To examine the effectiveness of play, consisting of virtual reality computer games, in reducing anxiety and symptoms of depression in children hospitalized for cancer treatment

Children hospitalized for cancer treatment were invited to participate in the study. Patients received 30 minutes of a play intervention, consisting of virtual reality gaming, five days per week. Play was in a small-group setting that included no more than four patients. A historical comparison group was used in the study. Study measures were obtained at hospital admission and at day 7.

• The study reported on a sample of 122 pediatric patients.
• Patient age range was 8–16 years.
• The sample was 53% male and 47% female.
• Most patients had leukemia or lymphoma and were undergoing inpatient treatment.
• At baseline, patients had high anxiety and depression scores.

• Single site
• Inpatient setting
• China

• Phase of care: active antitumor treatment
• Clinical application: pediatrics

 Prospective, single-blind trial with historical control comparison

• State-Trait Anxiety Inventory for Children
• Center for Epidemiological Studies Depression Scale for Children

ANOVA showed a main effect for time, suggesting significantly lower anxiety and depression symptoms in the group that participated in the play intervention. There were no significant differences in baseline scores between groups. In both groups, anxiety scores declined between baseline and day 7.

Play involving virtual reality may reduce symptoms of depression in children hospitalized for cancer treatment.

• The study had risk of bias due to no random assignment and no appropriate attentional control condition.
• Several age groups were involved. The study did not include subgroup analysis, to see if effects varied in different age and education groups.

Findings suggest that use of virtual reality play may help pediatric inpatients being treated for cancer. Further well-designed research in this area is warranted. It is unclear if virtual reality is more effective than other means of distraction.

To compare absolute neutrophil count (ANC) and febrile neutropenia (FN) in patients who receive pegfilgrastim on the same day of chemotherapy versus the next day

Data from a prior randomized, controlled trial was pooled for analysis. The trajectory of ANC and incidence of FN and related events were analyzed.

• N = 192   
• MEAN AGE = 58.9 years (SD = 12.7)
• MALES: 32.3%, FEMALES: 67.7%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Multiple tumor types—most were breast, lung, and non-Hodgkin lymphoma
• OTHER KEY SAMPLE CHARACTERISTICS: Sixty-two percent were at intermediate FN risk, and 38% were at high risk.

• SITE: Multi-site   
• SETTING TYPE: Not specified    
• LOCATION: United States

• PHASE OF CARE: Active antitumor treatment

• Secondary analysis of four phase-II, randomized, controlled trials

• Grade 3–4 FN defined at body temperature greater than or equal to 38.2 degrees Celsius, infection-related hospitalization, or infection related adverse event occurring within one day of grade 3–4 neutropenia
• Common Terminology Criteria for Adverse Events (CTCAE) for neutropenia grade

ANC at nadir was significantly lower in those who received same-day pegfilgrastim (p = 0.003). Time to nadir was slightly lower in those with same-day pegfilgrastim (p = 0.019). ANC at nadir was much lower among those who got same-day treatment (0.27 compared to 0.74 x 10⁹/l, p < 0.001).  Risk of grade 4 neutropenia was higher among those who got same-day treatment (odds ratio [OR] = 0.23, 95% CI [0.1, 0.49]). No significant difference existed between groups in incidence of FN as defined for this pooled analysis; however, the actual incidence was lower among those who received next-day treatment. ANC recovery was faster in those who received next-day pegfilgrastim.

Patients who received pegfilgrastim the day after chemotherapy had less severe ANC suppression and more rapid ANC recovery. No clear differences in incidence of FN were reported.

Initial trials were not designed to capture the incidence of FN and infections, so pooled analysis capability was limited.

This study adds to the body of evidence supporting the administration of pegfilgrastim as recommended, one to three days after chemotherapy.

• Median injections per patient: 4 (1–14) greater than 100K
• If TBI, leuprorelin stopped two months after irradiation
• Leuprorelin 3.75 mg subcutaneous every 28 days (except second administration at 21 days) until finishing chemotherapy and stable platelet count
• Nomegestrol acetate 10 mg days 1–35 and then as needed and combined with leuprorelin in the case of moderate or heavy bleeding  
• Six of 20 received oral contraceptives.
• Four received progestin only; two out of four of these were amenorrheic.

