To develop a mucositis oral care protocol and evaluate the impact of its implementation in the prevention and management of mucositis in the patient with hematopoietic cell transplant (HCT)

A standard protocol was developed. After development, the physician and nursing staff were educated about the protocol and effects of medications included in the protocol. Following education for three months, every patient admitted to the HCT service was managed according to the protocol. Retrospective review of the electronic medical record of mucositis management was done in cases during the three months prior to protocol use. The new protocol was included in the electronic order set used for HCT admissions.

The protocol included daily evaluation, brushing twice daily, ice chips 30 minutes prior to and throughout melphalan infusion, chlorhexidine gluconate mouthwash 15 ml 4 times daily, normal saline mouthwash 30 ml four times daily, calcium phosphate rinse 30 ml four times daily, magic mouthwash 15 ml four times daily as needed for oral pain, and phenol losenges every two hours as needed for oral pain. Palifermin was used at the physician’s discretion.

• The study reported on 24 patients receiving HCT (11 retrospective and 13 prospective).
• Mean age was 55 years (SD = 12) in the retrospective group and 59 years (SD = 12) in the prospective group.
• The sample was 76% female and 24% male.
• All were patients hospitalized for HCT. Most patients were receiving BEAM (carmustine, etoposide, cytarabine, melphalan) chemotherapy.

This was a single-site study conducted in an inpatient transplant unit at the Mayo Clinic in Florida.

The study used an exploratory descriptive design with historical controls.

• The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grading system was used.
• Data was retrieved by retrospective chart review.
• Use and duration of total parenteral nutrition (TPN) was recorded, as well as hospital length of stay.

• Patients who received the oral care protocol had lower incidence of grade 1 mucositis and lower duration of grade 1 mucositis (p = 0.02).
• No differences were found at any other grade level between groups.

• The sample size was small.
• The data was from chart audit only.
• No information was provided about actual components used and protocol adherence.
• Although TPN on the grading scale is indicative of grade 3 mucositis, only 17% of patients receiving TPN with the new protocol were grade 3. This calls the validity of findings into question.

This study does not significantly add to our understanding for the management of mucositis but suggests that use of a standardized protocol increases attention to mucositis management. This study also raises questions about the use of the criteria as receiving TPN as a measure of mucositis grade, as use of TPN may not only be a result of mucositis. This area of limitation also may indicate issues of reliability in the documentation of mucositis grade, as data here were solely obtained from the electronic medical record.

To assess the role of octreotide in the management of chemotherapy-induced diarrhea (CID) in patients with colorectal cancer

Databases searched were Pubmed, MEDLINE, and Cochrane Database (1984–2009).

Search keywords were ocreotide in chemotherapy-induced diarrhea, octerotide CID, colorectal cancer CID, and octreotide.

Studies were included in the review if they

• Were published in the English language.
• Reported on a sample that was all or primarily patients with colorectal cancer.

Studies were excluded if they

• Involved the use of chemotherapy used solely for the treatment of cancers other than colorectal cancer.
• Were solitary case reports.

The authors did not describe the literature review and evaluation process. The article did incorporate information on relevant clinical guidelines.

The authors reviewed two randomized trials; four nonrandomized, controlled studies; and two case series, involving a total of 169 patients.

• The two randomized trials demonstrated that octreotide was superior to loperamide in controlling severe CID.
• In one of the nonrandomized trials, patients with loperamide-resistant CID had complete (16%) or substantial (59%) resolution of CID.
• In another nonrandomized trial, which included patients with other types of cancer, 94% achieved complete resolution of diarrhea with octreotide.
• A prospective trial and two case series reported similar successful treatment of severe CID (grade 3 and above) with octreotide.
• The Canadian Working Group on CID has recommended that patients with refractory CID at grade 3 or 4 receive 100–150 mg octreotide subcutaneously three times daily, with potential increased doses up to 500 mg three times per day.
• For prophylaxis treatment, the group has recommended 30 mg octreotide long-acting release intramuscularly once every 28 days.
• Adverse effects included short-term local pain at the injection site (38%), fatigue (48%), weakness (33%), and nausea (28%). Long-term use in acromegaly has been associated with vitamin B₁₂ deficiency and risk of gallstone formation.
• A review of economic issues identified a study that found that the mean expenditure for CID in Canada was $2,559 per patient for grade 3 or 4 diarrhea. The average expenditure with grade 4 was $5,776. The cost of octreotide was not reported.

