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Badger, T. A., Segrin, C., Figueredo, A. J., Harrington, J., Sheppard, K., Passalacqua, S., . . . Bishop, M. (2011). Psychosocial interventions to improve quality of life in prostate cancer survivors and their intimate or family partners. Quality of Life Research, 20, 833–844.

Study Purpose

To test the effectiveness of two telephone-delivered psychosocial interventions for maintaining and improving quality of life (QOL).

Intervention Characteristics/Basic Study Process

The first intervention was a telephone interpersonal counseling (TIP-C) intervention delivered weekly for eight weeks to prostate cancer survivors and every other week, for four times, to partners. The second intervention included eight weekly health education attention conditions (HEACs) delivered by telephone.

Sample Characteristics

  • Seventy-one survivors (100% male) and 70 partners (5.7% male, 94.2% female) were included.
  • Mean age was 66.99 for survivors and 61.13 for partners.
  • Patients were survivors of prostate cancer.

Setting

  • Single site  
  • Home
     

Phase of Care and Clinical Applications

  • Patients were undergoing the long-term follow-up phase of care.
  • The study has clinical applicability for late effects and survivorship and elderly care.
     

Study Design

The study used a repeated measures experimental design.

Measurement Instruments/Methods

  • Center for Epidemiologic Studies Depression Scale (CESD)    
  • Positive and Negative Affect Schedule (PANAS)
  • University of California, Los Angeles Prostate Cancer Index (UCLA PCI)
  • Multidimensional Fatigue Inventory (MFI)
  • Social Well-Being Scale
  • Perceived Social Support–Family Scale (PSS–Fa)
  • Quality of Life, Breast Cancer version–Spiritual Well-Being subscale 

Results

Improvements in depression, negative affect, stress, fatigue, and spiritual well-being were significantly higher for survivors in the HEAC intervention than in the TIP-C intervention. Partners in the HEAC intervention showed significantly greater improvements in depression, fatigue, social support from family members, social well-being, and spiritual well-being compared to partners in the TIP-C intervention.

Conclusions

Both interventions were effective in improving multiple dimensions of QOL for men with prostate cancer and their partners.

Limitations

The study had a small sample size, with less than 100 participants.

Nursing Implications

Both interventions were effective, but further research is needed.

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Badger, T., Segrin, C., Dorros, S.M., Meek, P., & Lopez, A.M. (2007). Depression and anxiety in women with breast cancer and their partners. Nursing Research, 56, 44–53.

Intervention Characteristics/Basic Study Process

This intervention provided telephone-delivered psychosocial interventions.

One group received six weeks of telephone-delivered counseling (TIP-C) sessions based on interpersonal psychotherapy/counseling principles, covering the following topics.

  • Cancer education
  • Social support
  • Awareness and management of anxiety symptoms
  • Role transitions

These phone calls averaged 34 minutes.

A second group received six weeks of telephone-delivered, self-managed exercise protocol information. The exercise protocol consisted of engaging in regular, low-impact exercise (e.g., walking for a prescribed number of minutes at least four times per week). These phone calls averaged 11 minutes.

A third group received six weeks of attention control (AC) printed information about breast cancer with brief weekly phone calls averaging seven minutes. This group did not receive counseling or encouragement to exercise.

Data were collected at baseline (T1), one week after the final call (T2), and one month after the final call (T3).

Sample Characteristics

  • The study reported on a convenience sample of 96 women with breast cancer and 96 partners (N = 192).
  • Participants were randomized to three groups, stratified by stage and treatment.
    • Group 1 consisted of 38 women and 38 partners.
    • Group 2 consisted of 21 women and 19 partners.
    • Group 3 consisted of 33 women and 30 partners.
  • There were no significant differences between groups for treatment, stage, history of depression, participation in support groups or counseling, and use of antidepressants or antianxiety medications.

Study Design

The study used an experimental design: three-wave repeated measures with a between-subjects factor (treatment group).

Measurement Instruments/Methods

  • Positive and Negative Affect Schedule (PANAS) PLUS
  • Index of Clinical Stress to make eight-item composite index of anxiety
  • Instruments used have established reliability and validity.

