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Steindorf, K., Wiskemann, J., Ulrich, C.M., & Schmidt, M.E. (2017). Effects of exercise on sleep problems in breast cancer patients receiving radiotherapy: A randomized clinical trial. Breast Cancer Research and Treatment, 162, 489–499.

Study Purpose

The study goals were to (a) identify determinants of sleep disturbances in patients with breast cancer (BC) before radiotherapy, (b) determine the trajectory of sleep disturbances during radiotherapy and at 12-month follow-up, and (c) assess whether an exercise intervention could affect sleep trajectories.

Intervention Characteristics/Basic Study Process

The exercise intervention consisted of eight progressive resistance exercises (3 sets, 8–12 repetitions at 60%–80% of one repetition maximum). The relaxation control group did progressive muscle relaxation according to the Jacobson method. Both interventions were supervised and performed over approximately one hour twice weekly for 12 weeks along with other patients with cancer.

Sample Characteristics

  • N = 160 patients with BC; 25 controls (healthy women) 
  • AGE: Patients with BC M = 55.6 (SD = 9.0); healthy women M = 53.1 (SD = 10.0)
  • FEMALES: 100%
  • CURRENT TREATMENT: Radiation, other
  • KEY DISEASE CHARACTERISTICS: Stage 0-III primary BC after lumpectomy or mastectomy and scheduled for radiotherapy; 51% diagnosed in stage 1; 67.8 mean days since surgery 
  • OTHER KEY SAMPLE CHARACTERISTICS: Average BMI = 26.9 kg/m2; 21.3% had BMI ≥ 30; majority reported little engagement in exercise before BC diagnosis.

Setting

  • SITE: Single site    
  • SETTING TYPE: Hospital outpatient clinic     
  • LOCATION: Germany

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

Prospective randomized controlled intervention trial with attention control (relaxation) and healthy control

Measurement Instruments/Methods

  • Fatigue Assessment Questionnaire (FAQ), a self-report (in past week) of global sleep assessment using a single item indicating sleep disturbance with a 4-point Likert scale
  • EORTC-QLQ-C30 insomnia subscale
  • Sleep-related characteristics: sleep duration (hours per night), number of awakenings per night, daytime napping (minutes), frequency per week of sleep problems (> 30 minute sleep onset, trouble staying asleep, too early awakenings) using 5 categories (never, 1-2 days, 3-4 days, 5-6 days, all days)  
  • Sleep measures were completed at 6 time-points: before intervention/radiotherapy (t0), after 6 weeks (t1), after 12 weeks (t2), and at 2, 6, and 12 months postintervention (t3, t4, t5).

Results

Higher prevalence of sleep disturbances were observed among patients with BC who had previous chemotherapy, higher BMI and depressive symptoms, previous hysterectomy, degenerative diseases, thyroid disorders, and higher symptom burden (hot flashes, pain, breast or arm problems, dyspnea). Patients with BC experienced higher levels of sleep disturbance at all times, but the trajectory of sleep disturbances in exercising women was similar to healthy women. The exercise intervention significantly decreased sleep disturbances compared to the relaxation control group on a 0–100 scale (between-group mean differences of -10.2; p = 0.03) from baseline to the end of radiotherapy and -10.9 (p = 0.005) to the end of the intervention). Sleep disturbances decreased in the exercise group and increased in the control group. At 12 months, differences were observed but not statistically significant (mean difference = -5.9, p = 0.20) even after adjusting for potential confounders.

Conclusions

This exercise intervention trial supports the findings of smaller studies that radiotherapy worsens sleep disturbances in patients with BC compared to healthy women. Findings suggest that a 12-week resistance training during radiotherapy can have positive effects on sleep disturbances during the treatment phase and even months after treatment completion.

Limitations

  • Risk of bias (no blinding)
  • Risk of bias (sample characteristics)
  • Measurement or methods not well described
  • Measurement validity or reliability questionable
  • Other limitations/explanation: Measurement or methods not well described in this secondary analysis of the “BEST” study (unable to determine sample demographics, blinding, and protocol fidelity in this publication or other referenced earlier publications)

Nursing Implications

Sleep quality is associated with quality of life in patients with cancer. These findings about determinants of sleep disturbance, the course sleep disturbance during radiotherapy, and the effect of an exercise intervention are of significance to many patients with BC.

