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Gehring, K., Sitskoorn, M.M., Gundy, C.M., Sikkes, S.A.M., Klein, M., Postma, T. J., . . . Aaronson, N.K. (2009). Cognitive rehabilitation in patients with gliomas: A randomized, controlled trial. Journal of Clinical Oncology, 27, 3712–3722.

Study Purpose

The study was conducted to evaluate the effectiveness of a multifaceted cognitive rehabilitation program's (CRP's) measures of cognitive functioning in patients with gliomas whose disease was in remission.

Intervention Characteristics/Basic Study Process

An eligibility screening was conducted through

  1. Telephone interviews confirming at least one cognitive symptom from the Medical Outcomes Study Cognitive Functioning Scale among individuals who expressed an interest in CRP participation.
  2. Objective neuropsychological assessment, in which participants performed at least one standard deviation below a healthy comparison group's mean (n = 294) on at least 4 of 20 neuropsychological assessment variables.

The randomization procedure was a minimization method balancing age, sex, education, tumor grade, hemisphere, radiotherapy, neurosurgery, disease duration, and institution.

The control group received standard care without cognitive intervention, and had contact with research staff at similar intervals as the intervention group. Control participants received a telephone-based empathy session during which attention to possible cognitive problems occurred without the provision of advice. At the study's completion, control participants were offered the opportunity to receive the intervention.

The intervention group received six weekly individual sessions of two hours each, carried out by seven neuropsychologists. Two techniques were incorporated. 

  1. Cognitive retraining using a computer program (C-Car) consisting of a series of hierarchically graded tasks designed to strengthen various aspects of attention on the basis of patients needs.
  2. Compensatory training consisting of six psychoeducational sessions on attention, memory, and executive function. This training included didactic and practical elements aimed to help patients compensate for impaired cognitive function.

Sample Characteristics

  • All participants had glioma in remission.
  • The total number of participants was 140, with 70 patients each in the treatment group and control group.
  • The average participant age was 42 ± 9.4 years for the treatment group.
  • The average participant age was 43.8 ± 10.5 years for the control group.
  • The treatment group was 58.6% male and 41.4% female.
  • The control group was 57.1% male and 42.9% female.
  • The median number of years since treatment was 2.6 years for the treatment group.
  • The median number of years since treatment was 3.1 years for the control group. 

Setting

Patients were recruited from 11 Dutch hospitals, including 10 neurosurgical centers.

Study Design

The study utilized a randomized, controlled trial.

Measurement Instruments/Methods

  • Dutch Adult Reading Test (DART) and the Drie-Minuten-Toets Three Minute Test (DMT) for premorbid intelligence
  • Stroop Color-Word Test (SCWT), Digit Span (Forward and Backward), Memory Scanning Test (MST), and the Test of Everyday Attention (TEA) for attention
  • Multidimensional Fatigue Inventory (MFI) for mental fatigue, activity, and motivation
  • Community Intervention Questionnaire (CIQ) for home integration, social integration, and productivity
  • Visual Verbal Learning Test (VVLT) for memory
  • Concept Shifting Test (CST), Letter Fluency (LF), and Category Fluency (CF) for executive function
  • Medical Outcomes Study Cognitive Functioning Scale
  • Cognitive Failure Questionnaire (CFQ)
  • Behavioral Assessment of Dysexecutive Syndrome (BADS)

 

Results

Eighty percent of CRP subjects reported that the intervention addressed their problems; 87% used compensation strategies regularly, and 79% indicated a decrease in the impact of cognitive problems on daily functioning. The intervention group had significantly better combined attention scores (in four out of seven tests) than the control group (p = 0.004) at the six-month follow-up. Verbal memory and attention were improved for the intervention group at the six-month follow-up, suggesting the intervention's success with some sustainment in learned skills.

Effect sizes for the CRP ranged from 0.23 to 0.55. The intervention group had significantly better combined scores on verbal memory tests than the control group (p = 0.009). Effect sizes for the intervention group on two of three tests were 0.48 and 0.43. Mental fatigue on the MFI was improved in the intervention group at the six-month follow-up (p = 0.044), with an effect size of 0.41.

Self-reported cognitive function (CFS, CFQ, burden) was better in the intervention group on completion of the CRP (p = 0.001). Effect sizes ranged from 0.31 to 0.48. However, at the six-month follow-up this improvement was maintained, while the control group continued to improve.