Results

Both telephone counseling and exercise conditions helped to significantly reduce anxiety in women and their partners (p < 0.001). The AC group did not evidence the same improvement in decreased anxiety, and their partners’ anxiety scores increased. The authors reported mixed-model ANOVA significant effect for time (p = 0.001), no significant main effect for treatment group, and significant group x time interaction (p = 0.01).

Nursing Implications

The intervention required special training needs of a psychiatric nurse counselor with oncology expertise to deliver the telephone counseling sessions. These 34-minute (on average) phone calls per weekly session (x 2—one per patient and one per partner) required more than one hour per week per couple of time to deliver the intervention.

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Badger, T., Segrin, C., Dorros, S.M., Meek, P., & Lopez, A.M. (2007). Depression and anxiety in women with breast cancer and their partners. Nursing Research, 56, 44–53.

Intervention Characteristics/Basic Study Process

This intervention provided telephone-delivered psychosocial interventions. One group received six weeks of telephone-delivered counseling (TIP-C) sessions based on interpersonal psychotherapy/counseling principles, covering the following topics.

  • Cancer education
  • Social support
  • Awareness and management of anxiety symptoms
  • Role transitions

The phone calls averaged 34 minutes. Another group received six weeks of telephone-delivered, self-managed exercise protocol information. The exercise protocol consisted of engaging in regular, low-impact exercise (e.g., walking for a prescribed number of minutes at least four times per week). These phone calls averaged 11 minutes. The third group received six weeks of attention control (AC) printed information about breast cancer with brief weekly phone calls averaging 7 minutes. This group did not receive counseling or encouragement to exercise.

A convenience sample was used.

Data were collected at baseline (T1), one week after final call (T2), and one month after final call (T3).

Sample Characteristics

  • The study reported on a sample of 96 women with breast cancer and 96 partners (N = 192).
  • The sample was randomized to three groups, stratified by stage and treatment.
    • Group 1 had 38 women and 38 partners.
    • Group 2 had 21 women and 19 partners.
    • Group 3 had 33 women and 30 partners.
  • There were no significant differences between groups for treatment, stage, history of depression, participation in support groups or counseling, and use of antidepressants or antianxiety medications.

Study Design

The study used a three-wave repeated measures design with a between-subjects factor (treatment group).

Measurement Instruments/Methods

  • Positive and Negative Affect Schedule (PANAS) PLUS Index of Clinical Stress to make eight-item composite index of anxiety
  • Mixed-model ANOVAs
  • Depression and anxiety treated as separate dependent variables, with T1, T2, and T3 being the within-subject factor
  • Three treatment groups act as between-subject factor.
  • Group x time
  • Paired t tests
  • Cronbach’s alphas (reliability) reported across time for women and partners as well as addressing construct validity
  • Instruments used have established reliability and validity.

Results

Results showed mixed-model ANOVA significant effect for time (p = 0.001), no significant main effect for treatment group, and significant group x time interaction (p = 0.01).

Both telephone counseling and exercise conditions helped to reduce anxiety in women and their partners, with significant differences (p < 0.001). The AC group did not evidence the same improvement in decreased anxiety, and their partners’ anxiety scores increased.

Limitations

  • The intervention required special training of a psychiatric nurse counselor with oncology expertise to deliver the telephone counseling sessions.
  • The 34-minute phone calls (on average) per weekly session (x 2—one for patient and one for partner) required more than one hour per week per couple to deliver the intervention.
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Baden, L.R., Swaminathan, S., Angarone, M., Blouin, G., Camins, B.C., Casper, C., . . . Smith, C. (2016). Prevention and treatment of cancer-related infections, version 2.2016. Journal of the National Comprehensive Cancer Network, 14, 882–913. Retrieved from http://www.jnccn.org/content/14/7/882.full.pdf

Purpose & Patient Population

PURPOSE: To examine the portion of the guidelines highlighting sections on antifungal and antiviral prophylaxis
 
