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Zapolskaya, T., Perreault, S., McManus, D., & Topal, J.E. (2018). Utility of fosfomycin as antibacterial prophylaxis in patients with hematologic malignancies. Supportive Care in Cancer, 26, 1979–1983.

Study Purpose

To evaluate the incidence of breakthrough infections in patients with neutropenic hematologic malignancy unable to receive fluoroquinolone prophylaxis and receiving fosfomycin prophylaxis instead. Additional data collected to isolate offending organisms, types of infection, resistance patterns, and time from initiation of breakthrough infection to onset of fever.

Intervention Characteristics/Basic Study Process

  • Intervention: For those patients with high-risk neutropenic hematologic malignancy unable to receive fluoroquinolone antibacterial prophylaxis: received fosfomycin 3 gm orally every 48 hours for neutropenic duration or until onset of first fever. Note: Fosfomycin was not held or discontinued due to any adverse effects
  • Process: A retrospective chart review Yale-New Haven Hospital from December, 2011 to January, 2017, for patients with hematologic malignancies/HSCT receiving fosfomycin as antibacterial prophylaxis for neutropenia
  • Inclusion criteria: Aged 18 years or older, documented history of fluoroquinolone-resistant organisms, allergies/intolerances of fluoroquinolones or other identified contraindications, minimum of three days fosfomycin 
  • Exclusion criteria: Pediatric patients, use of fosfomycin for treatment of a culture-documented VRE UTI, unclear clinical indication and usage of fosfomycin and less than three days of treatment with fosfomycin 
  • Procedure: The EMR was accessed to collect data for reason for admission, type of malignancy, type of HSCT, previous history of fluoroquinolone-resistant organism in last six months, history of VRE/MRSA documented by positive surveillance culture, time from initiation of fosfomycin to onset of fever spike (fever defined as temperature of 38.3°C occurring either as a single temperature at 38.3°C  or sustained temperature of 38.3°C  for greater than one hour), culture documented microbiology results of isolated organisms and clinical manifestations of infection collected. 
  • Patients categorized as newly initiated fosfomycin prophylaxis as inpatient or a continuation from outpatient prophylaxis.

Sample Characteristics

  • N = 25 patients (data collected for these 25 patients across 42 admissions)  
  • AGE: Median age = 56 years; range = 23-74 years
  • MALES: 44%  
  • FEMALES: 66%
  • CURRENT TREATMENT: Chemotherapy, other
  • KEY DISEASE CHARACTERISTICS: AML was most common, followed by MM, B-cell lymphoma, cutaneous T-cell lymphoma, ALL, CLL,  MCL, myeloproliferative neoplasm, and T-cell lymphoma 
  • OTHER KEY SAMPLE CHARACTERISTICS: Reason for hospital admission: HSCT, chemotherapy, infection, NF, pneumonia, GVHD, N/V, and dizziness

Setting

  • SITE: Single site   
  • SETTING TYPE: Inpatient    
  • LOCATION: Yale-New Haven Connecticut

Phase of Care and Clinical Applications

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

Study Design

Retrospective chart review

Measurement Instruments/Methods

Descriptive statistics of collected data: median, range, frequencies, incidence rates, and percentages

Results

New start of fosfomycin prophylaxis = 81% of patients; continuation of fosfomycin prophylaxis = 19%; rate of FN while on fosfomycin prophylaxis = 55% (in 23 admissions), median time to start of fosfomycin to fever onset = 10.5 days (range = 3-21 days); breakthrough infections = 19% (in 42 admissions); bacterial organisms isolated: # 5 Klebsiella spp, # 2 S. mitis/viridans, #1 Pseudomonas aeruginosa, #1 coagulase-negative Staphylococcus; types of breakthrough infections: # 7 bacteremia, # 1 cellulitis, # 1 urine, # 1 bacteremia plus cellulitis; # 5 history of an infection six months prior to fosfomycin propylaxis, two of which had breakthrough infection not related to prior infection; no infection-related deaths for those experiencing breakthrough infections.

Conclusions

In a retrospective chart review of 25 neutropenic hematologic malignancy patients considered high risk for infection and unable to receive standard quinolones prophylaxis, received fosfomycin prophylaxis. The percentage of breakthrough infections while on fosfomycin prophylaxis was only 19%.