• N = 21 patients enrolled (one not eligible)
• AGE = 16–50 years
• MEDIAN AGE = 33 years
• WOMEN: 100%
• KEY DISEASE CHARACTERISTICS: Leukemia, Hodgkin disease, nonHodgkin lymphoma, or multiple myeloma with or without transplant
• OTHER KEY SAMPLE CHARACTERISTICS: Women undergoing myelosuppressive therapy with platelet nadir expected to be less than 100K. Platelet nadir was less than 20K in 17 patients.

• Efficacy was assessed clinically.
• Failure was defined by the occurrence of bleeding.
• Hormonal efficacy was checked by plasma assay of estradiol, follicle-stimulating hormone, and luteinizing hormone.
   

Nineteen bleeding episodes occurred in 11 patients. Three patients required additional treatment, including additional nomegestrol acetate, methylergometrine, and/or platelet transfusions. Eleven episodes of spotting and six episodes of moderate bleeding not requiring treatment occurred in 10 patients. The majority of bleeding episodes were short with a median of three days (1–23). Seventeen patients had no clinically or therapeutically relevant bleeding. There was no premature termination because of toxicity. There was one subcutaneous nodule at injection site and eight superficial hematomas.

• Seven of 21 patients were terminated early because of TBI (patients without vaginal bleeding) or patient death because of disease progression (3 of 20 patients); one patient of 20 was lost to follow-up.
• Small sample size completed treatment.
• No mention of controlling for comorbidities/other risk factors or actual nadir

To evaluate the efficacy and safety of palifermin in the reduction of oral mucositis (OM) associated with definitive chemoradiotherapy for locally advanced head and neck cancer (HNC)

• Patients were randomized to receive 180 mcg/kg palifermin or a matching IV placebo (consisting of sterile water, 4% mannitol, 2% sucrose, 10 mmol/L histadine, 0.010% polysorbate-20, pH 6.5, and no preservatives). Palifermin or placebo was administered as a bolus injection over 30–60 seconds in eight weekly doses, starting three days before initiation of radiation therapy (RT) and then once weekly after the week’s last RT treatment.
• Medications for mucositis and mouthwash solutions containing chlorhexidine, hydrogen peroxide, or diphenhydramine were not allowed.
• Hematopoietic growth factors were allowed only to manage severe anemia or myleosuppresion.

• The study reported on 188 patients with a mean age of 55.
• The study arm sample was 84% male and 16% female; the control arm was 85% male and 15% female.
• Patients were newly diagnosed with unresected stage III–IVB squamous cell carcinoma of the oral cavity, oropharynx, nasopharynx, hypopharynx, or larynx: no evidence of a secondary malignancy; and planned RT dose of more than 50 Gy to different subsites of the inspected oral cavity and oropahrynx.

The study was conducted in a multi-institutional setting.

Patients were undergoing the active treatment phase of care.

This was a randomized, placebo-controlled study.

• The World Health Organization (WHO) Oral Toxicity Scale was used for grading OM.
• Investigators were all trained uniformly, and the same investigators were asked to assess individual patients serially.    
• Patients reported mouth and throat soreness (MTS) scores with the Oral Mucositis Weekly Questionnaire-Head and Neck Cancer.
• Researchers recorded duration of severe OM, time to onset of severe OM, incidence of greater than or equal to 2 xerostomia at month 4, average MTS scores, opioid analgesic use, incidence of RT breaks of at least five consecutive fractions, and incidence of chemotherapy delays.

The incidence of severe OM was significantly lower in patients receiving palifermin than those receiving placebo (54% versus 69%). In the palifermin arm, the median time to severe OM was delayed, median duration of severe OM was shortened, and the incidence of xerostomia at grade 2 or more was lower, favoring palifermin; however, the differences were not significant after multiplicity adjustment.

Opioid analgesic use, average mouth and throat soreness scores, and chemoradiotherapy compliance were not significantly different between treatment arms.

Adverse events were similar between arms. The most common study drug related adverse events were rash, flushing, and dysgeusia. After median follow-up of 25.8 months, overall survival and progression-free survival were similar between the treatment arms.

There was no mention as to whether the study was blinded to the researchers.

Oral mucositis is a severe complication of treatment for head and neck cancer, and effective treatment strategies are still needed. Although palifermin reduced severe functional OM, its role in the management of locally advanced HNC during chemotherapy remains unclear. Effective treatment strategies to manage OM associated with high-dose chemoradiotherapy still are needed.

To test the feasibility of hypnosis as a preoperative intervention; to explore the effects of preoperative hypnosis on anxiety and pain

Investigators gathered baseline assessments of pain, nausea, vomiting, distress, and anxiety. The hypnosis intervention was a 15-minute scripted hypnotic experience provided, within an hour before surgery, in the preoperative holding area of the operating suite. Investigators collected data and interviewed patients postsurgery. Data pertaining to historical controls were obtained from medical records matched for age, date, and type of procedure.