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Rogers, L.Q., Courneya, K.S., Oster, R.A., Anton, P.M., Robbs, R.S., Forero, A., & McAuley, E. (2017). Physical activity and sleep quality in breast cancer survivors: A randomized trial. Medicine and Science in Sports and Exercise, 49, 2009–2015.

Study Purpose

The purpose was to determine the effects of a physical activity behavior change intervention compared to usual care on sleep quality in post-primary treatment breast cancer (BC) survivors.

Intervention Characteristics/Basic Study Process

Participants were randomized to a three-month, social cognitive theory-based Better Exercise Adherence after Treatment for Cancer (BEAT Cancer) behavior change intervention or usual care. BEAT Cancer included 12 supervised exercise sessions with exercise specialists during the first six weeks, followed by unsupervised home-based exercise supported by counseling sessions with exercise specialists every two weeks. Participants also completed 6 group discussion sessions with topics about exercise barriers and benefits, goal setting, behavioral modification, safety, relapse prevention, and exercise role models. The goal of BEAT Cancer was to complete ≥ 150 minutes of moderate-to-vigorous physical activity each week. Study measures were completed at three time points: baseline, immediately postintervention (month 3), and 3 months postintervention (month 6).

Sample Characteristics

  • N: 222 women with BC
  • AGE: Patients with BC M = 55.6 (SD = 9.0); healthy women M = 53.1 (SD 10.0)
  • FEMALES: 100%
  • CURRENT TREATMENT: Other
  • KEY DISEASE CHARACTERISTICS: History of ductal carcinoma in situ (DCIS) or stage I-IIIA BC, ≥ 8 weeks postsurgery and postprimary treatment (could be on longer-term treatments such as antiestrogen therapy) 
  • OTHER KEY SAMPLE CHARACTERISTICS: Reported average of ≤ 30 minutes of vigorous physical activity or ≤ 60 minutes of moderate activity per week during the past six months

Setting

  • SITE: Multisite   
  • SETTING TYPE: 3 academic institutions    
  • LOCATION: United States

Phase of Care and Clinical Applications

PHASE OF CARE: Transition (postprimary treatment, could be on hormonal therapy)

Study Design

Randomized controlled intervention trial with usual care control

Measurement Instruments/Methods

  • Pittsburgh Sleep Quality Index (PSQI)
  • MTI/Actigraph accelerometer models GT1M and GT3X (7 nights)

Results

The BEAT Cancer intervention significantly improved PSQI global sleep quality when compared with usual care at postintervention (mean between-group difference [M] = -1.4; 95% CI = -2.1 to -0.7; p < 0.001) and 3 months postintervention (M = -1.0; 95% CI = -1.7 to -0.2; P = .01), after adjusting for covariates. BEAT Cancer improved several PSQI subscales at postintervention (sleep quality M = -0.3; 95% CI = -0.4 to -0.1; p = 0.002; sleep disturbances M = -0.2; 95% CI = -0.3 to -0.03; p = 0.016; daytime dysfunction M = -0.2; 95% CI = -0.4 to -0.02; p = 0.027) but not 3 months postintervention. A nonsignificant increase in the percentage of participants classified as good sleepers was reported. No significant between-group difference was noted for accelerometer sleep latency or efficiency.

Conclusions

A social cognitive theory-based physical activity intervention reduced perceived global sleep disturbance at postintervention and 3 months postintervention compared to usual care, primarily related to improvements in various aspects of sleep quality. However, improvements were not detected with accelerometer.

Limitations

  • Risk of bias (no blinding)
  • Risk of bias (no appropriate attentional control condition)
  • Risk of bias (sample characteristics)
  • Unintended interventions or applicable interventions not described that would influence results
  • Measurement and methods not well described
  • Measurement validity and reliability questionable
  • Subject withdrawals ≥ 10%
  • Other limitations/explanation: No blinding, no attentional control group, lack of sample diversity, potential risk of intervention diffusion between groups, no reported participant withdrawals or protocol fidelity data 

Nursing Implications

Exercise adherence intervention may reduce perceived global sleep disturbance at 3 and 6 months postintervention. Additional exercise research in oncology is needed to optimize the use of physical activity in improving the health and well-being of cancer survivors through improved sleep.

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Papadopoulos, D., Papadoudis, A., Kiagia, M., & Syrigos, K. (2018). Nonpharmacologic interventions for improving sleep disturbances in patients with lung cancer: A systematic review and meta-analysis. Journal of Pain and Symptom Management, 55, 1364–1381.

