To evaluate the effectiveness of topical lidocaine spray for pain relief during cervical punch biopsies and endocervical curettage (ECC)

Women with abnormal cervical cytology requiring colposcopy-directed cervical biopsy with or without ECC were randomly assigned to receive 10% lidocaine or normal saline spray to the ectocervix prior to colposcopy.

• N = 214   
• MEAN AGE = 24.25 years
• FEMALES: 100%
• CURRENT TREATMENT: Not applicable

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

• PHASE OF CARE: Diagnostic

• Double-blind, placebo-controlled, randomized, controlled trail

• Wong-Baker FACES Pain Rating Scale

No significant difference in pain scores between groups was reported.

The use of sprayed local anesthetic prior to colposcopic punch biopsy did not reduce procedure-related pain.

• Measurement/methods not well described
• Measurement validity/reliability questionable
• Exactly when pain was measured is unclear.
• No subgroup analysis between those who also had ECC and those who did not

The use of a topical anesthetic spray prior to colposcopic procedures as studied here did not demonstrate effectiveness in reducing postprocedure pain. Further research is needed to determine the best approaches to reduce or eliminate pain associated with this type of procedure.

The study was a randomized, controlled trial. The intervention was a “Bedside Wellness System” (BSW) that included:  a virtual world for 20 minutes, with three-dimensional sound, wide angle display screens, gentle breezes, aromatherapy, and synchronized foot movement devices. There were three scenes:  a lake, a forest, and a country town. The control group interviewed before chemotherapy and the end of the trial.

• The sample was comprised of 30 patients.
• Age ranged from 18 to 70 years. 
• Most patients were women.
• Patients had multiple types of cancer.

• Outpatient chemotherapy
• Tokyo, Japan

The study was a randomized, controlled trial with pre-/posttests and two trials; both groups were subdivided into depressed versus nondepressed.

• Cancer Fatigue Scale (developed by the institution) 
• Fatigue visual analog scale (VAS)

An insignificant effect on fatigue was found when comparing the pre-/posttests of the depressed and nondepressed subgroups in the control group, comparing between the trials, although the depressed control subgroup seemed to have greater fatigue after chemotherapy than the nondepressed subgroup. Statistical significance was found after the second test in the control group, and post second trial tests showed significance compared to the control; however, no significance was found when comparing the depressed versus nondepressed subgroups.

• Data/charts in the article do not support the conclusion of decreased fatigue, except for the control group.
• The study had a small sample size; it was limited to chemotherapy patients and was random but not diverse.
• The equipment was expensive and requires expertise in virtual reality distraction techniques.

The intervention consisted of a virtual reality immersion system and was a six- to seven-minute system trial that included:  a wide three-screen LCD with stereo sound, a walking system for bedridden patients, scent with gentle breeze, and a vital signs monitor. Three scenarios were used:  a typical park, a plateau, and a cherry blossom avenue in bloom.

• The sample was comprised of 22 female, bedridden patients.
• Age ranged from 33 to 75 years. 
• Patients had breast (n = 18) and ovarian (n = 4) cancers.
• Performance Status:  0–2. 

• Inpatient
• Japanese cancer center

This was a single-arm, pilot study.

The authors used their own fatigue scale (not described).

Of the patients, 16 were not fatigued, four were a little fatigued, one was fairly fatigued, and one had no answer.

Major

• Analyses were poorly described.

Minor

• How patients were chosen was not described.
• This was a pilot study.
• The equipment was very expensive.

To develop a new treatment using virtual reality technology as an intervention to decrease chemotherapy-related side effects in patients with cancer

Patients chose a preferred aromatic essential oil, sound system (headphone or speakers), and content. Three virtual worlds (lake, forest, and country town) were available, and each lasted about 20 minutes. The length of the intervention depended on the length of chemotherapy. If chemotherapy was long, patients could rest and restart the intervention.

