To assess the effect of palifermin on mucositis and infection risk according to conditioning regimen used, and to evaluate the effect of palifermin on fibrinogen levels

This is a retrospective study of patients who underwent high-dose chemotherapy and autologous hematopoietic stem cell transplantation (auto-SCT) because of hematologic malignancies. The authors evaluated the differences between a cohort of patients who received prophylaxis with palifermin and a matched control group of patients who did not receive this agent, and assessed the effect of palifermin on infection risk according to the conditioning regimen used, comparing BEAM, BU-CY, THIO-CY, and HD-PAM conditioning regimens.

• N = 120 (40 with palifermen, 80 in control)  
• MEDIAN AGE = 47 years in palifermin group and 50 years in control group
• MALES: 65% in palifermin group, 55% in control; FEMALES: 35% in palifermin group, 45% in control group
• KEY DISEASE CHARACTERISTICS: Diagnosis of MM in 57.5% of both groups; lymphoma diagnosis in 22.5% of palifermin group and 31.2% of control group; other diagnoses in 20% of palifermin group and 11.3% in control group
• OTHER KEY SAMPLE CHARACTERISTICS: Pretreatment with less than two lines of therapy prior to SCT in 19% of palifermin group and 29% of control group; HD-PAM in 65% of palifermin group and 57.5% in control group; BEAM/BUS in 35% of palifermin group and 42.5% of control group

• SITE: Single site    
• SETTING TYPE: Inpatient  
• LOCATION: Italian transplantation center

• PHASE OF CARE: Active antitumor treatment

Total of 120 patients who underwent SCT from 2000–2009 who either received palifermin prophylaxis or did not receive palifermin (control group)

Weekly blood cultures, serum galactomannan assay, and skin and oral culture swabs were used in afebrile patients. Standard febrile workup was used including blood and urine cultures, chest radiography (CXR), and a CT of the thorax within 72 hours of the onset of fever. Any infection arising during the first 30 days was evaluated. Fever of unknown origin (FUO), pneumonia, febrile gram-positive bacteremia, and CVC-related infections were all evaluated. Mucositis was assessed for all patients using daily inspection and grading according to daily mucositis scoring using Eastern Cooperative Oncology Group (ECOG) Common Terminology Criteria for Adverse Events (CTCAE) criteria. Gastrointestinal (GI) toxicity was deemed as severe if there were five or more stools per day.

Palifermin reduced rates of severe mucositis when evaluation was conducted taking into account conditioning type. There was a significant reduction in the severe mucositis rate in the BEAM/BUS group, whereas there was no significant reduction in the HD-PAM group. Palifermin had no effect on GI toxicity. FUO was significantly reduced in palifermin treated group. A reduction in severe infections (p = 0.06) existed in the BEAM/BUS group. A highly significant reduction in gram-positive infections existed in the BEAM/BUS group but not in HD-PAM group. Rate of patients with fevers was decreased in the palifermin group, but not significantly. A reduction in serum fibrinogen peak levels during the aplastic phase was observed with palifermin in the BEAM/BUS group but not in HD-PAM group.

Palifermin reduced FUO and severe infections unrelated to gram-positive bacteria with a more evident effect after conditioning based on BEAM/BUS. Severe mucositis was also reduced in the BEAM/BUS group but not in the HD-PAM group. The reduction in fibrinogen level substantiates the beneficial effect and may suggest a reduction in risk of mortality.

• Risk of bias (no blinding)
• Retrospective study

Nurses should monitor fever, mucositis, and onset of infection; educate patients on infection prevention and use of medications; and advocate for use of palifermin in high-risk populations, including the elderly, those receiving BEAM/BUS therapy, or heavily pretreated patients.

To determine the risk of lymphedema associated with immediate breast reconstruction compared to mastectomy alone

Patients were screened for lymphedema prospectively, and lymphedema rates were compared between those who had immediate breast implantation, immediate autologous reconstruction, and those who had mastectomy alone. Each breast was considered individually in analysis. Follow-up was a median of 22.2 months.