Purpose

STUDY PURPOSE: To determine the effects of nonpharmacologic interventions on sleep quality in patients with lung cancer

TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy

DATABASES USED: Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CINAHL, WHO International Clinical Trials Registry Platform Search Portal and Clinical Trials.gov

YEARS INCLUDED: Open start date through December 2016

INCLUSION CRITERIA: Nonpharmacologic intervention studies of any design for patients with lung cancer at any stage or illness and at any point in treatment, compromising at least 25% of participants who used sleep disturbance or quality as primary or secondary outcome by subjective or objective measure

EXCLUSION CRITERIA: None noted

Literature Evaluated

TOTAL REFERENCES RETRIEVED: N = 1,259 

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Two authors reviewed all studies for eligibility, and disagreements were resolved through discussion and third author as needed.

Sample Characteristics

FINAL NUMBER STUDIES INCLUDED: N = 22

TOTAL PATIENTS INCLUDED IN REVIEW: 1,272

SAMPLE RANGE ACROSS STUDIES: ≤ 10 = 3 studies, > 10 < 100 = 16 studies , ≥ 100 = 3 studies 

KEY SAMPLE CHARACTERISTICS: 82.4% of participants had lung cancer, > 66% had stage III or IV illness and were undergoing treatment.

Phase of Care and Clinical Applications

PHASE OF CARE: Multiple phases of care

Results

Interventions were grouped into 3 categories. Standard exercise and rehabilitation programs showed statistically significant improvements in sleep outcome measures in the short-term follow-up period (SMD -0.43, 95% CI; -0.68, -0.19, p = 0.0005). No differences were seen at the medium- and longer-term follow-up periods. Information, psychoeducation, and symptom screening interventions showed significant differences when compared to control at short-term follow up but was not measured at a later interval (SMD: -0.87, 95% CI, -1.21, -0.54, p, 0.00001). Mind-body interventions (2 studies with n < 100) showed large effect in treating sleep disturbances in patients with lung cancer in the short-term follow-up period (SMD: -0.88, 95% CI, -1.59, -0.16, p = 0.02), which were not observed at the medium follow-up period.

Conclusions

Although the three groups of interventions, exercise, information, psychoeducation, and mind-body interventions appear to improve sleep disturbances in the short term following the interventions, the data quality is low. The series of 22 studies looks at multiple interventions per category, some with small sample sizes, and uses a variety of delivery methods. Based on individual assessments and results of studies in other cancer populations, nurses may want to recommend the interventions to patients with lung cancer, at least to try. However, the call for ongoing research in the area continues, with specific focus on larger sample sizes, specific disease states, and single interventions.

Limitations

  • Mostly low quality/high risk of bias studies
  • High heterogeneity
  • Low sample sizes

Nursing Implications

The data for recommending use of nonpharmacologic interventions for sleep disturbances in patients with lung cancer are not sufficient. It is clear that they are feasible and may be effective in some instances. It does appear that they may improve sleep disturbance in the short term, but further work is needed to conduct larger studies and examine individual interventions and their components, as well as the treatment phase for the patient in which the intervention in applied. Based on assessment of patient condition and desire, nurses can use their judgment to make recommendations for patients with lung cancer to try nonpharmacologic interventions to improve sleep.

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Peoples, A.R., Garland, S.N., Perlis, M.L., Savard, J., Heckler, C.E., Kamen, C.S., . . . Roscoe, J.A. (2017). Effects of cognitive behavioral therapy for insomnia and armodafinil on quality of life in cancer survivors: A randomized placebo-controlled trial. Journal of Cancer Survivorship, 11, 401–409.

Study Purpose

The purpose was to study the effects of cognitive behavioral therapy on quality of life (QOL) among patients post-cancer treatment through a reduction in insomnia.

Intervention Characteristics/Basic Study Process

Four participant groups were created: those receiving CBT-I + placebo, CBT-I + armodafinil, armodafinil, and a placebo. CBT-I interventions took place over 7 weeks, where participants met one-on-one with a trained therapist and followed a treatment manual. Sessions were conducted once a week, with the first, second, and fourth held in person, and lasted 30-60 minutes; the third, fifth, sixth, and seventh were held over the telephone over 15-30 minutes. For groups taking armodafinil, 50 mg was taken in the morning and afternoon for 47 days. QOL was measured using the Functional Assessment of Cancer Therapy-General (FACT-G) instrument, while insomnia severity was measured with the Insomnia Severity Index (ISI). These surveys were completed by participants before receiving the intervention, during the intervention, postintervention, and 3 months following the intervention completion.