Limitations

  • Small sample (less than 30)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Risk of bias (no appropriate attentional control condition)
  • Unintended interventions or applicable interventions not described that would influence results
  • Findings not generalizable
  • Other limitations/explanation: Retrospective study design unable to establish correlation or causality; limited statistical analysis

Nursing Implications

This retrospective chart review provides limited evidence for low rate of breakthrough infections on fosfomycin prophylaxis in high-risk hematologic malignancy patients. For those patients unable to receive fluoroquinolones, comparative effectiveness of fosfomycin as an alternative to fluoroquinolones needs further study with large multi-site RCTs.

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Hartman, S.J., Nelson, S.H., Myers, E., Natarajan, L., Sears, D.D., Palmer, B.W., . . . Patterson, R.E. (2018). Randomized controlled trial of increasing physical activity on objectively measured and self-reported cognitive functioning among breast cancer survivors: The memory and motion study. Cancer, 124, 192–202.

Study Purpose

Examine the preliminary efficacy of a moderate-intensity aerobic exercise intervention, compared with a waitlist/attention control, on cognitive function among sedentary breast cancer survivors who reported cognitive problems.

Intervention Characteristics/Basic Study Process

The intervention included two groups: aerobic physical activity (targeting a goal of at least 150 minutes of moderate-to-vigorous physical activity over 12 weeks)  versus waitlist/attention control (i.e., matching email contact frequency for intervention group with women’s health topics).

Participants randomly assigned to the aerobic physical activity group completed an in-person walking assessment, after which study staff used motivational interviewing to set physical activity targets to reach the target goal for the study. Participants were given a Fitbit, which was used by staff to provide feedback on increasing physical activity during calls at two and six weeks. Motivational emails were sent every three days.

Participants assigned to the control group received women’s health topic emails every three days.

Study assessments were done before and at the end of the intervention (i.e., approximately 12 weeks post-baseline).

Sample Characteristics

  • N = 87
  • MEAN AGE: 57 years (SD = 10.4)
  • FEMALES: 100%
  • CURRENT TREATMENT: Other
  • KEY DISEASE CHARACTERISTICS: Initial diagnosis of non-metastatic, invasive breast cancer (stage I-III)
  • OTHER KEY SAMPLE CHARACTERISTICS: Self-reported as sedentary at baseline, diagnosed less than 5 years before enrollment, no recurrence or other cancers within 10 years, 82% White, 71% completed college, 53% received chemotherapy (analysis stratified by receipt), 70% currently on endocrine therapy

Setting

  • SITE: Single site   
  • SETTING TYPE: Home    
  • LOCATION: California, USA

Phase of Care and Clinical Applications

PHASE OF CARE: Late effects and survivorship

Study Design

Unblinded randomized controlled trial of moderate-to-vigorous physical activity versus waitlist/attention control with repeated measures

Measurement Instruments/Methods

  • Objective cognitive function: NIH Toolbox
  • Self-reported cognitive function: PROMIS cognitive abilities, cognitive concerns
  • Other measures: Accelerometer, BMI

Results

  • Feasibility: 98% completed the study, 60% in intervention group met goal of 150 minutes per week of moderate-to-vigorous physical activity measured by actigraphy (compared to 19% at baseline; p = 0.006); adverse events not reported
  • Cognitive impairment: Self-reported cognitive concerns were lower in the physical activity group at baseline (p = 0.04). The physical activity group had greater improvements in processing speed (p = 0.049) than the control group. No group differences were found for other cognitive domains or for self-reported cognitive function.
  • Other outcomes: No group differences were found at baseline or over time in BMI.

Conclusions

This pilot study provides evidence that moderate-to-vigorous physical activity shows preliminary efficacy to improve a specific domain of objectively-measured cognitive function, processing speed.

Limitations

  • Small sample (< 100)
  • Baseline sample/group differences of import
  • Risk of bias (no blinding)
  • Risk of bias (no appropriate attentional control condition)
  • Findings not generalizable
  • Other limitations/explanation: The participants in the intervention group reported fewer cognitive concerns at baseline than the control group (potential ceiling effect for self-reported cognitive function). The waitlist/attention control condition only partially controlled for the attention received by the intervention group.

Nursing Implications

This study provides preliminary evidence that moderate-to-vigorous aerobic physical activity might improve the speed of doing mental tasks (i.e., processing speed), which is found to be impaired among some breast cancer survivors. The findings support future well-powered studies using aerobic physical activity to improve processing speed.

