The objective of this study was to report on the effectiveness of tunneled indwelling pleural catheters (TIPC) in patients with recurrent malignant pleural effusion (MPE) and impaired lung dilatability.

TIPC placement was performed on three groups of patients: those with a trapped lung who were not candidates for pleurodesis, those with recurrent pleural effusion after failed attempts at pleurodesis, and those with poor physical condition/limited lifespan who were not candidates for VATS procedure. Prior to TIPC placement, diagnostic or therapeutic interventions (i.e., pleuracenteses or pleurodesis) were performed on 54 patients to treat the pleural effusion. TIPC placement was performed by a thoracic surgeon as an inpatient procedure for 98 patients in an operating room via local anesthesia or VATS procedure. Following placement, patients and relatives or home care nursing staff were instructed in TIPC care and drainage through specific training, and subsequent drainage of the catheter system was performed three times weekly and afterward based on symptoms (pain or dyspnea) or fluid volume. TIPCs ultimately were removed as an outpatient procedure under local anesthesia when volume at three sequential drainage procedures was less than 50 mL and were drained once a week in an expanded lung by x-ray. Patients were then followed up until February 2008.

• The study reported on a sample of 100 patients.
• The mean age was 64 years, with a range of 30-91 years.
• Of the sample, 52% were males and 48% were females.
• Key disease characterstics included underlying cancer disease: lung (23), breast (20), mesothelioma (11), ovarian (4), pancreatic (5), cancer of unknown primary (5), other malignant disease (19), nonmalignant due to liver cirrhosis or chronic exudative pleurisy (13).
• Of the 107 patients undergoing TIPC procedures, 88 patients had malignant disease and 12 had nonmalignant effusions. Seven additional procedures included six contralateral procedures and one ipsilateral procedure.
• Patients with malignant pleural effusion and fully expandable lungs in good clinical condition were given talc poudrage during VATS procedure instead of TIPC. Also, intraoperative suspicion of pleural empyema was a contraindication for TIPC.

This single-site study was conducted in an inpatient setting (for TIPC insertion) and outpatient setting (for TIPC removal) in an operating room in Germany.

• Patients were undergoing multiple phases of care.
• The study has clinical applicability for end-of-life and palliative care.

The study was a retrospective analysis.

• Diagnostic VATS procedure prior to TIPC placement (54 patients)
• X-ray performed prior to TIPC removal to assess lung re-expansion
   

Median residence time of TIPC was 70 days (range 2-384 days) in all patients. In 52 procedures, TIPC remained indwelling until patients’ death (median 47 days; range 2-319 days). In these particular patients, further relief of recurrent effusion was achieved by a drainage system, such that no one required repeated investigations (via pleuracenteses or surgical interventions). Sixteen TIPCs remained at the end of the observation period with a median indwelling time of 87 days (range 30-389 days) because they still required relief for recurrent pleural effusion. Thirty-nine TIPCs were removed after a median indwelling time of 80 days after decreased drainage and lung re-expansion. Patients with carcinoma of unknown primary and pancreatic cancer had the worst outcome. Nine patients had their catheters removed following TIPC-related complications (empyema [4], pain [1], accidental dislodgement by patient [2], bronchopleural fistula [1], occlusion of drainage [1], and recurrent effusion requiring TIPC replacement [2]). Six patients died during hospitalization following TIPC placement due to rapid progressive malignant disease.

According to the authors, the three groups that appear to benefit the most are patients with an intraoperative find of a trapped lung in a diagnostic VATS procedure who are not candidates for talc pleurodesis; patients with a history of repeated pleuracenteses or past failed attempts at pleurodesis; and patients with limited life expectancy and reduced clinical condition due to underlying disease.

Tunneled indwelling catheters are useful in the palliative treatment of patients with recurrent malignant and nonmalignant pleural effusions.

• The study had no appropriate control group.
• Due to the nature of the study, authors were unable to control for patient death during the hospitalization and observation period.
• Only patients unable to tolerate VATS procedures were included, so results can only be generalized to patients with refractory pleural effusion in the setting of poor physical health.
• Authors suggest that the insertion of a “not-tunneled pleural mini-catheter” be considered as an alternative intervention. This point, however, seems to contradict the authors’ original conclusion that TIPC will be beneficial for patients with limited lifespan and reduced clinical condition due to underlying disease.
  
