To determine the effects of massage on sleep quality in patients with breast cancer

A random sample of women in a chemotherapy clinic was obtained, and individuals randomly were assigned to control and experimental groups. Those in the experimental group received effleurage style massage therapy by a certified practitioner for 20 minutes three times a week for four weeks in the clinic. Patients in the control group received usual care. Study measures were obtained at baseline and at four weeks.

• N = 57
• MEAN AGE = 43.5 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All had breast cancer and were an average of 3.5 months after surgery.
• OTHER KEY SAMPLE CHARACTERISTICS: About 13% in both groups were receiving hypnotics.

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

• PHASE OF CARE: Active antitumor treatment

• Single-blind RCT

• Pittsburgh Sleep Quality Index

In the experimental group, sleep latency, use of hypnotics, and sleep time improved (p < .001) from baseline. In the control group, sleep adequacy and use of hypnotics also improved (p < .05). No differences were seen in quality of life between groups.

Massage therapy may improve some aspects of sleep in women with breast cancer during active treatment.

• Small sample (less than 100)
• Baseline sample/group differences of import
• Risk of bias (no appropriate attentional control condition)
• Measurement/methods not well described
• Intervention expensive, impractical, or training needs
• Other limitations/explanation: The measurement used for quality of life is not described. The control group had overall lower sleep quality at baseline and more use of hypnotics. Because massage was done in the chemo clinic, whether contamination could have occurred with the control group in the same clinic is not clear. Reporting is unclear. Verbal discussion of results does not match tabular information.

Although this study does not provide strong support for the effectiveness of massage to improve sleep quality among women during therapy, massage is a low-risk intervention and these findings suggest that it might be helpful. For patients with sleep disturbance, massage may be an alternative that is helpful and preferred by some patients.

To investigate the effects of inoculation training on stress, anxiety, and depression

Forty patients were randomly selected and randomly assigned to study and control groups. Study group patients had weekly group education sessions for eight weeks. Sessions were aimed at understanding stress, relaxation, education, concepts of cognition, feelings and behaviors, role of negative self-talk, concentration and distraction techniques, and problem solving skills. Data were obtained before and after the intervention period.

• N = 40  
• AGE RANGE: 28-65 years
• MALES: 31.73%,FEMALES: 68.27%
• KEY DISEASE CHARACTERISTICS: Patients had non-hematologic cancers and were in the third course of chemotherapy. None were receiving radiation therapy.

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

• PHASE OF CARE: Active antitumor treatment

• Randomized, controlled trial

• Depression Anxiety and Stress Scale (DASS)

Anxiety and depression declined after the intervention, but did not decline in the control group. After eight weeks, anxiety was significantly lower in the intervention group (p = 0.00) and depression was significantly lower than controls (p = 0.04). Stress increased in the control group, but declined in the intervention group (p = 0.01).

The psychoeducational intervention tested here was associated with significantly less anxiety and depression compared to patients who did not receive this intervention.

• Small sample (less than 100)
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Unintended interventions or applicable interventions not described that would influence results
• Measurement/methods not well described
• Other limitations/explanation: No information is provided about the types of cancer, stage of disease, type of chemotherapy provided, other associated symptoms, or use of medication that may affect anxiety or depression–all of which could be expected to influence outcomes. The specific timing of postintervention measurement is not stated.

Findings suggest that the type of psychoeducational intervention provided here was helpful to manage anxiety and depression. Study design limitations affect the strength of evidence from this particular study; however, findings are in general concert with the body of evidence regarding effectiveness of psychoeducational interventions. Various psychoeducational interventions have been shown to be effective for anxiety and depression. These interventions can be incorporated into usual nursing practice.

To determine the effect of an oral mucositis prevention protocol on nutritional status and quality of life in patients receiving radiation therapy for head and neck cancers

The intervention group received an oral care protocol that included tooth brushing, features of the tooth brush, and a sodium bicarbonate mouth rinse. It also included an oral evaluation, precautions for oral mucositis, and a nutrition protocol. The nutrition protocol consisted of recommendations for wounds, irritation, intensive secretion, xerostomia, smell or taste changes, nausea, vomiting, and nutritional principles after radiation therapy (RT). The protocols were used for preventing oral mucositis and malnutrition, and interventions were used according to the grading of mucositis. Assessments were done weekly for seven weeks.