• The study consisted of 30 patients (6 males and 24 females).
• The average age of participants was 53.5 years, with a range of 18–70 years.

The setting was an outpatient clinic at a national cancer center hospital in Japan.

The study had a randomized, controlled design.

The following scales were used.

• Hospital Anxiety and Depression Scale
• Cancer Fatigue Scale
• Face Visual Analogue Scale (VAS)

Emesis was measured using a VAS after the experience.

Fatigue and emesis scores showed a statistically significant decrease three to five days after chemotherapy (p < 0.05 for both symptoms). Carry-over effects were detected. Emesis was strongly related to psychological state. The intervention also was associated with decreased postinfusion emesis.

Virtual reality may be a new way to treat emesis.

• Nausea was not measured. Only the number of times a patient vomited was measured.
• The VAS was used postemesis as a measure of vomiting.
• The study did not use available tools to measure nausea, vomiting, and retching.
• The fatigue scale was developed by an institution.
• Motion sickness is a potential side effect when using virtual reality.
• The cost of the virtual reality system and setup must be considered.

To examine the efficacy of palonosetron, dexamethasone, and aprepitant to prevent chemotherapy-induced nausea and vomiting (CINV) in patients with gastric cancer receiving S-1 (oral 5-fluorouracil analog) and cisplatin

• Day 1: 125 mg aprepitant PO 60 minutes prior to chemotherapy, then 9.9 mg dexamethasone IV and 0.75 mg palonosetron IV 30 minutes prior to chemotherapy
• Days 2 and 3: 80 mg aprepitant PO QAM and 8 mg dexamethasone PO BID
• Day 4: 8 mg dexamethasone PO BID
• Throughout observation: Rescue antiemetic as needed
• Vomiting, retching, changes in dietary intake, and impact on quality of life were measured for 120 hours post administration of cisplatin.

• N = 72, 70 patients completed Functional Living Index-Emesis (FLIE) questionnaires   
• AGE = 50–81 years
• MEDIAN AGE = 65 years
• MALES: 80.6%, FEMALES: 19.4%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Gastric cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Sixty-five patients had received previous chemotherapy, and no patients had a history of CINV.

• SITE: Multi-site   
• SETTING TYPE: Multiple settings    
• LOCATION: Japan

• PHASE OF CARE: Active antitumor treatment

• This was a prospective, observational, noncomparative study.

Patients with gastric cancer who received S-1 and cisplatin tolerated palonosetron and dexamethasone. When compared to a previous study in a similar population who received aprepitant, granisetron, and dexamethasone, no significant differences existed in the CR rate, complete protection, dietary intake, or quality of life.

• Small sample (< 100)

The CR rate and complete protection were observed in the majority of patients with gastric cancer on S-1 and cisplatin who received antiemetic prophylaxis with palonosetron and dexamethasone. Although CINV did not significantly affect the quality of life in most patients, dietary intake decreased during the five-day observation time.

To evaluate the feasibility of a structured aerobic exercise intervention during treatment in a predominately Hispanic population of women.

A convenience sample of women who met the criteria at the time of their outpatient appointments were included. Patients were weighed and measured and completed tests regarding side effect burden and fatigue. Patients were given a sports outlet gift card for walking shoes and a six-month membership to the community health club. They were instructed to make an appointment with a physical therapist and a community health club for exercise. The research intervention was exercise three times a week for one hour with a goal to continue for six months. Exercises involved 10 minutes of warm-ups, 30 minutes of resistance training to improve muscle tone, 20 minutes of brisk walking to improve heart strength, and 10 minutes of cool-down. Assessments occurred at three and six months.

• Thirteen participants (all female) were included, although five did not go to a health club; only eight were available for a one-on-one interview.
• Age ranged from 40 to 63 years.
• Patients had first-time diagnoses of stage II breast cancer.
• Patients had undergone surgery and were either receiving chemotherapy or had completed chemotherapy in the past six months.
• Eight participants were on leave from work following surgery and during chemotherapy/radiation treatment.
• Of the participants, 73% experienced chemotherapy-induced menopause.
• All patients were Hispanic.