There were no significant differences between groups on neuropsychiatric assessment scores at baseline. There were no statistically significant group differences in attention or verbal memory scores at completion of the CRP.

 

 

Conclusions

CRP was useful in improving cognitive function, with sustained improvements in verbal memory and attention over time.

Limitations

  • Mild cognitive impairment was detected by baseline cognitive function scores in the majority of subjects, which could impact the expected change from the CRP intervention (ceiling effect).
  • The study did not indicate whether hemispheric location of the tumor influenced cognitive functioning.
  • The authors did not specify whether they controlled for tumor characteristics, seizure frequency, and use of anti-epileptics in the analyses.
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Gebruers, N., & Tjalma, W.A. (2016). Clinical feasibility of axillary reverse mapping and its influence on breast cancer related lymphedema: A systematic review. European Journal of Obstetrics, Gynecology, and Reproductive Biology, 200, 117–122. 

Purpose

STUDY PURPOSE: To review current literature to (a) examine which approaches for axillary reverse mapping (ARM) are used, (b) determine the oncologic safety of ARM, and (c) determine whether ARM decreases the incidence of lymphedema after axillary lymph node dissection (ALND) and sentinel lymph node dissection (SLND).
 
TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: PubMed, Web of Science, Medline, and Cochrane clinical trials.
 
INCLUSION CRITERIA: Studies were included if (a) ARM was performed in ALND or SLND surgeries, (b) a description of the ARM procedure was provided, (c) assessment and definition of lymphedema were reported, (d) a clear distinction between the type of dissection (ALND or SNLD) was presented, (d) follow-up time after surgery was reported, and (e) if they were in English or Dutch.   
 
EXCLUSION CRITERIA: Secondary sources were excluded (doctoral dissertations, letters to the editor or editorials, conference proceedings, reviews, case studies, postmortem studies).
 
 

Literature Evaluated

LITERATURE EVALUATED: Studies were independently evaluated by two reviewers for quality using the checklists from the Dutch Cochrane center with a 1, 0, or ? (1 = if sufficient information was available and no likelihood of bias, 0 = sufficient information but missing a criterion, ? = no information available). No meta-analysis was done.

TOTAL REFERENCES RETRIEVED: 108
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: The method used to evaluate quality is explained; however, the method for assigning levels of evidence and the definition of each level are not described. Randomized, controlled trial (RCT) was assigned at a Level 2 evidence score, and all other studies were scored as Level 3.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 27 studies
  • TOTAL PATIENTS INCLUDED IN REVIEW = The number of patients was not provided for every article, so based on information provided, N = 959. Pooled results: ALND = 1,184, sentinel lymph node biopsy (SLNB) = 1,507
  • SAMPLE RANGE ACROSS STUDIES: 20–360 patients
  • KEY SAMPLE CHARACTERISTICS: Patient characteristics, ARM methodology, ARM feasibility (% on nodes found, % ARM crossover, tumor cells in ARM), assessment, definition, and incidence of lymphedema

Phase of Care and Clinical Applications

PHASE OF CARE: Diagnostic

Results

A total of 27 studies were systematically reviewed for content on the type of ARM, its safety, and whether it decreased the incidence of lymphedema. Three ARM procedures were described: (a) dermally injected blue dye, (b) injected radioisotope Tc-99m Nanocoll with subsequent lymphoscintigraphy, and (c) lymphofluoroscopic assessment using an intradermal injection of indocyanine green (ICG). The ARM detection rate was less in the sentinel lymph node biopsy (SLNB) cases (19.9%–100% with 100% representing one sample) than the ALND cases (46.6%–94.9%). Crossover nodes (those representing ARM and sentinel nodes) were identified in 5.6%–20% of ALND cases and 0%–14% of SLN cases. The recurrence of cancer in nodes that were ARM preserved would determine oncologic safety, in which studies from a referenced source deemed the ARM procedure as oncologically safe in clinically node negative, SLN positive cases, with the exception of the ARM and positive SLN being synonymous. The incidence of lymphedema reported for all ALND cases was 0%–30% and for all SLNB was 0%–4%. Lymphedema ranges for non-ARM ALND cases was 11.8%–53.5% and for SLN samples was 0%–15.8%.

