Participants were randomly assigned to the intervention or control group. The intervention one was a closed, structured group that met weekly for 10 two-hour sessions. It included didactic material, experiential exercises, and homework assignments (practicing relaxation exercises) and focused on learning to cope better. The control group participants received a condensed version of the intervention during a five- to six-hour seminar; it provided information but lacked the therapeutic group environment and support. Participants were assessed initially, post-treatment, at three months, and at nine months. The study was advertised by letters and posters, and participants phoned for eligibility screening.

• N = 100
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Stage 0, I, or II breast cancer

• SITE: Multi-site
• LOCATION: Several hospitals and medical practices in Miami, FL

• Outcomes measured: Distress (mood disturbance, depressive symptoms, and thought intrusion and avoidance), perceptions of benefit from having breast cancer, and general optimism regarding the future
• Scales: Profile of Mood States (POMS), Center for Epidemiological Studies-Depression (CES-D), Impact of Events Scale (IES), Life Orientation Test-Revised (LOT-R), and a 17-item measure of perceived benefits

The intervention group showed reduced prevalence of moderate depression per the CES-D. The intervention also influenced two measures of positive well-being—increasing reports of experiencing benefit from having had breast cancer and increasing general optimism about the future.

An implication here is that it is important to collect information on positive experiences as well as negative. Responding to adversity presents an opportunity to experience growth and positive change.

Although this is a well-designed RCT, several flaws exist.

• The sample is made up of volunteers who were relatively educated, affluent, and motivated. Only 26% identified themselves as an ethnic minority.
• The participants had non-metastatic cancers and were free from physical and mental health comorbidities at the time of recruitment, so generalizability is constrained.
• The measure of benefit finding is new; more information is needed regarding its validity.
• Levels of distress reported in this sample were generally low.

• FINAL NUMBER STUDIES INCLUDED = 23
• TOTAL PATIENTS INCLUDED IN REVIEW = Not listed
• KEY SAMPLE CHARACTERISTICS: Pediatric patients receiving antiemetics for CINV

PHASE OF CARE: Active antitumor treatment
 
APPLICATIONS: Pediatrics

Based on published evidence, many pediatric patients may not be receiving appropriate antiemetic therapy. The patients who were most likely to not receive recommended antiemetic therapy were those receiving highly emetogenic chemotherapy, which put those patients at an increased risk for experiencing CINV.

This study took place in the United Kingdom, which may have different medication availability and prescription practices than other locations.

In the pediatric population, antiemetic prescription practices may not be in line with published evidence. Current best-practice sources should be consulted to ensure pediatric patients are adequately medicated to prevent CINV.

Patients in the study group received 300 mg/m² amifostine 15–30 minutes before radiation therapy (RT) on days 1–5 of each week. Patients in both the study group and the control group received 90 mg/m² carboplatin once per week before RT. Treating physicians and patients reported data.

• The study enrolled 50 patients. Of these, 45 were assessable (22 in the study group and 23 in the control group).
• More men than women participated.
• The mean age was 59 years with a  range of 45–74 years.

The study was conducted between January 1997 and January 1998.

The Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/EORTC) 0–4 grading system was used.

• Mucositis increased from baseline to grade 2 more rapidly in the control group by week 3.
• In the control group, 23 patients (100%) experienced grade 2 mucositis versus only two patients (91%) in the study group (p < 0.0001).
• Most patients receiving amifostine (77.2%) experienced mild mucositis (grade 2) versus only 21% in the control group (p = 0.0001).
• During week 5, 52% of patients in the control group had grade 4 mucositis versus 4.5% of patients in the study group (p = 0.0006).
• The majority of patients in the control group (95.7%) experienced moderate to severe mucositis versus 63.6% of patients in the study group (p = 0.0098).
• Incidence of side effects was low with nausea and vomiting (4.5%) and hypotension (13.6%) most common.

• The sample size was small, and the study was not blineded.
• Limited mucositis data were presented.

To evaluate the efficacy of adding powdered ginger to prevent chemotherapy-induced nausea and vomiting (CINV) in women with breast cancer receiving moderately emetogenic chemotherapy

Women with breast cancer were randomized to receive either 500 mg ginger or placebo twice a day for three days, during the course of three cycles of chemotherapy.