• N = 616 women with breast cancer, 891 mastectomies
• MEAN AGE = 48 years
• AGE RANGE = 28–81 years 
• FEMALES: 100%
• CURRENT TREATMENT: Other
• KEY DISEASE CHARACTERISTICS: Patients with breast cancer who underwent mastectomy and immediate breast reconstruction or mastectomy alone
• OTHER KEY SAMPLE CHARACTERISTICS: Patients with breast cancer with risk of lymphedema; 65% (580 of 891) had an immediate implantation, 11% (101 of 891) had immediate autologous reconstruction, and 24% (210 of 891) had no reconstruction.

• SITE: Single site   
• SETTING TYPE: Outpatient    
• LOCATION: Massachusetts General Hospital, Boston, MA

PHASE OF CARE: Late effects and survivorship

Prospective cohort study

Arm measurements were performed preoperatively and during postoperative follow-up using a perometer. Lymphedema was defined as 10% or more arm volume increase compared to preoperative. Measurement was adjusted for body weight.

Overall incidence of lymphedema was 10.58%. Among those who had immediate breast reconstruction, the incidence of lymphedema was 5.13% compared to 26.66% among those with no immediate reconstruction. Both immediate implantation (HR = 0.172, p < 0.0001) and autologous (HR = 0.467, p = 0.0077) were associated with reduced risk of lymphedema compared to no reconstruction. Factors associated with increased risk of lymphedema were a body mass index greater than or equal to 30, axillary lymph node dissection (ALND), and number of lymph nodes dissected.

Immediate implantation reconstruction does not appear to increase the risk of lymphedema compared to mastectomy alone; however, the findings are limited by significant differences in cohort characteristics shown to be associated with lymphedema incidence.

• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Key sample group differences that could influence results
• Measurement/methods not well described
• Findings not generalizable
• Defining lymphedema as more than a 10% limb volume increase indicate moderate to severe lymphedema; the lower incidence of lymphedema should be cautioned since 5% of limb volume increase has a negative effect on patients’ quality of life. A significantly lower proportion of those in the immediate reconstruction group had a body mass index of greater than or equal to 30 and had ALND (p < 0.0001). Patients in the no-reconstruction group were significantly older, and age at surgery was a univariate predictor of lymphedema hazard.

Nurses should be advised that although immediate reconstruction may not increase the risk of lymphedema, risk reduction for this population should continue.

To evaluate the effect of 0.1% mometasone furoate on a acute skin-related toxicity in patients undergoing breast or chest-wall radiotherapy

Patients were randomly assigned to either 0.1% mometasone furoate cream or an identical-looking placebo cream. Patients were to apply toe cream once daily to the area under treatment not less than four hours before or after radiation therapy. Creams were used throughout the radiation therapy course. No other topical agents were to be used. If the primary physician initiated a medication other than the study agent, the study medication was discontinued and evaluations continued according to the study protocol. Patients were evaluated at baseline and weekly by treatment providers.

• The study sample (N = 166) was comprised of patients with breast cancer.
• Other sample characteristics were not clearly reported.
   

The study took place at the May Clinic in Rochester, NY.

The study used a double-blind placebo-controlled randomized clinical trial design.

• The National Cancer Institute's Common Termonology Criteria for Adverse Events (version 3.0) was used.
• Patient-reported outcomes were measured using the Skindex-16, the Skin Toxicity Assessment Tool, a Symptom Experience Diary (rated multiple skin toxicity signs and symptoms on a 0–10 scale), and a quality-of-life self-assessment.
   

There was no significant difference between groups in the mean grade of provider-assessed radiation dermatitis. The Skindex-16 showed no statistically significant difference between groups. In the Symptom Experience Diary, patients in the mometasome arm reported less burning, itching, and redness (p < 0.02). There was no difference between groups in quality of life.

Topical mometasone furoate was associated with less burning, itching, and redness but did not show any significant effect on overall radiation-induced skin toxicity.

• No demographic data were reported. 
• It is not stated if any patients were also receiving chemotherapy or whether any patients received other topical agents as allowed. 
• The only explanation provided for the 10% dropout rate was discontinuation.

