STUDY PURPOSE: To evaluate the effects of spiritual interventions in patients with cancer

TYPE OF STUDY: Meta-analysis and systematic review

• FINAL NUMBER STUDIES INCLUDED = 15
• TOTAL PATIENTS INCLUDED IN REVIEW = 827
• SAMPLE RANGE ACROSS STUDIES: 24–120 patients

PHASE OF CARE: Multiple phases of care 

APPLICATIONS: Palliative care

Primary outcomes were spiritual well-being and meaning of life. Anxiety and depression were secondary outcomes. Nine studies examined effects on depression, and six examined effects on anxiety. Seven studies were randomized, controlled trials. There was a moderate effect on spiritual well-being. A large effect size was seen for anxiety (d = - 0.87, p = 0.02), and a moderate effect size for depression was found (d = - 0.62, p = 0.001). The largest effect sizes were seen in studies that were not randomized, controlled trials. Interventions were categorized as religious or existential. Religious interventions had an impact on depression, and existential interventions had an effect on anxiety. There was substantial heterogeneity. This article reports numerous subgroup analysis results based on type of intervention, the intervention provider, and other variables. In the majority of cases, interventions were provided by nurses.

The findings of this meta-analysis suggest that religious and existential spiritual interventions have a positive and at least moderate effect on anxiety and depression as well as spiritual well-being and meaning of life.

The review included nonpeer-reviewed doctoral dissertation results, and an analysis showed a probable publication bias, suggesting that studies with negative findings may not have been retrievable. There was substantial heterogeneity and a varied risk of bias across studies. The highest effect sizes were seen in nonrandomized, controlled studies, which also had the highest risk of bias and heterogeneity. Most studies were of patients at the end of life, so findings may not be applicable to patients at other stages of care.

The findings of this meta-analysis suggest that spiritual interventions, particularly at the end of life, can be beneficial in reducing anxiety and depression and increasing a sense of spiritual well-being and meaning of life. Nurses traditionally recognize the importance of the spiritual dimensions of care, and these findings support that view. The findings must be viewed with caution given the limitations of these results. However, spiritual interventions are low-risk and, as shown here, can be delivered by nurses who already have relevant proficiencies such as engagement, caring, support, and communication.

To evaluate the effects of combined aerobic and strength exercise on physical performance and symptoms in patients who are hospitalized while receiving myeloablative therapy

Patients were randomly assigned to the exercise intervention or usual care. Usual care patients were allowed to undergo physical therapy as medically indicated according to standard practice. The intervention group included ergometer endurance training for 10–20 minutes and resistance exercises for main muscle groups for 20 minutes. Exercises were done five days per week during the entire hospital stay, and training intensity was individually adjusted based on spiroergometry at study entry. Training was suspended if patients experienced fever, infection, thrombocytopenia (platelet < 20,000) cardiac arrhythmia, or life-threatening clinical complications. Neutropenic patients wore masks when they left their rooms. Follow-up assessment was done at 12 months.

• N = 48
• MEAN AGE = 52 years
• MALES: 70.8%, FEMALES: 29.2%
• KEY DISEASE CHARACTERISTICS: Most frequent diagnoses were acute myeloid leukemia (AML) and non-Hodgkin's lymphoma (NHL)

• SITE: Single-site  
• SETTING TYPE: Inpatient  
• LOCATION: Germany

• PHASE OF CARE: Active antitumor treatment

Randomized controlled trial

• Spiroergometry oxygen consumption measurement
• European Organization for Research and Treatment of Cancer Quality of Life (EORTC-QLQ-C30) scale
• Modified Fatigue Impact Scale (MFIS)

The median duration of exercise training was 15 days with the median hospital stay being 21 days. The control group’s lung function as measured by oxygen consumption increased. Treatment group oxygen consumption and expiratory minute ventilation volume was significantly higher at the end of the study compared to controls (p < .05). EORTC physical functioning was significantly higher in the treatment group compared to controls (p = .04). There were no other differences in symptoms between groups. The treatment group complained of fatigue for fewer days than those in the control group (p = .04). Self-report of overall condition at 12 months indicated no significant difference between groups. There were no exercise-related adverse events.