• N = 50  
• AGE = less than 39 to greater than 60
• MALES: 86%, FEMALES: 14%
• KEY DISEASE CHARACTERISTICS: Nasopharyngeal, laryngeal, salivary gland, gingiva, hypo pharyngeal, and tongue
• OTHER KEY SAMPLE CHARACTERISTICS: Education status from illiterate to high school or higher

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

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

Randomized, controlled, experimental study

• Face to face interviews were done using an oral assessment guide, oral toxicity scale from the World Health Organization (WHO), a Visual Analog Scale (VAS), the Subjective Global Assessment (SGA) index, and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ).
• A data analysis was conducted using SPSS v15.0 and SigmaStat v3.5.

Oral mucositis severity was lower in the group receiving the oral care protocol compared to the control group. As the post-treatment period progressed, the prevalence of malnutrition in the intervention group was lower than the control group, and the intervention group experienced significantly less pain related to oral mucositis. A similar deterioration in quality of life was noted in each group.

Oral mucositis severity was lower in the two groups receiving the oral care protocol compared to the control group. This study demonstrated that oral mucositis rate may be reduced with an oral care protocol.

• Small sample (< 100)
• Risk of bias (no blinding)
• Unintended interventions or applicable interventions not described that would influence results
• Findings not generalizable
• Other limitations/explanation: This study reported a number of patients who experienced occasional breakdowns in RT treatment devices with delays that could have affected results. It was not clear what care patients in the control group received when they developed mucositis.

Nurses working in RT units should explain oral care protocols to patients before treatment and assess patients' mouths every week using evidence-based assessment criteria. Healthcare professionals should evaluate the nutritional status of individuals receiving RT before, during, and after treatment, and patients should be offered education and training. Nurses should use evidence-based protocols for patient care. This study added to the body of evidence pointing to the importance and effectiveness of standardized oral care for the reduction of mucositis severity.

Participants were randomly assigned to receive either 3 mg oral budesonide three times per day for a total of eight weeks during two cycles of irinotecan or a placebo. Rescue medication was given at an initial dosage of 4 mg loperamide followed by 2 mg every two hours until free of diarrhea for 12 hours.

The study reported on 56 patients with advanced colorectal cancer receiving 125 mg/m² irinotecan once per week.

This was a prospective, double-blind, placebo-controlled, multicenter, randomized phase III trial for prevention of diarrhea.

Patients recorded presence of diarrhea (defined as more than four stools per day), duration of diarrhea, and use of loperamide in patient diaries.

Diarrhea could be prevented in 58.3% of the budesonide-treated patients compared to 38.5% of the patients receiving the placebo (p = 0.257).

Budesonide provided superior prevention of diarrhea compared to placebo in the first cycle. However, the trial failed to show that budesonide provided a statistically significant benefit in preventing irinotecan-induced diarrhea.

• The sample size was small.
• Therapeutic administration might be more efficacious than prophylactic administration.

In a previous study (Lenfers, 1999), budesonide was found to be effective in treatment chemotherapy-induced diarrhea in patients who had treatment failure with loperamide. Budesonide also has been proposed as a therapeutic approach for inflamed bowel. However, this study did not support that finding. Further research is warranted.

To compare the safety and efficacy of oral and intravenous palonosetron when used to prevent chemotherapy-induced nausea and vomiting (CINV) in patients receiving cisplatin-based chemotherapy

On day 1 of chemotherapy, subjects were given either 0.50 mg oral palonosetron or 0.25 mg IV palonosetron in addition to oral dexamethasone at 20 mg on day 1 followed by 8 mg orally as needed on days 2–4. The use of rescue medication was considered a treatment failure. Metoclopramide tablets were available, the use of other 5HT3s was discouraged, and the use of palonosetron was not allowed. 

