To determine whether physical exercise training improves the quality of life and physical fitness of survivors of breast cancer.

Patients were randomized to the exercise intervention or control group. The duration of the exercise intervention was 12 months, with the aim of attaining permanent changes in lifestyle. The intervention consisted of both supervised and home training.  Supervised training, delivered to a group of 15 to 20 individuals, included step aerobics and circuit training. Home training consisted of walking, aerobics cued by a video, cycling, or swimming; participants could choose the activity.

• The sample was comprised of 573 participants.
• Participant age ranged from 35 to 68 years.
• All participants were female.
• All participants had breast cancer; were pre- or postmenopausal; and had undergone adjuvant chemotherapy within four months, started adjuvant endocrine therapy no fewer than four months previously, or had started a combination of chemotherapy and endocrine therapy no fewer than four months previously.

• Multisite
• Outpatient
• Multiple locations in Finland

• Patients were undergoing multiple phases of care.
• The study has clinical applicability for palliative care.

This was a randomized, controlled trial.

• European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30)
• EORTC QLQ-BR-23 questionnaire to assess quality of life of patients with breast cancer
• Functional Assessment of Cancer Therapy-Fatigue (FACT-F)
• Finnish version of the Beck Depression Inventory (BDI)
• Two-hour walking test
• Figure-eight running test

No significant differences were found between the exercise group and control group in regard to changes in quality of life during the intervention or in regard to depression or fatigue.

This study did not show that the exercise intervention had an effect on fatigue, depression, or quality of life. Lack of effect may be due to a ceiling effect in both groups because most study participants had relatively high activity levels at baseline.

• The study had risks of bias due to no blinding, no appropriate attentional control condition, and as a result of sample characteristics. Key sample group differences could have influenced the results.
• Most participants were physically active before the study. (Only a few patients [0.25%] were sedentary before the study.) Control patients were also motivated to remain active. Actual activity levels of control patients were not analyzed.
• Findings were not generalizable.
• One of the physical fitness tests used, two-hour walking test, cannot be generalized to other countries.
• The main strength of this study was its size.   

The ability of physical exercise, especially group exercise, to improve quality of life and reduce fatigue and depression in patients with breast cancer during and following treatment is generally known. The fact that this study did not support the widely held view may be due to the fact that most participants had a high level of activity at baseline. The study did not clarify whether exercise interventions are needed or effective for individuals who already have an active lifestyle and are motivated to maintain it.

To develop, run, and evaluate a program for patients with cancer at any stage of their illness.

Groups of no more than six patients were led by an occupational therapist and a physiotherapist for two to three hours per session for four weeks. The program involved group discussion and support, practical sessions, information, and homework to achieve individual goals. Information was collected through evaluation forms and fatigue scales. Patients were invited to attend the program by clinical nurse specialists (CNSs).

• Twenty-eight patients (23 females, 5 males) completed the fatigue course.
• Age ranged from 37 to 82 years, with the majority being in their 50s and 60s.
• Diagnoses included were gynecological cancer (43%), breast cancer (18%), lung cancer (11%), and other (28%).
• Stages of treatment ranged from curative to palliative.

• Single site
• Patients were recruited from clinical sites through CNSs from groups in Doncaster.

The study was a prospective trial.

Evaluation forms included a linear analog scale using a 0-to-10 scale and a comment field about their opinion of the program.

Patients reported positive thoughts about the time of the course, the location, and the knowledge of the instructors.

The study demonstrated a program that can potentially be used in a fatigue population that desires a group therapy intervention. Patient reports were positive, and no adverse effects were reported.

• The study had risks of bias due to no control or blinding procedures.
• Data were given as patient opinion and, therefore, could not be analyzed statistically.
• There may also be some issue in terms of staff required to lead the group sessions.

The study intervention could be easily taught to nurses desiring this type of intervention for their patients if the intervention proved effective.