This study demonstrated that exercise training during myeloablative chemotherapy is feasible, well-tolerated, and may improve physical performance during treatment.

• Small sample (< 100)
• Risk of bias (no blinding)
• Subject withdrawals ≥ 10% 
• Other limitations/explanation: High drop-out rate

Findings suggest that exercise training during hospitalization for myeloablative chemotherapy is generally well-tolerated. The study was underpowered to show any effect on symptoms of fatigue; however, exercise training was associated with improved physical performance measures. Nurses can advocate for exercise programs for this group of patients.

To evaluate the effectiveness of various interventions to manage the skin effects of cetuximab.

All 31 patients developed the typical acneform rash that occurs from six to 20 days after the first dose of cetuximab. Emollients were recommended for grade 1 acneform eruptions. For patients who developed grade 2 reactions, the same topical treatment as for grade 1 was used, with the addition of topical antibiotic treatment: 1% solution of clindamycin BID for two to three weeks until pustules ceased. The H1 antihistamine loratadine was recommended to relieve itching.

All patients were advised to wash with bath oil or shower with tepid water, avoid sun exposure, and use sunscreen products with high sun protection factor. For grade 1 rash, patients were advised to use topical preparations for moisturizing that contain dexpanthenol (e.g., Bepanthen^® cream or lotion), applied BID. For grade 2 rash, patients used the same topical preparation, plus a topical antibiotic treatment. Finally, for grade 3 rash, treatment with cetuximab was discontinued until the reaction resolved and a combination of emollients, topical antibiotics, and systemic antibiotics was given.

• The study reported on a sample of 31 patients with metastatic colorectal cancer who were treated with cetuximab as third-line or further-line treatment after failure with irinotecan.
• Mean patient age was 56.3 years (range 36–76 years).
• Nineteen patients were men, and 12 were women.

Institute of Oncology in Ljubljana, Slovenia

This was a descriptive study on the effectiveness of various interventions for dermatological toxicities related to cetuximab.

Skin toxicity was evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.

• Of 31 patients in this study, 6 had grade 3 rashes, 16 had grade 2 rashes, and 9 had grade 1 acne-like rashes.
• The authors reported the numbers of patients who used various treatments, but did not report the effectiveness of emollients for grade 1 or grade 2 rashes. They stated, “Generally, for treatment of skin reactions (relief of pain, discomfort, and healing) for the patients experiencing Grade 1 acneform eruptions, the skin should be treated with emollients and moisturizers (containing dexpanthenol) to ensure a maximal hydration of the skin for at least two weeks.”

Grade 3 skin rash was generally manageable with emollients, topical antibiotics, and systemic antibiotics. The effectiveness of emollients on grade 1 and 2 rashes was not reported.

• This was a descriptive study, not a randomized controlled trial.
• The sample of patient reports was small.
• Treatment was based on expert opinion.
• A combination of interventions was used; therefore, determining the effectiveness of the individual interventions is difficult.

Patients receiving cetuximab were seen weekly and started with topical 0.1% vitamin K1 cream with urea applied BID, beginning with first noted rash.

• The study reported on a sample of 30 patients.
• The sample comprised patients with colorectal cancer being treated with cetuximab who experienced acne-like rash (grade 3: n = 6; grade 2: n = 18; grade 1: n = 6).

Department of Medical Oncology at the Institute of Oncology Ljubljana in Slovenia

This was a case report series.

Severity was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.

Rash was improved in all patients after eight to 18 days of initiating cream with urea and 0.1% vitamin K1 applied BID.

Application of cream with urea and 0.1% vitamin K1 BID was effective in managing cetuximab-induced rash.