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Gokal, K., Munir, F., Ahmed, S., Kancherla, K., & Wallis, D. (2018). Does walking protect against decline in cognitive functioning among breast cancer patients undergoing chemotherapy? Results from a small randomised controlled trial. PLOS ONE, 13, e0206874.

Study Purpose

Assess the preliminary effectiveness of moderate-intensity walking, compared to usual care, on cognitive function during chemotherapy for non-metastatic, invasive breast cancer.

Intervention Characteristics/Basic Study Process

The intervention included two groups: moderate-intensity walking (targeting a self-managed goal of 150 minutes over 12 weeks) versus usual care.

Participants randomly assigned to the moderate-intensity walking group were given a booklet promoting reaching of the goal through self-management, starting with at least 10 minutes of walking and moving up to 30 minutes 5 days per week over 12 weeks. Participants were given a pedometer and were asked to record daily steps and complete the Borg Rating of Perceived Exertion Scale in a daily diary. Participants were also asked to log their weekly goals. 

Participants assigned to the usual care group received no intervention.

Study assessments were done pre-chemotherapy (familiarization, no data collected); midway through chemotherapy (pre-randomization); and after chemotherapy (i.e., postintervention).

Sample Characteristics

  • N = 50
  • MEAN AGE: 52 years (SD = 10.4) 
  • FEMALES: 100%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Initial diagnosis of non-metastatic, invasive breast cancer (stage I-III)
  • OTHER KEY SAMPLE CHARACTERISTICS: Undergoing neo-adjuvant (18%) or adjuvant (82%) chemotherapy with FEC with or without taxotere, reported less than 150 minutes of moderate-intensity activity per week, aged 18-75, 62% postmenopausal, race/ethnicity not reported, 44% completed college

Setting

  • SITE: Single site   
  • SETTING TYPE: Home    
  • LOCATION: England, UK

Phase of Care and Clinical Applications

PHASE OF CARE: Active anti-tumor treatment

Study Design

Unblinded randomized controlled trial of moderate-intensity walking versus usual care with pre-/post- assessments

Measurement Instruments/Methods

  • Objective cognitive function: Battery of tests of executive function, working memory, attention, visuospatial skills
  • Self-reported cognitive function: Cognitive Failures Questionnaire
  • Other measures: Physical activity (accelerometer [data not usable], pedometer, perceived exertion), psychosocial patient-reported outcomes (results reported elsewhere)

Results

  • Feasibility: 79% completed the study, 80% in intervention group met goal of 150 minutes per week of moderate-intensity walking (no significant difference in minutes walked between week 1 and week 12); adverse events not reported
  • Cognitive impairment: Self-reported cognitive failures were lower in the intervention group at baseline and did not worsen during the walking intervention, while the usual care group started with more self-reported cognitive failures that worsened with time (p = 0.05). Greater levels of physical activity were associated with fewer cognitive failures (p = 0.05). No group x time effects were found for any domain of objective cognitive function. The physical activity group had better working memory overall than the control group (p < 0.001), and all participants improved in working memory over time (p = 0.03). 
  • Other outcomes: No associations were found between psychosocial patient-reported outcomes and cognitive function.

Conclusions

This  study provides evidence that a self-managed, home-based walking program of moderate-intensity is feasible during chemotherapy and may reduce declines in self-reported cognitive function during treatment.

Limitations

  • Small sample (< 100)
  • Baseline sample/group differences of import
  • Risk of bias (no blinding)
  • Risk of bias (no appropriate attentional control condition)
  • Findings not generalizable
  • Subject withdrawals ≥ 10%  
  • Other limitations/explanation: The participants in the intervention group reported fewer cognitive failures at baseline than the control group (potential ceiling effect for self-reported cognitive function). Generalizability unclear with no attention control and limited to women with stage I-III breast cancer.

Nursing Implications

This study provides preliminary evidence that self-managed, moderate-intensity walking might improve self-reported cognitive function, which is commonly reported to be impaired by breast cancer survivors. The findings support future well-powered studies evaluating walking to improve cognitive function.

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Myers, J.S., Mitchell, M., Krigel, S., Steinhoff, A., Boyce-White, A., Van Goethem, K., . . . Bender, C.M. (2019). Qigong intervention for breast cancer survivors with complaints of decreased cognitive function. Supportive Care in Cancer, 27, 1395–1403.

Study Purpose

This purpose of the study is to evaluate the feasibility of conducting a three-arm single-blind RCT of an eight-week intervention to improve objectively and subjectively measured cognitive function in breast cancer survivors reporting cognitive complaints.

