienced a 10% lymph volume increase two to four weeks post-surgery and at six months decreased their lymph volume to less 5% at the 12-month visit. BMI did not change significantly. No control group was used, so the benefits of this treatment could not be determined.

This educational and behavioral program may be effective to enhance lymphedema risk reduction. The study provided initial evidence for an emerging change in lymphedema care from treatment focus to proactive risk reduction.

• Baseline sample/group differences of import
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment) 
• Other limitations/explanation: Single-site study

Studies with more rigorous research designs (i.e., randomized, controlled trials) are needed to replicate the findings from this study, evaluate the effectiveness of the OLF program, and determine the dosage and contribution of individual components of the program.

To evaluate the effectiveness of electroacupuncture (EA) and hormone therapy (HT) on health-related quality of life (HRQoL) and sleep in breast cancer survivors with vasomotor symptoms.

Women who had completed treatment for breast cancer were randomized to receive EA for 12 weeks or HT for 24 months. They completed the Psychological and General Wellbeing Index (PGWI) and Women’s Health Questionnaire (WHQ) pretreatment for vasomotor symptoms; during treatment; and at 6, 9, 12, 18, and 24 months after the start of treatment.

• The sample was comprised of 18 female patients.  
• Mean age was 54.1 years (range 47–69). 
• Patients had completed treatment for breast cancer in situ for a T1 or T2 tumor with a maximum of four metastatic lymph nodes or T3 tumors without metastatic lymph nodes.
• Patients also had:
  • Vasomotor symptoms 
  • Been seen by a breast surgeon or oncologist within the last three months and were not receiving active treatment for breast cancer  
  • No clinical or mammographic signs of recurrence.

Women were excluded if they were receiving ongoing breast cancer treatment other than tamoxifen; had other malignancies; or had a history of thromboembolic, cereverbrovascular, or liver disease; porphyria; or active cardiovascular disease.

• Multisite   
• Outpatient
• Sweden

• Patients were undergoing the long-term follow-up phase of care.
• The study has clinical applicability for late effects and survivorship and elderly care.

The study was a multicenter, randomized, prospective trial.

• WHQ
• PGWI
• Log books for hot flushes and for sleep data, specifically the number of hours slept and times woken

Nineteen women completed 12 weeks of EA. Eleven women were excluded due to changes in treatment. About 40% of the patients had no other treatment. The HT group had 11 women complete the 24 months of treatment. In both groups, reduction of hot flushes was noted. The EA group had a decrease in the median number of flushes/24 hours of 55% (p < 0.001) after 12 weeks. The decrease was 29% (p = 0.026) after 24 months. In the HT group, the median number of hot flushes/24 hours decreased by 100% (p = 0.001) after 12 weeks of treatment with no further changes. Sleep parameters improved significantly in both groups from baseline, with a WHQ sleep score in the EA group at baseline of 0.50 and at 24 months 0.33; in the HT group, the baseline score of 0.33 to declined 0.00 at 24 months.

The study showed improvement in sleep scores of both groups up to 21 months. The numbers of hours slept per night did not increase, but the numbers of flushes and distress caused by them decreased, resulting in fewer times woken, with overall improvement in HRQoL. Both groups also showed a significant decrease in the number of HF experienced, which was maintained up to 21 months after treatment was stopped.

EA, compared to HT for management of hot flashes in breast cancer survivors, shows some potential benefit in reducing numbers of hot flashes/24 hours, improving overall WHQ scores.

• The study had a small sample size, with less than 30 patients.
• There was a high number of drop-outs in EA group.

HT is not recommended as a safe treatment for vasomotor symptoms for breast cancer survivors. Thus, the value of using that group to compare with a group that received EA is of concern. EA needs further investigation in larger sample sizes. Further research is needed for efficacy of EA in hot flash management for breast cancer survivors and in women treated with aromatase inhibitors experiencing hot flash distress, as this study did not address that phenomenon. 

To describe hot flushes in men with prostate cancer and their treatment methods.

TYPE OF STUDY Systematic review

DATABASES MEDLINE, ISI Web of Knowledge, Cinahl & PsycINFO

KEYWORDS  Prostate cancer, androgen deprivation therapy, vasomotor symptoms, hot flashes treatment

INCLUSION CRITERIA All studies were randomized controlled studies (RCT) that addressed hot flashes (HF) in men with any stage of prostate cancer, treated with androgen deprivation therapy either medically or surgically. The studies addressed treatment for hot flashes where the main outcomes were frequency of hot flushes, distress from hot flushes, or hot flash score.

