Nevasic, a medical device, is an audio program that generates an antiemetic reaction. Nevasic is thought to work by emitting specific constructed tones, frequencies, and pulses that disrupt the normal auditory signal chain at the vestibular level, affecting the experience of nausea and vomiting.

This study was a pilot, multicenter, randomized, controlled trial with three parallel arms (intervention, attention, and control) in Mashhad, Iran. After randomization, all participants were given the treatment progression questionnaire. Those in the intervention and attention groups also were issued a CD player and headphones with the Nevasic program or music files. Patients could keep the equipment at the end of the study. The procedure for the intervention and attention groups were identical except that those in the Nevasic intervention group listened to the active intervention of Nevasic, and those in the attention group listened to preselected music. Participants were given clear instructions on the use of the Nevasic program or the music, which included: only listening through the headphones provided; listening to Nevasic or the music immediately once they started feeling nauseous or vomiting during or after chemotherapy administration; listening to the Nevasic or music program all the way through the 27 minutes or till they felt symptoms diminished; and not skipping any part of the Nevasic or music program. They were instructed to repeat these stages if their symptoms returned. The duration of the intervention or attention was six days. Participants in all three groups were told to take their antiemetics after chemotherapy as prescribed. The participants were instructed in the completion of the measures and follow-up questionnaire. They were asked to return the measures and questionnaires using prepaid, selfaddressed envelopes.

• N = 99 (Nevasic Arm: 34, Music Arm: 32, Control Arm; 33)  
• MEAN AGE RANGE = 46–51 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast cancer

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

• PHASE OF CARE: Active antitumor treatment

Pilot, multicenter, randomized, controlled trial with three parallel arms (intervention, attention, and control)

• The frequency and duration of nausea and the amount of vomiting was measured using the translated (Persian) version of Rhodes Index of Nausea, Vomiting, and Retching (INVR).
• Health-related quality of life (HR-QOL) was measured with the validated Iranian version of the European Organization Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and EORTC QLQ-BR23 (Safaee and Dehkordi, 2007).

Based on these study results, Nevasic is not an effective treatment in the management of CINV. The researchers stated that the findings from the trial highlight the need for several modifications to the design and the mode of intervention delivery.

• Small sample (< 100)
• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Other limitations/explanation: First, this feasibility trial was not powered to detect statistically significant differences between groups. Second, no blinding was used for this study, and participants were aware of which arm they were in.

Based on these study results, Nevasic is not an effective nonpharmacologic treatment technique to control or manage CINV.

To determine the proportion of women who experience significant treatment-induced peripheral neuropathy

Women with gynecologic cancer received combination chemotherapy consisting of cisplatin and paclitaxel via IV 175 mg/m² over three hours, followed by amifostine 740 mg/m² and cisplatin 75 mg/m² administered over 90 minutes beginning 15 minutes after amifostine administration.

• N = 29 enrolled in this limited-access study; 21 completed all six cycles of therapy plus the three-month evaluations
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Women with ovarian, primary peritoneal, fallopian tube, endometrial, cervical, or uterine sarcoma
• OTHER KEY SAMPLE CHARACTERISTICS: Proposed treatment included both cisplatin and paclitaxel chemotherapy.
• EXCLUSION CRITERIA: Prior chemotherapy or radiation or history of neuropathy

• Phase II study

• Measures were done at baseline, before each chemotherapy cycle, and three months after completion of treatment.
• Chemotherapy-induced peripheral neuropathy (CIPN) was measured using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) toxicity scale, neurotoxicity subscale of the Functional Assessment of Cancer Therapy and Gynecologic Oncology Group, and vibration perception threshold (VPT) testing using the Vibratron II device.

Four of 27 assessable patients experienced dose-limiting toxicity grade 2 or higher CIPN as measured by clinical assessment and NCI CTCAE grading. The number of neuropathic events exceeded the predetermined threshold level for a second stage of accrual and the study was closed.

Amifostine’s level of activity was insufficient to warrant further study in a phase III trial.