• This was a case report series.
• Various grades of rash existed with additive interventions dependent on grade.

To analyze the outcome of maintenance combined physical therapy (MCPT) for five years in patients with unilateral breast cancer-related lymphedema

This was a review of the outcomes of MCPT after five years in patients with lymphedema after unilateral mastectomies, noting adherence to therapy and garments as prescribed. Maintenance consisted of compression garments, a program of physical exercise, preventive and hygiene education, and regular follow-up visits every six months. Outcomes were compared between those who continued regular follow-up and those who did not.

• N = 60
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Unilateral mastectomy with lymphedema
• OTHER KEY SAMPLE CHARACTERISTICS: Recurrent cancer diagnoses were excluded.

• SITE: Single site
• SETTING TYPE: Outpatient
• LOCATION: Lymphedema clinic St. Lazarus Hospice in Kraców, Poland

Descriptive

• Limb volume measurements
• Garment suitability assessment

Factors determining effectiveness included access to treatment. Patients who completed initial CPT and regularly followed up showed a reduction in volume and maintained this reduction.

• Small sample (< 100)
• Baseline sample/group differences of import
• Risk of bias (sample characteristics)
• Selective outcomes reporting
• Other limitations/explanation: Potential treatment bias was seen in a statement not measured by the article: \"A marked and rapid improvement was achieved using the full scope of ICDT although similar results can also be obtained without manual lymph drainage.\"

Adherence to long-term therapy is important for successful maintenance. Identifying barriers such as access to treatment, financial issues related to garments, and perceived barriers to maintenance, which was not fully addressed in this article, is important.

PHASE OF CARE: Active antitumor treatment
 
APPLICATIONS: Pediatrics, elder care

The primary outcome (overall severity of oral mucositis) of this analysis was that prophylactic LLLT reduced the overall risk of severe mucositis when compared to a placebo or no therapy (RR = .37, 95%, CI = .18–.67, p = .001). The absolute risk reduction was -.35 (95%, CI = -.48– -.2, p < .0001). Secondary outcomes included a decreased risk of severe mucositis at the time of expected worst severity with prophylactic LLLT (RR = .34, 95%, CI = .20–.59, p = .0001). Overall mean grade of mucositis: standardized mean difference = -1.49, 95%, CI = -2– -.95;=, p < .0001. Duration of severe (grade 3 or 4) mucositis: weighted mean difference = -5.32, 95%, CI = -9.45– -1.19, p = .01. Incidence of pain: RR = .89, 95%, CI = .76–1.04, p = .15. Incidence of severe pain: RR = .26, 95%, CI = .18–.37, p < .0001. Overall mean pain score: WMD = -2.46, 95%, CI = -4.4– -.77, p = .004. Number of patients needing opioid analgesia: RR = .47, 95%, CI = .37–.60, p < .0001. Unplanned interruption in radiation (from mucositis in patients with head and neck cancer): RR = .23, 95%, CI = .12–.44, p < .0001.

The overall risk of severe mucositis is decreased by the use of low-level laser therapy. The duration of mucositis, the risk of severe pain, the need for opioid analgesia, and radiation treatment interruption also is positively impacted by LLLT.

There is heterogeneity to the laser schedules, mucositis assessment scales, laser parameters, intervals, and time points for assessment and outcome reporting (per the authors). It is difficult to generalize this study to the pediatric population. The feasibility of using laser therapy continues to be an issue in nursing.

Prophylactic LLLT shows benefit in the prevention of oral mucositis. Additional research to delineate the feasibility of this intervention and define best practice is needed.

To evaluate the impact of a computer- and web-based tool on the anxiety of women who had an abnormal mammogram.

Patients were randomized in to a study group and comparison group. The study group received an email with instruction for using the Comprehensive Health Enhancement Support System (CHESS). The comparison group received a list of five credible breast imaging websites. Impact of CHESS evaluated anxiety and breast cancer worry and patient satisfaction with their physician interaction at three time points.