To evaluate the effect of zoledronic acid (ZOL) on skeleton-related events (SREs) and bone pain; to determine if baseline bone pain affects clinical outcomes of patients receiving ZOL

Patients were initially randomized to receive placebo or ZOL 4 mg by infusion every three weeks for up to 24 months. Bone pain was assessed at six-week intervals, and investigators recorded data about radiotherapy or surgery to bone, changes in antineoplastic treatment of bone pain, and SREs (e.g., pathologic fracture, spinal cord compression).

• The sample was composed of 422 patients.
• Mean patient age was 72.5 years.
• All patients were male.
• All patients had prostate cancer; 73% had bone pain at baseline, with an average BPI score of 2.84.

• Multisite
• Outpatient
• The report did not state the study locations.

Secondary analysis of phase III placebo-controlled randomized study

Brief Pain Inventory (BPI)

Bone pain increased over time in all patients. However, compared to patients receiving placebo, patients receiving ZOL reported smaller increases in mean BPI composite scores throughout 24 months (p < 0.04). This difference was most significant (p = 0.003) at three months. This difference was seen whether or not patients had reported bone pain at baseline. In patients with pain at baseline, ZOL lengthened the median interval to first SRE by about six months, compared with placebo (p = 0.087). In patients without bone pain at baseline, patients on ZOL had not had SREs at the 24-month follow-up. Those who were on placebo had a median time to SRE of 15 months (p = 0.04). There was no difference in median overall survival between placebo and ZOL groups.

ZOL postponed the onset of severe bone pain and skeletal events in patients with prostate cancer.

• The study did not discuss or analyze the medications taken for pain over the course of the study, so whether differences were due only to the use of ZOL versus other pain management is unclear.
• Authors note that SREs may have been underreported.

This study highlights the importance of intervention before symptoms of bone involvement develop. Some current guidelines have recommended ZOL for treatment of bone metastases; however, this study suggests that administration of ZOL prior to known bone metastases may reduce pain and delay skeletal events. Nurses can advocate for prophylactic approaches to manage these problems in patients with prostate cancer.

Subcutaneous GM-CSF (250 mcg/m²) was started one week before radiation and stopped two weeks after completion. GM-CSF was given within two hours after each radiation fraction on Monday, Wednesday, and Friday. Doses were held on days that patients received chemotherapy.

Patients with head and neck cancer with radiation ports on 50% or more of oral cavity or oropharynx to 60-70 Gy.

GM-CSF: n = 63
Placebo: n = 58

October 2000-September 2002
 

• CTC acute toxicity scale
• Severity and duration of mucositis
• Quality of life (QOL): University of Washington Head and Neck symptom questionnaire
   

No statistical differences in mucositis or QOL scores

Some participants discontinued study because of unspecified “toxicity”. Drug supply ended before all patients completed therapy.

To determine the dose and efficacy of ginger at reducing the severity of chemotherapy-induced nausea (CIN) on day one of chemotherapy

Patients were randomly assigned to four arms.

• Placebo
• 0.5 g ginger
• 1.0 g ginger
• 1.5 g ginger

Nausea occurrence and severity were assessed at a baseline cycle and the two following cycles during which patients were taking their assigned study medication. All patients received a 5-HT₃ receptor antagonist antiemetic on day one of all cycles. Patients took three capsules of ginger (250 mg) or placebo twice daily for six days starting three days before the first day of chemotherapy. Patients reported the severity of nausea for days 1–4 of each cycle, four times daily.  Compliance was determined by pill counts.

• The sample consisted of 576 patients.
• Mean age was 53 years.
• The sample was 91% female.
• All participants had been diagnosed with cancer and were receiving chemotherapy.
• All patients had to have experienced nausea in a previous chemotherapy cycle and be scheduled to receive a 5-HT₃ plus dexamethasone for antiemetic management. 
• Baseline values showed that more than 50% of the sample had had previous chemotherapy. Baseline nausea ranged from 2.2–2.5.

This was a multisite study conducted at 23 private practice oncology groups  affiliated with the University of Rochester.

• Patients were in mutliple phases of care.
• Applications exist for palliative care.

This was a phase II/III randomized, double blind, placebo-controlled clinical trial.