Conclusions

No definite conclusions can be drawn because of the low level of evidence assigned to the studies reviewed, with the exception of one RCT with an assigned evidence level of 2. While feasibility appears to exist with the use of the ARM procedure, a vast range in the rate of ARM nodes and a decreased incidence of lymphedema were detected.  
 
Reviewer conclusion: The criteria for evidence is unclear; therefore, drawing conclusions from the study comparisons in regard to the use of the ARM procedure in reducing the incidence of lymphedema is difficult. The wide ranges of incidence are attributed to several limitations relevant to the lack of consistency in procedure, lymphedema assessment and definition, and varying follow-up intervals that were used to answer the research questions. Theoretically, the ARM procedure should be studied more rigorously in clinical trials, with uniform reporting in comparison with non-ARM lymphedema incidence. This study gives encouraging data in this regard; however, the limitations of the study prohibit generalization.

Limitations

  • Limited search
  • Low sample sizes
  • Lymphedema definition varied
  • Method of lymphedema measurement varied
  • Level of evidence for all studies except one RCT was low.
  • Oncologic safety was based on one source.
  • No information about the patient population and medical characteristics
  • Four indices were used for search.

Nursing Implications

The implications for nursing would be in the area of patient education, if and when the ARM procedure becomes a standard of care. For the present, nurses need to be knowledgeable of clinical trials involving ARM.

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Gautam, A.P., Fernandes, D.J., Vidyasagar, M.S., & Maiya, G.A. (2012). Low level helium neon laser therapy for chemoradiotherapy induced oral mucositis in oral cancer patients: A randomized controlled trial. Oral Oncology, 48, 893–897.

Study Purpose

To evaluate the therapeutic effects of a low level He-Ne laser on chemoradiation (CRT) -induced oral mucositis (OM), associated severe pain, and use of total parenteral nutrition (TPN) in patients with oral cancer

Intervention Characteristics/Basic Study Process

Block randomization was done using a computerized program taking primary oral cancer stage as a matching variable of 121 primary patients with oral cancer scheduled to undergo CRT (RT dosage = 66 Gray/33 fractions for five days per week and chemotherapy was three weeks cisplatin). Patients were randomized to either laser (n = 60) or placebo (n = 61). Both groups received standard oral care and hygiene. Patients and outcomes assessor were kept blinded for the laser intervention. OM, its associated pain, and TPN were assessed every week by a blinded assessor. Opioid analgesic use, weight loss, and any CRT breaks were recorded.   

Laser treatments used He-Ne 632.8 nm, power output of 24 mW, beam spot diameter of 0.6 mm, noncontact method (Technomed Electronics, Advanced Laser Therapy 1000, Chennai, India). This was applied to the anatomical sites in the oral cavity (buccal mucosa, lateral and ventral tongue, labial mucosa, floor of the mouth and palate), excluding cancer site daily just before radiation session for 6.5 weeks.

The placebo group received sham therapy (the probe was kept off, and there was only a beep sound) just before radiation for 6.5 weeks. 

Sample Characteristics

  • The study reported on 121 patients with cancer of the oral cavity.
  • The mean age of patients in the laser group was 51.71 years, and the mean age of patients in the placebo group was 52.60 years.
  • The sample was 91% male and 9% female.

Setting

This was a single-site study in a nonspecified setting in India.

Phase of Care and Clinical Applications

  • Patients were undergoing the active treatment phase of care.
  • The study has clinical applicability for end of life and palliative care.

Study Design

This was a prospective double blinded, randomized controlled trial.

Measurement Instruments/Methods

  • An experienced radiology oncologist who was blinded for the intervention group performed the assessment of the oral mucositis using the Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer scoring system (grade 0–4).
  • The need for TPN was recorded at the end of every week.
  • Opioid analgesics use, weight less, CRT break during severe oral mucositis (grade > 2), and pain severity (using a visual analog scale [VAS]) of greater than 7 were recorded.

Results

During the last weeks of CRT, incidence of mucositis greater than grade 2 was less in the laser group than in the placebo group (p < 0.0001). The mean duration of severe grades of OM was less than in the placebo group.

At the third week of CRT, no statistical difference was found between groups for incidence of OM, severe pain, TPN, and weight loss.

The laser group had less need for opioid use (p < 0.001). None of the patients in the laser group required a break in CRT, but 9% of patients in the placebo group required a break in CRT.