EXCLUSION CRITERIA Studies were limited to human studies and publications appearing between 1966 - 2009. Excluded were reviews & meta-analysis.

TOTAL REFERENCES RETRIEVED: 252

METHOD OF STUDY EVALUATION The Jadad score was used to assess the quality of the randomized controlled trial (RCT), on a five-point scale, and the QUORUM guidelines for systematic review were considered.

This summary did not include the measures that were used by the participants in reporting their hot flashes: i.e, diaries, skin temperature measurements, QOL surveys.
 

FINAL NUMBER STUDIED INCLUDED; N = 5   TOTAL SAMPLE SIZE: N = : 328 men were analyzed.   SAMPLE RANGE ACROSS STUDIES : Sample sizes ranged from 12 - 177.

KEY SAMPLE CHARACTERISTICS: Samples included men with prostate cancer who had undergone surgical or medical castration and were currently experiencing hot flushes.
 

PHASE OF CARE Active Treatment

APPLICATIONS Late Effects and Survivorship; Elderly Care

In the five studies analyzed, the treatments that were studied included cyproterone acetate (CA), megestrol acetate (MA), gabapentin, transdermal clonidine, and diethylstilbestrol (DES). Unfortunately, none of the studies analyzed the same treatment. Because the studies looked at different interventions to relieve hot flushes (HF) in castrated men with prostate cancer, it was not possible to combine the studies to strengthen the outcomes. The studies' outcomes demonstrated varying degrees of success in relieving the hot flushes: Cyproterone acetate 100 mg, once per day, yielded 75% fewer HF than placebo  (p<0.001), and 100% of men on CA had a 50% or greater reduction of mean number of HF, compared to placebo group. Megestrol acetate  20 mg, twice per day, yielded an 80% reduction of the  median number of HF compared to a 19% reduction in the placebo group (p<0.001), an 87% reduction of median HF score vs. a 16% reduction for placebo (p<0.001), and a 50% or greater reduction of median number of HF (p<0.001) reported by 79% of MA group and 12% of placebo group. Gabapentin (4 schedules) achieved a 45.5% reduction of the median number of HF with 900mg gabapentin per day vs. 21.5% with placebo (p=0.02). Transdermal clonidine demonstrated no difference between the  treated group and placebo. Diethylstilbestrol (1 mg) yielded a 100% reduction in the median number of HF vs.13% with placebo. 100% of DES and 14% of placebo reported a 50% or greater reduction of the median number of HF.

The systematic review of studies on treatment approaches to managing hot flushes in men after castration for prostate cancer showed very few such studies. Only five RCT studies were identified, and none of them analyzed the same treatment approach. Several of the studies that were presented demonstrated successful treatment approaches, including DES as the most effective, followed closely by MA and CA. However, these medications are linked to side effects that are not well tolerated by all patients.

Only five RCT studies were identified, and none of them analyzed the same treatment approach. 

Large randomized placebo controlled studies are needed to clarify the data and provide clearer direction to managing HF in men who have been castrated as a treatment for prostate cancer. The summary, although providing insight for possible medical management, addressed only briefly the drop-out rates due to side effects. Further investigations of the drop-out subgroup could explore correlations among the medications to reveal unacceptable side effects  in managing the participants’ hot flash symptoms. Further investigations comparing medications used and providing more specific information about measurements of QOL and hot flash reporting by participants are warranted.

To evaluate the effects of electro-acupuncture (EA) and hormone therapy (HT) on vasomotor symptoms in women with a history of breast cancer

Twenty-seven women were randomized to EA for 12 weeks, 18 received  HT for 24 months. The total population was 45.

This was an international, multicenter study, HABITS19, involving patients from three centers in Sweden between April 1998 and December 2002.

Randomized, controlled study

The patients were monitored with daily entries made in a log book, recording the numbers of hot flashes during day and night and how disturbing they were (range 0 for no distress to 10 for worst possible distress). The log books were completed daily for 1–3 weeks before treatment, continuously during the first 12 weeks of treatment, and thereafter for 1 week per month; altogether for 24 months. The measuring points were baseline, the 12th week of treatment, and at 1 week and 6, 9, 12, 18, and 24 months after start of treatment.