• N = 738  
• MEAN AGE = 58 years
• MALES: 59%, FEMALES: 41%
• KEY DISEASE CHARACTERISTICS: 87% white and 13% Asian; primary cancer diagnoses were 47% lung, 23% other, 18% head and neck, and 7% gastric; 51% had primary disease; 46% had metastatic disease; 3% local recurrence
• OTHER KEY SAMPLE CHARACTERISTICS: Inclusion criteria included: age ≥ 18 years old; histologically or cytologically confirmed malignant solid tumor; Eastern Cooperative Oncology Group performance status of 0–2; and adequate hepatic, renal, and hematologic function. Exclusion criteria included the inability to receive moderately or highly emetogenic chemotherapy on days 2–5 following cisplatin or radiation therapy to the abdomen or pelvis within one week prior to day 1.

• SITE: Multi-site    
• SETTING TYPE: Not specified    
• LOCATION: United States, Latin America, Europe, Asia, and the Commonwealth of Independent States

• PHASE OF CARE: Active antitumor treatment

Randomized, controlled, double-blinded, double-dummy, parallel-group, stratified study

• Impact on quality of life was measured by the modified Function Living Index-Emesis (FLIE).
• Safety assessments included a physical examination, vital signs, electrocardiogram, laboratory analysis, and reports of adverse events.

The acute phase complete response (CR) rate was 89% in the oral palonosetron group and 86% in the IV group. The CR rate in the delayed phase was 76% for oral versus 75% for IV palonosetron. There was no difference in the percentage of patients with no emesis in the delayed (79% oral versus 78% IV) and overall phases (76% oral versus 73% IV). There was no overall statistical difference in nausea and the use of rescue medication between the oral and IV groups in the acute, delayed, and overall study phases. Study drug treatment-emergent adverse events were rare (3.2% oral versus 6.5% IV).

IV palonosetron was not superior to oral palonosetron in preventing CINV from platinum-based highly emetogenic chemotherapy. Both routes had similar efficacy in the acute, delayed, and overall phases. 

Oral 0.50 mg and IV 0.25 mg palonosetron were effective in preventing CINV in highly emetogenic chemotherapy regimens containing cisplatin without increasing the risk of adverse events. The availability of oral antiemetics provides opportunities to decrease the amount of time patients spend in the clinic receiving IV premedications. This may decrease the cost of treatment because of the decrease in chair time.

• Cyproheptadine 8 mg by mouth three times daily versus placebo
• Patients stratified for
  • Primary disease site: lung, gastrointestinal, or other
  • Chemotherapy: CDDP or non-CDDP
  • Amount of RT: whole or upper abdomen

• N = 293 evaluable patients (143 cyproheptadine, 150 placebo)
• KEY DISEASE CHARACTERISTICS: The three groups entered had the following key disease characteristics.

1. Advanced malignant disease with no definite planned cytotoxic therapy with weight loss of five pounds over two months and intake less than 20 calories/kg
2. Same as 1 but patients receiving chemo or immunotherapy
3. Same as 1 but receiving upper abdominal or whole abdominal RT with planned dose greater than 2500 cGy

• EXCLUSION CRITERIA: Tube feeding or parenteral nutrition; life expectancy less than six weeks; ascites, pedal edema; mechanical obstruction; brain tumors; glaucoma; urinary hesitancy; concomitant treatment with steroids, progestational agents, and MAOI inhibitors

• Randomized, placebo-controlled, double-blinded clinical trial

• Percentage of weight change from baseline values (Patients’ weights were monitored monthly by HCP, and patients were asked to weigh themselves weekly at home.)
• Patient appetite questionnaire
• Food intake questionnaire
• Perceived drug benefits and toxicities (e.g., lethargy, sedation, nausea, dry mouth)

• Appetite improved
  • 64% of cyproheptadine
  • 50% of placebo
  • P = 0.02
• Average maximum weight gain
  • Cyproheptadine: 0.9 pounds
  • Placebo: 0.5 pounds
  • P = 0.78
• Average weight loss
  • Cyproheptadine: 4.5 pounds
  • Placebo: 4.9 pounds
  • P = 0.72
• Toxicities: Lethargy, dizziness, dry mouth

Cyproheptadine in patients with advanced malignant disease showed mild appetite enhancement but no significant weight enhancing effect.

• Patients remained in the study for a short time. The median time in the study was 34 days with cyproheptadine and 39 days with placebo. Only 25% of the patients entered still were participating in it after three months. 
• The intervention was done late in the disease trajectory.