OM progressed at a slower rate in the laser group than in the placebo group. Pain was less severe as rated by pain scores, and TPN was significantly less in the laser group than in the placebo group.

Conclusions

Low level He-Ne laser was found to decrease the incidence of CRT-induced, severe OM and its associated pain; opioid analgesic use; and TPN for patients with oral cancer.

Nursing Implications

Low level helium neon laser therapy for the reduction of chemotherapy-induced OM in patients with oral cancer appears to be helpful, but the therapy is limited because of the need for the laser and an experienced laser therapist. The laser therapy in this study included standard oral care and hygiene; therefore, laser therapy does not eliminate this need.

Long-term follow-up on the effects of laser on OM is recommended to understand the carryover effects of laser in these patients. Studies explaining the exact mechanisms of action of laser also are recommended.

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Gautam, A.P., Fernandes, D.J., Vidyasagar, M.S., Maiya, A.G., & Vadhiraja, B.M. (2012). Low level laser therapy for concurrent chemoradiotherapy induced oral mucositis in head and neck cancer patients: A triple blinded randomized controlled trial. Radiotherapy and Oncology, 104, 349–354.

Study Purpose

To examine the efficacy of low level laser therapy (LLLT) in patients with head and neck cancer receiving chemotherapy and radiation therapy (RT)

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to receive LLLT or sham treatment. Both groups received standard oral care and oral hygiene protocol, including frequent mouth washes with sodium bicarbonate. Patients in the LLLT group were treated with helium neon laser in 15–20 minute sessions, five sessions per week, at six anatomical sites in the oral cavity. Treatment was done daily prior to RT for 45 days. Patients, outcomes assessors, and statisticians were blinded to patient group assignment. Oral mucositis was assessed and graded daily.

Sample Characteristics

  • The study reported on 221 patients with a mean age of 55.4 years (SD = 11.4 years).
  • The sample was 85.5% male and 14.5% female.
  • All patients were newly diagnosed and receiving 100 m/m2 cisplatin on days 1, 22, and 43 and 66 Gy radiation in 33 fractions, five days per week.
  • All had stage 3 or 4 disease.  

Setting

This was a single-site, outpatient study conducted in India.

Phase of Care and Clinical Applications

Patients were undergoing the active antitumor treatment phase of care.

Study Design

The study design was a randomized triple-blind sham-controlled randomized clinical trial.

Measurement Instruments/Methods

  • The European Organization for Research and Treatment of Cancer (EORTC) mucositis scoring system was used.
  • The need for supplemental analgesics and parenteral nutrition was recorded.
  • A visual analog scale was used to measure pain.

Results

  • Oral mucositis increased in both groups over time, but progressed more slowly in the laser group (p < 0.0001).
  • At the end of treatment, incidence of grade 3–4 mucositis was about three times lower in the laser group.
  • Duration of severe mucositis was less with the laser group.
  • The average number of RT fractions after which severe mucositis developed was higher in the laser group. 
  • Average pain scores were consistently lower in the laser group (p < 0.00001).
  • The need for total parenteral nutrition was lower in the laser group (p < 0.00001). 
  • Fewer patients in the laser group required any treatment delays.

Conclusions

Prophylactic LLLT in patients with head and neck cancer receiving concomitant radiation and chemotherapy was effective in reducing the incidence of severe oral mucositis.

Limitations

Without a longer-term follow up, long-term effects of LLT are not known.

Nursing Implications

Prophylactic use of LLLT was able to prevent and treat severe oral mucositis in this group of patients. This study adds to the growing body of evidence supporting the effectiveness of LLLT in patients with head and neck cancer receiving treatment, particularly in patients receiving chemotherapy with RT. Nurses can advocate for the use of LLLT in this patient population.

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Gautam, A.P., Fernandes, D.J., Vidyasagar, M.S., Maiya, A.G., & Guddattu, V. (2015). Low level laser therapy against radiation induced oral mucositis in elderly head and neck cancer patients—A randomized placebo controlled trial. Journal of Photochemistry and Photobiology, B: Biology, 144C, 51–56. 