• The study contained a relatively small sample size (n = 29) and used a one-group design.
• Frequent evaluations of CIPN were performed by different professionals, but a detection bias may have been present.
• Although VPT testing is considered to be the gold standard, it can be inaccurate if the same digits are not used at each assessment.
• Low inter-observer agreement (46%) was found using the NCI CTCAE.

The researchers' aim was to determine the proportion of women who experience significant treatment-induced peripheral neuropathy.

Women with gynecologic cancer received combination chemotherapy consisting of cisplatin and paclitaxel via IV 175 mg/m² over three hours followed by amifostine 740 mg/m² and cisplatin 75 mg/m² administered over 90 minutes beginning 15 minutes after amifostine administration.

Twenty-nine women enrolled in the limited-access study and 21 completed all six cycles of therapy plus the three-month evaluations. The eligibility criteria for this phase II study included having ovarian cancer and primary peritoneal, fallopian tube, endometrial, cervical, or uterine sarcoma. Exclusion criteria include prior chemotherapy or radiation therapy and having a history of neuropathy.

Measures were conducted at baseline, before each chemotherapy cycle, and three months after completion of treatment. Chemotherapy-induced peripheral neuropathy (CIPN) was measured using the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) toxicity scale, the neurotoxicity subscale of the Functional Assessment of Cancer Therapy–Gynecologic Oncology Group (FACT-GOG), and vibration perception threshold (VPT) was tested using the Vibratron II device.

Four of the 27 assessable patients experienced dose-limiting toxicity (greater than grade 2 CIPN) as measured by clinical assessment and the NCI-CTCAE. The number of neuropathic events exceeded the predetermined threshold level for a second stage of accrual and the study was closed. The level of activity for amifostine was insufficient to warrant additional study in a phase III trial.

The study contained a relatively small sample size (29 participants) and used a one-group design. Frequent evaluations of CIPN were performed by different professionals, but a detection bias may have been present. Although VPT testing is considered to be the gold standard, it can be inaccurate if the same digits are not used at each assessment. Low interobserver agreement (46%) was found using the NCI-CTCAE.

STUDY PURPOSE: To examine the effect of a variety of supportive care measures on quality of life (QOL), depression, anxiety, coping skills, and self-efficacy among men with prostate cancer in various states of care. (Note: Many more outcomes were reported among studies, but the four above were the most frequent.)

TYPE OF STUDY: Systematic review

• FINAL NUMBER STUDIES INCLUDED = 26  
• TOTAL PATIENTS INCLUDED IN REVIEW = 2,740 participants
• SAMPLE RANGE ACROSS STUDIES: Less than 50 to over 200. Seven were pilot studies. 
• KEY SAMPLE CHARACTERISTICS: Twenty studies were based in the USA (most were government-funded or national research groups), two were based in Canada (similar funding as in USA), and others were based in Ireland, Sweden, or Hong Kong. Other funding sources were public, private, or not described. Seven studies were rated at high risk for bias. One study included patients with breast cancer and prostate cancer in the power calculation. Control group designation, services, or support were inconsistently described across trials.

PHASE OF CARE: Multiple phases of care
 
APPLICATIONS: Elder care

Most trials reported no effect of supportive care measures on the stated outcome variables. The findings indicated appropriate interventions and outcomes measures, but small samples with insufficient power contributed to lack of evidence for improvements. Recommendations included resources to support the design, conduct of trials, and reporting (CONSORT guidelines) improvements. Also included were recommendations to diversify sampling across sociodemographic profiles to include unpartnered men who may be less likely to have a social support network, address all stages of care, provide clear descriptions of usual care and control group activities, and use reliable and valid outcome measures.

• Mostly low quality/high risk of bias studies
• Minimal confidence can be put in the study findings as a result of the design and analysis limitations.

The value of this systematic review is that supportive care probably works, but the evidence is lacking because of inconsistencies in study design and reporting. Clear, perhaps standardized, descriptions of the broad variety of interventions called \"supportive care\" are needed. Comparative information was not available across more than two to six trials of a particular intervention. The effect of supportive care in patients with prostate cancer can be examined by creating studies that have strong design quality and methodology. The authors’ provide important recommendations for study areas to be addressed so that results are comparable. One finding is seldom sufficient to change or influence practice.