• Nausea and emesis were measured on a 7-point scale using a modified four-day patient report diary developed by Burish and Carey.
• A 13-item Symptom Inventory was used to assess potential side effects of ginger, as well as anticipatory nausea, on an 11-point scale.
• Anticipatory nausea was analyzed using the nausea item on the Symptom Inventory completed prior to chemotherapy.
• Quality of life was assessed using the 27-item Functional Assessment of Chronic Illness Therapy-General (FACIT-G) at baseline and follow-up assessments .

• No significant differences were found between the treatment arms in regard to the use of antiemetics.
• The mixed model analyses across both study cycles 2 and 3 revealed that all doses of ginger significantly reduced acute CIN in both study cycles compared to placebo (p = 0.013, 0.003). Differences in the least-squares means showed that 0.5 g and 1.0 g daily ginger were the most effective at reducing acute nausea.
• Data suggested that patients reported more severe delayed nausea compared to acute nausea, and no differences were found between groups in delayed nausea.
• Overall, no significant differences were observed in vomiting or quality of life between the three ginger arms and placebo.
• The majority of patients did not report episodes of vomiting (mean incidence = 0.5). 
• Analysis revealed that anticipatory nausea (p < 0.0001) was a factor in acute CIN.
• A total of 24 adverse events were reported during the course of the study. Only nine of the reported adverse advents were considered to be related to study drug.

Ginger given at 0.5 g-1.0 g daily, may aid in the reduction of acute-phase CIN in patients receiving standard antiemetics. The ability to clearly interpret results is difficult because of lack of information on chemotherapy agents involved and differences in antiemetic regimens used.

• The chemotherapy agents used were not described, so the emetogenicity of the treatment or potential differences between groups, which could have affected results, are not known. 
• No discussion was provided regarding use or non-use of rescue medications or any other management strategies that may have been used.
• The antiemetic regimens used were varied, and it is known that different regimens have different levels of effect. 
• Though inclusion criteria identified use of 5-HT₃ medication, results reported show that four different types of regimens were actually employed.

This study showed that ginger significantly reduced nausea in these patients during the acute phase but had no apparent effect on delayed nausea. Studies in the use of ginger have had mixed results, and meta analysis have shown no effect, in contrast to this study. Here, only nausea was examined, which may partially explain differences. Application of these findings is difficult, because the chemotherapy regimens used are not described, so emetogenicity or differences in regimens between groups cannot be evaluated. Also, the antiemetic medications used were varied and subgroup analysis was not done; how this influenced findings is not clear. Even with maximum current pharmacologic management of chemotherapy-induced nausea and vomiting, control of nausea, as opposed to vomiting, has remained problematic. Further research in approaches to effectively manage nausea, as well as emesis is needed.

To determine the risk of surgical site infection (SSI) reduction using local gentamicin collagen implants (GCIs) following preoperative radiotherapy and total mesorectal excisions (TMEs)

• Short-term radiotherapy (5 x 5 Gy) for rectal cancer preoperatively
• A GCI was inserted into the wound after surgical excision and prior to the closure of the cavity.

• N = 176   
• MEAN AGE = 63 years
• MALES: 63.3%, FEMALES: 32.7%
• CURRENT TREATMENT: Combination radiation and chemotherapy, other
• KEY DISEASE CHARACTERISTICS: Rectal cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Preoperative radiation (XRT), then surgery within six days post XRT, but pushed out to 6–8 weeks if necessary

• SITE: Single site   
• SETTING TYPE: Inpatient    
• LOCATION: Warsaw, Poland

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Pediatrics, elder care

• Randomized, controlled trial

• SSI definition included superficial and organ space infections as defined by the Centers for Disease Control and Prevention (CDC)
• Intrabdominal infections defined according to the Scottish Surveillance of Healthcare Associated Infection Program (e.g., cultures, abcesses, or other evidence of infection based on fever, symptoms, and diagnostic tests)

No statistically significant differences existed between the study and control groups in early postoperative complications (25.6% and 34.1%, respectively, p = 0.245). The reoperation rate was similar in both groups: 12.8% versus 9.4%, p = 0.628, risk ratio [RR] = 1.359, 95% confidence interval [CI] [0.575, 3.212]. The total rate of SSI and organ space SSI were 22.2% and 15.8% without differences between the study and control groups. In patients without anastomotic leakage, the risk of organ space SSI was significantly reduced in patients who received the GCI: 2.6% versus 13%, p = 0.018.