Study Purpose

To evaluate the effects of low level laser therapy (LLLT) for the prevention and treatment of radiation-induced oral mucositis (OM) in older adult patients with head and neck cancer (HNC)

Intervention Characteristics/Basic Study Process

All patients were treated with definitive radiation therapy (RT) with a dosage of 66 Gy given in 33 fractions daily, five days a week, for over 6.5 weeks. Just prior to radiation treatment, patients in both groups received the same amount of “laser treatment” sessions. The laser group was treated with laser therapy, and the placebo group received \"treatment\" with the laser probe turned off, although the beep signaled the end of treatment. Treatment was delivered to six anatomical sites bilaterally in the oral cavity: the ventral and lateral surface of the tongue, the labial mucosa, buccal mucosa, floor of the mouth, and palate. Doses were standardized.
 
The participants were assessed by an experienced radiation oncologist for OM, pain, and weight loss at the end of every week. Also, the need for morphine analgesics, enteral feeding, and RT break was recorded.

Sample Characteristics

  • N = 46  
  • AGE = Older than 60 years
  • MALES: 20 (90.9%) in the laser group and 19 (79.2%) in the placebo group, FEMALES: 2 (9.1%) in the laser group and 5 (20.8%) in the placebo group
  • CURRENT TREATMENT: Radiation 
  • KEY DISEASE CHARACTERISTICS: Primary HNC
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients with lock jaw, any medical condition affecting healing mechanisms like diabetes, and who had prior radiation for HNC or were receiving any chemosensitizer were excluded.

Setting

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

Phase of Care and Clinical Applications

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

Study Design

  • Randomized, placebo controlled trial

Measurement Instruments/Methods

  • Radiation Therapy Oncology Group/European Organization for Research and Treatment for Cancer (RTOG/EORTC) scoring system for OM
  • Visual Analog Scale (VAS) for pain and weight loss
  • Weight changes
  • Data analysis was done using descriptive statistics.
  • ANOVA tests of repeated measures
  • Shapiro-Wilk test to test the normality of the data

Results

Laser group: Progression of OM toward higher grades was slower, less patients had severe oral pain, significantly less patients experienced OM (grade III and IV) (p = 0.016), less patients required total parenteral nutrition (TPN) support, the mean duration of severe oral pain was less (10 versus 16.5), the mean duration of TPN required was less, without statistical difference. Statistically significant difference existed in the duration of severe OM (p = 0.048) and severe oral pain (p = 0.028). Less patients required supplement opiod analgesics in the laser group (8.3%) than in the placebo group (35.7%).
 
Both groups experienced weight loss, but the laser group experienced less (2.58 kg versus 5.57 kg in placebo group) (p = 0.004). No significant differences arose among the groups in the first two weeks; however, week 3 onward showed a statistically significant difference, with greater loss in the placebo group (p < 0.05).
 
Radiation break due to severe OM was not required for any patient in the laser group; 14.3% of participants in the placebo group required a break.

Conclusions

LLLT seems to be an effective intervention in preventing OM in older adult patients with HNC. Larger, multisite trials are needed for validation.

Limitations

  • Small sample (< 100)
  • Intervention expensive, impractical, or training needs
  • Subject withdrawals ≥ 10%  
  • Patients all were said to have been kept on “standard oral care,” but that was never defined.
  • Lack of inter-rater reliability in using the scales, no mention of training or consistency in using the scales between the radiation oncologists
  • No mention of the calibration of the scales used to measure weight or mention of who weighed the patients

Nursing Implications

Nurses are vital in educating patients on good oral hygiene both before and during radiation treatments. Nurses see patients weekly, sometimes daily, and are essential to managing OM while patients undergo treatment, in combination with other methods such as LLLT investigated in this study. Reducing OM allows more patients to finish treatment.

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Gautam, A.P., Maiya, A.G., & Vidyasagar, M.S. (2011). Effect of home-based exercise program on lymphedema and quality of life in female postmastectomy patients: Pre-post intervention study. Journal of Rehabilitation Research and Development, 48(10), 1261–1268.

Study Purpose

To determine the effectiveness of a home-based independent exercise regimen, comprised of upper-limb resistance exercises and deep breathing exercises, in relieving lymphedema symptoms and improving quality of life

Intervention Characteristics/Basic Study Process

Participants received education from a qualified physiotherapist on how to perform the at-home exercise regimen for the first few sessions. Once satisfactory performance of the exercises had been completed, the patients received a handout about the exercise program and a log book to journal their progress. The exercise regimen was to be performed five days a week. Deep breathing exercises were to be performed between each set. It was recommended to only increase the weight if 2 sets of 15 repetitions became very easy to perform. The exercise regimen consisted of scapular retraction, shoulder extension, scapular protraction, scapular depression, elbow flexion, elbow extension, wrist flexion and extension, and ball squeeze. Patients were monitored weekly via telephone, and the fourth week all patients had a follow-up appointment with the investigators either in the home or at the hospital.  
 