TYPES OF PATIENTS ADDRESSED: Patients with cancer who become severely immunosuppressed following treatment

Type of Resource/Evidence-Based Process

RESOURCE TYPE: Evidence-based guideline

PROCESS OF DEVELOPMENT: Information taken from a main document on NCCN.org (specifics not noted in this highlighted article), comprehensive literature search by panel members, evaluation and determination of best practices based on the evidence
 
DATABASES USED: PubMed
 
INCLUSION CRITERIA: Studies published from 2013 to 2015; English; clinical trials of patients in phases II, III, and IV; guidelines and meta-analyses; randomized, controlled trials and validation studies

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Results Provided in the Reference

An initial search resulted in 1,162 citations, which were delimited to 277 references that contributed to these guidelines. High-level evidence findings were included as well as a review of lower-level evidence by panel members in areas where high-level evidence was lacking.

Guidelines & Recommendations

Algorithms were established for the use of antifungal and antiviral therapies and the use of vaccinations, specifically therapeutic drug monitoring of azoles; enhanced recommendations for HBV, HCV, and HIV; and vaccination utilization (outlined by disease/therapies and level of risk, p. 884–890). Overall, infection control should include prophylactic anti-infective therapies, per protocol per case, as well as ensure standards of care (e.g., hand hygiene). Considerations for susceptibility and resistance are paramount.

Limitations

  • No major limitations were noted. These werecomprehensive guidelines from a national work group.

Nursing Implications

Assessment of patient diagnosis, treatment, and preexisting comorbidities (e.g., HSV, HIV, CMV) can guide proper prophylactic anti-infective agents and vaccines. Together with following standards of practice (e.g., hand hygiene), nurses can optimize infection control.

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Badar, T., Cortes, J., Borthakur, G., O'Brien, S., Wierda, W., Garcia-Manero, G., . . . Mattiuzzi, G. (2015). Phase II, open label, randomized comparative trial of ondansetron alone versus the combination of ondansetron and aprepitant for the prevention of nausea and vomiting in patients with hematologic malignancies receiving regimens containing high-dose cytarabine. BioMed Research International, 2015, 497597. 

Study Purpose

To compare the effectiveness of antiemetic regimens including ondansetron with and without aprepitant to prevent chemotherpy-induced nausea and vomiting (CINV)

Intervention Characteristics/Basic Study Process

Patients were randomized to receive (a) an antiemetic regimen consisting of ondansetron 8 mg IV 30 minutes before chemotherapy followed by 24 mg IV in a continuous infusion daily till 6–12 hours after the last dose of chemotherapy or (b) the same ondansetron regimen with the addition of oral aprepitant 125 mg 6–12 hours before chemotherapy and 80 mg daily till one day after the last dose of chemotherapy. Data were collected for six days following chemotherapy administration.

Sample Characteristics

  • N = 83
  • AVERAGE AGE = 51 years
  • MALES: 56%, FEMALES: 44%
  • KEY DISEASE CHARACTERISTICS: Acute myeloid leukemia, high-risk myelodysplastic syndrome, or chronic myeloid leukemia in blast phase
  • OTHER KEY SAMPLE CHARACTERISTICS: Receiving cytarabine-based chemotherapy at a dose ≥ 1 g/m2 per day for at least three days

Setting

  • SITE: Not stated  
  • SETTING TYPE: Not specified    
  • LOCATION: Not described

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Randomized, controlled trial

Measurement Instruments/Methods

  • Not well described
  • Daily diary to record episodes of nausea or vomiting and any rescue medications needed

Results

There were no statistically significant differences in the prevention of CINV or use of rescue medications between the two arms.

Conclusions

There was no difference in CINV prevention between antiemetic regimens of ondansetron with or without aprepitant.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Measurement/methods not well described
  • Measurement validity/reliability questionable

 

Nursing Implications

There was no significant difference between antiemetic regimens of ondansetron with or without aprepitant in the prevention of CINV. There may not be a benefit to adding aprepitant to standard antiemetic therapy in this population of patients.