Inconclusive: Applying the GCI in the pelvic cavity after short-term preoperative XRT and TME may reduce the risk of organ space SSI but only in the absence of anastomotic leakage.

Postoperative complications were a secondary aim and, therefore, the study lacked adequate power. Fewer patients received GCI because of a protocol deviation. Organ space SSI was not confirmed by bacteriological swabs. Sometimes, SSI was determined by a CT or physical symptoms and, therefore, could be misconstrued as infection when it was really an inflammatory reaction. This suggests that anastomotic leakage is such a significant risk factor for organ space SSI that the application of GCI does not prevent it. Patients were not given preoperative antibiotics, which is a current standard of care.

Nursing implications for this are clearly good surgical patient care postoperatively, such as using the aseptic technique while changing dressings; encouraging walking to prevent pneumonia; and teaching good nutrition for healing and excellent handwashing. The actual test depends on the surgeon’s suturing and excising techniques to prevent leakage. This study did not provide strong evidence for the use of CGIs to prevent SSIs.

To evaluate the efficacy of a psychoeducational nursing intervention for pain management on pain outcomes

Patients were randomly assigned to control or intervention groups. The intervention was a version of the PRO-SELF pain control program adapted from the work of Miaskowski et al. A specially trained oncology nurse visited patients in their homes on weeks 1, 3, and 6, and did telephone interviews on weeks 2, 4, and 5. Individual patient knowledge deficits were identified based on responses on the pain experience scale, and educational information was tailored to meet individual needs. Patients were given written instructions about pain and the management of adverse effects, and they were taught how to use a weekly pill box and how to use a script to communicate with their physicians about unrelieved pain. During telephone contact, education was reinforced and patients were coached about how to modify pain management or contact the physician to improve pain outcomes. Home visits also involved additional coaching and ongoing education. Patients in the control group were given a booklet about cancer-related pain management and received home visits and telephone interviews with the same timing, focusing on encouraging patients to maintain a pain diary. Pain assessments were done during telephone interviews. The principal investigator listened to tapes of the intervention and control group nurses to ensure the fidelity of the intervention and control conditions.

• N = 147
• MEAN AGE = 65.5 years
• MALES: 52%, FEMALES: 48%
• KEY DISEASE CHARACTERISTICS: Various tumor types; breast and prostate cancer were most frequent. 
• OTHER KEY SAMPLE CHARACTERISTICS: Baseline average pain score was 3.6 and worst pain scores were 5; greater than 50% reported breakthrough pain, and about 50% had been in pain for seven months or more; average daily intake of oral morphine equivalents was 190 mg 

• SITE: Single site  
• SETTING TYPE: Home  
• LOCATION: Norway

• APPLICATIONS: Palliative care 

Randomized, controlled trial with attention control

• Patients kept daily diary of numeric ratings of pain for least, average, and worst pain and whether they had breakthrough pain episodes.  
• Daily opioid doses were also recorded in the diaries.

There was a significant reduction in least, worst, and average pain in both groups. There were no differences based on group or the combinations of group and time. For both groups, there were significant decreases over time in total doses of opioids taken and no differences between groups in dosage changes. There were no differences between the groups in adjuvant pain medication use or other relevant interventions such as bone-modifying agents.

As used here, the psychoeducational nursing intervention to increase self-care in pain management did not have an impact on pain outcomes. It is not clear if the intervention changed patient behavior in pain management, though both groups in the study had some reduction in pain intensity.