Sample Characteristics

  • N: 95   
  • AGE: Range = 26-75 years, Mean = 56.2 years
  • MALES: 11.6%  
  • FEMALES: 88.4%
  • CURRENT TREATMENT: Not applicable
  • KEY DISEASE CHARACTERISTICS: Cancer survivors of any type who had completed chemotherapy and/or radiation therapy at least one month or longer prior to the study start, with an inclusion criteria of baseline clinically diagnosed chronic insomnia.

Setting

  • SITE: Multisite   
  • SETTING TYPE: Multiple settings    
  • LOCATION: Two northeastern U.S. cities

Phase of Care and Clinical Applications

PHASE OF CARE: Late effects and survivorship

Study Design

Four groups were established in an RCT. Participants were blinded to medication but not CBT-I. Control groups received a placebo.

Measurement Instruments/Methods

QOL was measured using the Functional Assessment of Cancer Therapy General (FACT-G), an instrument measuring physical, functional, social, and emotional well-being and scored from 0-108, with higher scores indicating better QOL. Insomnia severity was measured using the Insomnia Severity Index, ranging from 0-28, with higher scores indicating worse insomnia.

Results

Both CBT-I groups reported improvement of significance in QOL scores with mean increase of 9.5 on the FACT-G scale (p < 0.0001) compared to the groups without CBT-I. There was no statistical difference in QOL reports between the CBT-I + placebo and CBT-I + armodafinil groups. However, correlational and path analysis indicated that these improvements on QOL were associated with improvements in insomnia and that CBT-I did not demonstrate a direct effect of significance on QOL scores but rather, a significant effect on insomnia severity (p < 0.0001) that demonstrated a significant improvement in QOL scores (p < 0.0001) From baseline, changes in QOL from pre- to postintervention for CBT-I+ placebo, CBT-I + armodafinil, armodafinil, and placebo were 9.6, 11.6, -0.2, and 3.3. Follow-up QOL for CBT-I + placebo, CBT-I + armodafinil, armodafinil, and placebo was 91.4, 93.8, 78.7, and 78.6, respectively, which did not demonstrate significance from postintervention.

Conclusions

CBT-I demonstrated a significant effect in the reduction of insomnia among cancer survivors, which resulted in an indirect improvement in patient QOL. However, generalizability and broad feasibility may be limited because of cultural and socioeconomic variances, as well as resource availability.

Limitations

  • Small sample (< 100)
  • Intervention expensive, impractical, or training needs
  • Subject withdrawals ≥ 10%

Nursing Implications

Patient sleep quality and associated effect on QOL are important considerations for nursing. Regardless of intervention, this study demonstrates meaningful improvement of QOL can occur when sleep quality is improved. Nurses are in a relevant position to assess and advocate for interventions for sleep disturbance.

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Van Vu, D., Molassiotis, A., Ching, S.S.Y., & Le, T.T. (2017). Effects of qigong on symptom management in cancer patients: A systematic review. Complementary Therapies in Clinical Practice, 29, 111–121.

Purpose

STUDY PURPOSE: The purpose of this systematic review of the literature was to evaluate the effectiveness of Qigong on symptom management in patients with cancer. Qigong is a complementary therapy with the goal of relaxation involving simple, repeated body posture or movements, breathing exercises, and meditation performed in synchrony.

TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: PubMed/MEDLINE, CINAHL, Cochrane Library, and PEDRO

YEARS INCLUDED: From 1995 through 12/2015

INCLUSION CRITERIA: RCTs, quasi-experimental with comparison group, and feasibility trials; adults ≥ 18 years of age; cancer diagnosis; receiving care in any healthcare setting; using Qigong during or after cancer treatment versus placebo, usual care, or other intervention to manage symptoms, including patient-reported physical-psychological symptoms reported as continuous or dichotomous and quality of life. 

EXCLUSION CRITERIA: Trials including patients receiving hospice care or were at the end-of-life

Literature Evaluated

TOTAL REFERENCES RETRIEVED: N = 266

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Cochrane Collaboration’s Tool for Assessing Risk of Bias (Cochrane Collaboration, 2011) and strength of the evidence were evaluated using the Oxford Centre for Evidence-Based Medicine Levels of Evidence (Oxford Centre for Evidence-Based Medicine, 2009).