• The sample was composed of 20 patients.
• The age range of patients was 30–79 years. Authors did not report mean patient age.
• All the patients were female.
• All the patients had breast cancer and were undergoing surgical procedures. Authors do not cite specific procedures.
• Of all patients, 65% were married or partnered and 65% were Caucasian.
• Of all participants, 90% reported previous experience with mind-body techniques: 90% had used prayer, 45% had used deep breathing, and 40% had used relaxation.

• Single site
• California, United States

Active treatment

Prospective pre- and postdesign with historical control comparisons; mixed method

• MD Anderson Symptoms Inventory, condensed and modified
• Measures of physical symptoms
• Assessment of personal preference (Authors developed this assessment to allow a patient to show intervention preference, on a continuum of imagery-hypnosis and other preferences.)

Postintervention measures showed a decrease in anxiety, worry, and nervousness; however, authors did not report significant pre- and poststudy differences. The hypnosis group had a higher prevalence of postoperative pain and nausea than did the historical group.

Providing a hypnosis intervention preoperatively appears to be feasible. Results reported do not provide substantial evidence of the efficacy of hypnosis in preventing postoperative pain and nausea.

• The study had a small sample size, with fewer than 30 participants.
• The study had a risk of bias due to no appropriate prospective control and no blinding.
• Authors did not list the procedures that participants underwent.
• Authors did not describe the timing of postintervention measurement or the method of extracting measurements from medical records.

This study suggests that providing a hypnosis intervention preoperatively can be feasible. The impact of such an intervention cannot be determined from this study.

To evaluate the effects of aluminum- and nonaluminum-containing deodorants

Patients were randomly assigned to use (a) just soap and water, (b) nonaluminum-containing deodorant and soap and water, or (c) aluminum-containing deodorant and soap and water. Low irritant soap was provided to study participants for use, as were both deodorants. The axilla of the breast or chest wall undergoing radiation was assessed weekly. One month after completion of treatment, patients were interviewed to assess their compliance with the treatment assignment.

• N = 285
• MEAN AGE = 55.67 years
• AGE RANGE = 31–88
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All had breast cancer.
• OTHER KEY SAMPLE CHARACTERISTICS: A little more than one-third were obese with a high body mass index. The majority received at least 50 Gy in 25–28 fractions.

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

PHASE OF CARE: Active antitumor treatment

Randomized, controlled, three-arm trial

• Radiation Therapy Oncology Group (RTOG) skin toxicity scale
• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLC-30)
• Hyperhidrosis Disease Severity Scale (HDSS) for underarm sweating
• Visual analog scale (VAS) for assessment of itch, pain, and burning sensation

There were no skin toxicities at two weeks, and at four weeks, less than 5% in all groups had at least grade 2 skin toxicity. At seven weeks, 66.7% of 12 remaining aluminum-containing users, 80% of the remaining 10 nonaluminum-containing deodorant users, and 58.8% of the 17 remaining controls had at least grade 2 toxicity. There was no statistically significant difference in axillary skin toxicity associated with study group, and there were no significant differences among groups in pain, itch, or burning sensation.

This study found no evidence that aluminum- or nonaluminum-containing deodorant use had an adverse effect on axillary skin toxicity during radiation therapy.

• Unintended interventions or applicable interventions not described that would influence results
• Subject withdrawals ≥ 10%
• On follow-up evaluation for compliance, it was found that many patients also used sorbolene cream during treatment.
• One specific brand of deodorant and soap were used, so results may not apply to all available brands.

This study demonstrated that the use of deodorants, including aluminum-containing deodorant, did not adversely effect skin reactions during radiation therapy for breast cancer. Nurses can educate patients that they do not need to avoid using such deodorants during radiation therapy.

The Enhancing Connections program is a five-session multicomponent cognitive behavioral educational counseling intervention delivered at two-week intervals. Each session is scripted and lasts one hour. Components include home-based interactive didactics for mothers, experiential exercises, skilled efficacy-enhancing rehearsals led by a patient educator, mother-child booklets about cancer, mother-child workbooks, and between-session telephone access to a patient educator.

13 mothers with stage 0, I, and II breast cancer and 13 school-age children

Pacific Northwest of the United States

Single-group pre- and post-test design

Maternal measures: Center for Epidemiological Studies Depression Scale, State-Trait Anxiety Inventory Form Y, and Cancer Self-Efficacy Scale.