   

Though TIPC placement under local anesthesia is less invasive and offers the advantage of very low postoperative mortality rate, it may not be an appropriate intervention for patients with a “very limited lifespan” based on underlying disease. Hence, its use in this population should be considered cautiously, given the procedure's aggressive or semi-aggressive, invasive nature. Patient/caregiver capacity to care for the catheter and perform drainage may influence the appropriateness of this intervention.

To compare Calendula officinalis with essential fatty acids (EFAs) for the prevention and treatment of radiodermatitis among people with head and neck cancers

• Active control arm: EFAs
• Experimental arm: Calendula officinalis
• A pharmacy compounded the treatments and placed them in bottles.
• Radiation oncology nurses applied 10 ml of treatment on gauze after radiation therapy. Participants reapplied treatment 12 hours later.

• N = 51 total, n = 27 (control), n = 24 (Calendula)  
• MEAN AGE: EFA group: 60.44 years (SD = 10.53), Calendula group: 62.38 years (SD = 12.71)
• MALES (%): Not reported, FEMALES (%): Not reported, but the study included males and females. Most participants were male.
• KEY DISEASE CHARACTERISTICS: Head and neck cancers
• OTHER KEY SAMPLE CHARACTERISTICS: All patients were treated with Colbalt-60.

• SITE: Single site    
• SETTING TYPE: Not specified    
• LOCATION: Radiotherapy department, Curitiba, Parana, Brazil

PHASE OF CARE: Active antitumor treatment

Prospective, random assignment, double-blind, controlled clinical trial

Radiation Therapy Oncology Group (RTOG) scale for skin toxicity

The proportion of grade 2 radiodermatitis was significantly higher in the EFA group ascompared to the Calendula group (p = 0.012). The EFA group’s Kaplan-Meier survival curve was consistently lower (i.e., fewer survivors) than the Calendula group curve at every point of the survival curve (p = 0.00402). In patients receiving concurrent chemo/radiation therapy, grade 2 dermatitis was more frequent in the EFA group, with grade 1 dermatitis more frequent in the Calendula group (p = 0.0179).

Calendula was more efficacious than EFAs for the prevention and treatment of radiation-induced skin toxicity among individuals with head and neck cancers.

• Small sample (< 100)
• Risk of bias (sample characteristics)
• Measurement/methods not well described
• Findings not generalizable
• Subject withdrawals ≥ 10%
• The authors did not provide a table listing the demographics of the sample.
• The participants in the EFA arm were more likely to be orally fed than those in the Calendula arm (92.59% versus 70.83%).
• The authors reported using chi-square, the Fisher and G Williams test for categorical variables, and Mann-Whitney U and Wilcoxin tests for quantitative variables. However, the authors reported numerous percentages, a few p values, and a Kaplan-Meier curve in the article.
• The authors used “a team of trained researchers” but did not address inter-rater reliability.
• The control product (EFAs: sunflower oil, 1% vitamin A, 0.2% vitamin E, and 5% caprylic acid) and the experimental product (Calendula: 4% Calendula oil, 1% vitamin A, and liquid Vaseline) were compounded by the hospital pharmacy. This helped maintain double-blinding but made it more difficult to compare these results with studies conducted by Pommier (2004) and Sharp (2013) because the Calendula products differ in each of the studies.
• More than 50% of the control group and 42% of the experimental group members withdrew before the end of the study.

These results neither negate nor support the current Oncology Nursing Society's Putting Evidence into Practice (PEP) guidelines for the use of Calendula in radiodermatitis.

Virtual reality (VR) is a computer-simulated technique during which individuals wear a head-mounted device and become immersed in scenarios through visual and auditory stimuli that they manipulate. Patients wore a VR headset during an intravenous (IV) chemotherapy treatment and chose from the following scenarios:

1. Deep sea diving
2. Walking through an art museum
3. Exploring ancient worlds
4. Solving a mystery.

Each scenario was long enough to last the entire length of the chemotherapy infusion (45–90 minutes). Patients were free to change scenarios at any time. During the control and VR conditions, patients sat in a reclining treatment chair. In the control condition, patients were free to participate in any activities they chose during treatment, such as watching television, talking with others, or reading. Patients were randomly assigned to receive the VR distraction intervention during one chemotherapy treatment and to receive the control (no intervention) during an alternate matched chemotherapy treatment. Outcomes were assessed at baseline (T1), immediately after chemotherapy (T2), and 48 hours postchemotherapy (T3).