Intervention Characteristics/Basic Study Process

The study comprised three groups: (a) Qi-gong (Six Healing Sounds form: combination of diaphragmatic breathing, chanting of six healing sounds, and specific gentle arm movements), (b) gentle exercise (gentle arm movements and postures only), (c) attention control (survivorship-focused support group sessions facilitated by a clinical psychologist). Each group met for eight weekly 60-minute sessions. For both the Qi-gong and gentle exercise groups, participants were given instructions to complete 15-minute practice sessions, twice a day, and keep a log. Feasibility was defined by (a) achieving 45 evaluable patients (15 in each group); (b) 75% or greater adherence to weekly attendance for all groups and twice daily home practice for Qi-gong and gentle exercise; (c) 25% or less attrition. Patient-reported outcomes collected at baseline (T1), 8 weeks (T2), and 12 weeks (T3). Neuropsychological testing at T1 and T3 only.

Sample Characteristics

  • N = 36   
  • MEAN AGE: 54 years (SD = 11.19) 
  • FEMALES: 100%
  • CURRENT TREATMENT: Other
  • KEY DISEASE CHARACTERISTICS: Stage I-III breast cancer, 2 months to 8 years after chemotherapy, 52% were treated with radiation therapy, 34% treated with anti-HER-2 therapy, 78% treated with anti-estrogen therapy 
  • OTHER KEY SAMPLE CHARACTERISTICS: 90% Caucasian, 90% non-Hispanic/Latino, 88% post-menopausal, mean = 2.3 (SD = 1.65) years post-chemotherapy

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Multiple settings    
  • LOCATION: Kansas, USA

Phase of Care and Clinical Applications

PHASE OF CARE: Transition phase after active treatment

Study Design

Single-blinded three arm randomized controlled trial (Qi-gong/Gentle Exercise/Attention Control)

Measurement Instruments/Methods

  • Objective cognitive function: Rey Auditory Verbal Learning Test (RAVLT), F-A-S test, TMT-A/B
  • Subjective cognitive function: FACT-Cog (perceived cognitive impairment, perceived cognitive abilities, QOL), PROMIS applied cognition (general concerns, abilities)
  • Other: MD Anderson Cancer Symptom Inventory (fatigue, sleep disturbance, distress)

Results

Feasibility (primary aim): 36 evaluable patients at T3 (Qi-gong = 15, gentle exercise = 10, Attention control = 11). Adherence was 44%-67% for weekly sessions and 21%-31% for twice-daily home practice. 28% overall attrition rate. 
Cognitive function (exploratory aim): Improvements in self-reported cognitive function, as measured by the FACT-Cog, were significantly greater in the Qi-gong group versus gentle exercise between T1 and T2 (perceived cognitive impairments subscale: p = 0.01, d = 1.14; perceived cognitive abilities subscale: p = 0.04, d = 0.75). No significant differences in self-reported cognitive function were noted between the groups from T2 and T3. Improvements on objectively measured processing speed (TMT-A) were significantly greater in the Qi-gong group versus gentle exercise between T1 and T3 (p = 0.07, d = 1.21). The attention control group improved more than the gentle exercise on the F-A-S test of verbal fluency between T1 and T3 (p = 0.02, d = 1.14). 

Other: QOL improved for all three groups between T1 and T2. Distress significantly improved in the Qi-gong group compared to the support group (p = 0.05, d = 0.81) between T1 and T2. There was no significant improvement in fatigue or sleep disturbance scores.

Conclusions

This study provides support for the design of large studies to confirm the effectiveness of Qi-gong, which combines mindfulness-based elements with gentle exercise, for the improvement of perceived cognitive function and processing speed.

Limitations

  • Small sample (< 100)
  • Findings not generalizable
  • Intervention expensive, impractical, or training needs
  • Subject withdrawals ≥ 10%  
  • Other limitations/explanation: Weekly intervention sessions delivered by group leaders trained in six healing sounds form of Qi-gong require specialized training. 28% overall attrition rate (21% for Qi-gong group, 50% for the gentle exercise group and 0% for the attention control group) suggest that some aspects of the intervention may not be feasible.

Nursing Implications

Interventions that combine mindfulness and gentle exercise, such as Qi-gong, may be feasible for some patients after chemotherapy for breast cancer and may have benefits in reducing cognitive complaints and improving speed in performing mental tasks. However, larger studies are needed to confirm these findings.

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