Mother-child measures: Relatedness Scale and Family-Peer Relationship Scale.

Child measures: Illness-related Pressures Scale, Cancer-Worries Scale, Disenfranchised Grief Scale, Revised Child Manifest Anxiety Scale, Child’s Depression Inventory, and the Child Behavior Problem Checklist.

The program resulted in significant improvements between baseline and post-test in mother’s depressed mood, state anxiety, and self-efficacy in regard to caring for self and family and dealing with the impact of cancer. For children, the program resulted in significant improvements in behavior and emotional functioning, in anxiety or depressed mood, and in reduction of cancer worries.

Evidence suggests that the Enhancing Connections program helped mother and children improve functioning.

• Single-group design with very small sample.
• Results do not generalize to mother-child dyads involving children with clinically elevated anxiety or symptoms of depression or to mother-child dyads in which the mother-child relationship is poor. Results should be viewed with caution.

To enhance spouses’ skills and confidence in communicating and interpersonally supporting their wives with breast cancer

To improve spouses’ self-care, depressed mood, anxiety, and marital adjustment

Baseline measures of the six study scales were obtained: depression, spouse skills, anxiety, self-efficacy of spouse, marital quality, and interpersonal sensitivity and mutuality. Five one-hour sessions were scheduled and delivered at two-week intervals. Details of the fully scripted educational counseling intervention session were described, and content was presented in a tabular format. Homework for each participant to complete with his wife was assigned to build skills and enhance efficacy. An exit interview with each participant and his wife was conducted. Post-test measures were taken.

• The sample (N = 40) was comprised of 20 wives with breast cancer and 20 male spouses. A total of 26 spouses consented and completed baseline inventories, after which 6 spouses dropped out of the study. A total of 20 spouses completed the intervention program and study post-test measures.
• Mean age of spouses was 53 years (SD = 9.5); mean age of wives was 48 years (SD = 8.6).
• Of the 20 wives, 19 were Caucasian and one was Black.
• Of the 20 spouses, 18 were Caucasian, one was Asian, and one declined to specify ethnicity.
• Wives were diagnosed with local or regional breast cancer (stages 0–III) within the past six months and had been diagnosed an average of 4.1 months at the beginning of the study (median time since diagnosis of 4.2 months).
• Ten wives (50%) were receiving chemotherapy, radiation therapy, or both at the time the spouses were participating in the study. Types of treatment received were breast-conserving surgery (55%) and surgical (45%), such as partial, radical, or prophylactic mastectomy.
• Of the sample, 80% of spouses and 85% of wives had college degrees or higher, and 85% of spouses and 70% of wives worked full- or part-time.
• The average length of marriage was 17.1 years (SD = 10.7), with a median of 14.8 years.
• Half (50%) of the couples had one child or more living at home.

• Multisite
• Outpatient setting
• Pacific Northwest: One-hour counseling intervention sessions were scheduled and delivered at two-week intervals in a private clinic room.

A pre/post-test pilot study design was used.

• Spouse Skills Checklist: This 11-item checklist was developed for the study and included two parts: a 5-item wife support subscale and a 6-item self-care stress management report.
• Center for Epidemiologic Studies–Depression (CES-D) Scale: This is a 20-item self-report of symptoms, with a score of 16 or higher indicating need of referral for clinical evaluation of depression. Significant (p = 0.001) reduction in depressive symptoms was reported.
• Spielberger State-Trait Anxiety (STAI-Y) Scale: Significant (p < 0.001) anxiety reduction was reported.
• Cancer Self-Efficacy Scale–Spouse (CASE-S): Total scale (19-item self-report) spouse skills significantly (p < 0.001) improved. Subscale improvements were also reported.
• Dyadic Adjustment Scale (DAS): Four subscales measured affectional expression, consensus, cohesion, and satisfaction. There was significant (p = 0.028) improvement on affectional expression, but was not significant on the remaining subscales.
• Mutuality and Interpersonal Sensitivity Scale (MIS): There were no significant changes in this 32-item measure of cancer-specific marital quality.

Depressed mood and anxiety were significantly (p = 0.001 and p < 0.001, respectively) diminished; self-efficacy was significantly improved; spousal skills were significantly (p < 0.001) improved; and marital quality was significantly (p = 0.028) improved but only on one of the affectional expression subscales. There was no significant improvement on the other subscales of marital quality. There were no significant changes in the cancer-specific measure of marital quality. Spouses verbalized that the educational counseling intervention was helpful, specifically for listening skills.