• Single site
• Cancer Center Therapy & Research Center, San Antonio, Texas

The study used a mixed qualitative and quantitative, repeated measure, quasiexperimental design.

• Side Effect Burden Scale
• Revised Piper Fatigue Scale (PFS)
• Five-minute walk test
• Strength and range of motion testing
• Penn Shoulder Score
• Hip and waist measurements
• Percent body fat and body mass index
• Pearson correlation coefficients (used in analysis)

Fatigue was significantly correlated with age (p = 0.05), fasting blood glucose (p = 0.05), and weight gain (p = 0.01). Mean weight gain was 15 lb. No changes were seen in fatigue. Qualitative analysis identified physical limitations, family responsibilities, lack of transportation, return to work, and lack of habit development as factors that influenced adherence to the exercise program. Sources of support for adherence included family, peers, employer, and health care providers. Several patients indicated that they preferred to exercise in an area that had only women. Self-report of exercise adherence was 66% at the first follow-up and 7% at the study conclusion.

Social, physical, and psychosocial factors influenced the women’s exercise adoptions. The provision of a gift card and recommendations did not have an effect on fatigue in these individuals.

• The study had a small sample size, with less than 30 participants.
• Observational data relied on recall.
• This was a Hispanic population, so specific qualitative findings may not be applicable to other cultural groups.

A structured exercise program appears to facilitate recovery from cancer. These Hispanic women had difficulty setting aside time to exercise. Support from health care providers was identified as a facilitator of adherence to exercise, suggesting that encouragement to exercise may be helpful. Concrete barriers, such as lack of transportation and dealing with family responsibilities, need to be addressed if patients are to be able to participate in exercise programs. Interventions need to fit lifestyle needs and preferences of the individual.

To determine if medical Qigong changed fatigue, depression, and sleep in patients with cancer and survivors

Participants were asked to review and complete a packet of information with instruments before their first class and after their last class. They were involved in a one and a half-hour class for five weeks that included the history of Qigong and movements for relaxation that they were encouraged to perform on their own.

• N = 22  
• MEAN AGE = 57.63 years (range = 36–75 years, SD = 11.3 years)
• MALES: Not provided, FEMALES: Mostly women
• KEY DISEASE CHARACTERISTICS: Patients with cancer and survivors undergoing active treatment or no treatment
• OTHER KEY SAMPLE CHARACTERISTICS: Aged greater than 18 years; spoke and read English

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

• PHASE OF CARE: Multiple phases of care
• APPLICATIONS: Palliative care 

Descriptive pre- and post-test design

• Brief Fatigue Inventory (BFI)
• Center for Epidemiologic Studies-Depression (CES-D)
• Pittsburgh Sleep Quality Index (PSQI)

Of the 38 participants, 38 completed the preintervention, 22 completed the postintervention, 16 did not attend the class, 15 completed the pre/post PSQI, and 19 completed the CES-D and BFI. There was a reduction in depression. The study found only CES-D scores to be improved postintervention, and all the scores were more favorable after the classes. Sleep scores were improved after classes.

This pilot study indicated a reduction in depression with the use of medical Qigong after five weeks. This is shorter than other studies in the literature that were performed over a 12-week period. The findings are limited by the small sample size.

• Small sample (< 30)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment) 
• Risk of bias (no appropriate attentional control condition)  
• Risk of bias (sample characteristics)
• Findings not generalizable
• Intervention expensive, impractical, or training needs
• Subject withdrawals ≥ 10%
• Other limitations/explanation: Sample characteristics not well described; five-week intervention compared to 12 weeks in the literature; number subjects not completing various aspects of the program was high; specific training for this type of intervention might be impractical if you do not have someone who is an expert in Qigong; most participants were active, were motivated to learn, were not receiving cancer treatment, and reported a positive outlook and adequate social support; depression and fatigue interventions would likely not be a priority for this group

Complementary and alternative medicine therapies are an alternative to offer patients for symptom management, especially to potentially help with depression. Nurses can educate patients about these types of alternatives to alleviate the symptoms of cancer treatment and its aftereffects. The findings of this study were limited by the sample size and high rate of patients who did not participate and did not show the effects of the intervention.