Octreotide has been shown to be effective and safe for short-term treatment of severe CID.

Few studies have been done with the long-acting formulation and for prophylactic use. Further studies in these areas would be useful.

Nurses should be aware of potential side effects with long-term use as seen in other than cancer cases.

To compare the efficacy and safety of transmucosal fentanyl and oral morphine for breakthrough pain

Patients were randomized to receive 200 mcg of transmucosal fentanyl or 10 mg immediate-release oral morphine when needed for breakthrough pain for three days. Patients were hospitalized during the study for monitoring. The intensity of breakthrough pain was assessed at time 0 and at 5, 15, 30, and 60 minutes after receiving the study drugs.

• N = 186  
• MEAN AGE = 47.7 years
• MALES: 54%, FEMALES: 46%
• KEY DISEASE CHARACTERISTICS: Not reported
• OTHER KEY SAMPLE CHARACTERISTICS: The bseline intensity of persistent pain was 4.92–5.17, and the intensity of breakthrough pain was 7.85–8.11.

• SITE: Multi-site  
• SETTING TYPE: Inpatient    
• LOCATION: India

• APPLICATIONS: Palliative care

Open-label, randomized trial with an active control

• Numeric Rating Scale (NRS) for pain intensity

Oral transmucosal fentanyl had a more rapid onset with better pain relief at 15 minutes. 56% of breakthrough episodes treated with fentanyl had a greater than 33% reduction in pain intensity at 15 minutes compared to 39% of episodes treated with morphine (p < 0.0001). Rescue medication was needed in 2.1% of patients receiving fentanyl and no patients using morphine. This difference was not significant. No adverse events were reported in either group. At all assessment time points, those receiving fentanyl had a lower pain intensity.

Oral transmucosal fentanyl citrate was effective in reducing the intensity of breakthrough pain more quickly than oral morphine sulfate with no adverse events.

• Risk of bias (no blinding)
• Other limitations/explanation: Short study duration

Oral transmucosal fentanyl citrate was shown to be safe and more effective for short-duration episodes of breakthrough pain than immediate-release oral morphine sulfate. Because this was a brief study, the long-term efficacy or differences in outcomes is not known. For patients with breakthrough cancer-related pain, nurses can advocate for those medications that are shown to provide the most rapid-onset reduction in pain intensity. Fentanyl has a relatively short duration of action, so it may be most appropriate for use with the acute onset and short duration of breakthrough pain.

To evaluate the effects of preoperative gabapentin on anesthesia requirements and postoperative pain

Patients were randomized to receive either 600 mg gabapentin or placebo two hours prior to surgery for breast cancer. Patients were followed for 24 hours after surgery. Postoperative analgesia was provided with intramuscular diclofenac sodium 1.5 mg every eight hours and IV morphine 3 mg on demand or when the pain score was 4 or higher.

• N = 40
• MEAN AGE = 46.6 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast cancer

• SITE: Single site 
• SETTING TYPE: Inpatient 
• LOCATION: Taiwan

• PHASE OF CARE: Active antitumor treatment

• Double-blind, placebo-controlled RCT

• Physiologic measures and medication dosages from medical records
• 11-point numeric pain rating scale

Propofol requirements for induction (p = .02) and maintenance of anesthesia (p = .009) was significantly lower in the gabapentin group. Patients in the gabapentin group had significantly lower pain scores up to two hours postoperatively (p < .001). More patients in the control group required rescue analgesics (p = .03). There were no significant differences between groups in duration of surgery or intraoperative analgesics.

Preoperative gabapentin may reduce anesthesia dose requirements and short-term postoperative pain.