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Badalamenti, G., Incorvaia, L., Provenzano, S., Bronte, G., Leto, G., Fulfaro, F., & Maltese, G. (2013). Lenograstim in preventing chemotherapy-induced febrile neutropenia in patients with soft tissue sarcoma. Anticancer Research, 33, 679–684.

Study Purpose

The purpose of the study was to evaluate incidence of febrile neutropenia and grade 4 neutropenia after receiving lenograstim prophylaxis.

Intervention Characteristics/Basic Study Process

All patients received G-CSF prophylaxis with 263 mcg from days 5–9 in patients receiving three cycles of epirubicin and ifosamide for soft tissue sarcoma. Patients were observed for three cycles. Blood counts were done on days 8,15, and 22.

Sample Characteristics

  • 36 total participants
  • Median age was 53, range was 19–72
  • 48% were male, 52% were female
  • All had soft tissue sarcoma and were receiving chemotherapy regimens associated with a 50% risk of febrile neutropenia 
  • All patients were chemotherapy naive.

Setting

  • Single site
  • Outpatient
  • Italy

Phase of Care and Clinical Applications

Active antitumor treatment

Study Design

Observational

Measurement Instruments/Methods

  • CTCEA [v.4.03]
  • Febrile neutropenia was defined as an absolute neutrophil count of less than 1,000/mm3 and single temperature greater than 38.3ºC.

Results

There were no episodes of febrile neutropenia. Grade 4 neutropenia was seen in 17% of patients—58% on day 8, 29% on day 15, and 13% on day 22.  No treatment delays or dose reductions were required.

Conclusions

G-CSF as given here was effective in preventing the risk of febrile neutropenia and grade 4 neutropenia in patients receiving chemotherapy associated with high risk for these adverse events.

Limitations

  • Small sample (less than100)
  • Risk of bias (no control group) 
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Risk of bias(sample characteristics)
  • Findings not generalizable
  • Homogenous group of patients receiving the same chemotherapy regimen
  • Findings may not be generalizable to other groups

Nursing Implications

Prophylactic G-CSF reduced risk of febrile neutropenia and grade 4 neutropenia in patients at risk for these problems during chemotherapy for soft tissue sarcoma. The most appropriate timing of prophylactic colony-stimulating factor is not clear. The timing studied here appeared to be effective.

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Bach, H.V., Kim, J., Myung, S.K., & Cho, Y.A. (2016). Efficacy of ginseng supplements on fatigue and physical performance: A meta-analysis. Journal of Korean Medical Science, 31, 1879–1886. 

Purpose

STUDY PURPOSE: To investigate the effectiveness of ginseng supplements for reduction of fatigue and enhancement of physical performance

TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy

DATABASES USED: PUBMED, EMBASE, Cochrane Library
 
INCLUSION CRITERIA: Randomized, controlled trials comparing ginseng to placebo

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 155
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Jadad scale for methodological quality

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 12, 4 on fatigue reduction and 8 for physical performance 
  • TOTAL PATIENTS INCLUDED IN REVIEW = 458 for fatigue, 212 for performance
  • SAMPLE RANGE ACROSS STUDIES: 19–271
  • KEY SAMPLE CHARACTERISTICS: Most studies were of healthy adults. One study on cancer, one on multiple sclerosis, and one on chronic idiopathic fatigue

Phase of Care and Clinical Applications

PHASE OF CARE: Not specified or not applicable

Results

Ginseng supplements were associated with an overall standard mean difference of 0.34  (95% confidence interval [0.16, 0.52]) for fatigue reduction; however, duration of use was only six weeks or less, and doses of less than 1000 mg/day showed no effect. No effect was seen for physical performance.

Conclusions

Ginseng may be helpful for fatigue reduction; however, this analysis included few studies and only one study on individuals with cancer. This analysis provides insufficient evidence to draw firm conclusions.

Limitations

  • Limited number of studies included
  • Low sample sizes
  • Authors stated that numerous randomized, controlled trials were excluded because of insufficient data.