• N = 130  
• AGE: Older than aged 21 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Recalled after a screening mammography
• OTHER KEY SAMPLE CHARACTERISTICS: English literate; access to Internet

• SITE: Single site    
• SETTING TYPE: Outpatient    
• LOCATION: University of Wisconsin Breast Center

• PHASE OF CARE: Diagnostic
• APPLICATIONS: Elder care

Pilot study; randomized intervention and comparison group

• State anxiety (SA) subscale of the State-Trait Anxiety Inventory (STAI)
• The breast cancer worry subscale of the Lerman Breast Cancer Worry Scale (LBCWS)
• Patient Satisfaction with Doctor Questionnaire (PSQ-MD)

There was a significant difference in the anxiety scores for the intervention group at the biopsy stage (p = 0.02). There was no difference in the two groups at the diagnostic phase. There was no significant difference in the two groups for breast cancer worry.  Satisfaction with the physician was not analyzed because study participants had difficulty identifying who their physician was during the three time points.

Early CHESS may decrease anxiety in woman recalled for abnormal mammograms when combined with an identifiable care team.

• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)  
• Risk of bias (sample characteristics)
• Measurement/methods not well described

Providing resources to women with abnormal mammograms is most effective when a healthcare team interaction is provided to reduce anxiety. Online support system may have some benefit but additional research is needed to determine effectiveness for anxiety and other symptoms, and long-term efficacy needs to be examined.

STUDY PURPOSE: To evaluate the overall effect of interventions using cognitive behavioral therapy (CBT) components and to explore possible moderators of this effect, including trial design, outcomes evaluated, demographic variables, intervention duration and modality of delivery, illness-related variables among patients, and study quality

TYPE OF STUDY: Meta-analysis and systematic review

• FINAL NUMBER STUDIES INCLUDED = 36
• TOTAL PATIENTS INCLUDED IN REVIEW = 3,820 analyzed
• KEY SAMPLE CHARACTERISTICS: Randomized, controlled trials (RCTs) (K = 27) comparing CBTs with a nonactive control condition (K = 21). Individual (as opposed to group) (K = 28) therapy for couples/dyads (K = 28), and delivered face-to-face (K = 22). Patients with mixed stages of cancer (K = 14). Twelve studies explicitly stated that the intervention adhered to a cognitive behavioral framework. The most commonly employed treatment components (see definition above) were coping skills training (K = 24), problem solving (K = 15), cognitive restructuring (K = 14), structured homework (K =11), and relaxation (K = 10).

A small statistically significant effect of CBTs (Hedges' g = 0.08, p = 0.014) was revealed, which disappeared when RCTs were evaluated alone (Hedges' g = 0.04, p = 0.2). A number of variables were explored as moderators. Only the percentage of female participants was positively associated with the effect size. More specifically, females were more responsive to CBT interventions with an effect on physical health and mastery.

Based on the negligible effect of CBTs across outcomes, future studies should consider moving beyond traditional CBT methods, as these do not appear efficacious. Future interventions should orient toward advances in the basic affective sciences and derived therapies to better understand and treat the emotional struggles experienced by ICs.

• High heterogeneity
• Low sample sizes
• Variability in theoretical definition and use of CBT across studies

Translating CBT interventions to practice has been a challenge in the nursing discipline. These findings suggest that, although CBT techniques like problem solving could be meaningful, CBT may be one component of a mulitmodual intervention for the best effect for the family caregiver. Nurses should also recognize that gender may influence the possible benefit patients experience from a CBT intervention.

The purpose of this review was to review guidelines for the supportive treatment of patients undergoing adjuvant breast cancer, and to evaluate strategies that can be used to improve the safety of these regimens.  All of the studies included were with patients receiving chemotherapy for breast cancer.

Databases used were not stated.