• Small sample (less than 100)
• Baseline sample/group differences of import
• The control group had higher American Society of Anesthesiologists scores at baseline, and although not statistically significant, this could have influenced findings. 
• Patients were only followed for 24 hours.
• Authors report lower anxiety with gabapentin preoperatively but do not describe the method or timing of this measure.

Preoperative gabapentin may reduce anesthesia dose needs and postoperative pain.

The purpose of this study was to review the best current evidence for the efficacy of G-CSFs (filgrastim, pegfilgrastim, and lenograstim) for the primary and secondary prophylaxis of chemotherapy-induced neutropenia, specifically for the primary outcomes of incidence and risk of neutropenia, infections, and infection-induced mortality. Secondary aims include review of the best and current evidence for the efficacy of G-CSFs for the outcomes of duration of neutropenia, hospitalizations, and antibiotic therapy.

MEDLINE (1966 to date), EMBASE (1980 to date), the Cochrane Library, and the Odyssey databases were searched.
Key words included colony-stimulating factors, filgrastim, nuepogen, pegfilrastim, neulasta, lenograstim, granocyte, neutropenia, fever

Inclusion criteria:

• Randomized, controlled trials (RCTs) from the year 2000 and newer with more than 80 participants that investigated the named G-CSFs in comparison to placebo, other G-CSFs or no treatment, or in combination with antibiotics versus antibiotics alone for initiation of treatment (prior to neutropenia onset) or secondary prophylaxis during chemotherapy (minimum three-week follow-up (initiated during chemotherapy cycles following neutropenia of febrile neutropenia onset in a previous cyle).
• Data from meta-analyses, overviews of more than two studies, and systematic reviews of trial involving the named G-CSFs and where available, cost-effectiveness analyses of any of the studies meeting the inclusion criteria also were included.

Exclusion criteria:

• Non-English publications and studies published in abstract form only

Initially, 11 RCTs, two study overviews, four meta-analyses, and three economic analyses were reviewed. One RCT was excluded to bring the total to 10.

The inclusion criteria state that RCTs included in this review needed to have more than 80 participants, yet one study included had 49. In addition, the inclusion of three economic studies did not match the study aim of efficacy of use of G-CSFs for reduction of neutropenia and related complications. Two of these economic studies were analyses of two of the RCTs being evaluated for efficacy in neutropenia prevention/reduction. The third economic study did not have details about the trial disclosed.

• 20 studies were included in the total sample
• 7,409 subjects in total
• The sample range across studies was 49–1,823 subjects

The use of G-CSF is overall effective for the reduction of neutropenia, febrile neutropenia, associated infections, antibiotic use, and hospitalizations in various populations of adult patients with cancer. The use of pegfilgrastin is more effective than filgrastin in reducing the risk of febrile neutropenia and pegfilgrastin is as effective as filgrastin in reducing the duration of severe neutropenia.

In the pediatric population with cancer, use of G-CSFs is effective in reducing the risk of febrile neutropenia and associated hospitalizations, but is not effective in reducing infections.In older adult populations, G-CSFs were effective for reduced use of antibiotics but not for risk of febrile neutropenia.

Current trials show that G-CSFs are overall effective in reducing the risk of neutropenia, febrile neutropenia, and associated infections, hospitalizations, and antibiotic use for various populations of patients with cancer undergoing chemotherapeutic treatments.

Current American Society of Clinical Oncology recommendations promote the use of G-CSFs for patients receiving chemotherapeutic treatments that have a greater than 20% risk of inducing febrile neutropenia. Although this review found mixed results within the studies evaluated and the criteria for this review stated was not completely followed; overall findings do indicate that G-CSF continues to be an effective therapy in the reduction of neutropenic events and related sequelae.

Implications for nursing practice include understanding the use and effectiveness of administration of G-CSF, promoting its use, and continued monitoring for neutropenia, febrile neutropenia, and infections.

