To study the effectiveness of back massage on anxiety, stress markers, and sleep quality in the caregivers of patients with cancer

Caregivers were randomized to treatment and control groups. Caregivers in the treatment group rested for 10 minutes in a silent room then were given a 15-minute back massage each evening. The control group rested quietly in a separate silence room. Study measures were obtained at baseline and on day 7. Blood samples were obtained on day 7 for cortisol levels.

• N = 44
• MEAN AGE = 42.31 years (range = 24–60 years)
• MALES: 36.4%, FEMALES: 63.6%
• KEY DISEASE CHARACTERISTICS: Not stated
• OTHER KEY SAMPLE CHARACTERISTICS: Caregivers had secondary school education or less. About 50% were spouses, and the rest were parents of the patient. 

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

Randomized, controlled trial

• State-Trait Anxiety Inventory (STAI)
• Cortisol levels
• Blood pressure and heart rate
• Pittsburgh Sleep Quality Index (PSQI)

Overall, 100% of the intervention group had moderate levels of anxiety at baseline, and those in the control group had low to high anxiety. Anxiety declined in the intervention group (p = 0.000) and remained essentially stable in the control group. Cortisol levels declined in the intervention group (p = 0.01) and were within reference levels. At baseline, 77.3% of caregivers in both groups had PSQI scores of 5 or greater, indicating poor sleep quality. Sleep quality scores declined in the intervention group (p = 0.000) and increased in the control group (p = 0.003) among those with initial scores greater than 5.

Daily back massages for caregivers reduced anxiety and improved sleep quality.

• Small sample (< 100)
• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Other limitations/explanation: Cortisol levels were within reference levels, so it was not clear how meaningful these changes were. Many patients in the control group had low baseline anxiety levels, and there could have been floor effects in this measure. Measurements were taken immediately after the massage was given, so the duration of effect was not clear.

Back massage is a simple technique that nurses can use to help reduce anxiety and stress for the caregivers of patients with cancer. This is a complementary nursing action that can be used to support caregivers.

To examine the effects of preoperative instruction on anxiety levels after gynecology oncology surgery

A random sample of patients scheduled for surgery was selected, and patients were assigned to intervention and control groups. Those in the control group received typical preoperative teaching. The intervention group was informed in detail with written information provided in an interactive situation to patients and caregivers. Instruction included anatomical information, routine preoperative preparation (e.g., removal of dentures, medications for the procedure), and postoperative care (e.g., management of pain, Kegel exercises). Instruction also included information on relaxation and imagery techniques. Study measures were obtained prior to surgery and after surgery immediately prior to hospital discharge.

• N = 120    
• AGE = Median and range were not provided. 50% were older than age 49 years.
• MALES: 0%; FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Ovarian, endometrial and cervical cancers
• OTHER KEY SAMPLE CHARACTERISTICS: 61% had no previous surgical experience.

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

• PHASE OF CARE: Active antitumor treatment

• Nonrandomized two-group comparative quasiexperimental design

• State-Trait Anxiety Inventory (STAI)

Authors reported STAI-I results and STAI-II results, but it is not clear what STAI-II refers to. STAI postoperative results declined similarly in both groups. STAI-II postoperative results were higher in both groups and increased more in the intervention group than the control group. The difference between postoperative study groups showed overall lower anxiety scores in the intervention group (p = .004).  Baseline anxiety was higher in the control group but not statistically different from the intervention group.

No firm conclusions regarding the effects of the preoperative teaching were given, and conclusions on postoperative anxiety cannot be drawn.

• 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)
• Key sample group differences that could influence results
• Measurement validity/reliability questionable
• Other limitations/explanation: Measurement results as reported are unclear. It is surprising that the difference in anxiety scores was greater between groups at baseline but was not statistically significant. However, smaller differences postoperatively were significant. No subgroup analysis was done based on extent of surgery or stage of disease, which could be expected to influence anxiety.

Study limitations preclude the ability to draw any firm conclusions from this research.

Analyze the effectiveness of two noninvasive mechanical and electrical therapies on salivary flow and severity of oral mucositis in patients undergoing allogeneic HCT.