Sample Characteristics

  • The sample (N = 32) was comprised of female patients with breast cancer (stages I–II).
  • Mean age of the sample was 46.56 years.
  • All patients had underwent a unilateral mastectomy.
  • One and a half years before study participation, patients completed neoadjuvent chemotherapy and radiation (March 2006–February 2008).
     

Setting

The study took place at multiple sites in Manipal, India.

Phase of Care and Clinical Applications

Patients were transitioning between phases of care.

Study Design

The study used a pre-post design. 

Measurement Instruments/Methods

  • The arms were measured using two different methods, arm circumference and water displacement, to determine volumetric changes.
  • Quality of life was assessed using the 36-Item Short-Form Health Survey (SF-36).

Results

A statistically significant reduction in upper-limb circumference was found at three measurements (p < 0.001) and in affected upper-limb volume (p<0.001). The mean volume reduction was 122 ml. The metacarpophalanfeal joint circumference reduction measurement was not found to be statistically significant (p = 0.04). A statistically significant change in quality-of-life score from the SF-36 was found after completion of the exercise regimen.

Conclusions

The study has shown statistically significant improvements in limb volume and circumference reduction as well as improvement in QOL using this at-home exercise program.

Limitations

  • The sample was small (N < 100).
  • The study did not have a control group or random assignment (all patients received the intervention).
  • Patient adherence to the exercise regimen can affect results.

Nursing Implications

Because the findings from the study is statistically significant, it would be great for this research to be repeated with a more rigorous study design (i.e., randomized controlled trial) with a larger sample size to clarify effectiveness of the exercise regimen. If repeatedly proven that this exercise regimen is effective in reducing lymphedema, it would be a good program for nurses to teach their patients during discharge instructions because it is extremely simple and anyone can complete the exercises with common household items.

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Gatt, M., Willis, S., & Leuschner, S. (2016). A meta-analysis of the effectiveness and safety of kinesiology taping in the management of cancer-related lymphoedema. European Journal of Cancer Care. Advance online publication. 

Purpose

STUDY PURPOSE: To determine the effectiveness and safety of kinesiology taping (KT) compared to compression bandaging

TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy

DATABASES USED: CINAHL, Cochrane Collaboration, PubMed, Web of Science, PEDro, and multiple sources for ongoing trials and conference proceedings.
 
INCLUSION CRITERIA: Cancer-related lymphedema; evaluation of KT with or without combined decongestive therapy (CDT); comparison to compression bandages or hosiery; randomized, controlled trials (RCT)
 
EXCLUSION CRITERIA: Primary lymphedema or secondary to conditions other than cancer; nonrandomized, controlled trials

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 251
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Risk of bias from Cochrane Collaboration tool. Four studies had high risk of bias.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 6 studies, 5 in meta-analysis 
  • TOTAL PATIENTS INCLUDED IN REVIEW = 203
  • SAMPLE RANGE ACROSS STUDIES: 190–70
  • KEY SAMPLE CHARACTERISTICS: All had breast cancer–related lymphedema.

Phase of Care and Clinical Applications

PHASE OF CARE: Late effects and survivorship

Results

No statistically significant difference existed between KT and compression bandaging, although the analysis showed overall results in favor of compression bandaging with or without CDT. In five of the six studies, 10%–21% dropped out because of skin-related adverse events. Skin adverse events were reported only in KT groups. The findings regarding patient discomfort or satisfaction with the intervention were mixed. Reported limb reduction volumes varied widely. Four or five studies in the meta-analysis showed greater limb reduction volume in the compression bandaging group.

Conclusions

KT produced lower limb reduction volume and was associated with more skin adverse effects. No difference existed in patient comfort with KT versus compression bandages.

Limitations

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

Nursing Implications

The findings of this analysis did not provide strong support for the use of KT because no better volume reduction existed and it was associated with more skin problems. If used in clinical practice, KT should be used with caution in patients where bandaging cannot be used. No evidence exists regarding KT use other than for upper extremity lymphedema in this review.