Nursing Implications

Limited evidence exists to show the efficacy of ginseng supplements overall for fatigue reduction, and evidence here does not show any improvement in physical performance with ginseng.

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Bacelar Arruda, M.A., Garcia, M.A., and Santos Garcia, J.B. (2016). Evaluation of the effects of music and poetry in oncologic pain relief: A randomized clinical trial. Journal of Palliative Medicine, 19, 943–948. 

Study Purpose

To evaluate the effects of listening to music and poetry on pain, depression, and hope

Intervention Characteristics/Basic Study Process

Patients were randomly selected for inclusion and then randomly assigned to listen to instrumental music or poetry readings on a MP3 players or to a control group. Therapies were offered for three days and for 30 minutes at a time. Study measurements were obtained before and after the intervention on day 1 and again on the last day. Listening was monitored. The daily variations in pain of the music and poetry group were compared to those of the control group.

Sample Characteristics

  • N = 65   
  • AGE RANGE = 18 years to older than 60 years
  • MALES: 28%, FEMALES: 72%
  • KEY DISEASE CHARACTERISTICS: Various tumor types
  • OTHER KEY SAMPLE CHARACTERISTICS: Of the participants, 38% were receiving NSAIDs and weak opioids, and 43% were receiving NSAIDs and strong opioids.

Setting

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

Study Design

Randomized, parallel-group, prospective trial

Measurement Instruments/Methods

  • Visual analog scale (VAS) for pain
  • Beck Depression Inventory (BDI)
  • Herth Hope Scale

Results

Listening to music was associated with improvement in pain (p < 0.001) and depression (p = 0.004). Listening to poetry was associated with improvement in pain (p < 0.001), depression (p = 0.001), and hope (p = 0.009). Individuals with either intervention had improvement in pain compared to the controls (p < 0.001), but no difference was observed in other outcomes.

Conclusions

Listening to music or poetry reading may help in the management of pain and depressive symptoms.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Unintended interventions or applicable interventions not described that would influence results
  • Measurement/methods not well described
  • Although measurements were conducted at several time points during the study, the actual measurement used for reporting was not specified.
  • No information was provided on the reason for patient hospitalization. 
  • No information was provided regarding analgesic dosages or changes during the study period.

Nursing Implications

Listening to music or poetry may be beneficial to patients in the management of pain and dealing with depressive symptoms. Flaws in this study limit the strength of these findings; however, these are low-risk and low-cost interventions that might be beneficial. The type of music and poetry would likely affect the results for various patients.

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Babu, G., Saldanha, S.C., Kuntegowdanahalli Chinnagiriyappa, L., Jacob, L.A., Mallekavu, S.B., Dasappa, L., . . . Arroju, V. (2016). The efficacy, safety, and cost benefit of olanzapine versus aprepitant in highly emetogenic chemotherapy: A pilot study from South India. Chemotherapy Research and Practice, 2016, 3439707. 

Study Purpose

To compare the efficacy, safety, and cost of olanzapine-based triplet antiemetics compared to the use of aprepitant as part of antiemetics in chemotherapy-naïve patients receiving highly emetogenic chemotherapy

Intervention Characteristics/Basic Study Process

The olanzapine group received 10 mg olanzapine orally (PO), 0.25 mg palonosetron intravenously (IV), and 20 mg dexamethasone IV on day 1; and then 5 mg olanzapine PO and 4 mg dexamethasone PO on days 2–4. The aprepitant group was given 125 mg aprepitant PO, 0.25 mg palonosetron IV, and 12 mg dexamethasone IV on day 1; 80 mg aprepitant PO on days 2 and 3; and 4 mg dexamethasone PO on days 2–4. Patients were asked to record the intensity of nausea, the use of rescue medication, and vomiting daily in a diary. Patients were contacted daily for reminders to record symptoms.

Sample Characteristics

  • N = 100   
  • MEAN AGE = 43.6 years
  • MALES: 30%, FEMALES: 70%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Patients had various tumor types, and the majority were breast cancer.
  • OTHER KEY SAMPLE CHARACTERISTICS: The study included patients receiving various types of highly emetogenic chemotherapy, and all received six cycles.