INTERVENTION DESCRIPTION
Patients undergoing myeloablative conditioning for allogeneic HCT  were randomized to four groups: (1) control group (no salivary stimulation therapy, (2) salivary stimulation using a mechanical chewing instrument, (3) TENS stimulation, and (4) combination of TENS and mechanical chewing. Saliva samples were obtained twice before HCT and three times after transplantation. Severity of mucositis was evaluated by a single examiner four days per week from day 7 to day 30 post-HCT.  Patients assigned to the mechanical chewing used a silicone instrument and were instructed to perform mastication exercises after meals 4 times daily for 10 minutes. TENS stimulation was given 3 times a week for 30 minutes each, with electrodes placed at 3 regions of the face corresponding to parotid, submandibular, and sublingual salivery glands.
 

The study was comprised of 35 patients with a mean patient age of 33.56 years (SD = 12.46 years).

MALES 33.7%, FEMALES 66.3%

KEY DISEASE CHARACTERISTICS:  All received conditioning with cyclophosphamide with or without busulfan for HCT. Cyclosporin in combination with methotrexate or mycophenolate mofetil was used for GVHD prophylaxis. All underwent allogeneic HCT. Underlying diseases were bone marrow aplasia, AML, ALL, Hodgkin’s lymphoma, and mantle cell lymphoma. 75% had malignant diseases.
 

SITE: Single site

SETTING TYPE: Inpatient

LOCATION: Brazil

PHASE OF CARE: Active antitumor treatment

 Single, blind, randomized controlled trial

• Salivary collection and analysis and calculation of salivary flow rates over time
• WHO oral mucositis scale
• Salivary cytokine levels
   

Resting salivary flow showed a tendency toward decrease in all patients.  In all therapy groups combined, salivary flow showed less of a decrease than control patients, but this difference was not significant. At the end of the study, the TENS and TENS plus chewing group showed an increase in salivary flow, while the other two groups showed a decline (p < 0.05). Mucositis occurred in 68.5% of patients. There were no differences in grades of mucositis between groups. There was a tendency of lower salivary flow in patients with mucositis of any grade.There were no significant differences seen in salivary TNF and IL-10 levels in relation to occurrence of mucositis.

Electrical salivary stimulation therapy, alone or combined with mechanical chewing therapy appeared to increase salivary flow when compared to chewing therapy alone or no salivary stimulation therapy; however, there was no significant difference seen in mucositis occurrence or severity based on study group or salivary flow.

• Small sample (<100)
• Unintended interventions or applicable interventions not described that would influence results*
• Selective outcomes reporting*
• Measurement/methods were not well described.

Salivary flow decline may contribute to development and severity of oral mucositis. This study shows that electrical stimulation may improve salivary flow. Further research in this are is needed to fully evaluate the effectiveness of salivary stimulation in the management of oral mucositis.

To evaluate the efficacy of ginger powder in reducing chemotherapy-induced nausea and vomiting (CINV) in children and young adults

Participants were randomly assigned to receive either ginger powder tablets or placebo tablets to be taken daily at night during the first three days of chemotherapy and then three times daily for the next two days after chemotherapy was completed. The total dose of ginger powder was 1,000–2,000 mg per day, based on body weight. Ondansetron and dexamethasone were used as standard antiemetics.

Randomization was done for each cycle of chemotherapy. Data were analyzed according to treatment cycle grouping. Patients received a follow-up telephone call on the seventh and tenth days of chemotherapy to reinforce diary use.

• The sample consisted of 32 patients who were studied over a total of 60 chemotherapy cycles.
• Patient ages ranged from 8–21 years old.
• Data was reported by chemotherapy cycle, not known in patient sample.
• All patients had been newly diagnosed with bone sarcoma.

All participants were pediatric patients in active treatment.

This was a randomized, double-blind, placebo-controlled trial.

• The Edmonton Symptom Assessment Scale (ESAS) and National Cancer Institute guidelines for grading of nausea and vomiting were used to measure symptoms.
• Patients or guardians were instructed to complete daily diaries recording of emesis episodes and questions related to grading of nausea and vomiting.

• Incidence of acute nausea in both study groups was 100%. In the control group, acute moderate-to-severe nausea was 93.3% compared to 55.6% in those receiving ginger (p < 0.003).
• Complete absence of vomiting was reported in 3.3% of controls, compared to 14.81% in the experimental group.
• Moderate to severe delayed nausea was seen in 73.3% of control cycles compared to 25% in the experimental group (p < 0.001).
• Moderate to severe delayed-phase vomiting was seen in 46.7% of controls and 14.8% of those who received ginger (p = 0.022).
• No adverse effects were seen with ginger or the placebo.

Ginger powder may have a positive impact in reducing acute and delayed nausea as an adjunct to standard antiemetic treatment in children and young adults, and it was not associated with any adverse effects.