Sample Characteristics

FINAL NUMBER STUDIES INCLUDED: N = 22

TOTAL PATIENTS INCLUDED IN REVIEW: 1,751

SAMPLE RANGE ACROSS STUDIES: 20-211

KEY SAMPLE CHARACTERISTICS: Studies were conducted in Hong Kong, China, Taiwan, Malaysia, South Korea, United States, Israel, and Australia. Various cancer diagnoses were included (i.e., breast, prostate, gynecologic, nasopharyngeal, hepatocellular, colon, non-Hodgkin lymphoma, lung cancer, and gastrointestinal cancers) from early in the treatment period through the recovery phase. Median intervention duration was 6 weeks (ranged from 3 to 24 weeks).

Phase of Care and Clinical Applications

PHASE OF CARE: Multiple phases of care     

APPLICATIONS: Elder care

Results

Of the 22 studies that met inclusion criteria, there were 14 RCTs and 8 controlled clinical trials. A high risk of bias was reported in 16 studies (73%) specifically in lack of blinding, allocation concealment, and incomplete outcome data. The efficacy of Qigong was examined for symptom management among patients with various cancers. Effects were described according to primary outcome measures, including physical (e.g., fatigue, sleep disturbances, pain, dyspnea) and psychological (e.g., depression, anxiety) symptoms, and quality of life. For example, 10 studies included a fatigue outcome whereas 3 studies included a sleep disturbance measure. In addition, 19 studies evaluated ≥ 2 outcomes. Results indicated that participants in Qigong groups were significantly improved postintervention compared with the control groups or there were positive trends from pre- to postintervention scores. Protocols used to deliver the interventions varied and included seven types or forms of Qigong. Interestingly, all seven styles of Qigong were effective for ≥ one outcome variable. Secondary outcomes found that Qigong was safe and feasible without unwanted side effects. The majority of outcomes were self-reported, but there were a few significant objective clinical outcomes: muscular strength, range of motion, six-minute walk test, and body mass index.

Conclusions

Results of this systematic review suggest that some of the symptoms were significantly improved in the Qigong group postintervention compared to controls. These somewhat promising results are tempered by some major limitations. There was a high risk of bias related to allocation concealment, lack of blinding, and incomplete outcome data. Limitations pertain to the potential incompleteness of the evidence reviewed. Conclusions regarding superiority of one form of Qigong over another were beyond the scope of this review.

Limitations

Limited number of studies included

Mostly low quality or high risk of bias studies

High heterogeneity

Low sample sizes

Nursing Implications

Qigong for improving symptoms in patients with cancer are encouraging in some but not all reported studies in this review. For example, only one out of three studies that evaluated sleep quality reported significant improvement with Qigong. More research is needed before Qigong can be recommended for relief of cancer-related symptoms.

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Irwin, M.R., Olmstead, R., Carrillo, C., Sadeghi, N., Nicassio, P., Ganz, P.A., & Bower, J.E. (2017). Tai chi chih compared with cognitive behavioral therapy for the treatment of insomnia in survivors of breast cancer: A randomized, partially blinded, noninferiority trial. Journal of Clinical Oncology, 35, 2656–2665.

Study Purpose

The purpose was to examine whether tai chi chih (TCC) is noninferior in effect to cognitive behavioral therapy (CBT-I) in reducing insomnia in breast cancer survivors.

Intervention Characteristics/Basic Study Process

Participants were randomly assigned to two groups: those receiving CBT-I and those receiving TCC. Prior to the intervention, participants were enrolled in a 2-month phase-in period to establish their degree of insomnia. CBT-I and TCC groups were comprised of 7-10 participants and consisted of weekly 120-minute sessions. Interventions were held over two months, with a third month of skill consolidation and adherence (three months total intervention exposure). Remission of insomnia was also measured by an interviewer blinded to intervention exposure who evaluated remission according to DSM-IV-TR criteria. Assessments  of insomnia, a daily sleep diary, polysomnography levels, levels of fatigue, sleepiness, depressive symptoms, body mass index, and physical activity levels were collected at month 2 (baseline data), month 3 (post intervention), and follow-up assessments at months 6 and 15.

Sample Characteristics

  • N: 90   
  • AGE: Range = 42-83 years, Mean = 59.6
  • FEMALES: 100%
  • CURRENT TREATMENT: Not applicable
  • KEY DISEASE CHARACTERISTICS: Breast cancer survivors met the DSM-IV-TR criteria for insomnia had reported sleep difficulties at least 3 times or more per week for at least three months or more; had finished surgical, radiation, or chemotherapy treatment at least 6 months prior; and did not have recurrence of cancer or a new tumor.