• N = 150 patients (450 chemotherapy cycles)  
• MEAN AGE = 48.6 years
• AGE RANGE = 25-79 years
• FEMALES: 100%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Breast cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Chemotherapy-naïve patients receiving at least three cycles of doxorubicin-based chemotherapy

• SITE: Single site   
• SETTING TYPE: Outpatient    
• LOCATION: Namazi Hospital in Iran

PHASE OF CARE: Active antitumor treatment

Double-blind, randomized, longitudinal

Not described; only states that participants were asked to “record the episodes of vomiting and nausea severity”

No significant difference in nausea or vomiting existed when comparing the ginger group to the placebo group.

The results of this study do not indicate that powdered ginger capsules (1 g daily) are effective in reducing CINV in women with breast cancer receiving chemotherapy.

Measurement/methods not well described

Powdered ginger capsules may not offer CINV relief for patients receiving chemotherapy.

To compare the efficacy between topical alpha ointment, which contains natural henna, and topical 1% hydrocortisone cream in the healing of radiation-induced dermatitis in patients with breast cancer

Patients in both arms were instructed to wash the area of the treatment field daily. The intervention included topical alpha ointment, which contains natural henna (i.e., Lawsonia inermis Linn), applied twice a day in a thin layer over the chest wall field commencing the last day of treatment and continuing for three weeks. The active control included topical 1% hydrocortisone cream applied twice a day in a thin layer over the chest wall field commencing the last day of treatment and continuing for three weeks. The patient’s dermatitis area was examined independently by two physician raters each week. The patient’s reported skin burning, pain, pruritus, and amount of discharge were recorded during the weekly physician visit. The primary endpoint of the study was speed measured in cm/week of dermatitis healing (i.e., complete reepithelialization of moist desquamation).

• N  = 60 (30 in each arm)    
• AGE = 28–81 years old in the alpha ointment arm; 25–72 years old in the hydrocortisone cream arm
• MALES: Not described, FEMALES: Not described
• KEY DISEASE CHARACTERISTICS: Newly pathologically proven, locally advanced breast cancer (treated with modified radical mastectomy, followed by sequential adjuvant chemotherapy and chest wall radiotherapy [45–50.4 Gy])
• OTHER KEY SAMPLE CHARACTERISTICS: Grade 2 and/or 3 radiation-induced dermatitis

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

• PHASE OF CARE: Transition phase after active treatment

• Open-label, randomly-assigned, actively-controlled phase II clinical trial of alpha ointment in the management of grade 2 or 3 radiodermatitis of the breast

• Skin toxicity: Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
• Cumulative radiation dose (Gy)
• Dermatitis area (cm²)
• Dermatitis healing (complete reepithelialization of moist desquamation)
• Healing rate (cm/week)
• Patient-reported “skin burning” (0 = no complaint, 1 = mild, 2 = moderate, 3 = severe)
• Patient-reported “pain” (0 = no complaint, 1 = mild, 2 = moderate, 3 = severe)
• Patient-reported “pruritus” (0 = no complaint, 1 = mild, 2 = moderate, 3 = severe)
• Patient-reported “amount of discharge” (0 = no complaint, 1 = mild, 2 = moderate, 3 = severe)

Originally, 63 patients were assessed for eligibility, and three were ineligible. Of the remaining 60 patients, with 30 in each arm, none were lost to follow-up. There was no statistically significant difference in mean age, dermatitis area, dermatitis grade, and total radiation dose between members of the two arms. The mean area of grade 2 and 3 radiodermatitis was significantly less in the alpha ointment arm (51.64 ± 59.04 cm²) as compared to the hydrocortisone arm (74.77 ± 71.20 cm², p = 0.007) during the second week but not at baseline, the first week, or the third week. There was no difference in patient-reported burning throughout the study. Alpha ointment significantly decreased patient-reported pain (p < 0.001), pruritus (p = 0.009), and the amount of discharge (p = 0.010) at three weeks as compared to hydrocortisone cream.

Alpha ointment significantly enhanced radiation dermatitis healing as compared to hydrocortisone cream. Alpha ointment also reduced patient-reported pain, pruritus, and the amount of discharge, but not skin burning.