To evaluate the feasibility of acupuncture as a treatment for concurrent hot flashes (HFs) and sleep disturbances.

• This was an eight-week study using certified community acupuncture providers for three acupuncture treatments over a two-week period per patient.
• Wrist actigraphy and sternal skin conductance was used for measuring HF occurrence and duration.
• Completion of questionnaires was required at baseline and weeks 5 and 8.
• Self-reported symptom data were gathered during treatment and each week at follow-up.

• The sample was comprised of 10 female patients. 
• Patients were 18 years or older; mean age was 53 years.
• Patients had breast cancer stage 1; a possible other stage was not defined.
• Patients were perimenopausal/postmenopausal.
• Patients could not change sleep or HF medication during study.

Patients were included if they

• Reported sleep disturbances over the past month
• Had daily HFs
• Lived within a 100-mile radius of the study site
• Spoke English
• Were diagnosed with nonmetastatic breast cancer
• Had no history of other cancers
• Were at least three months postcompletion of surgery, radiotherapy, and chemotherapy.

• Multisite   
• Outpatient   
• University

• Patients were undergoing the transition phase after initial treatment.
• The study has clinical applicability for late effects and survivorship.

The study used a quasiexperimental, single-group, nonrandomized design.

• Protocol for acupuncture points
• Demographic questionnaire
• Disease and treatment information
• Acupuncture session notes
• 6-item Devilly and Borkovec Outcome/Expectancy Credibility Questionnaire (DBO/ECQ)
• Wrist Actigraphy and Sternal Skin Conductance Monitoring Biolog model 3991
• Sleep diary

Ten breast cancer survivors (BSCs) completed baseline, and two withdrew after the last baseline assessment. The remaining eight BSCs completed all time points. There was no significant difference among acupuncture points used per patient for the three treatments or the four providers. Sessions were mainly conducted at a single clinic. The study described patients as having high outcome expectations for acupuncture effectiveness and its acceptability. Sleep patterns were affected:  sleep latency increased and time spent awake after sleep onset decreased. The average number of HFs decreased.

Expectations for and credibility and acceptability of acupuncture in managing vasomotor and sleep symptoms were high for the BSCs.The study demonstrated minimal improvement in total sleep time and some sleep latency improvement immediately following completion of acupuncture sessions but not at week 8 (not a sustainable effect); waking after sleep onset improved.

• The study had a small sample size, with less than 30 patients.
• The majority of the patients enrolled were not taking a hormone modulator at the time of enrollment; therefore, the authors were unable to extrapolate the results found here to apply to BSCs using aromatase inhibitors or tamoxifen in treating their breast cancer.
• The number of acupuncture treatments was limited to three over two weeks.
• Reproducible results were limited because the study mainly occurred at one site with one acupuncturist.
• No control group was used for comparison to the intervention of acupuncture.

The study showed that women may be amenable, especially highly motivated women, to pursuing acupuncture as a nonpharmacological approach to managing HFs. Further investigations with larger sample sizes are needed to note if there are any correlations with socioeconomic/cultural influences for the acceptability of acupuncture and to compare acupuncture to another intervention for the control of HFs/sleep quality.