Key words used include anthracyclines, filgrastim, hematopoietic growth factors, myelosuppression, pegfilgrastim, cost/benefit analysis

The number of studies included in the report was 29.

Sample sizes were not reported.

One meta-analysis showed that adding G-CSF prophylactically during the first cycle of chemotherapy in patients being treated for various cancer types helped to decrease the rate of febrile neutropenia from 39% in the control group versus 22.4% in the G-CSF group and made chemotherapy more tolerable, allowing patients to get the appropriate dosages. Another trial compared patients receiving TAC versus FAC initially without G-CSF for either group; researchers did give G-CSF to patients in the TAC group after febrile neutropenia rates soared and rates of febrile neutropenia in the TAC group declined and the rate of trial completion of chemotherapy increased. CALGB9741 also was analyzed and it was discovered that patients receiving the two-week cycle with G-CSF, as compared to the three-week cycle, did remarkably better in declining rates of febrile neutropenia. Another phase III trial showed that patients receiving pegfilgrastim versus placebo had significantly lower rates of febrile neutropenia.

Many of the studies mentioned by the author contributed to the determination that G-CSF should only be given on day 2 due to the elimination period of the drug and that giving it earlier than day 2 may actually increase the risk of febrile neutropenia. The other studies cited in the article were different studies that all showed improvement of febrile neutropenia rates and increase compliance with therapy due to G-CSF.

G-CSF decreases the risk of febrile neutropenia in patients with cancer undergoing chemotherapy treatment. Chemotherapeutic regimens that are dose dense also benefits from G-CSF to decrease the risk of febrile neutropenia. These studies also determined that day 2 is the appropriate day to administer G-CSF, as giving it earlier may actually increase the risk of febrile neutropenia.

The study's primary aim was to evaluate the effects of erythropoietin (epoetin alfa) on cognitive function and mood in patients with breast cancer. Its secondary aim was to evaluate the effects of erythropoietin on fatigue and quality of life of patients with breast cancer.

At the beginning of 4 weeks of chemotherapy, patients were randomly assigned to receive 40,000 units of epoetin alfa subcutaneously once weekly or a placebo, as administered over 12 weeks.

• All participants were female and had breast cancer.
• The number of participants was 94.
• There were 47 participants in the erythropoietin group and 47 in the placebo group.
• The average participant age was 53.3 ± 9.7 years in the erythropoietin group and 54.3 ± 12.0 in the placebo group.
• All participants were scheduled to receive four cycles of anthracycline-based adjuvant or neoadjuvant chemotherapy with or without a taxane.
• All participants had a Karnofsky performance score of ≥ 70% and an estimated life expectancy of ≥ 1 year.

The study took place at 13 sites in the United States.

The study utilized a longitudinal, exploratory, double-blind, randomized, placebo-controlled design.

• The Executive Interview (EXIT-25) measured executive function.
• The Clock Drawing Task (CLOX) measured executive function.
• The Functional Assessment of Cancer Therapy (FACT)-Anemia measured cancer-related quality of life specific to the symptom of anemia.
• The Karnofsky Performance Status scale (KPS) measured general well-being. Scores range from 0 (death) to 100 (perfect health with no complaints or signs of disease).
• Quality of life was measured by a linear analogue scale assessment.
• The Profile of Mood States (POMS) was also utilized. 

Although patients in the treatment arm had a greater improvement in executive function between baseline and after completion of the treatment phase, this difference was not significant. The mean change over time in executive function was similar between the two groups at the six month follow-up assessment.

The study was unable to demonstrate an effect of erythropoietin on executive cognitive functioning.

• The number of doses of erythropoietin given in the treatment group was unclear.
• The authors stated that the CLOX test was found to be an insensitive measure for detecting cognitive changes.
• There was a lack of alternate forms for repeated administration with the EXIT-25 and CLOX tests.
• The results were confounded by chemotherapy treatment variations and the eventual administration of epoetin to the placebo group after the initial treatment phase.