Two studies evaluated patient anxiety using the Spielberger State-Trait Anxiety Inventory. Anxiety declined in both study groups, but the reduction in anxiety was significantly greater in the control group (n = 169, SMD = .4, p = .02). Other results of training explored were sensitivity of communications, display of empathy, patient trust, quality of life, and patient recall of information, distress, and satisfaction. One study showed no impact on patient depression.

Provider communication skill training was not shown to have a positive effect on patients' level of anxiety or depression. Physician training was more likely to result in communications showing empathy.

Type, duration, and timing of training interventions were very diverse, making the synthesis of findings difficult. Similarly, the timing of study follow-up assessments varied. For the individual outcomes examined, the number of available studies was small.

Communication skill training is likely to improve some communication skills of providers, but evidence regarding any impact of this on patient outcomes is lacking, and long-term effects are unknown. The most effective training method also is unclear. Given the current emphasis on shared decision-making and patient-centered care, the importance of provider communication and information-giving skills is evident. The content of training should be aimed at achieving these aspects and empowering patients. Further research is needed to determine the best approaches to achieve these goals.

The purpose of the study is to demonstrate a safe and feasible methodology to evaluate the infection rate in pediatric patients with cancer randomized to the neutropenic diet or the U.S. Food and Drug Administration (FDA)-approved food safety guidelines.

Pediatric patients (aged 1–21 years) undergoing myelosuppressive chemotherapy were randomized to receive a neutropenic diet or a diet based on the FDA food safety guidelines (emphasis on safe handling and cooking). Patients were enrolled during one cycle of chemotherapy.

Primary outcome was febrile neutropenia.  
Secondary outcome was adherence and diet tolerability.

• The sample size was 19.
• The two groups of participants were matched on all variables except history of febrile neutropenia.

Two hospitals in New York

Prospective, randomized, controlled pilot study

• Infection was measured with hospital admission data for febrile neutropenia.  
• Localized infection (along with an ANC less than 500 cells/mm³) also was included.  
• Dietary adherence measured by 24-hour diet recall.
• Student t test measured differences between the groups.

No statistically significant differences in infection was found between the two groups.  
Four patients on each arm developed febrile neutropenia.  
Adherence rate was 94% for neutropenic diet and 100% for FDA-approved food safety guidelines.

• Small sample size.  
• Difficulty adhering to the neutropenic diet was reported.  
• Adherence measured by 24-hour diet recall.

To evaluate changes in cerebral blood associated with a mindfulness-based art therapy program (employing functional magnetic resonance imaging) and correlate such changes to stress and anxiety in women with breast cancer

The Mindfulness-based Art Therapy (MBAT) intervention arm consisted of the basic mindfulness-based stress reduction (MBSR) curriculum paired with expressive art tasks. The design of MBAT was intended to provide opportunities for self-expression, facilitate coping strategies, and improve self-regulation. The MBSR aspect of the MBAT intervention provided standardized tools to help participants observe, assess, and negotiate their objective and subjective experiences of the illness process. A variety of mindfulness meditation techniques were taught during the eight-week program, including body scan, awareness of breathing, awareness of emotions, and mindful yoga, walking, eating, and listening.

• The study reported on 18 female patients with breast cancer.
• Mean patient age was 55 years (range = 45–67).
• Patients received their breast cancer diagnosis between 6 months and three years prior to enrollment and were not in active treatment.

• Urban setting
• Thomas Jefferson University, Philadelphia, PA

• Patients were not receiving active treatment.
• The study has clinical applicability for elder care and palliative care.

A randomized, qualitative study design was used.

Response to the program was evaluated using the Symptom Checklist-90 Revised (SCL-90-R) as a way to rate behavior. The SCL-90-R was obtained pre- and post-MBAT and within one week of the pre- and post-functional MRI scans. The SCL-90-R is a 90-item inventory that assesses nine symptom dimensions and a summary score, the Global Severity Index. Functional MRI scans were also obtained as a way to correlate scores on the SCL-90-R with results of the functional MRI.