• The sample was small with less than 100 participants.
• Patients may have received either ginger or placebo during different chemotherapy cycles; however, the study design was not done as an actual crossover design. This is a substantial design flaw in this study.
• Results showed that there was a complete absence of vomiting in the control cycles for the acute phase; however the authors did not discuss or explain this observation, since all other observations suggested reduction in CINV with ginger. 
• No discussion of compliance with diary documentation of nausea grading was provided.
• Analysis of subgroups according to the cycle of chemotherapy was not possible, and anticipatory CINV was not measured.
• Gender distribution between control and experimental groups was significantly different with more males in the experimental group. Known gender differences occur in adults in response to antiemetic therapies. It is not clear if this is also the case in pediatric patients.

Ginger may be helpful in mitigation of CINV symptoms for younger patients; however, effectiveness remains unclear.

Systematic review: Homeopathy for anxiety and anxiety disorders

A comprehensive search of major biomedical databases including MEDLINE, EMBASE, CINAHL, PsycINFO, and Cochrane Library, as well as specialist complementary and alternative medicine (CAM) databases AMED, CISCOM, and Hom-Inform, was conducted.

Only eight randomized controlled trials (RCTs) were identified. The types of anxiety studied were test anxiety, generalized anxiety disorder, and anxiety related to medical or physical conditions, such as cancer or surgical procedures. Single case reports/studies were the most frequent study type, but others also were found. Three of the uncontrolled case studies were on patients with cancer with anxiety, which were referred to U.K. homeopathic hospital. The interventions were individualized homeopathy. All three used the Hospital Anxiety and Depression Scale as one measure, as well as others.

The sample sizes of the three case studies were 50, 100, and 45.

A comprehensive search demonstrated that there is limited evidence on the benefit of homeopathy in anxiety. The results were contradictory. Some patients’ anxiety improved, while others experienced worsening of symptoms and reappearance of old symptoms.

The reviewers felt it was difficult to assess the extent to which any response could be attributed to homeopathy.

• The RCTs measured different types of anxiety and reported contradictory results, were underpowered, or lacked methodology details.
• The three studies involving patients with cancer were not controlled or randomized, and they utilized consecutive patients.

Patients were randomized to one of three groups. In group one, patients received 100 mg of pentosanpolysulfate (PPS) three times per day. PPS is a glycosaminoglycan marketed as Elmiron^® and SP54. It has been used to treat radiation-induced sequelae of the bladder. In group two, patients received 200 mg PPS three times per day. In group three, patients received placebo three times per day. If no improvement occurred in two months, treatment was discontinued. If symptoms improved or resolved, treatment was continued for an additional four months.

• The study initially involved 180 patients from 34 institutions. The final study reported on 168 evaluable patients.
• Group one consisted of 48 patients, group two consisted of 50 patients, and group three consisted of 53 patients.
• Subjects had received radiation therapy to the abdomen or pelvis and experienced grade 1–3 treatment-related proctitis, diarrhea, and melena at least four weeks after completion of therapy. No concurrent chemotherapy was included.

• National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE)  was used to measure proctitis, diarrhea, and melena. 
• A complete response was defined as the absence of symptoms and cessation of symptom medications.
• A partial response was defined as a reduction in severity grade.
• Quality of life endpoints were evaluated via the following tools.
  • Functional Alterations Due to Changes in Elimination (FACE) questionnaire
  • Functional Assessment of Cancer Therapy (FACT) questionnaire
  • Medical Outcomes Survey (SF-12®)
  • Spitzer Quality of Life Index (SQLI)

No significant differences were found among the three arms of the study.

• A previous pilot study had more promising results not found in this study. Further dosing trials or possible rectal administration are recommended.
• A proportion of patients (20%–25%) reported deterioration in the first three months of the study.

To assess the efficacy of different intermittent pneumatic compression (IPC) protocols on edema volume reduction in women with postmastectomy lymphedema

Study subjects were randomly allocated to four groups with different cycles and sleeves for IPC. All women underwent IPC treatment for five weeks, five times per week for one hour for 25 sessions in total. Arm volume measurements for both arms were performed before and after each session. Group I (n = 17) received one-to-one cycles of compression and interval (90 seconds each), with a single chamber sleeve. Group II (n = 9) received a one-to-one cycle of compression and interval (90 seconds each), with a three-chamber sleeve. Group III (n = 11) received a one-to-one cycle of compression and interval (45 seconds and 15 seconds, respectively), with a single chamber sleeve. Group IV (n = 20) received a one-to-one cycle of compression and interval (45 seconds and 15 seconds, respectively) with a three-chamber sleeve.