• The sample was comprised of 123 adults receiving initial chemotherapy treatments.
• Mean age was 53.97 years (range 32–78).
• The majority of the patients were female (77%) and Caucasian (91%), and about half had a diagnosis of breast cancer (52%).
• Patients were excluded if they were younger 18 years, non-English speaking, had evidence of primary or metastatic disease to the brain, or had a history of motion sickness or seizures.

Outpatient clinic at a comprehensive cancer center in southeastern United States

Patients were undergoing the active treatment phase of care.

The study used a randomized, crossover, within-subjects design with a:

1. VR distraction intervention
2. Control.

Revised Piper Fatigue Scale (PFS)

The VR intervention did not improve fatigue outcomes. Although the treatment group experienced a greater decline than the control from T1 to T2, the difference did not reach statistical significance.

• The intervention was only used once with each patient, and determining whether patients had enough exposure to VR to produce an effect on symptoms was not possible.
• In some cases, a stronger “dosage” of VR may be needed.
• The study was conducted at a single site, and the the study population was homogenous.
• The study lacked standardized measures to capture satisfaction with VR use during chemotherapy treatment.

The two-arm study included virtual reality, pre-/post second day tests, and three scenario choices for chemotherapy infusion. Patients were randomized to the first or second chemotherapy session to an approximately 45-minute intervention.

• The sample was comprised of 20 women with breast cancer.
• Age ranged from 27 to 55 years. 
• Patients had no brain metastases or primary and no history of motion sickness or seizures.

• Outpatient
• Comprehensive cancer center

The study was a randomized, crossover trial.

• Piper Fatigue Scale (PFS)
• Self-Directed Search (SDS)
• State Anxiety Inventory (SAI)
• Open-ended questionnaire “Eval VR Intervention\"

There was a trend toward lower scores after the intervention, although the difference was not statistically significant.

• The study had a small sample size.
• Only patients with breast cancer were included.
• The intervention was not useful for cognitive impairment.
• The equipment was expensive, and special training was required.

In the virtual reality intervention (VRI), there were three scenarios from which to choose. Every patient was given a gift worth $10 at completion.

• The sample was comprised of 16 women.
• Mean age was 57.7 years (range 50–77). 
• Patients were included if they
  • Had breast cancer
  • Were 50 years or older
  • Had at least two matched intravenous chemotherapy cycles
  • Could read/write English
  • Had no primary or metastases to the brain
  • Had no history of seizures or motion sickness.

• Outpatient
• Comprehensive cancer center

This was a crossover study, with the intervention either occurring during the first or second treatment.

Piper Fatigue Scale (PFS)

When compared to the treatment cycles in which no VRI was given, there was a statistically significant decrease in fatigue immediately following chemotherapy treatments in which women received the VRI. Two days after treatment, there was a trend toward lower fatigue scores, although the differences did not reach statistical significance.

• The study had a small sample size.
• Time exposure of the intervention was not controlled or reported.
• Only patients with breast cancer were included. 
• Special equipment was required.

Nursing time is needed for follow-up telephone calls.

This intervention was a computer-simulated visual and auditory intervention (virtual reality, or VR) with headset and choice of four scenarios during chemotherapy. Patients were randomized to receive VR during their first or second chemotherapy session.

The study reported on a sample of 123 patients receiving chemotherapy for breast, colon, and lung cancers.

One U.S. hospital

A crossover design was used.

• State Anxiety Inventory (SAI)
• Revised Piper Fatigue Scale (PFS)
• Presence Questionnaire
• Evaluation of virtual reality intervention
• Adapted Symptom Distress Scale–2 (ASDS-2)
• ASDS-2, SAI, and PFS after chemotherapy, before leaving clinic, and 48 hours after chemotherapy

There was no statistical difference (main effect) in symptom distress or anxiety (p = 0.15). There was significant crossover effect at time 2, suggesting that VR may be more effective in decreasing distress during the first visit. Significant altered time perception equated to distraction effect of VR.

• The study sample was older and included multiple diagnoses.
• The one-time intervention consisted of a single session of VR and was conducted at a single site.
• No baseline measures were reported.