Setting

  • SITE: Single site   
  • SETTING TYPE: Not specified    
  • LOCATION: Los Angeles, CA

Phase of Care and Clinical Applications

PHASE OF CARE: Late effects and survivorship

Study Design

Two groups were established in a randomized, partially blinded, noninferiority trial. Participants were blinded to the hypothesis and the alternate treatment group.

Measurement Instruments/Methods

  • Sleep quality was measured using the Pittsburgh Sleep Quality Index and Athens Insomnia Severity Index. 
  • Objective sleep continuity was measured using polysomnography and subjectively with sleep diaries. 
  • For secondary outcomes, insomnia remission was evaluated using DSM-IV-TR criteria and reviewed utilizing board-certified psychiatrists and psychologists. Fatigue was measured using the Multidimensional Fatigue Symptom Inventory, sleepiness was measured using the Epworth Sleepiness Scale, and depressive symptoms were measured using the Inventory of Depressive Symptoms. Body mass index and physical activity levels (Yale Physical Activity Survey) were also measured. A noninferiority margin of 50% was used.

Results

Responsiveness to CBT-I or TCC treatment was comparable with a responsiveness rate of 43.6% and 46.7%, respectively. The noninferiority margin for this study’s purposes was set at 50%, and noninferiority of TCC was observed at month 3 (p = 0.02), month 6 (p =< 0.01), and month 15 (p = 0.02). Both treatments resulted in comparable insomnia remission rates at month 15 (46.2% and 37.9%, respectively). Differences in change of PSQI or AISI, as well as change in sleep time and wake after sleep onset, and effects on fatigue, sleepiness, or depression from baseline were not significant in comparing treatment groups (p > 0.3, p > 0.4, p > 0.5, respectively). PSG did not demonstrate treatment effects or differences across groups of significance.

Conclusions

CBT-I and TCC demonstrated high patient responsiveness and sustainable insomnia reduction at follow up yet yielded nonsignificant differences between treatment groups, thereby demonstrating noninferiority of TCC to CBT-I. Improvements in sleep quality, fatigue, sleepiness, and depressive symptoms were observed among both groups, but group differences were again not significant.

Limitations

  • Small sample (< 100)
  • Findings were not generalizable.
  • Intervention was expensive and impractical, and training was needed.
  • Subject withdrawals ≥ 10%

Nursing Implications

Given not only the prevalence, but debilitative effect insomnia has on patients with cancer, alternative treatments to CBT-I, such as TCC, are important for nurses to assess and identify for patients, who may have variances in access to clinical CBT-I treatment.

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Zhang, B., Dong, J.N., Sun, P., Feng, C., & Liu, Y.C. (2017). Effect of therapeutic care for treating fatigue in patients with breast cancer receiving chemotherapy. Medicine, 96, e7750.

Study Purpose

The purpose was to evaluate the effect of therapeutic care (TC) with acupressure on fatigue in patients with breast cancer receiving chemotherapy.

Intervention Characteristics/Basic Study Process

Patients were randomized to the intervention or sham control arm. The intervention consisted of acupressure to three points related to energy in the human body (bilateral Hegu, Zusanli, & Sanyinjiao) administered 30 minutes per day, 10 minutes per point, 3 days a week for 12 weeks. Sham control included three points reported to have no relationship to alleviate cancer-related fatigue, first metacarpal head, patella, and inner ankle with same treatment administration, frequency, and duration. Fatigue, anxiety, depression, and sleep were measured at baseline, 6 weeks, and 12 weeks.

Sample Characteristics

  • N = 48 
  • AGE: Mean age of the intervention group was 51.8 years (SD = 9.6) and control was 52.4 years (SD = 9.3).
  • FEMALES: 100% 
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Breast cancer, actively receiving chemotherapy    
  • OTHER KEY SAMPLE CHARACTERISTICS: s/p lumpectomy or mastectomy, did not take herbs or supplements, and did not report medication-related fatigue

Setting

  • SITE: Single site
  • SETTING TYPE: Not specified    
  • LOCATION: China

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

Randomized control trial

Measurement Instruments/Methods

Multidimensional fatigue inventory (MFI), Hospital Anxiety and Depression Scale (HADS), and Pittsburgh Sleep Quality Index (PSQI)

Results

For those in the intervention group, fatigue improved statistically (p < 0.01) at 6 weeks and maintained improvement at 12 weeks (p < 0.01). Anxiety, depression, and sleep quality improved at 12 weeks (p < 0.01).