• Risk of bias (no blinding)
• Subject withdrawals ≥ 10%

The psychoeducational intervention used here improved patients’ knowledge about pain management, but it was not clear if it resulted in any behavior change, and there were no differences in pain outcomes between those who received the full intervention and those who were given attention and written instructions for pain control. More evidence is needed to determine the most effective components of this type of intervention. These findings also suggest that the provision of written directions for pain control, daily patient attention via diary use, and simple nursing attention may be as effective as more structured interventions.

To evaluate the effects of a psychoeducational intervention on increasing patients’ knowledge and attitudes of cancer pain management

Prior to the intervention, nurses were trained by the PI and study oncologist. The PI listened to audio recordings of the sessions with nurses and patients in the intervention and control groups to ensure fidelity. The Norwegian version of the Pro-Self Pain Control Program intervention was used. A trained oncology nurse made home visits at 1, 3, and 6 weeks and telephone interviews at 2, 4, and 5 weeks. At the week 1 visit, the nurse delivered educational information tailored to each patient’s needs and patients received written instructions about pain and side effect management and were taught how to use a pillbox and how to use a script to help discuss pain management with their physician. At weeks 2, 4, and 5, the intervention group was contacted via phone to review pain score and medication use. The consent of the Pro-Self Pain Control Program was reinforced, and patients received coaching on how to address pain management needs. The same was done for home visits on weeks 3 and 6. The control group was given a booklet about cancer pain management and received home visits and telephone calls on the same schedule as intervention patients. The focus of interaction in the control group was adherence with completing the study diary. Both groups recorded measurements in a pain diary every night.

• N = 179
• MEAN AGE = Pro-Self group: 64.32 years (SD = 11.4 years), control group: 67.38 years (SD = 11.4 years)
• MALES: 47.1% in the Pro-Self group, 55.4% in the control group; FEMALES: 52.9% in the Pro-Self group, 44.6% in the control group
• KEY DISEASE CHARACTERISTICS: Patients with cancer who had bone metastasis, confirmed radiographically
• OTHER KEY SAMPLE CHARACTERISTICS: Primary diagnoses include breast, prostate, and colon cancer; 19.5% with other diagnosis; outpatients; able to read, write, and understand; Karnofsky Performance Status (KPS) of 50 or greater; pain intensity score of 2.5 or greater on a 0–10 scale

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

• PHASE OF CARE: Multiple phases of care
• APPLICATIONS: Elder care, palliative care

• Randomized, controlled trial

• KPS
• 0–10 pain intensity scale
• Pain experience scale (PES)
• Demographic questionnaire
• Independent student t-tests or chi-squared analysis, mixed-model analysis

At baseline, control patients reported a higher KPS score than those in the intervention group (p = 0.0003). Improvement in all individual and overall (p < 0.001) scores on the PES was noted for patients in the Pro-Self group. A statistically significant improvement was seen in nine items on the PES scale for patients in the intervention group.

The study resulted in an increase in knowledge of cancer pain management in the Pro-Self group.

• Baseline sample/group differences of import: Difference in KPS scores
• Risk of bias (no blinding)
• Risk of bias(sample characteristics): Control group had higher KPS score than the Pro-Self group at enrollment, and patients in the Pro-Self group had a lower PES score on one item than the control group
• Other limitations/explanation: The PES was modified when it was translated into Norwegian, some items on the PES were reverse coded, a drug dependence item on the PES was deleted (because of translational issues), and an item was added because it was included on another pain questionnaire by the American Pain Society’s Quality of Care Committee.

Additional research is recommended to examine the influence of the level of education of participants on interventions to improve cancer pain management.  A similar study was completed in the United States using a similar intervention, but the results were not as dramatic (the U.S. study yielded significant improvements in only five of the nine items on the PES, versus significant improvements in all 9 areas in the Norwegian study), which suggests cultural, educational, and demographic influences. Although individualized patient education tends to be more effective, this requires additional time and resources for planning and intervention.

To evaluate the effectiveness of chlorhexidine sponges in prevention of central venous catheter infections inserted for cancer chemotherapy

All patients received chlorhexidine and silver-impregnated, triple-lumen central venous catheters (CVC) that were intended for at least five-day use. Catheter insertion was done using maximal barriers, and skin antisepsis was done with alcohol. Catheter dressings were changed weekly. Patients expected to have catheters in place for less than five days were not included in the study.