To compare the efficacy and safety of granisetron injection extended-release (APF530) versus ondansetron for delayed chemotherapy-induced nausea and vomiting (CINV) after highly emetogenic chemotherapy, following a guideline-recommended three-drug regimen

Patients receiving highly emetogenic chemotherapy were randomized into either the APF530 or ondansetron arm for the study. Patients in the APF530 arm received APF530 500 mg subcutaneously and saline placebo in place of ondansetron. Patients in the ondansetron arm received ondansetron 0.15 mg/kg intravenously and a saline placebo subcutaneously in place of APF530 on day 1. All patients also received fosaprepitant 150 mg IV and dexamethasone 12 mg IV on day 1; dexamethasone 8 mg orally once daily on day 2 and twice daily on days 3–4. A topical anesthetic was applied to the injection site before APF530 or its placebo were administered. On day 1, all study medications were administered 30 minutes before the start of chemotherapy.

• N = 902   
• MEAN AGE = 55.7 years and 55.6 years for the APF530 and placebo arms, respectively
• MALES: 20.4% and 17.5% of patients enrolled in the APF530 and placebo arms, respectively; FEMALES: 79.6% and 82.5% of patients enrolled in the APF530 and placebo arms, respectively
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: No specific tumor types were recruited.
• OTHER KEY SAMPLE CHARACTERISTICS: Men and women aged 18–80 years receiving the first cycle of a single-day highly emetogenic chemotherapy for a histologically or cytologically confirmed malignancy

• SITE: Multi-site   
• SETTING TYPE: Not specified    
• LOCATION: Seventy-seven medical centers across the United States

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Elder care

• Prospective, randomized, double-blind, double-dummy, parallel-group, multicenter, phase-III trial

Patients were monitored during four clinic visits:

• screening: day –21 to –1
• baseline/day 1 
• day 6 
• final safety follow up on the day of the patient’s next chemotherapy administration

Patients completed symptom diaries during days 1–6 to self-report nausea, vomiting, retching, and rescue medication usage.

A higher percentage of patients receiving APF530 had delayed-phase complete response when compared to patients receiving ondansetron. The absolute treatment difference was 8% (95% CI [1.7, 14.4], p = 0.014). Delayed-phase CR rates for the cisplatinum arm were 65.3% with the APF530 regimen and 54.7% with the ondansetron regimen. The absolute treatment difference here was 10.6% (95% CI [–1.4, 22.7]). For the non-cisplatinum arm, the delayed-phase CR rates were 64.4% for APF530 and 57.4% for ondansetron regimens. This absolute treatment difference was 7% (95% CI [–0.9, 12.1], unadjusted p = 0.092).

APF530 provided superior control of delayed-phase CINV after highly emetogenic chemotherapy when compared with standard three-drug regimens.

• Short follow-up time

APF530 was found to be a well-tolerated  extended-release granisetron formula with clinical benefit for the control of CINV after highly emetogenic chemotherapy.

To compare treatment with topical 0%–1% methylprednisolone versus 0%–5% dexpanthenol and historical controls in a cohort of patients undergoing fractionated radiation therapy

After obtaining baseline data on an initial control cohort of untreated patients (n = 15), a subsequent cohort of patients was randomized to either 0%–1% methylprednisolone aceponate cream or 0%–5% dexpanthenol cream. Patients were instructed to apply the assigned cream twice daily from initiation of radiation therapy and for a two-week period after completion. No other topical medications, emollients, or powders were used during this period.

• The study sample was comprised of historical controls as well as patients using methylprednisolone aceponate cream (n = 10) and patients using dexpanthenol (n = 11).
• Mean age of the methylprednisolone group, dexpanthenol group, and historical controls was 62, 44, and 55 years, respectively, with a range of 39–75 years, 35–74 years, and 29–75 years, respectively.
• All patients were women with breast cancer.

The study took place at the University of Innsbruck in Austria.

The study used a prospective randomized double-blind study design with comparison to historical controls.

• Patients were assessed immediately prior to initiation of radiation therapy and weekly thereafter or erythema, desquamation, erosion, induration, and hyperpigmentation on a four-point scale: none (0) to severe (3). The total clinical score was a sum of individual ratings.
• To assess the impact of radiation therapy on epidermal barrier function, transepidermal water loss was measured weekly over four different areas within the irradiated field (one test per quadrant) and over one control area on the volar forearm using an evaporimeter.
• Recordings were not taken over skin showing extensive erosions.
• Quality of life was measured at the beginning of radiation therapy and after completion of the follow-up period to evaluate skin-specific (Skindex) and general outcome measures (SF-36).