In 19 women who completed 12 weeks of EA, the median number of hot flashes per 24 hours decreased from 9.6 at baseline to 4.3 at 12 weeks of treatment. At 12 months after start of treatment, 14 women with only the initial 12 weeks of EA had a median number of flashes per 24 hours of 4.9, and at 24 months 7. Women with no other treatment than EA had 2.1 hot flashes per 24 hours.

Limitations included small sample size and relatively large attrition rate.

Repifermin (keratinocyte growth factor-2)
25 or 50 micrograms/kg
IV for 3 days prior to conditioning regimen and continued after transplant for up to 10 days.

Assessments before HSCT regimen, day of transplant, and 3x/wk until mucositis resolved.
 

The study was comprised of  42 patients (8 sites), with a mean age of 50.
21 each dose level – 14 study agent, 7 placebo
Auto HSCT
 

Multi-center

Randomized, double blind, placebo-controlled, phase I/II study

• NCI-CTC mucositis toxicity scale for BMT OMAS
• Severity of pain (0-10)
• Severity of pain while swallowing
• Duration of pain
• Ability to eat score (1 = normal, 2 = soft solids, 3 = liquids, 4 = nothing)
• Narcotic use for pain
• Frequency, severity, and duration of diarrhea
   

• Grade 2 – 4 mucositis
• Placebo 100%, 64.2%
• 25 mcg  p = 0.041
• Placebo vs 50 mcg  (50%) p = 0.006

Effectiveness not established; study was not designed to have sufficient statistical power in identifying differences in efficacy between groups.

Number of end points suggest better outcome for 50 mcg group (mean duration, pain on swallowing, days on narcotic pain medication).

• Study predominantly designed for “safety” not “efficacy”.
• Small sample group used (n = 42)
• Multiple conditioning regimens were used; this may affect final outcome as far as efficacy.
• Auto HSCT population only
• Multiple doses were used in study.

Number of post-transplant doses required was unclear.

Larger trial is needed.

To prevent the recurrence of neutropenic events (NEs) in patients with solid tumors and identify potential predictive factors of recurrence of NEs

The study was a prospective, multi-center, observational study to describe prophylactic strategies, including cycle delay, dose reduction, and granulocyte colony-stimulating factor (G-CSF), that were developed to prevent the recurrence of an NE subsequent to a previous episode in patients with solid tumors, and to evaluate their respective efficacy (primary endpoint). Secondary objectives assessed the recurrence rate of NEs and factors predictive of recurrence.

• N = 548  
• MEDIAN AGE = 63 years (range: 18–92 years)
• MALES: 31%, FEMALES: 69%
• KEY DISEASE CHARACTERISTICS: 40% were patients with breast cancer; no hematologic malignancy
• OTHER KEY SAMPLE CHARACTERISTICS: 43.6% of patients were older than 65 years; 59.9% were treated for metastatic disease

• SITE: Multi-site   
• SETTING TYPE: Outpatient   
• LOCATION: 62 cancer centers in France

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

• Observational

• Incidence of febrile neutropenia, treatment delays, and chemotherapy dose reductions
• Neutropenic events defined as any episode of febrile neutropenia (single temperature elevation over one hour) or any episode of neutropenia with a significant impact in terms of cycle delay or dose reduction

During cycle A, 16.1% experienced febrile neutropenia, 7.7% experienced neutropenic fever, and 76.3% experienced all-grade neutropenia. Cycle B was delayed in 44.5%, dose reductions occurred in 22.3%, and prophylactic G-CSF was given to 85% (59.7% received pegfilgrastim). The incidence of cycle delay and chemotherapy dose reduction decreased with further cycles of chemotherapy. The median number of G-CSF administrations with subsequent cycles, excluding pegfilgrastim, was five. The proportion of patients who experienced an NE was 29% when receiving G-CSF versus 68% for patients who did not. Only use of G-CSF was associated with a lower recurrence rate of febrile episodes (p < .001). In multivariate analysis, factors associated with a greater rate of NE occurrence were prior episode of febrile neutropenia, lung or colorectal cancer, metastatic disease, and prior radiotherapy.

Only the prophylactic administration of G-CSF was found to be an independent predictor of lower recurrence rate of NEs.

• 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)

Teaching needs to be done related to G-CSF administration and the necessity of use. Further research is needed in G-CSF prophylaxis and the quality-of-life impact of other methods such as delay/dose reduction.