Overall, the study showed significant differences in cerebral blood flow in the insula, caudate, and amygdala in patients who underwent an eight-week MBAT program. Given the improvements in anxiety levels (lower scores on the SCL-90-R), these findings suggest that at the level of these brain structures, the MBAT intervention may help to mediate emotional responses in women with breast cancer.

Women who used MBAT techniques had lower scores on the anxiety scale, and also a difference in cerebral blood flow in the insula, caudate, and amygdala regions shown through functional MRI studies. These areas have known correlations with stress and anxiety.

• The study had a small sample, with less than 30 participants.
• The study had risk of bias due to lack of blinding.
• Findings are not generalizable.
• The intervention was expensive, impractical, or required training needs.
• Functional MRI is prohibitively expensive and only available in university settings.

Brief guided imagery or simple meditation techniques could be employed by nurses to relieve patients’ stress and anxiety. Guiding patients toward reading about meditation and guided imagery and encouraging them to try these techniques on their own may also be useful.

To estimate the effectiveness of adjunctive presurgical hypnosis in the control of symptoms after surgery

• Databases searched were MEDLINE and PsycLIT.
• Search keywords were hypnosis or hypnotherapy and surgery or operation.
• Studies were included in the review if they
  • Included administration of hypnosis to at least one group undergoing surgery
  • Included a control or usual-care group
  • Provided statistical data that allowed calculation of effect sizes

Authors did not report

• Total literature evaluated
• Quality rating of studies described or apparently used in the analysis

• Authors analyzed 20 papers.
• The studies the papers described included 1,624 patients. Overall, sample size was 20–339 participants.
• Of the studies analyzed, two studies involved patients with cancer—one involved patients with head and neck cancer and the other involved women undergoing breast biopsy. These two studies involved a total of 52 patients.

Results demonstrated an effect size of D = 1.17 (95% CI 0.41–1.93) in favor of presurgical hypnosis as a means of decreasing pain severity. The effect size regarding impact on pain medication was D = 1.69 (95% CI 0.56–2.82). Results were similar whether hypnosis intervention was provided by tape or by means of a live session. Mean effect size, across several clinical outcome categories in studies involving cancer, was 0.63 in cases of head and neck cancer and 0.9 in cases of excisional breast biopsy.

This analysis demonstrated that adjunctive presurgical hypnosis helped control postoperative pain in the majority of patients undergoing various types of surgery.

• Only two of these studies related to patients with cancer. Both of these studies had small sample sizes.
• The majority of studies did not provide an attentional control condition.
• Authors provided no analysis of heterogeneity among the studies.

Findings suggest a positive effect of presurgical hypnosis, delivered by tape or in a live session, for the management of the postoperative pain of surgical patients. This report and findings are limited by lack of information about how pain was measured, failure to examine heterogeneity in pooled data, and lack of information about the timing of outcome measures. Findings are also limited by the lack of attentional control conditions in the majority of studies and the lack of randomization in more than half the studies. The sample spans about 40 years. This meta-analysis does not provide strong evidence for the use of presurgical hypnosis as a way to decrease the postsurgical pain of patients with cancer.

Both the hypnosis and attention control sessions were standardized and provided for patients individually by clinical psychologists. All four interventionists were PhD-level clinical psychologists trained in the use of hypnosis in medical settings. The hypnosis intervention was provided in a 15-minute session on the morning of surgery one hour before surgery. Sessions included a relaxation-based induction (including imagery for muscle relaxation), suggestions for relaxation and peace, specific symptom-focused suggestions, a deepening procedure, and instructions for how patients could use hypnosis on their own following the intervention session. Patients in the attention control condition spent identical amounts of time with the same interventionists that led the hypnosis intervention. Patients were allowed to direct the flow of the conversation, and therapists provided supportive/empathic comments according to standardized procedures. Patient outcome measures were evaluated before discharge on the same day of surgery. Interventions were based on previously published work.