Setting

  • SITE: Single site   
  • SETTING TYPE: Outpatient    
  • LOCATION: India

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

  • Prospective, two-group, non-randomized trial

Measurement Instruments/Methods

  • Visual analog scale (VAS) for nausea intensity 
  • CTC
  • Complete response defined as no emesis and no rescue medication
  • Complete response recorded for acute, delayed, and overall periods

Results

No significant differences existed between groups in complete response rates or nausea severity. No grade 3 or 4 toxicities existed. Adverse events associated with olanzapine were sedation and dizziness in less than 10% of patients.

Conclusions

Olanzapine-based triplet antiemetic therapy was as effective as aprepitant-based triplet antiemetics in this study.

Limitations

  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • No information provided on timing of measurements analyzed or trends over time
  • No information on rescue medications used

Nursing Implications

Findings suggest that the use of olanzapine in substitution for an NK1 in a triplet antiemetic regimen was effective. The study is limited by its lack of random assignment to study groups, but the groups were well matched on most demographic and other treatment variables. Olanzapine is much less expensive than an NK1 and may be a good alternative for patients who have limited financial resources or insurance coverage for antiemetics.

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Babaee, N., Moslemi, D., Khalilpour, M., Vejdani, F., Moghadamnia, Y., Bijani, A., … Moghadamnia, A. (2013). Antioxidant capacity of calendula officinalis flowers extract and prevention of radiation induced oropharyngeal mucositis in patients with head and neck cancers: A randomized controlled clinical study. Daru: Journal of Faculty of Pharmacy, Tehran University of Medical Sciences, 21(1), 18.

Study Purpose

To determine the effect of Calendula officinalis flowers extract mouthwash as an oral gel on radiation-induced oropharyngeal mucositis (OM) in patients with head and neck cancer and to determine possible mechanism of action; total antioxidant, polyphenol, and flavonoid content; and quercetin concentration of mouthwash

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to either the calendula mouthwash group or a placebo group. Both solutions were in a gel formation. Patients were to use 5 ML solution twice per day (every 12 hours) and hold the solution in the oral cavity for at least one minute.

Assays were done to assess antioxidant activity, phenol content of the mouthwash, and flavonoid content. Two physicians performed mucositis grading and grading of oral ulcers.

Sample Characteristics

  • The study reported on 38 patients with an age range of 46–72 years.
  • The sample was 50% male and 50% female.
  • Patients were diagnosed with head and neck cancer and receiving curative radiotherapy or chemoradiotherapy. Radiotherapy was prescribed at 30–35 sessions for seven weeks with a cumulative dose of 6000–7000 cGy.
  • Patients with comorbidities, poor oral hygiene, or receiving concurrent medications were excluded.

Setting

The study was conducted at a single outpatient site in Babolsar, Iran.

Phase of Care and Clinical Applications

Patients were undergoing the active antitumor treatment phase of care.

Study Design

This was a double-blind, placebo-controlled, randomized trial.

Measurement Instruments/Methods

The Oral Mucositis Assessment Scale (OMAS) was used.

Results

No patients in the treatment group required medication for OM, and radiation was not stopped for mucositis. Three patients in the treatment group did not develop OM during the whole treatment period. Overall OMAS scores were significantly lower in the treatment group at weeks 2, 3, and 6 of the study (p < 0.001).

Conclusions

Calendula-containing oral mouthwashes may be effective in decreasing OM intensity in this patient population.

Limitations

The authors make reference to some participants withdrawing, but numbers of participants do not seem to reflect this. The number of patients analyzed and the number of patients reported as leaving the study do not add up correctly. Reasons for study withdrawal are not fully described. Very little data are presented in the article. 

Nursing Implications

Oral use of a calendula-containing agent might be an effective and simple intervention. The agent was prepared specifically for this study; therefore, availability of the agent is not clear. No conclusions can be drawn from this study alone, but, given the promising results and lack of known effective preventive agents, further research in this area would be helpful.

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