Conclusions

Acupressure may be an effective method or type of complementary and alternative therapy in improving fatigue, anxiety, depression, and sleep in patients with breast cancer receiving chemotherapy.

Limitations

  • Small sample (< 100)
  • Subject withdrawals ≥ 10%  
  • Other limitations or explanation: Single site, all Chinese patients

Nursing Implications

Acupressure focused on points known to help energy may be useful in treating cancer-related fatigue, anxiety, depression, and sleep quality.

Print

Lo Vecchio, A., Schaffzin, J.K., Ruberto, E., Caiazzo, M.A., Saggiomo, L., Mambretti, D., . . . Guarino, A. (2016). Reduced central line infection rates in children with leukemia following caregiver training: A quality improvement study. Medicine, 95, e3946.

Study Purpose

A quality improvement project to educate caregivers on CL management and CLABSI prevention among children

Intervention Characteristics/Basic Study Process

The intervention consisted of nine in-person classes for education and practice on children and mannequins.

Sample Characteristics

  • N: 120   
  • AGE: Not mentioned
  • MALES: Not diversified  
  • FEMALES: Not diversified
  • CURRENT TREATMENT: Other
  • KEY DISEASE CHARACTERISTICS: ALL, AML, CL, CLABSI, QI, Pediatric hemato-oncology
  • OTHER KEY SAMPLE CHARACTERISTICS: Leukemia, caregivers

Setting

  • SITE: Single site   
  • SETTING TYPE: Multiple settings    
  • LOCATION: Santobono-Pausilipon Children’s Hospital, Italy

Phase of Care and Clinical Applications

  • PHASE OF CARE: Multiple phases of care
  • APPLICATIONS: Pediatrics

Study Design

QI project for in-person caregiver training classes; no ICF needed.

Measurement Instruments/Methods

CLABSI rate per 1,000 CL days in children with acute leukemia. The baseline was calculated based on previous 12 months of the QI project between March 2012 and April 2013 and was compared with cumulative CLABSI rates computed with 95% confidence intervals (CI).

Results

A total of 118 children were diagnosed with acute leukemia and included in the study. 120 caregivers of 118 children agreed to participate. Baseline CLABSI rate was 6.86 per 1,000 CL days; within 8 months, 3.7 per 1,000 CL days; 46.1% reduction attributable to intervention alone.

Conclusions

Implementing an education intervention for the reduction of CLABSI occurrences using evidence-based practices resulted in dramatic improvement of CLABSI rates and, in turn, survival rates of leukemic children.

Limitations

Subject withdrawals 10% or greater

Nursing Implications

Nursing is synonymous for teaching and educating the patient population. Nurses would be at the forefront of this intervention creating a comprehensive explanation of the disease process in a palatable form for caregivers as well as reinforcement and encouragement.

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Vicente, M., Al-Nahedh, M., Parsad, S., Knoebel, R.W., Pisano, J., & Pettit, N.N. (2017). Impact of a clinical pathway on appropriate empiric vancomycin use in cancer patients with febrile neutropenia. Journal of Oncology Pharmacy Practice, 23, 575–581.

Study Purpose

To determine the appropriateness of vancomycin prescribing, based on consistency with guideline (IDSA and NCCN) recommendations before and after implementation of FN clinical pathway. Secondary endpoint was to determine influence of comorbidities with inconsistent vancomycin use based on guideline recommendations.

Intervention Characteristics/Basic Study Process

Using IDSA and NCCN guidelines for prescribing vancomycin in adults patients with cancer with FN and a risk assessment tool for adverse clinical outcomes a pathway was developed to increase compliance with guidelines. 337 patient records were analyzed to evaluate effectiveness of FN clinical pathway at academic medical center. Patients admitted with FN and no allergy to beta-lactam were included. Four groups were evaluated: pre-pathway vancomycin use consistent with guidelines, post-pathway vancomycin use consistent with guidelines, post-pathway vancomycin use inconsistent with guidelines and post-pathway vancomycin use inconsistent with guidelines. Vancomycin use was defined as use for at least 48 hours to exclude those receiving it for procedural prophylaxis.