To evaluate the feasibility of providing an individualized problem-solving education intervention to patient-caregiver dyads during stem cell transplantation

The intervention was based on the COPE model involving creativity, optimism, planning, and expert information. Sessions used an active problem identified by each dyad to apply the COPE problem solving model. The clinician interventionist guided the dyad in problem identification, review of related expert information, and development of a plan to address the problem. Scripting, peer supervision, and session audiotapes were used to ensure integrity of the intervention. Data were collected with a log and subject interviews. Audiotaped interviews were transcribed for analysis, and a second transcriber did quality monitoring on 100% of the tapes to ensure accuracy and completeness. Four sessions were provided—prior to transplantation, at the time of hospital discharge, two weeks after discharge, and four weeks after discharge. Dyads also attended usual admission and discharge education classes provided as part of usual care. Data collection occurred at baseline, each of these time points, and six weeks after initial hospital discharge.

• The sample included eight dyads (patient and spouse pairs).
• The mean age of patients was 56.5 ± 7.9, and the mean age of caregivers was 53.9 ± 9.67.
• Females made up 25% of patients and 62.5% of caregivers.
• Males made up 75% of patients and 37.5% of caregivers.
• Non-Hodgkin Lymphoma was the most prevalent cancer type.
• Eastern Cooperative Oncology Group (ECOG) performance status was 0 in 37.5%, 1 in 50%, and 2 in 12.5%.
• Initial hospitalization for transplantation was a median of 14.5 days (range 11–29).
• 63% required hospital readmission during the study period.
• Overall, subjects and caregivers reported levels of symptom distress suggesting a low symptom burden.
• All caregivers were the patients' spouses.
• The study period was the acute episode of care.

• Single site
• Inpatient and outpatient setting
• Transplant unit in Maryland
• Large research center

A single group repeated measures mixed method design was used.

• Brief Symptom Inventory (BSI)
• Social Problem-Solving Inventory (SPSI-R)
• Family Adaptability and Cohesion Evaluation Scale (FACES-IV)
• Symptom Distress Scale (SDS)

Ninety-four percent of scheduled sessions were completed. Session length was a median of 45 minutes, ranging from 15–60 minutes. Clinicians reported session scheduling as the greatest challenge.

Themes that emerged from qualitative analysis were “opportunity to talk,” “expert information,” and “creative thinking.” Effect sizes for each measure for patients and caregivers over time were reported. Subjects’ SPSI-R scores were within normative group range, suggesting effective problem solving ability prior to the intervention. Patient baseline distress was significantly related to a change in SPSI-R scores over the course of the study (r = 0.8, p = 0.031). It was noted that the caregiving experience was not limited to a spouse, and the study experience pointed to the need to expand the network to all those involved. Effect sizes of change in measures were provided, but there were no differences in outcomes over time.

Provision of this type of intervention appears to be feasible, and although scheduling sessions was shown to be challenging to clinicians, a high proportion of sessions were completed. The study provides some initial effect size data in the outcome variables measured. Authors identified the need to include a broader network of caregivers and further explore alternative timing and scheduling approaches for this type of intervention.

• The sample had less than 30 participants. This was a small feasibility study, and although some effect size data was gained, the sample was very small.
• The sample was a fairly homogenous ethnic group.
• A study goal was to determine feasibility, but there was no control or comparison group.
• The full study period was a relatively short period of time, encompassing mainly the acute episode of care.

Findings suggest that provision of individualized counseling and problem solving sessions using the COPE model is feasible with patients who have undergone stem cell transplant. In provision of caregiver support, nurses need to consider involving a number of caregivers because the network of individuals who are involved is often beyond a dyad. A broader involvement may also be helpful in dealing with session scheduling difficulties because of competing spouse priorities. Further research is warranted to evaluate effect sizes, different dosage, and timing of such interventions and involving various cultural groups. Further research including control groups is warranted as other similar studies have shown improvement in various patient and caregiver measures as a function of time alone.

Data were acquired by the investigators from the patients’ medical records at each of the study centers and were transferred to a standardized case report form (CRF). Data collected included patient demographics, characteristics of cancer disease and treatment, disease-related symptoms and adverse effects experienced by the patients, and the course of the disease. Outcomes were assessed at yearly intervals until the end of the observation or treatment period.

A total of 681 women with primary breast cancer were included.