The study group used oral cryotherapy, via ice cubes “at a size that could be moved easily in the mouth and whose corners have been smoothed in order that they will not cause irritation in the mouth,\" beginning five minutes before chemotherapy initiation and maintained use during IV infusions of etoposide, platinol, mitomycin, and vinblastin. For random allocation, patients were assigned to the study group or a control group in sets of five.

• The study involved 60 patients, with 30 in the study group and 30 in the control group.
• The majority of patients (66.7%) were older than 60 years of age.
• Patients were excluded from the study if they
  • Had previously undergone their first chemotherapy.
  • Were not receiving combined courses.
  • Were given chemotherapy agents other than etoposide, platinol, mitomycin, or vinblastine.
  • Had malignancy in the oral cavity. Five of the patients had oral infection findings in the oral cavity prior to study.
• Cancer diagnoses were epidermoid (43.3%), small cell (28.3%), adenocarcinoma (11.7%), and mesothelioma (16.7%).
• Chemotherapy regimens were one-day etoposide-platinol (43.3%); three successive days of etoposide-platinol (28.3%); one-day mitomycin, vinblastin, platinol (11.7%); and one-day mitomycin-platinol (16.7%).

The study was conducted at a respiratory disease clinic in Turkey from August 2000 to May 2001.

• A data collection form and patient-judged 0–4 mucositis grading scale were used on days 1–21. A 0–4 physician-judged mucositis grading scale was used on day 21 for patients receiving single-day protocols and on days 2, 3, and 21 for patients receiving three-day protocols. The mucositis grading scales were based on the Mucositis Grading System of the World Health Organization (WHO).
• An oral pH measurement scale was used before and after single-day chemotherapy regimens, before and after each day of chemotherapy for multiday chemotherapy regimens, and on day 21 for all subjects.

• The study group experienced a decrease in the severity and duration of mucositis and in oral pH values.
• Rates of mucositis were lower in the study group.
  • Patient-judged mucositis was 36.7% in the study group and 90.0% in the control group (p < 0.05).
  • Physician-judged mucositis was 10.0% in the study group and 50.0% in the control group (p < 0.05).

• The sample size was small.
• Physicians only assessed mucositis on days 1, 2, 3, and 21, but not during the entire chemotherapy course.
• Application to other chemotherapy agents is not known.

To determine efficacy of back massage on fatigue and anxiety in patients receiving chemotherapy

Before chemotherapy infusions were started, patients completed study data collection in face-to-face interviews. During chemotherapy administrations, patients in the intervention group received a back massage for 15 minutes before the infusions and between 25–40 minutes of each one-hour period of chemotherapy administration. Data collection was repeated immediately after the massage intervention, and patients were interviewed by phone 24 hours after the chemotherapy treatment for the completion of postintervention data collection. Patients were not randomly assigned to treatment and control groups.

• N = 40  
• MEAN AGE = 49.94 years (SD = 11.31 years)
• MALES: 45% (intervention group); 50% (control group), FEMALES: 55% (intervention group); 50% (control group)
• KEY DISEASE CHARACTERISTICS: Breast and lung cancers were the most frequent diagnoses.
• OTHER KEY SAMPLE CHARACTERISTICS: All patients were receiving single-day chemotherapy. Massage interventions were done during the third or fourth chemotherapy treatment. None of the patients were actively working at the time.

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

• PHASE OF CARE: Active antitumor treatment

Quasi-experimental, cross-sectional cohort study

• Spielberger State-Trait Anxiety Inventory (STAI)
• Brief Fatigue Inventory (BFI)

Fatigue scores were significantly different between groups at baseline and higher in the control group the day after chemotherapy. There were no significant differences between groups in the change of fatigue pre- and postintervention. Mean anxiety scores in the control group increased after chemotherapy while those in the intervention group declined. Differences between groups were not statistically significant.

Findings provide limited evidence that back massages may be helpful in reducing anxiety and fatigue experienced during treatment with chemotherapy.

• Small sample (< 100)
• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (no random assignment) 
• Risk of bias (no appropriate attentional control condition)  
• Other limitations/explanation: Completion of data collection forms by investigators increases potential bias. Only very short-term effects were measured.