• The sample included 200 patients with breast cancer (mean age = 48.5 years) scheduled to undergo excisional breast biopsy or lumpectomy. 
• The majority of patients were white (intervention group = 71%, control group = 55%), and about half were married (intervention group = 50%, control group = 45%).
• Patients in the hypnosis group received less intraoperative medications than patients in the control group. 
• Patients were not eligible if they were scheduled for mastectomy or lumpectomy with full axillary dissection or if they had any uncontrolled major comorbid mental or physical illness.

Patients were recruited from two Mount Sinai Medical Center surgical practices.

Patients were undergoing the active treatment phase of care.

The study was a randomized, controlled trial:

1. Hypnosis (n = 105)
2. Attention control (n = 95).

Visual analog scales (VASs)

A MANOVA showed an overall effect of the intervention on the six outcomes (as assessed by VASs), including patient-reported pain intensity, pain unpleasantness, nausea, fatigue, discomfort, and emotional upset (p < 0.0001). One-way ANOVAs of the effects of the intervention on VAS outcomes revealed that each outcome was statistically significantly lower in patients in the intervention group compared to those in the control group. In all cases, mean differences were clinically meaningful.

A cost-effectiveness analysis revealed that the intervention group had reduced costs compared to the patients in the attention control condition. These cost savings were primarily a result of reduced time in surgery in the hypnosis group.

• Patients were not blinded to group assignment because patients in the hypnosis group had to be aware and actively participate in the intervention.
• Formal assessment of the effectiveness of blinding research and clinical staff was not conducted.
• The study did not analyze the long-term effects of the intervention.

To test the effectiveness of a psychological intervention combining cognitive-behavioral therapy (CBT) and hypnosis (CBTH) to treat radiotherapy-related fatigue.

Forty-five patients were randomized to two groups:  CBTH and standard medical care. Weekly and daily fatigue were measured with two covariates:  neuroticism and history of chemotherapy. In the CBTH group, the patients participated in a 15-minute hypnosis session with guided imagery and suggestions for reduced fatigue and a sense of relaxation and energy. Patients were given a CD of the hypnosis intervention to listen to at home. The therapist provided a 30-minute CBT skills session, including how to recognize negative beliefs, consequences of those beliefs, how to change these, and how to practice behavioral strategies and exercise to manage treatment-related fatigue. The therapist reviewed information and progress with each patient twice weekly for a total of 12 sessions in 5- to 15-minute sessions.

• The sample was comprised of 42 patients (100% female). 
• Patients were older than 18 years.
• Mean age was 53.45 years (standard deviation [SD] = 10.43 years) for the CBTH group and 52.78 (SD = 11.65 years) for the control group.
• Patients had breast cancer stage 3 or lower.
• Karnofsky Performance Status (KPS) was 98.75 (SD = 3.19) in the CBTH group and 96.57 (SD = 7.45) in the control group.

• Type1
• Single site
• Urban radiation oncology clinic

The study was a randomized, clinical trial using a repeated measures design.

• Weekly fatigue was measured using the Functional Assessment of Chronic Illness Therapy (FACIT)–Fatigue Subscale (FS)
• Daily levels of fatigue were measured using a 100-mm visual analog scale (VAS). 
• Possible covariates were neuroticism, measured using the NEO-Five Factor Inventory Neuroticism Subscale (NEO-N) shortened form self-report questionnaire; the second covariate was history of chemotherapy, assessed via medical record review and scored as yes or no.

Among the control group, weekly FSs increased over time at a rate of 1.57 points/week (p < 0.001). Over the course of radiotherapy, individuals in the intervention group had little increase in FS fatigue (0.6 points/week) (p = 0.01).

An intervention combining CBT and hypnosis was effective for controlling fatigue in patients with breast cancer undergoing radiotherapy, independent of neuroticism or past chemotherapy.

• The study had a small sample size, with less than 100 patients.
• The study lacked a sufficient attentional control.

Replication of the intervention effects should be studied in a larger population with appropriate attentional control procedures.