Findings suggest that topical corticosteroid use or mometasone does not significantly reduce the severity of radiodermatitis but may reduce patient symptoms of burning, itching, and redness. Though topical steroids may not prevent dermatitis, their use may help patients be more comfortable during radiation treatment.

To evaluate the rate of lymphedema occurrence in patients who recieved a mastectomy and a sentinel lymph node biopsy (SLNB) with radiation therapy (RT) compared to an axillary lymph node dissection (ALND) with or without RT, with a secondary purpose to identify risk factors for development of lymphedema

• N = 627  
• MEDIAN AGE = 50 years (range = 22–85 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Individuals who underwent mastectomies after a diagnosis of primary breast cancer between September 2005 and February 2013.

• SITE: Single-site  
• SETTING TYPE: Not specified  
• LOCATION: Massachusetts General Hospital in Boston, United States

• PHASE OF CARE: Multiple phases of care

Pre/post design with repeated measures

• A perometer was used to measure arm volume.
• Weight-adjusted arm volume change (WAC) was used to detect arm volume change in each arm individually.
• Lymphedema was defined as a measurement of ≥ 10% WAC.

Avoiding completion ALND and receiving SLNB with RT may decrease lymphedema risk in patients requiring a mastectomy. This study indicates that the application of the American College of Surgeons Oncology Group's Z0011 treatment protocol may reduce the risk of lymphedema for patients who receive a mastectomy.

• Risk of bias (no random assignment)
• Key sample group differences that could influence results
• Other limitations/explanation: The group that received SLNB without RT was small (n = 34). Less than half (44%) of patients who received SLNB without RT had a positive SLNB. This was a single-site study.

The study provides nurses with information about SLNB with RT and how its use may decrease the risk of developing lymphedema compared to patients who recieve ALND. However, the nonrandomized, controlled trial design and the different sample sizes of each study group limit the ability to generalize this study's findings. Future randomized, controlled studies are warranted.

• Databases searched were MEDLINE and CINAHL (1990-2002).
• Search keywords were nausea, vomiting, chemotherapy and neoplasm, assessment, management, complementary therapies, pharmacological, and nonpharmacological.
• Studies were included in the review if they included primary research, literature reviews, opinion articles, and information leaflets/booklets.
• Studies were excluded if they involved anticipatory nausea and vomiting associated with chemotherapy, because the authors felt that symptoms with a psychological basis should be addressed in a separate paper.

• Nonpharmacologic management interventions were reviewed with the intention that they do not replace standard antiemetic therapies but, rather, are adjuncts to improve quality of life (QOL).
• Intervention articles were reviewed for progressive muscle relaxation, guided imagery, self-hypnosis, acupressure/acupuncture, transcutaneous electrical nerve stimulation, biofeedback, cognitive distraction, and music therapy.

Support for the use of nonpharmacologic interventions for the treatment of chemotherapy-induced nausea and vomiting (CINV) was weak.

Many studies were flawed because of small sample sizes and confounding variables (e.g., stage of disease, various chemotherapy regimens, culture, patient compliance).

Preliminary available evidence suggests positive benefits through nonpharmacologic techniques; however, larger randomized trials are needed to demonstrate the exact benefits, including economic.

The intervention was a 75-minute supportive-affective group that met monthly offering Life-Threatening Illness Supportive-Affective Group Experience (LTI-SAGE). These groups were for education and support, not group therapy. Topics included

• Group dynamics and expectations
• Recognizing and asserting needs
• Feelings and emotions
• Symptom control
• Living well while ill
• Intimate relationships
• Spiritual needs
• Asking for help
• End-of-life care planning/decision making
• Legacy
• Hope
• Group closure.

Groups consisted of three to eight patients, with one or two group facilitators.

Two measurements were taken: baseline and 12 months

In the intervention group (n = 37), group assignment was based on diagnosis and race.

In the control group (n = 32), patients received quarterly mailings of existing, readily available self-help resource materials, with a phone call to ensure that mailings were received.