To evaluate the effect of low-level laser therapy (LLLT) on the severity of oral mucositis (OM) and the release of salivary molecules (TNF~a, IL-1b, IL6, IL10, TGF-b, EGF< FGF< VEGF< MMP2/TIMP2, and MMP9/TIMP2) during chemoradiation in patients with head and neck cancer

• N = 25  
• AGE = 10 were aged greater than 60 years, and 15 were aged less than 60 years
• MALES: 84%, FEMALES: 16%
• KEY DISEASE CHARACTERISTICS: Head and neck cancer (nine oral cavity, seven pharynx, and nine oropharynx)
• OTHER KEY SAMPLE CHARACTERISTICS: In the laser group, three patients died during the course of the study, two from pneumonia and one from hemorrhagic complications (not explained). In the control group, two patients dropped out of treatment. The sample started with 30 patients, and only 25 completed treatment.

• SITE: Single site  
• SETTING TYPE: Unknown
• LOCATION: Brazil

• PHASE OF CARE: Active treatment

Randomized, double-blinded, placebo-controlled clinical trial

• The severity of OM was rated according to the National Cancer Institute (NCI) and World Health Organization (WHO) mucositis grading scales.

LLLT reduced OM in the experimental group when compared to the control group. This study added to the growing body of literature demonstrating that LLLT is an effective intervention for OM in patients receiving treatment for cancer.

• Small sample (< 30)
• Key sample group differences that could influence results
• Other limitations/explanation: Six patients in the laser group had T3 or T4 disease while 10 patients in the control group had T3 or T4 disease. There was no mention of comorbid conditions such as diabetes, which might affect healing time and salivary concentrations. There were no limits on medications taken by the participants, which could have affected the outcomes.

Reducing OM can have a distinct impact on patients' quality of life, pain control, and ability to complete chemoradiation in a timely manner. Nurses have daily interactions with patients to assist them through the completion of therapy. This study contributed to the growing body of literature demonstrating that LLLT is an effective intervention for OM.

To compare stellate ganglion block and pregabalin in terms of efficacy and safety for the treatment of hot flashes in survivors of breast cancer

Patients were randomized to two groups. Stellate ganglion block at the anterolateral aspect of the C7 vertebra on the right side under fluoroscopy was done for 20 women experiencing hot flashes, and 20 other women received 75 mg pregabalin twice daily. Monthly symptom questionnaires were obtained at baseline and for the following three months.

• N = 40  
• MEAN AGE = 21 and older, with at least a six-month life expectancy
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Women with a diagnosis of breast cancer. All had received chemotherapy in the past. Subjects were not included in the study if they were currently receiving antineoplastic chemotherapy, androgens, estrogens, or progesterone analogs. The use of other agents for treating hot flashes, including vitamin E, antidepressants, or gabapentin, was not allowed prior to study initiation.
• OTHER KEY SAMPLE CHARACTERISTICS: Subjects experienced hot flashes for at least a month prior to study. They could receive tamoxifen, raloxifene, or aromatase inhibitors. No subject had a hysterectomy.

• SITE: Not stated/unknown    
• SETTING TYPE: Not specified    
• LOCATION: Not specified

• PHASE OF CARE: Late effects and survivorship

• Prospective single blind

All of the participants completed daily hot flash diaries that included four levels of severity of hot flashes (mild, moderate, severe, and very severe). The hot flash score was not selective to hot flashes at night or during the day; instead, it looked at the total number of hot flashes and their intensity during the 24-hour period. The side effects of pregabalin were assessed.

The stellate ganglion block group had a significant (p < 0.05) decline in the frequency of mild, moderate, and very severe levels and total hot flashes in comparison with the pregabalin 75 mg twice daily group during the three months of follow-up period.

During this study with a short follow-up of three months in a small group of subjects, stellate ganglion block had superior efficacy in the management of hot flashes in survivors of breast cancer.

• Small sample (less than 100)
• Measurement validity/reliability questionable 
• Findings not generalizable
• Intervention expensive, impractical, or training needs

Randomized trial exploring the effectiveness of stellate ganglion block and pregabalin suggests stellate ganglion is more effective in decreasing hot flashes. The sample size is small (n = 40); there is limited information about how the hot flash score was calculated.  Follow-up period was three months. More research on both interventions is needed.