A brief, structured, skill-focused, efficacy-enhancing educational counseling intervention has the potential to positively affect spouses’ adjustment (mood and anxiety), skills, self-efficacy, and self-care during the diagnosis and treatment phase of their wife’s breast cancer. The program focuses the intervention on the spouse to reduce tension and improve interpersonal communication regarding the wife’s diagnosis, treatment, feelings, and associated emotions.

• The sample was small (< 30).
• The stated purpose and goals of the study and intervention did not specify the impact on the wives of participants, yet the wife of each participant was included in the exit interview. Wives’ opinions and responses were not included at the beginning of the study, so there was no baseline for comparison of their responses.
• The sample was primarily white people with relatively long marriages.
• Whether the exit interviews were conducted before or after the post-test measurements is not entirely clear.

The Helping Her Heal program offers promise to assist with building coping skills and support strategies for couples by educational counseling intervention among spouses of people with breast cancer and other chronic conditions.

To determine the extent to which protein meals along with ginger, when used as adjuvant therapies for standard antiemetic treatment, reduce delayed nausea

Patients were assigned randomly to 1 of 3 experimental groups. The Protein (P) and High Protein (HP) Groups received test meals of varying protein content and dried powdered ginger root in addition to standard antiemetic medication; the Control Group received only standard antiemetic medication.

The P and HP Groups were asked to consume two test meals daily for three days beginning 24 hours after their first chemotherapy session. Patients in the Control Group consumed their normal diet.

Patients completed daily diaries during the three-day study. Investigators called patients daily to monitor for adverse events, answer questions, remind patients to eat the test meals, and remind them to complete diaries.

• The study consisted of 28 participants.
• Patient ages ranged from 29–83 years with a mean of 54.3 years.
• The majority of patients were female (75%).
• Cancer diagnoses were breast, Hodgkin and non-Hodgkin lymphoma, bladder, lung, gastric, and prostate.
• Patients were treated with 13 different chemotherapy regimens using six different types of antiemetics.
• Patients were receiving their first chemotherapy treatment with moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC).

The setting was not reported.

All patients were in active treatment.

This was a randomized controlled trial, non-blinded study.

An Electrogastrogram Symptom Diary was used to report nausea symptoms incidence, frequency, and intensity. Patients also recorded use of as-needed antiemetics.

• Reports of nausea, frequent nausea, and bothersome nausea were significantly less common (p < 0.01) among the HP Group patients than among the Control and P Group patients.
• Significantly fewer patients in the HP Group used antiemetic medication (p < 0.05). The differences between the P and Control groups were not statistically significant.
• In the five patients who had tests of gastric myeoelectrical activity performed, a significant decrease in gastric dysrhythmia occurred after ingestion of the protein and ginger (p <  0.05).

High-protein meals with ginger reduced delayed nausea associated with chemotherapy and use of antiemetic medications.

• The sample size was small.
• A standardized measurement tool for report of nausea was not used.
• Conclusions cannot be drawn on the role of ginger in reducing nausea because of possible interactions between ginger and high doses of protein.
• Samples were widely variable in terms of cancer types, cytotoxic agents, and prescribed antiemetic medications.
• The study lacked an adequate control group for the ginger component of the test meals and a placebo meal that contained neither ginger nor protein.
• Daily phone calls to patients from investigators may have skewed results.

The limitations of this study limit the ability to draw conclusions for nursing practice.

• Cognitive therapy
  • Baseline phase no intervention
  • Weeks 3–8, patients completed daily mood diary
  • Hospital Anxiety and Depression Scale (HADS) weekly
  • Once eight weekly sessions of cognitive therapy were completed, daily mood diary and HADs weekly

• N = 6 (3 completed)
• AGE = 42–66 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Stage IV metastatic breast cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Beck Depression Inventory (BDI) score of 17 or more or HADS score of 7 or more; at end of life but with more than two months expected to live

• PHASE OF CARE: End of life

• Single-case experimental design to show efficacy or no efficacy of cognitive therapy for depression in women with metastatic cancer

• Fatigue is associated with depression, but which scale was used is not spelled out.

A statistically significant improvement in fatigue level was seen.

• Study not representative
• Excessive withdrawals
• A lot of written scales to give someone to complete at end of life
• Resident in psychiatry was independent psych evaluator; licensed therapists to conduct intervention