• N = 601   
• MEDIAN AGE = 47
• AGE RANGE = 18–73
• MALES: 55.4%, FEMALES: 44.6%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: All had hematological malignancies
• OTHER KEY SAMPLE CHARACTERISTICS: The majority had CVCs placed in the internal jugular vein

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

• PHASE OF CARE: Active antitumor treatment

• Stated randomized, controlled trial

• Diagnosis of central line–associated bloodstream infection (CLABSI) was made based on clinical assessment symptoms of fever, swelling, and/or hypotension for which no other source was identified.

Mean catheter duration was 15.8 days among controls and 16.6 days in the experimental group. Among the treatment group were 19 cases of CVC infection (3.8 per 1,000 catheter days) compared to 34 cases (7 per 1,000 catheter days) in the control group (p = 0.016).

The use of chlorhexidine-impregnated dressings was associated with a lower rate of catheter-related infections.

• Risk of bias (no blinding)
• Measurement/methods not well described
• No information on the chemotherapy agents used
• Unclear definition of catheter-related infection by clinical determination
• Stated as an RCT, but randomization was not described and usual care not described 
• Stated that experienced clinician inserted the experimental group catheters, and procedure described
• Information about insertion or sites for \"control\" group was not described.

This study demonstrated supportive evidence for efficacy of chlorhexidine-impregnated dressings in CVC care to reduce the incidence of catheter-related infections. Patients with hematologic cancers receiving chemotherapy as included here are generally at high risk for infection. Interventions that can reduce the risk of infection in this patient population are important to incorporate into practice.

Intervention consisted of structured sessions, which began with 20 minutes of conditioning exercises conducted by a physical therapist followed by an educational session with cognitive-behavioral strategies for coping with cancer and open discussion with group leaders and other participants. Sessions were balanced with didactic material, a question and answer period, sharing, reflecting, relaxation, and physical activity. Participants attended eight sessions throughout four weeks following enrollment . Intervention was delivered three days per week. After the fourth week, patients filled out quality of life questionnaires, and questionnaires were collected at 8 and 27 weeks after enrollment via mail.

• N= 103 patients
• MEAN AGE = 59.6 years
• AGE RANGE = 31–85 years (85.7% older than 50 years)
• MALES: 66, FEMALES: 37
• KEY DISEASE CHARACTERISTICS: Dominant disease status most commonly gastrointestinal (36.7%)
• OTHER KEY SAMPLE CHARACTERISTICS: 59.2% undergoing current chemo, 77.6% married, 57.1% currently employed
• INCLUSION CRITERIA: Diagnosed within the past year, an expected survival time of at least six months, and a treatment recommendation of radiation therapy of at least two weeks
• EXCLUSION CRITERIA: Previous radiation therapy, recurrent disease after a disease-free period longer than six months, psychiatric disorders or active suicidality

• LOCATION: Mayo Clinic Rochester

• PHASE OF CARE: Active treatment

• Randomized, stratified, two-group, controlled clinical trial
  • Structured intervention arm (N = 49)
  • Standard medical care arm (N = 54)

• Linear Analogue Self Assessment (LASA)
• Profile of Mood States (POMS)
• Spielberger State-Trait Anxiety Inventory (STAI)
• Symptom Distress Scale (SDS)
• Functional Assessment of Cancer Therapy (FACT)

Mean score for fatigue scale of the LASA was lower at week four for the intervention group in comparison to the standard care group, but this difference was not significant. No significant differences were observed between groups for the SDS and FACT measures of fatigue at week four. Although intervention may have impact on overall quality of life, no significant effects were observed on fatigue.

• Sample was primarily white and from the Midwest; therefore, results may not be generalizeable.
• Cost and availability of multidisciplinary team to deliver intervention may limit its application/implementation in areas that are not large academic health centers.
• Cost was approximately $2,000 per participant for the entire eight-session period. However, costs would be reduced if more individuals participated.