• Small sample (< 100)
• Risk of bias (no blinding)
• Other limitations/explanation: The treatments were not blinded. However, one treatment was an ointment while the other was a cream. Did not control for breast size or smoking. Said that “sex” was a variable collected, but did not mention whether males were included in the study. “Sex” was not reported in any of the published statistical analyses. Two physician raters were used to determine the dermatitis area; however, the authors did not include an assessment of inter-rater reliability or how the “final” dermatitis area was determined.

Alpha ointment with an active ingredient of henna may be an effective treatment to manage grades 2 and 3 radiodermatitis. Additional studies are needed.

To compare the efficacy and safety of (arm 1) combined treatment with L-carnitine (4 g/day) plus celecoxib (300 mg/day) plus antioxidants (lipoic acid 600 mg/day, carbocysteine 2.7 g/day) plus megestrol acetate (MA) 320 mg/day versus (arm 2) MA 320 mg/day alone (considered standard of care) for the treatment of advanced neoplastic disease-associated symptoms in gynecologic patients with progressive or recurrent disease previously treated with one or more lines of chemotherapy

Primary endpoints included increase in lean body mass (LBM), decrease in resting energy expenditure (REE), decrease in fatigue, and an improvement in global quality of life (QOL). Secondary endpoints included appetite, grip strength, Glasgow Prognostic Score (GPS), Eastern Cooperative Oncology Group (ECOG) performance score, and serum markers of inflammation and oxidative stress: C-reactive protein (CRP), interleukin 6 (IL-6), tumor necrosis factor (TNF), leptin, reactive oxygen species (ROS), glutathione peroxidase (GPx), and superoxide dismutase (SOD). 

Baseline anthropometric measures, physical examination, vital signs, tumor site, stage, chemotherapy regimen, weight loss in previous three to six months, performance status, Glasgow Prognostic Score, and QOL were assessed. After baseline assessment, randomization was completed by a biostatistician to arm 1 or arm 2. Treatment duration was planned for four months. All patients received 150 UI/kg of low molecular weight heparin subcutaneously for the treatment duration. Endpoints were assessed at baseline (before treatment) and at 4, 8, and 16 weeks, although all analysis was presented as a comparison between baseline and 16 weeks. Safety was monitored with weekly evaluations of adverse events and toxicity. All patients also received psychosocial counseling.

• The study reported on 124 patients.
• Mean patient age was 60.5 years (SD = 12.74), with a range of 35–76 years.
• The sample was 100% female.
• Patients had histologically confirmed advanced-stage gynecologic tumors with progressive or recurrent disease after one or more lines of chemotherapy, loss of at least 5% of ideal or preillness body weight in the previous three months, and life expectancy of more than six months. Patients could be treated with concomitant antineoplastic chemotherapy with palliative intent (low-dose regimens). All had cancer of the endometrium, cervix, or ovary (mostly stage IV, with five patients having stage IIIC).
• Patients with mechanical obstruction, history of thromboembolism, cardiac disease, cerebrovascular events, inflammatory bowel disease, or gastrointestinal ulcers were excluded.

This multisite study was conducted in an inpatient setting in Italy.

• Patients were undergoing long-term follow-up care.
• The study has clinical applicability for end-of-life and palliative care, and late effects and survivorship.

This was an open-label, randomized, controlled, prospective study.

• LBM: dual-energy x-ray absorptiometry assessment    
• REE: indirect calorimetry  
• Fatigue: Multidimensional Fatigue Symptom Inventory–short form
• QOL: European Organization for Research and Cancer Core Quality of Life questionnaire (EORTC QLQ-C30, Italian version)
• Secondary endpoints: Grip strength: dynamometer; appetite: visual analog scale, performance status (ECOG scale), GPS, and serum markers for inflammation and oxidative stress: IL-6, TNF, CRP, leptin, ROS, GPx, and SOD

Groups were similar in patient characteristics. At 16 weeks, LBM increased significantly (p = 0.032) in arm 1 with a mean difference of +4.65 kg compared to arm 2. REE changes were decreased significantly in arm 1 (p = 0.046) compared to arm 2. Arm 1 had significant decreases in fatigue symptoms (p = 0.049) and a higher mean QOL score (p = 0.042) compared to arm 2. Arm 1 gained a significant amount of weight with a mean increase of 0.5 kg per week over 16 weeks (p = 0.002). REE and fatigue decreased in arm 1 significantly at 16 weeks but not in arm 2. Both arms had significantly increased appetite (p < 0.05) and decreased ECOG scores. There was no difference between groups in appetite. Serum markers for inflammation and oxidative stress decreased significantly in arm 1 at 16 weeks. No significant arm 2 findings resulted. Leptin increased significantly in arm 1 and moderately but nonsignificantly in arm 2. Two patients had grade 3 diarrhea in arm 1.