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Gatt, M.E., Strahilevitz, J., Sharon, N., Lavie, D., Goldschmidt, N., Kalish, Y., . . . Paltiel, O.B. (2015). A randomized controlled study to determine the efficacy of garlic compounds in patients with hematological malignancies at risk for chemotherapy-related febrile neutropenia. Integrative Cancer Therapies. Advance online publication. 

Study Purpose

To evaluate the efficacy of garlic compounds to reduce the risk and severity of infections among patients with hematologic malignancies

Intervention Characteristics/Basic Study Process

Patients were stratified according to National Comprehensive Cancer Network criteria for febrile neutropenia (FN) to receive either garlic or a placebo. Patients began the intervention after the last day of their courses of chemotherapy and continued until the resolution of neutropenia. Garlic was given in two doses of 450 mg active compound per day.

Sample Characteristics

  • N = 95
  • MEAN AGE = 56 years (range = 20–82 years)
  • MALES: 64.2%, FEMALES: 35.8%
  • KEY DISEASE CHARACTERISTICS: Patients had acute myeloid leukemia, non-Hodgkin lymphoma, acute lymphoblastic leukemia, Hodgkin disease, and other types of hematologic malignancies; most patients had active disease at the time of the study and slightly less than half had previous FN in both study groups 
  • OTHER KEY SAMPLE CHARACTERISTICS: Greater than 60% of patients in both groups were receiving trimethoprim or sulfamethoxazole.

Setting

  • SITE: Single site  
  • SETTING TYPE: Multiple settings  
  • LOCATION: Israel

Phase of Care and Clinical Applications

  • PHASE OF CARE: Transition phase after active treatment

Study Design

Placebo-controlled, double blinded, randomized trial

Measurement Instruments/Methods

  • Complete blood counts
  • Primary outcomes were time to and onset of fever greater than 38°C   
  • Number of FN episodes

Results

The majority of patients in both groups developed neutropenia and febrile episodes at similar rates. The number of positive cultures was similar. More patients receiving garlic stopped before the end of the period of neutropenia (19.5% in the garlic group compared to 4% in the placebo group). In the very high-risk group, more patients receiving garlic developed fever. In the intermediate risk group, fewer patients receiving garlic developed fever. There were no adverse events associated with garlic use.

Conclusions

Garlic did not appear to provide any protective effect against the development of febrile episodes during neutropenia in these patients.

Limitations

  • Small sample (< 100)

 

Nursing Implications

Garlic extract appeared to be safe for patients with hematologic malignancies but did not show any efficacy for the prevention of fever or infection during neutropenic periods.

Print

Gaston-Johansson, F., Fall-Dickson, J. M., Nanda, J., Ohly, K. V., Stillman, S., Krumm, S., . . . Kennedy, M. J. (2000). The effectiveness of the comprehensive coping strategy program on clinical outcomes in breast cancer autologous bone marrow transplantation. Cancer Nursing, 23, 277–285.

Intervention Characteristics/Basic Study Process

The comprehensive coping strategy program (CCSP) provided patients with information emphasizing the use of pain control to decrease psychological distress and physical symptoms, such as fatigue. Patients were provided with handouts that explained ways to reduce pain, the use of cognitive restructuring information on distorted thinking, and positive coping self-statements. Patients were taught how to perform a brief muscle relaxation, which included a guided imagery component. Handouts were provided that described relaxation therapy and its benefits. A handheld recorder was given to patients to guide them through the relaxation exercise. Patients were instructed to use a five-minute audiotape recording at least every day and before stressful events. Patients were instructed to record their use of audiotapes and handouts in a diary. Outcomes were assessed at baseline, two days before allogeneic bone marrow transplant (ABMT), and seven days after ABMT. 

Sample Characteristics

  • In total, 128 women with breast cancer scheduled for ABMT were included.
  • Most patients were aged between 41 and 50 years.
  • Of the patients in the CCSP group, 90% were married, which was significantly higher than the control group (57% married; p < 0.001), and 40% had practiced some earlier coping method, which was significantly higher compared to 21% of the those in the control group (p < 0.05).