The study reported on a sample of 69 African American and Caucasian patients with any serious medical condition severe enough to create a limited life expectancy (not cause death within six months).

The study was a randomized pre/post-test trial with a longitudinal design.

• Beck Depression Inventory
• State-Trait Anxiety Inventory (STAI)
• Death Distress Scale
• Spiritual Well-Being Scale
• Illness Disability Index
• Perceived Social Support Inventory
• Analysis of covariance
• Statistics done in two ways: intent-to-treat basis (with the seven noncompliant patients) and also with the seven noncompliant patients removed from the intervention group

• In the intervention group, 7 patients attended 3/12 groups and 21 patients attended 9/12 groups.
• There were no significant statistical differences between groups in anxiety levels. The intervention group did enjoy reduced depression, increased spiritual well-being, and reduced death-related feelings of meaninglessness; p level set at 0.10.
• STAI stats: t(40) = 0.8 with p value 0.40 at baseline
• SSAI postintervention: p = 0.70

• The study had a small sample size.
• Not all patients were diagnosed with cancer.
• The intervention required specially trained facilitators to teach groups.

• FINAL NUMBER STUDIES INCLUDED = 8
• TOTAL PATIENTS INCLUDED IN REVIEW = 1,356
• SAMPLE RANGE ACROSS STUDIES = 40–496 patients 
• KEY SAMPLE CHARACTERISTICS: Most study participants had advanced cancer, all were in palliative care, and all were adults over the age of 18 years. Various corticosteroids were used in studies including dexamethasone, methylprednisolone, and betamethasone. Range of doses (dexamethasone-equivalent doses) ranged from 3–25 mg per day via various routes including oral and IV. One study included the use of metoclopramide, one included the use of megestrol, and four studies included use of a placebo.

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

All studies showed an improvement in appetite with the specific steroid used in the study. Side effects were an issue for continued treatment and led to attrition of rates between 16% and 63%. Improvement in appetite was shown to continue through up to eight weeks of therapy. Side effects were a common cause of attrition.

Corticosteroids can be beneficial in treating anorexia in patients with malignancies who are in the palliative care setting. There is inadequate data to recommend a specific steroid over another or a specific dose of the steroid for the management of anorexia.

Various steroids, various routes of administration, and various doses were used, making it difficult to make any conclusions. Steroids are associated with significant side effects including gastrointestinal bleeding, oral candidiasis, and proximal myopathy.  

Anorexia is a significant problem in individuals with cancer, especially in certain malignancies and at the end of life. Nurses need to be aware of potential treatment options and side effects of these treatments to enhance patients' quality of life.

To determine the effectiveness of laxative administration for constipation in patients receiving palliative care; to differentiate among laxatives being used regarding efficacy for constipation management.

Databases searched were Medline, Embase, CANCERLIT, PubMed, CINAHL, System for Information on Grey Literature in Europe (SIGLE), National Technical Information Service (NTIS), Department of Health and Social Security (DHSS-DATA), Science Citation Index, Cochrane Central Register of Controlled Trials (CENTRAL), Dissertation Abstracts, and the Index to Scientific and Technical Proceedings. Conference proceedings and references of articles reviewed were also hand searched.

Search keywords were palliative care, cathartics (adverse effects; therapeutic use), constipation (drug therapy), and randomized controlled trial as topic. 

Studies were included in the review if they

• Were a randomized controlled trial (RCT) of the efficacy of laxatives in palliative care patients
• Reported on a sample of adult patients receiving palliative care interventions who reported constipation
• Involved the use of any oral or rectal laxatives
• Included the outcome measures patient-reported relief of constipation in terms of frequency and ease of defecation, relief of related symptoms such as distension, appetite improvement, and improvement of quality of life.

Studies were excluded if they included healthy volunteers, patients with constipation as a result of drug misuse, patients with bowel obstruction, or other interventions such as opioid antagonists.