The multimodal arm (arm 1) had improved physical, inflammatory, oxidative stress markers and QOL compared to MA alone, but did not appear to make a difference in appetite.

• There are challenges to clinical application due to the complexity of symptoms and clinical management; which component of the multimodal arm 1 intervention had the effect is unclear.
• The sample included patients with gynecologic cancers only.
• Safety and toxicity were described and measured minimally. 
• Although the study reports significant improvements in fatigue and anorexia, there is no description of how these were measured.

Study findings support multimodal approaches, including psychosocial support, for symptom management. More work should include patient-reported outcomes, toxicity, and safety of the intervention.

To evaluate the feasibility and tolerability of prophylactic administration of a single, very high dose of liposomal amphotericin B (L-AmB) in adult patients newly diagnosed with acute myeloid leukemia (AML) and undergoing induction chemotherapy

The study was a pilot, phase II, single-center trial. The L-AmB was used to evaluate its efficacy and the level of toxicity. The study enrolled patients with AML undergoing first remission induction chemotherapy from January 2004–January 2011.

• N = 48      
• AGE = 32–78 years
• MALES: 61.7%
• KEY DISEASE CHARACTERISTICS: Induction chemotherapy; type of AML; toxicity level

• SITE: Not stated/unknown   
• SETTING TYPE: Inpatient   
• LOCATION: Not specific

• PHASE OF CARE: Transition phase after active treatment
• APPLICATIONS: Palliative care

• Phase II, single-center trial

• Common toxicity criteria (CTC)
• Pharmacokinetic study

Overall, 18 of the 48 (37.5 %) patients experienced at least one adverse effect (all CTC grade) after the first or second L-AmB, and only six of them (12.5%) reported CTC grade 3 adverse events related to L-AmB administration.

The study demonstrates the feasibility and safety of a single, very high dose of L-AmB as antifungal prophylaxis in patients with AML undergoing induction chemotherapy.

• Small sample (less than 100)
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Measurement/methods not well described
• Measurement validity/reliability questionable

This study basically determines the use of L-AmB to be used safely in patients with AML undergoing induction chemotherapy and does not have enough specification related to nursing.

To augment the literature on methadone applications in pediatric oncology

This was a retrospective review of all patients treated with methadone at St. Jude Children’s Research Hospital over a five-year period (October 2001–September 2006).

• N = 41
• AGE = 7 patients were younger than 10 years old, 16 patients were aged from 11–17 years, and 18 patients were aged 18 years or older.
• MALES: 58.5%, FEMALES: 41.5%
• KEY DISEASE CHARACTERISTICS: Leukemia/lymphoma (31.2%), solid tumor (56.1%), hematologic/congenital disorders (9.8%)

• SITE: Single setting
• SETTING TYPE: Three inpatient units, multiple outpatient units
• LOCATION: Tertiary cancer center

• PHASE OF CARE: End-of-life care
• APPLICATIONS: Palliative care

• Retrospective review of demographic characteristics, diagnoses, type of pain (i.e., nociceptive, neuropathic, mixed), causes of pain, and indications, dose regimens, adverse effects, and outcomes of methadone treatment

• Inpatients and outpatients who received methadone during the study period were identified by reviewing the institution’s pharmacy records. Data were abstracted from the medical records. Data included age, sex, primary oncology diagnosis, type of pain experienced (i.e., nociceptive, neuropathic, or mixed) at the time of methadone prescription, and the clinical context of pain (i.e., chemotherapy, bone marrow transplant, amputation, limb-sparing surgery, tumor,  other).
• The clinical uses of methadone also were ascertained from the medical records and were categorized as  nociceptive pain unresponsive to other opioids (33.3%), neuropathic pain (39.2%), facilitation of opioid weaning and prevention of withdrawal (21.6%), and pain management at the end of life (5.9%).
• Pain intensity scores were recorded at the beginning of treatment with methadone, at weekly intervals during the first month, and at monthly intervals thereafter for the duration of treatment or six months.
• Adverse effects of methadone were captured by review of the outpatient clinic notes or the inpatient nursing or physician notes. Sedation, nausea, constipation, confusion, respiratory depression, and pruritus were recorded as present or absent.
• A successful outcome was defined as a reduction of pain scores between the start and end of methadone treatment and/or documentation of the effectiveness of treatment for the specified indication.
• Age-appropriate pain assessment tools were used as per the institution’s pain standard of care—the Face, Legs, Activity, Cry, Consolability (FLACC) scale for children younger than 3 years, the Wong-Baker FACES Pain Rating Scale for children aged 4–6 years, and the numeric rating scale for children aged 7 years or older.