Study Group

• N = 167
• Mean age was 55.11 years.
• Statistically significant tendency to more severe diseases and higher disease stages
• Most patients were receiving hormone therapy (71.9%), which was significantly more than the control group.

Control Group

• N = 514
• Mean age was 54.63 years.
• The majority of patients were receiving hormone therapy (48.2%).

Patients were excluded if they received other mistletoe products except the study medication, if they suffered from a relapse or metastatic disease at the beginning of the postoperative treatment, or if a secondary malignancy was detected.

The study was conducted in 53 randomly selected hospitals or practices representatively distributed in Germany, including oncologists, gynecologists, and general practitioners.

Unclear

This was a controlled, multicenter, comparative, epidemiological, cohort study.

Data were collected on CRFs in which, prior to data collection, the data elements required for the study were identified and defined.

The complementary standardized mistletoe extract study group reported a statistically significant lower number of fatigue or tiredness symptoms compared to the control group during an aftercare period of about five years, with 0.6% versus 1.0% reporting fatigue symptoms for the study and control groups, respectively.

To determine the efficacy of short-term psychodynamic psychotherapy among women with breast cancer diagnosed with depression

Patients were randomized to study intervention or usual care groups. The usual care group received information about local counseling centers, and psychological diagnostic information was provided to their general practitioners. Physicians could refer for further treatment. Those in the experimental group received up to 5 pretreatment and 20 additional weekly psychotherapy sessions provided by psychotherapists who were trained in specific techniques for the study and a treatment manual. To ensure treatment fidelity, psychotherapists presented each patient in group supervision three times during the study. Study assessments were done at baseline, 6 months, and 12 months.

• N = 106  
• MEAN AGE = 51.8 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast cancer; all had depression at baseline as determined by Structured Clinical Interview for DSM (SCID) and Hospital Anxiety and Depression Scale (HADS) score of at least 8.
• OTHER KEY SAMPLE CHARACTERISTICS: 55.8% were married, 32.7% had previous psychotherapy, and 56% were employed full-time or part-time.

• SITE: Multi-site
• SETTING TYPE: Outpatient 
• LOCATION: Germany

Randomized clinical trial

Remission at follow-up determined by SCID–I interview and HADS

By intention-to-treat (ITT) analysis (p = .007) and per protocol analysis (p = .02), remission rate was higher in the STPP group by HADs analysis. There was no difference in rates of remission by SCID criterion. Variables that were predictive of remission were study group, higher depression level at baseline, and time until post-treatment measure. STPP patients received an average of 18 sessions compared to an average of 2.4 sessions among controls. There was a trend for more use of antidepressant medication in the STPP group (p = .09).

Individual psychotherapy was shown to improve depression among depressed patients with breast cancer.

• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Key sample group differences that could influence results
• Subject withdrawals ≥ 10%
• Other limitations/explanation: Level of depression by HADs was higher at baseline in the experimental group. There was a > 30% drop-out rate.

Individual psychotherapy can be beneficial for patients with cancer experiencing clinical depression. Screening for depression can identify those patients who may benefit from interventions.

To evaluate the effectiveness of preperitoneal continuous wound infusion (CWI) with ropivacaine, compared to continuous epidural infusion (CEI) with ropivacaine, on pain control after open colorectal surgery and on the quality of patient recovery

The intervention group had preperitoneal CWI analgesia. The control group had preperitoneal CEI analgesia. Participants were randomly assigned and received either CWI or CEI during first 48 hours postop. Infusion consisted of 0.2% ropivacaine at 10 ml/hour. All patients received morphine patient-controlled analgesia during the first 72 hours postop. All received standardized postoperative care not adhering to fast-track surgery programs. Investigators used the 100 mm visual analog scale (VAS) to measure pain.

A 4.5-point difference in VAS pain score showed that preperitoneal CWI was not inferior to CEI analgesia.

• The sample was composed of 106 patients. 
• The range of patient age was 57.9–73.5 years.
• Of all patients, 52% were male and 48% were female.
• All patients had colorectal cancer and underwent open nonemergency colorectal surgery for cancer.
• Types of surgery represented in the sample were hemicolectomy, rectal resection, segmentary colonic resection, and total colectomy. Authors noted differences regarding duration of surgery (in minutes), length of wound catheter in intervention group, and vertebral level of epidural catheter insertion in control group.