• The study sample was comprised of female patients with breast cancer-related upper-extremity lymphedema who were post-treatment.
• Mean age ranged from 39–80 years.

The study took place at Wroclaw Medical University, in Wroclaw, Poland.

The study used a randomized trial design.

• Arm volume measurements were performed by water displacement.
• Distance between the tip of the third finger and bottom of axillary fossa was determined for each extremity; each subsequent measurement was repeated to this distance and mean value was recorded.
• Degree of lymphedema was represented by a difference in volume between the swollen upper extremity and the health upper extremity and was expressed in percent.

Significant differences in edema (29%–47%) were observed in all groups post-treatment with the most significant decrease seen in Group IV. The least reduction was observed in Group III, with Groups I and II experiencing similar decreases. Further comparison revealed the 45 second cycles with a three compartmental sleeve proved almost twice as effective as the 45 second cycle with single compartment sleeve.

IPC can be effective in decreasing lymphedema in upper extremities in patients with breast cancer post-treatment. Further studies are needed to validate the finding of enhanced results with a shorter compression cycle and cyclic sequential massage.

• The sample size was small, with less than 100 participants.
• The description of the study population is limited (i.e., length of time post-treatment or extent of surgical intervention).

IPC devices may be efficacious in treatment of lymphedema. More studies are needed to compare pneumatic compression devices and determination of standard equipment for treatment. Nurses need to build awareness for prevention and early detection and early intervention.

To determine if breast intensity-modulated radiation therapy (IMRT) can lead to significant reduction in radiation-induced skin toxicity

Participants randomly assigned to receive 50 Gy in 25 fractions to the whole breast using either standard RT or breast IMRT. Random assignment was stratified for use of boost and breast size. Standard skin care during the radiation treatment was similar between groups. Patients were assessed weekly during and up to six weeks after RT.

• The sample was comprised of 331 female patients receiving either IMRT (n = 170) or conventional RT (CRT) (n = 161).
• Mean age in the IMRT group was 57.1 years, with a standard deviation (SD) of 10.7 years.
• Mean age in the CRT group was 56.4 years, with a SD of 10.5 years.
• All patients had early-stage breast cancer treated by breast conserving surgery with three or fewer involved lymph nodes.

The study too place at two cancer centers in Canada.

The study used a phase III, double-blind, randomized, controlled trial design.

• Acute skin reaction or pain was measured using the National Cancer Institute Common Toxicity Criteria (NCI CTC) scale and ccurrence of moist desquamation.
• Quality-of-life (QOL) data was coded using the European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C-30 general module and the BR-23 module self-assessment questionnaires.
• Breast size was defined as small (bra sizes 32A or 32B, 34A or 34B, and 36A), medium (bra sizes 32C, 34C, 36B, or 36C and 38A, 38B, or 38C), or large (larger bra sizes).

A lower proportion of patients experienced moist desquamation during or up to six weeks after radiation treatment with IMRT (31.2%) compared to 47.8% with standard treatment (p = 0.002). Multivariate analysis found IMRT (p = 0.003) and smaller breast size (p = 0.001) significantly associated with a decreased risk of moist desquamation. Breast IMRT (31.2%) significantly reduced the occurrence of moist desquamation compared to a standard wedged technique (47.8%) (p = 0.002).

IMRT was associated with reduced risk and prevalence of moist desquamation.

No information was given on what the standard skin care was during the radiation treatments, just that it was similar between sites.

To evaluate current evidence regarding the effect of mindfulness-based therapy (MBT) on symptoms of anxiety and depression in patients with cancer

• Databases used in the search were EMBASE, PubMed, PsycINFO, Web of Science, Scopus, and Cochrane Collaboration.
• Search keywords were mindfulness, MBT, MBSR, and cancer.
• Inclusion criteria were English-language studies reporting on adult patients with a current or former diagnosis of cancer who were receiving MBT or mindfulness-based stress reduction (MBSR) as an intervention. Studies included pre- and postintervention valid continuous measures of anxiety or depression symptoms.
• Exclusion criteria were unspecified.

• The study included 670 references.
• Authors used the Jadad scale to evaluate and comment on the literature.

• A final number of 22 studies were included in the review.   
• Sample range across studies was 1,409 participants, with a range of 12–287.
• Mean participant age was 55 years.
• Women with breast cancer represented 86% of the sample.