Massage is a low-risk intervention that may be helpful to some patients during active chemotherapy treatment to reduce anxiety or fatigue. This study, however, does not provide strong supportive evidence due to multiple study design limitations.

To examine effects of music and visual imagery on anxiety and chemotherapy-induced nausea and vomiting (CINV) in patients receiving chemotherapy

Patients were assigned to the control group during their second cycle of chemotherapy and to the experimental condition during the third cycle of chemotherapy. Anxiety and CINV were measured before and after chemotherapy administration. Nature paintings were used for visual imagery, and instrumental Turkish music was selected for each image. Patients selected the image that was most appealing to them and were told to imagine being in the location of the painting. Patients were given the related music CD to listen to during chemotherapy with headphones.

• The study reported on a sample of 40 patients.
• Mean patient age was 59.65 ± 9.67 years.
• The sample was 77.5% male and 22.5% female.
• Of the sample, 80% had lung cancer, and all were receiving highly emetogenic chemotherapy.

The study was conducted at a single site, outpatient setting in Turkey.

Patients were undergoing active antitumor treatment.

A pre- and post-test repeated measures, single-group design was used.

• The Spielberger State-Trait Anxiety Inventory was used.
• Nausea was rated on a 100-mm visual analog scale (VAS).
• The Morrow Assessment of Nausea and Vomiting was used.

Anxiety declined from prechemotherapy to postchemotherapy administration in both conditions. Both pre- and postchemotherapy state anxiety levels were lower during the intervention course of treatment. CINV declined over time for both pre- and postchemotherapy administration. Both pre- and postchemotherapy CINV levels were significantly lower during the intervention condition.

This study does not provide any clear conclusions about the effects of music and visual imagery.

• The study had a small sample, with less than 100 participants.
• The study had risk of bias due to lack of a control group, blinding, random assignment, and an appropriate attentional control condition.
• The authors stated use of a 100-mm VAS but then stated that they grouped scores into 1 cm intervals. It is not clear if actual score differences were maintained, as this was not well described.
• The authors concluded that the intervention was effective based on analysis of differences before and after chemotherapy between the two study conditions; however, they did not show analysis of the change between pre- and postscores in each condition. This does not make sense as an approach to evaluate the effects.
• The study design had multiple risks of bias and threats to internal validity. Patients were assigned to the experimental condition in the third cycle—it is possible that anxiety and CINV simply declined over time, unrelated to the intervention.

Findings are inconclusive regarding the efficacy of music and visual imagery for anxiety and CINV during chemotherapy administration because of numerous study design and analysis limitations.

To evaluate the effects of kinesiophobia, quality of life, and home exercise programs on women with upper-extremity lymphedema

All patients underwent complete decongestive physiotherapy consisting of a combination of manual lymph drainage using the Foldi method, multi-layer bandages, remedial exercise, and skin care.

• The sample was comprised of 62 patients.
• Mean age of the sample was 56.7 years. 
• The sample was 100% female.
• All patients had upper-extremity edema following axillary node dissection after sentinel node biopsy as part of breast cancer therapy.
• Patients were included in the study if they had mild, moderate, or severe edema.
• Patients were excluded if attendance was irregular.

The study was conducted at a single-site outpatient setting at Dokuz Eylul University Hospital.

The study used a prospective trial design.

• Circumference was measured using a fiberglass tape measure.
• Water displacement in water cylinder was used to measure volume.
• Fear of movement was measured using the Tampa Scale Kinesiophobia (TSK) based on a Likert scale.
• Quality-of-life measurements were based on the Functional Assessment of Cancer Therapy for Patients With Breast Cancer (FACT-B) and four questionnaires.

• Edema of arm-volume significantly reduced after treatment with decongestive therapy (p = 0.000).
• Patient fear of activity decreased after treatment (p < 0.05).
• More exercise habits equaled less fear of activity (p < 0.05).

A correlation between severity of edema and fear of activity was established. Increased fear of activity showed to decrease quality of life.

• The study sample was small with fewer than 100 patients.
• Patients with poor attendance were eliminated from the study analysis.

Encouraging activity and education are important for the management of lymphedema in patients after sentinel node biopsy.