Comparison of treatment groups with the historical, untreated control group suggested that either of the two topical regimens was superior to no treatment with respect to transepidermal water loss measurements, but not statistically significant. Transepidermal water loss levels did not differ between patients who received adjuvant chemotherapy and those who did not. There were no differences in quality-of-life findings. No quality-of-life data were obtained from untreated individuals in the preliminary cohort group. Skindex scores showed appearance of radiation dermatitis in virtually all participants. The dexpanthenol group showed deterioration that reached statistical significance for dimensions of depression, embarrassment, discomfort, and limitations (p < 0.05).

Prophylactic and ongoing use of topical therapy with topical corticosteroid or dexpanthenol-containing emollient does not prevent radiation dermatitis.

• The study sample was small.
• The 36-SF has been used to assess qualityo f life in patients with acne and psoriasis but not patients with radiation dermatitis.
• Skindex has been used to assess quality of life in a variety of dermatologic conditions, but not specifically used for radiation dermatitis.
• Median age of patients vary by 18 years, with an older median in methylprednisolone group.
• Scale for dermatitis grading is difficult to compare to standard scales used for radiation therapy-induced dermatitis.

To compare the effectiveness of adding an aprepitant regimen to an ondansetron and dexamethasone regimen for chemotherapy-induced nausea and vomiting (CINV)

Patients were randomized to receive the treatment arm (aprepitant, ondansetron, and dexamethasone on day 1; aprepitant and dexamethasone on days 2–3; dexamethasone on day 4) or the control arm (ondansetron plus dexamethasone on days 1–4).

The study looked at 489 patients with solid malignancies receiving chemotherapy (patients were cisplatin-naïve). The treatment arm had 231 participants, and the comparison group had 229 participants.

The study was a prospective, randomized, double-blind trial with sponsor blinding.

Measurement instruments were

• Patient diaries used to record number of episodes of vomiting
• Use of rescue medication
• Nausea visual analogue scale (VAS).

Patients were considered treatment failures if they needed to take rescue medication.

• Complete response (CR) was defined as no vomiting and no rescue medication in the overall period (days 1-5 after cisplatin infusion).
• The aprepitant regimen was superior to the control arm in the overall treatment period (CR = 72% versus 61%, p = 0.003).
• No significant difference was observed among groups in control of nausea.
• The aprepitant group had higher rates of drug-related adverse events.

Efficacy might be further improved if ondansetron is given on days 1-4 as well (as per guidelines), rather than only on day 1 as done in this study.

The addition of aprepitant to prevention of CINV provides an objective improvement in control of vomiting as compared to ondansetron and dexamethasone alone; however, the triple-drug combination is recommended for practice.

To assess the effects of controlled weight lifting for breast cancer survivors with lymphedema

For the first 13 weeks, participants in the intervention group received supervised 90-minutes session twice weekly led by certified fitness professionals employed by the fitness centers, who received three days of training. There was no upper limit on weight lifting. Participants were given a custom-fitted compression garment at 6 and 12 months and were required to wear the garments during weight lifting.

• The study sample (N = 130) was comprised of female patients who had a history of unilateral, nonmetastatic breast cancer 1–15 years before the study.
• Patients were included in the study if they had a body mass index of less than or equal to 50, at least one lymph node removed, and clinical diagnosis of stable breast cancer-related lymphedema.

The study took place at community fitness centers near participants' homes in Philadelphia, PA.

The study used a randomized controlled trial design.

• Lymphedema was measured using water volume displacement.
• Percentage body fat was measured.
• Physical activity level was measured using metabolic equivalent of task.

Weight lifting did not significantly affect the severity of breast cancer-related lymphedema. Weight lifting reduced the number and severity of arm and hand symptoms, increased muscular strength, and reduced the incidence of lymphedema exacerbation. Median attendance at exercise sessions was 79%. The proportion of women who experienced at least 5% increase in limb volume was 17% in the control group and 11% in the weight lifting group. Among women who had five or more lymph nodes removed, 7% in the weight-lifting group and 22% in the control group had more than 5% increase in limb volume.

The results of this study should reduce concerns that weight lifting will worsen arm and hand swelling with lymphedema in breast cancer survivors.

• Evaluations for exacerbations were not completed by a single therapist, although the six lymphedema therapists followed a standardized algorithm for evaluation.
• The study had no blinding.

Nurses need to review current handouts and information regarding exercise therapy. The findings of this study support the potential benefits of a slowly progressive weight-lifting program, with appropriate use of compression garments and close monitoring for arm and hand swelling.