Two hundred twelve studies were initially retrieved. After removal of duplicates and studies that did not meet inclusion criteria, three studies were finally included. Study quality was assessed using the Jadad scale and additional criteria identified including issues of accrual, homogeneity, attrition, interventions, quality of outcome measurement, and clarity of results presentation. The review provided extensive detail on quality assessment findings and rationale for study exclusion. Included studies used senna, lactulose, danthron combined with poloxamer, misrakasneham, and magnesium hydroxide combined with liquid paraffin.

The final sample of three studies involved a total of 162 patients, with study samples ranging from 36 to 75.

• One study found no differences between groups taking senna and lactulose.
• One study found no difference between patients with advanced cancer taking misrakasneham and senna.
• One study of hospice patients with cancer found that those taking lactulose plus senna had significantly higher stool frequency than those using danthron and poloxamer. This pattern was true in patients at varied levels of opioid use. This study used a crossover design and showed that significantly fewer patients reported constipation when taking lactulose plus senna.
• One study in hospice patients with cancer found no difference between patients taking lactulose plus senna versus those taking magnesium hydroxide and liquid paraffin. In patients taking different levels of opioids, a trend to less constipation existed in the lactulose plus senna group, but the trend was not statistically significant.
• No significant differences were found between opioid-level groups in terms of laxative results.
• Diarrhea was reported as an adverse effect in studies for both senna and lactulose.
• Where patient preference was reported, no differences were found between most combinations. Patients preferred lactulose plus senna over magnesium hydroxide and liquid paraffin. The basis of preference was usually taste.
• The authors included a general literature review of constipation treatments.

The treatment of constipation in palliative care patients is not based on sufficient data from RCTs. Recommendations for laxatives may be based as much on cost as on efficacy. Polyethylene glycols are widely used in palliative care despite lack of evidence. The authors did not note evidence in this area in other patient populations that may be applicable.

This review and included studies did not provide sufficient information to draw conclusions about the laxatives in terms of weighing effectiveness versus adverse side effects.

• Little research exists in this area, and very few direct comparisons have been done between laxative classes and combinations to compare efficacy.
• Because of the lack of evidence in this area, determining most effective treatments is difficult.

This area could benefit from research to compare effects and cost effectiveness. Some findings suggested effect and preference for lactulose combinations, whereas lactulose tends to be much more expensive than alternatives.

Test the effect of Tibetan sound meditation on cognitive function

Patients randomly were assigned to the treatment group or a wait list control group. The intervention consisted of 12 meditation sessions that were 60 minutes long and incorporated instructions on developing breathing, awareness, and concentration skills, as well as visualization maneuvers. The intervention was offered twice a week over six weeks. A CD recording and printed materials were provided to the participants with the expectation that they practice the intervention independently at home. Objective and subjective outcome measures were evaluated at baseline and one month after completion of the intervention. Subjective measures also were completed during the last week of the intervention. Class attendance and participant satisfaction were tracked to measure the feasibility of the intervention program.

• N = 42 (18/24)  
• MEAN AGE = 53.6 years
• MALES: 0%, FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All subjects had breast cancer, had received chemotherapy 6–60 months prior to study participation, and were on hormonal therapy at the time of enrollment.
• EDUCATION: Some college or higher: 95.6%, TSM: 74.9%

• SITE: Single-site  
• SETTING TYPE: Outpatient  
• LOCATION: MD Anderson Cancer Center

• PHASE OF CARE: Late effects and survivorship
• APPLICATIONS: Late effects and survivorship  

Randomized clinical trial

• Digit span test
• Digit symbol test
• Controlled Oral Word Association Test
• Rey Auditory Verbal Learning Test
• Functional Assessment of Cancer Therapy (FACT)-Cog
• Center for Epidemiologic Studies Depression Scale (CES-D)
• Pittsburgh Sleep Quality Index (PSQI)
• Brief Fatigue Inventory (BFI)
• Medical Outcomes Study 36-item (SF-36)
• Functional Assessment of Chronic Illness Therapy—Spiritual Well-being Scale (FACIT-Sp)

No significant differences were seen between the intervention or control groups in either objective or subjective measures of cognitive function over time. Although significantly less depressive symptoms were found in the treatment group (p = 0.05) during the last week of the intervention, this effect was no longer significant one month later, indicating that the result was not sustainable. No significant differences between groups over time were found for fatigue or sleep-wake disturbances. Although all treatment group participants attended at least 50% of the class sessions, compliance was a variable for both class and individual participation.