Multiple phases of care

Among nonrandomized studies, overall effect size for anxiety was 0.60 (Hedges’s g, p < 0.001) and 0.42 (p < 0.001) for depression. Among randomized controlled trials, effect size for anxiety was 0.37 and 0.44 (p < 0.001) for depression. Most studies used the Profile of Mood States scale or the State-Trait Anxiety Inventory. The range of Jadad quality scores was 0–4, with only six studies having scores greater than 2. This score indicates low quality. Heterogeneity among studies was moderate.

Findings demonstrate a low to moderately significant effect of MBT in reducing anxiety and symptoms of depression among patients with cancer. Heterogeneity among studies suggests that findings be viewed with caution.

• Most participants were women with breast cancer. Findings may not be generalizable to males and to other diseases.
• The quality of many of the assessed studies was low. 
• Most studies did not include patients with clinically significant levels of anxiety or depression at baseline.
• Studies were done at various phases in the cancer trajectory, so how the phase of care may have influenced findings is unclear. 
• In general, anxiety and depression symptoms improve over time with no intervention. The research did not consider this fact.

MBT may benefit patients with cancer by reducing anxiety and symptoms of depression. The use of MBT appears to be feasible in cancer care. The low quality of studies in this analysis points to the need for well-designed research on the effects of MBT.

To evaluate the efficacy of a triple-drug combination (palonosetron + aprepitant + dexamethasone) to prevent acute and delayed emesis after high-dose chemotherapy with BEAM (carmustine + etoposide + cytarabine + melphalan) before hematopoietic stem cell transplantation (HSCT) by comparison with historical control of patients treated with dexamethasone + ondansetron or dexamethasone + palonosetron

Triple drug antiemetic regimen (aprepitant 1 hour before chemotherapy [125 mg on day one and 80 mg on days 2 & 3] + 0.25 mg IV palonosetron 30 minutes before chemotherapy and 20 mg IV dexamtheasone 15 minutes before chemotherapy for day 1 and 12 mg daily for rest of chemotherapy regimen) was compared to data from historical control patients that received 32 mg ondansetron and IV dexamethasone daily during chemotherapy or palonosetron and dexamethasone (dexamethasone given as 20 mg IV day 1 and 12 mg daily for rest of chemotherapy regimen in all cases). Acute phase was defined as the first 24 hours after receiving chemotherapy, and delayed phase was definied as days 2–5.

• The study consisted of 96 participants.
• The age and gender of patients was not provided.
• The study group sample consisted of 54 patients with non-Hodgkin lymphoma and 42 patients with Hodgkin lymphoma for patients receiving “triple drug regimen.” Historical controls were described as “comparable in terms of numbers, age, sex, weight and underlying diseases.\"
• Historical control patients received ondansetron (32 mg IV daily during HDC) or palonosetron (assumed to be daily). Both regimens included dexamethasone.

The study was conducted at a single inpatient setting in Warsaw, Poland.

All patients were in active treatment.

This was a descriptive study with comparison to historical controls.

• Severity of nausea was measured on a 4-point scale with none = no nausea; mild = slight nausea but no disruption to daily activities; moderate = nausea and some disruption to daily activities; and severe = extreme nausea and severe disruption to daily activities. 
• Emetic response rate was evaluated using the following criteria: complete response = no emetic episodes; major response = 1-2 episodes; minor response = 3-5 episodes; and treatment failure = more than 5 episodes.
• Response to study drugs was measured on 4-point scale based on the relief of nausea and vomiting: highly effective, moderately effective, slightly effective, and not effective.

Patients treated with the triple-drug antiemetic combination showed higher response rates than those receiving palonosetron or ondansetron (+ dexamethasone) during both the acute and delayed phases in reduction of chemotherapy-induced nausea and vomiting (CINV).

Drawing conclusions based on the information provided in the study is difficult.

• The sample size was small with fewer than 100 participants.
• The researchers did not use validated tools to measure response.
• The article does not clearly indicate whether the study was observation or self-report. 
• The authors did not provide clear descriptions of the patients in the historical controls (e.g., number of patients, diagnosis, ages, sex). 
• The authors did not describe the statistical analysis process.
• The method of describing the results was confusing and difficult to interpret.

Although the study appeared to support the use of established CINV guidelines established by the National Comprehenaive Cancer Network (NCCN) and the American Society of Clinical Oncology (ASCO), the data in this study were of questionable significance because of the information provided and poor quality of the study.