• Multisite 
• Inpatient
• Italy

• Phase of care: transition phase after active treatment
• Clinical application: eldercare

Multicenter randomized controlled trial (noninferiority design)

The primary outcome measure was a VAS whose scale ranged from 0 (no pain) to 100 (worst pain imaginable). 

Other outcome measures included

• Morphine titration and usage
• Morphine patient-controlled analgesia at varying intervals during the first 72 hours postop
• Time of first flatus
• Time of first bowel movement
• Duration of hospital stay, from surgery to discharge
• Quality of sleep (0–10 scale)
• Patient satisfaction with pain control (rated poor, good, or excellent) at 72 hours postop
• Side effects noted during the first 30 days postop (Side effects included hypotension requiring treatment, central nervous system toxicity, nausea and vomiting requiring medication, and presence of motor block [epidural complications in control group and abdominal complications in intervention group].)

• At 2, 6, 12, and 24 hours postop, the CEI and CWI groups demonstrated similar responses, indicating achievement of sufficient pain control. 
• At 48 and 72 hours postop, the CWI group—in contrast to the CEI group—demonstrated a statistically significant reduction in reported pain score.
• In terms of the secondary end-point measures, the results the CWI group achieved were similar to those the CEI group achieved in regard to duration of hospital stay, quality of night sleep, and requirement for rescue analgesia.
• In the CWI group, 45.3%  reported excellent pain control at 72 hours postop. In the CEI group, 7.6% reported excellent postop pain control.
• Compared to the CEI group, the CWI group demonstrated a significantly shorter time to first flatus (p = 0.002) and first bowel movement (p = 0.001). 
• Compared to the CEI group, the CWI group had a statistically significant lower incidence of postop nausea and vomiting at 24 hours (p = 0.02), 48 hours (p = 0.01), and 72 hours (p = 0.007).

CWI provides an acceptable alternative to CEI for the management of patients' pain after colorectal surgery for the treatment of cancer.

The study had a risk of bias due to no blinding.

This study shows that oncology nurses, as advocates for patients, can support CWI as an alternative to CEI as a means of postoperative pain management. Because CWI was associated with significant benefits regarding postoperative sleep disturbance, bowel function, and nausea and vomiting—as well as pain management—nurses can advocate for the use of CWI to address several symptoms of concern to oncology patients and direct-care nurses.

To evaluate the efficacy and safety of SAMITAL in reducing mucositis in patients undergoing treatment for hematologic malignancies

Patients used SAMITAL mouth rinse three to four times daily and held it in the mouth for one minute.

• N = 25  
• AGE: 18–84 years (Note: in the abstract, age was 18–74 years)
• MALES: 19 (76%), FEMALES: 6 (24%)
• KEY DISEASE CHARACTERISTICS: Adult patients with cancer undergoing treatment for hematologic malignancies

• SITE: Single site  
• SETTING TYPE: Inpatient   
• LOCATION: Hospital Clinico Regional de Valdivia, Valdivia, Chile

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

• Observational, uncontrolled study

• World Health Organization (WHO) mucositis grading scale (variables: stomatitis, dysphagia, gastritis, enteritis, pain, and feeding) performance status of less than 2

The grade of mucositis was reduced from grade 2 to 0–1 in seven patients (25%). It is stated that pain, mucosal erosions, bleeding, and dysphagia were reduced; however, it is unclear how these were measured.

SAMITAL may have some benefit in the prevention and management of oral mucositis.

• Small sample (< 30)
• Risk of bias (no control group)
• Risk of bias (no blinding)  
• Risk of bias (no random assignment)
• Risk of bias(sample characteristics)
• Selective outcomes reporting
• Findings not generalizable
• Other limitations/explanation: Due to the small sample, the researchers performed only descriptive statistics.

The authors suggested performing randomized, placebo-controlled clinical trials to confirm the suitability of SAMITAL for the treatment and prophylaxis of mucositis.