Setting

National Cancer Institute (NCI)–designated comprehensive cancer center located in the eastern United States

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

This was a randomized, controlled, prospective clinical trial that included

  • Patients scheduled for ABMT who received the CCSP
  • Patients scheduled for ABMT who received standard medical care.

Measurement Instruments/Methods

Visual analog scale (VAS)

Results

Fatigue was experienced by 91% of the participants. The peak fatigue level was observed days before ABMT for both groups; the CCSP group experienced a 10.80-point increase, and the control group experienced a 20.33-point increase. The CCSP group experienced a statistically significant improvement in fatigue seven days after ABMT in comparison to the control group (p < 0.05); however, this difference disappeared after controlling for demographic variables and fatigue two days prior to ABMT. An index of nausea and fatigue was created for day seven after ABMT, and there was a statistically significant difference between the groups, with demographic variables controlled, with the control group reporting more nausea and fatigue than the intervention group (p < 0.05).

Limitations

The generalizability of the results was limited to the sample, which consisted primarily of highly educated, married, Caucasian women with high incomes.

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Gasser, P., Holstein, D., Michel, Y., Doblin, R., Yazar-Klosinski, B., Passie, T., & Brenneisen, R. (2014). Safety and efficacy of lysergic acid diethylamide-assisted psychotherapy for anxiety associated with life-threatening diseases. Journal of Nervous and Mental Disease, 202, 513–520. 

Study Purpose

To evaluate previous findings regarding the effectiveness of lysergic acid diethylamide (LSD)-assisted psychotherapy

Intervention Characteristics/Basic Study Process

Participants were recruited through general information in media, flyers, cancer support groups, and hospitals. Patients were randomized to the LSD group receiving an oral dose of 200 mcg LSD or to an active placebo of 20 mcg LSD. Participants were required to taper off antidepressants and antianxiety medications and avoid alcohol and recreational drugs for 24 hours before sessions. Urine drug tests were done prior to each psychotherapy session. Two experimental sessions with LSD were completed. After each experimental session, three dug-free therapy sessions took place. A follow-up evaluation was completed two months after the second experimental session. At that time, participants in the placebo group could cross over to an identical open label treatment with LSD. The final evaluation was conducted 12 months after the last LSD-assisted session. About two-thirds of the LSD-assisted session was focused inward and one-third was brief conversation. The session ended after eight hours when acute effects subsided and was followed by a review of the day’s experience.

Sample Characteristics

  • N = 12  
  • MALES: Not reported, FEMALES: Not reported
  • KEY DISEASE CHARACTERISTICS: Not reported
  • OTHER KEY SAMPLE CHARACTERISTICS: All reported a > 40 score on the State-Trait Anxiety Inventory (STAI), and half were diagnosed with generalized anxiety disorder by a structured clinical interview.  

Setting

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

Phase of Care and Clinical Applications

  • PHASE OF CARE: End-of-life care

Study Design

Placebo-controlled, randomized, controlled trial

Measurement Instruments/Methods

  • Structured clinical interview 
  • Speilberger State-Trait Anxiety Inventory (STAI)
  • European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)
  • Hospital Anxiety and Depression Scale (HADS)
  • Patient daily diary 
  • Visual Analog Scale (VAS) for pain
  • State of Consciousness Questionnaire (SCQ)

Results

The visit-by-group interaction testing for differences between groups showed a significant difference between groups (p = .033) and 65.5% power. Three of eight experimental group subjects dropped lower than the threshold of 40 on the anxiety inventory while all active placebo subjects experienced increases in anxiety. The two- and 12-month follow-up results of those who received LSD in either blinded or crossover conditions showed that benefits were sustained over time. Neither the experimental nor the placebo dose of LSD produced any severe drug-related adverse events. Adverse events reported were those commonly associated with LSD, and most resolved when the drug effects diminished. There were no events of prolonged anxiety or lasting psychotic or perceptional disorders.

Conclusions

This study demonstrated the safety of LSD-assisted psychotherapy sessions in a small group of patients with life-threatening diseases. There were positive trends of anxiety reduction after two LSD-assisted therapy sessions.

Limitations

  • Small sample (< 30)
  • Risk of bias (no blinding)
  • Intervention expensive, impractical, or training needs

Nursing Implications

Findings from this small pilot study suggest that LSD-assisted psychotherapy may be beneficial to patients facing the end of life to reduce anxiety. Additional research studies to confirm its safety and efficacy are needed.

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