Methadone dosing data were available for 37 patients. Four patient records lacked baseline doses because methadone was initiated at another institution. Starting doses ranged from 0.06–3.8 mg/kg/d. The highest methadone dose was 9.4mg/kg/d. More than one-third of the patients (34.1%) had no documented adverse effects. The most common adverse effect was sedation (24.4%). No respiratory depression or pruritus were documented. Pain reduction was reported by comparing the maximum pain score on the day that methadone was discontinued to the maximum pain score on the day that methadone was initiated. Fourteen of the 41 patients had documented pain scores for both time points. Nine patients (64.3%) showed reduction of the pain score, and seven (50%) had complete resolution of pain.

Methadone was effective for pediatric patients with neuropathic pain or nociceptive pain unresponsive to other opioids, and it effectively prevented opioid withdrawal.

• Small sample size
• Retrospective design

Prospective studies are needed to evaluate specific methadone regimens for each of the clinical entities described and to determine opioid conversion scales to and from methadone in the pediatric population.

To assess the efficacy of mindfulness-based meditation therapy on the anxiety, depression, and spiritual well-being of Japanese patients undergoing anticancer treatment

Researchers used a modified version of the Mindfulness-Based Stress Reduction (MBSR) Program. The modification focused on cyclic mediation (breathing and meditation). Each session lasted 30–60 minutes and was conducted by nurses or a clinical psychologist. The first session consisted of the cyclic mediation program and recommendations to perform the mediation at home once daily, using a CD or DVD. After two weeks the patients met with interviewers and discussed impressions.

• N = 28.
• Females: 24; males: 4.
• Mean patient age was 60 years (SD = 9.2 years).
• Patients' performance status was 0–2, and all patients were able to visit the hospital.
• Primary tumor sites: breast (21), colon (2), stomach (2), bladder (2).

• Single site
• Outpatient
• Japan

Pre- and postintervention questionnaire

• Hospital Anxiety and Depression Scale (HADS), Japanese version
• Functional Assessment of Chronic Illness Therapy—Spiritual (FACIT-Sp), to measure sense of meaning
• Caregiving Consequences Inventory modified to eight items, to measure psychological appreciation
• Benefit-finding scale, to measure pain, constipation, nausea, fatigue, and sleep disturbance by using three items per symptom and ratings on a 0–10 numeric scale

• HADS anxiety score decreased from 6.9 ±3.6 to 5.1 ±3.9 (p = 0.01).
• HADS depression score decreased from 5.1 ±2.9 to 3.5 ±3.1 (p = 0.009).
• Total HADS score decreased from 12 ±5.3 to 8.6 ±6.3 (p = 0.004) after the intervention.
• FACIT-Sp scores increased from 32 ±6.5 to 33 ±6.9 (p = 0.69), a change that was not significant.
• Researchers noted relationships between FACIT-Sp and HADS (r = –0.78, p = 000), FACIT-Sp and growth (r = –0.35, p = 0.04), FACIT-Sp and pain (r = –0.41, p = 0.02), and growth and appreciation (r = 0.45, p = 0.009).

The mindfulness-based intervention as provided in this study was associated with decreased anxiety and depression.

• The study had a small sample size, with fewer than 30 participants.
• The study had no control group and used convenient sampling.
• Study results were not generalizable.
• Methods were not well described.
• Researchers modified the measurement tools, using only some tool items. The researchers presented no information about the validity or reliability that resulted from these modifications.

Nursing interventions that can help reduce the anxiety and depression of cancer treatments need exploration. More studies that result in reproducible measures are needed.