Findings from this study do not provide clear support for a significant effect of Tibetan sound meditation on cognitive function, fatigue, or sleep-wake disturbances. However, this intervention may have a limited, short-term effect on decreasing depression.

• Small sample (< 100)
• Risk of bias (no appropriate attentional control condition)
• Unintended interventions or applicable interventions not described that would influence results
• Findings not generalizable
• Subject withdrawals ≥ 10%
• Feasibility may be an issue, as evidenced by subject withdrawal prior to the initiation of the intervention (may indicate that the “treatment” is too burdensome) and the variability in overall treatment participation. Generalization of the result to all patients with cancer is not possible due to the population used for the study.

Although this treatment was not associated with improvements in objective or subjective measures of cognitive function, it was underpowered and lacking consistent patient compliance with the intervention. Further research with larger sample sizes may be warranted to determine effectiveness.

To examine the feasibility and preliminary efficacy of Tibetan yoga practice as a supportive approach for patients and caregiver dyads during radiation therapy for lung cancer

Participants had two to three weekly sessions of yoga for 45–60 minutes over five to six weeks. The program included deep breathing awareness and visualization, guided meditation, compassion-based meditation, and gentle movements coordinated with specific breathing patterns. Patients and caregivers completed study measures at baseline and at the end of the program.

• N = 10 dyads  
• MEAN AGE = 71.22 years (patients, range = 61–82 years); 68.77 years (caregivers, range = 61–78 years)
• MALES: Patients 50%; caregivers 10%, FEMALES: Patients 50%; caregivers 90%
• KEY DISEASE CHARACTERISTICS: All patients had lung cancer and were receiving radiation therapy. 50% had stage IIIb disease. Average time since diagnosis was 2.88 months, range 1.13–5.97 months.
• OTHER KEY SAMPLE CHARACTERISTICS: Slightly greater than 50% of participants had some college level or higher education, 80% were white, and 75% had incomes greater than $50,000 per year.

• SITE: Single-site    
• SETTING TYPE: Outpatient  
• LOCATION: Texas

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

Single-group, prospective pilot study

• Center for Epidemiologic Studies Depression Scale (CES-D)
• Anxiety dimension of the Brief Symptom Inventory (BSI)
• Pittsburgh Sleep Quality Index (PSQI)
• Brief Fatigue Inventory (BFI)
• Medical Outcomes Study Short-Form Health Survey (SF 36)
• Functional Assessment of Cancer Therapy Spiritual Well Being Scale (FACT-Sp)
• Finding meaning in cancer scale

Ten of 19 consenting dyads completed the study and attended a mean of 12 sessions (range = 6–15). For patients, there was a significant increase in spiritual well-being (d = 1.12, p = .03), improvement in sleep (d = .60), and depressive symptoms (d = .52). There were small effects for anxiety. For caregivers, there were significant decreases in fatigue (d = .89, p = .03) and anxiety (d = .81, p =.04) and some reduction in sleep disturbance (d = .71, p =.08). Class attendance and home practice frequency was not associated with differences seen in symptoms for either patients or caregivers.

A couple-based yoga program was seen as feasible for patients, including those with advanced disease. Medium effect sizes were seen for depressive symptoms and sleep disturbance.

• Small sample (< 30)
• Risk of bias (no control group)
• Subject withdrawals ≥ 10%

Couple-based yoga sessions were shown to be feasible, and findings suggest that this type of supportive care during radiation therapy may be beneficial in some patients and caregivers for symptoms of fatigue, anxiety, depression, and sleep disturbances. The high drop-out rate suggests that many patients may not be interested or able to participate in such a program, but for those who are interested, it may be helpful. The fact, however, that the number of sessions attended and frequency of home practice were not related to the magnitude of results seen causes one to question whether it was the yoga practice or general support and attention provided that caused effects.