Sample Characteristics

  • N = 337   
  • AGE: Adults reported in mean and standard deviation for each group. Consistent vancomycin pre = 59 (SD = 13.3), consistent vancomycin post = 59.4 (SD = 15.6), inconsistent vancomycin pre = 55.5 (SD = 15.3), inconsistent vancomycin post = 51.3 (SD = 12.2)
  • MALES: 59%  
  • FEMALES: 41%
  • CURRENT TREATMENT: Chemotherapy, other
  • KEY DISEASE CHARACTERISTICS: Hematologic malignancy, solid tumor malignancy, stem cell transplantation autologous and stem cell transplantation allogeneic
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients with diagnosis of neutropenia ICD 9 codes 288.00, 288.02, 288.03, 288.04, 299.08, and ICD 9 for fever. Adult FN patients who received an appropriate anti-pseudomonal beta-lactam with or without vancomycin were included in the analysis. Patients transferred from outside facility or with documented penicillin or vancomycin allergy were excluded.

Setting

  • SITE: Single site   
  • SETTING TYPE: Not specified    
  • LOCATION: University of Chicago Medical Center

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active anti-tumor treatment
  • APPLICATIONS: Elder care

Study Design

Evaluate appropriate prescribing of vancomycin based on consistency with guideline recommendations pre- and post-implementation of a FN clinical pathway.

Measurement Instruments/Methods

Antimicrobial usage report generated from electronic medical record. Hematopoietic Cell Transplantation Comorbidity Index (HCT CI)

Results

The rate of vancomycin use, inconsistent with guideline recommendations in the pre-pathway implementation time frame, was significantly greater (n = 74, 35.9%) versus use in the post-pathway implementation time frame (n = 5, 11.4%; p = 0.001). No comorbidities or specific HCT CI scores were predictive of vancomycin without indication on multivariate analysis.

Conclusions

Implementation of a guideline-based pathway for FN in adult patients with cancer can significantly improve adherence to guideline recommendations for antimicrobial (vancomycin) use

Limitations

  • Findings not generalizable
  • Other limitations/explanation: The use of HCT CI has not been validated in another malignancy except hematologic

Nursing Implications

Use of clinical pathways can improve compliance with guidelines for managing at-risk patients, leading to better outcomes.

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Vanderway, J., Vincent, C., Walsh, S.M., & Obrecht, J. (2017). Implementation of a pathway for the treatment of fever and neutropenia in pediatric patients with cancer. Journal of Pediatric Oncology, 34, 315–321.

Study Purpose

Implement a pathway to achieve Time To Antibiotics (TTA) in less than 60 minutes form presentation for outpatient evaluation of FN in pediatric patients with cancer. Other endpoint was to improve bedside nurses’ understanding of fever, neutropenia, and importance of Rapid Time To Antibiotics (RTTA).

Intervention Characteristics/Basic Study Process

Implementation of Clinical Pathway for RTTA in less than 60 minutes

Inservice and poster board used to educate nurses about fever and neutropenia. Knowledge measured with pre- and post-tests.

Sample Characteristics

  • N: 25 patients and 12 nurses
  • AGE: From birth to age 18 years
  • MALES: Not reported  
  • FEMALES: Not reported
  • CURRENT TREATMENT: Combination radiation and chemotherapy
  • KEY DISEASE CHARACTERISTICS: Pediatric oncology patients in the Ambulatory Infusion Center with fever and neutropenia receiving antibiotics.  Patients without implanted vascular access devices were excluded.

Setting

  • SITE: Single site   
  • SETTING TYPE: Outpatient    
  • LOCATION: University of Chicago

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active anti-tumor treatment
  • APPLICATIONS: Pediatrics

Study Design

TTA was tracked using retrospective chart review to determine pre-pathway metrics.

Measurement Instruments/Methods

Retrospective chart review using electronic health record filters was used for pre-pathway data collection. A computerized spreadsheet was used for post-pathway data collection.

Nursing knowledge was tested using a 9-item Fever and Neutropenia Questionaire. A bulletin board with key FN concepts and an in-service by APNs were sources of education.

Results

Nurses had a mean score of 7.5 correct answers for the pre-education questionnaire and an 8.92 mean score for post-education (p = 0.0002).

Conclusions

Improvement in nurses knowledge of FN was improved with education and TTA was improved with a clinical pathway. The study included a very small sample of pediatric patients and nurses from one cancer center, resulting in limited application to other settings.

Limitations

  • Small sample (< 30)
  • Measurement validity/reliability questionable 
  • Findings not generalizable

Nursing Implications

Based on literature review and limited findings of this QI project, clinical pathways and nursing education are successful ways to improve care of patients with FN. Recommendations for implementing in other settings will need larger studies demonstrating success with these interventions to demonstrate applicability.

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