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Garland, S.N., Rouleau, C.R., Campbell, T., Samuels, C., & Carlson, L.E. (2015). The comparative impact of mindfulness-based cancer recovery (MBCR) and cognitive behavior therapy for insomnia (CBT-I) on sleep and mindfulness in cancer patients. Explore, 11, 445–454. 

Study Purpose

To compare the impact of a mindfulness-based cancer recovery (MBCR) intervention versus cognitive behavioral therapy for insomnia (CBT-I) on mindfulness and dysfunctional sleep beliefs, to examine associations of insomnia severity and changes in mindfulness and dysfunctional sleep beliefs, and to compare changes in insomnia severity between treatment groups

Intervention Characteristics/Basic Study Process

MBCR was used on-site at weekly 90-minute group classes with one six-hour silent retreat between weeks 6 and 7 as an opportunity for extended practice. The program consists of several types of mindfulness practices and didactic instruction on application of mindfulness attitudes. The facilitator was a nurse with more than 10 years of experience delivering MBCR. The CBT-I program consisted of eight weekly 90-minutes sessions, including stimulus control, sleep restriction, relaxation, cognitive strategies aimed at dysfunctional sleep beliefs, and sleep hygiene. The facilitator for the CBT-I program was a doctoral level trainee in a nationally accredited clinical psychology program and was supervised by a PhD-level Clinical Health Psychologist.

Sample Characteristics

  • N = 72  
  • MEAN AGE: No sample mean
  • AGE RANGE: 36–88 years
  • MALES: 27.8%, FEMALES: 72.2%
  • KEY DISEASE CHARACTERISTICS: The study included patients with breast, prostate, blood/lymph, female genitourinary, lung, head/neck, or colorectal cancers; and survivors with non-metastatic disease who had completed treatment at least one month prior to study participation.
  • OTHER KEY SAMPLE CHARACTERISTICS: 64% were married and 58% were employed.

Setting

  • SITE: Single site
  • SETTING TYPE: Outpatient  
  • LOCATION: University of Calgary/Alberta Health Services

Phase of Care and Clinical Applications

  • PHASE OF CARE: Late effects and survivorship

Study Design

  • Secondary analysis of randomized, controlled trail data
  • Parent study compared MBCR with CBT-I for treatment of insomnia in patients with cancer

Measurement Instruments/Methods

  • Five Facet Mindfulness Questionnaire (FFMQ)
  • Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16)
  • Insomnia Severity Index (ISI)

Results

Mindfulness outcomes not reported. There were significant group, time, and group X time effects on overall and subscale scores for the DBAS with large effect sizes. The CBT-I group had more improvements than the MBCR group. Baseline to post-program improvements were noted that persisted at three-month follow-up. Associations between DBAS subscale and total scores and insomnia severity were not reported. Aspects of mindfulness were negatively correlated with a number of DBAS subscales and total score. Insomnia severity was negatively correlated with mindfulness non-judging. Insomnia severity (severe, moderate, mild, none) was not significantly different at baseline, post-program, and follow-up between MBCR and CBT-I groups.

Conclusions

CBT-I has a greater impact on DBAS measures than MBCR, but both have large effect sizes on DBAS. Aspects of mindfulness account for some variability in DBAS scores. Both MBCR and CBT-I have a positive impact on insomnia severity over time.

Limitations

  • Small sample (less than 100)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Key sample group differences that could influence results
  • Findings not generalizable
  • A number of risks for bias are unknown. The parent study is not referenced; therefore, the number of people who refused to participate or the attrition rate or allocation sequence and concealment is unknown. Analysis was per protocol. Results should be taken with caution.

Nursing Implications

Both CBT-I and MBCR may improve insomnia in survivors. CBT-I has a greater impact in decreasing dysfunctional beliefs about sleep.

Print

Garland, S.N., Carlson, L.E., Stephens, A.J., Antle, M.C., Samuels, C., & Campbell, T.S. (2014). Mindfulness-based stress reduction compared with cognitive behavioral therapy for the treatment of insomnia comorbid with cancer: A randomized, partially blinded, noninferiority trial. Journal of Clinical Oncology, 32, 449–457. 

Study Purpose

To examine whether mindfulness-based stress reduction (MBSR) is noninferior to cognitive behavioral therapy for insomnia (CBT-I) for the treatment of insomnia in patients with cancer

Intervention Characteristics/Basic Study Process

CBT-I was delivered to groups of 6–10 individuals over the course of eight weekly, 90-minute sessions for a total of 12 contact hours. The intervention followed the format of previously published CBT-I trials in patients with cancer. CBT-I contains the following four individually validated strategies: stimulus control, sleep restriction, cognitive therapy, and relaxation training, which target and reduce sleep-related physiologic and cognitive arousal to re-establish restorative sleep function.
 
MBSR was delivered to groups of 15–20 people over the course of eight weekly, 90-minute sessions, plus one six-hour, weekend, intensive silent retreat for a total of 18 contact hours. The program provides patients with psychoeducation on the relationship between stress and health, while meditation techniques and gentle yoga are practiced to support the development of mindful awareness and responding to stress.

Sample Characteristics

  • N = 111  
  • MEAN AGE = 58.89 years (SD = 11.08 years)
  • AGE RANGE = 35–88 years
  • MALES: 28%, FEMALES: 72%
  • KEY DISEASE CHARACTERISTICS: Patients with mixed nonmetastatic cancer who had insomnia and completed primary treatment at least one month prior; 48% had breast cancer, and 12% had prostate cancer; mean cancer duration was 3.9 years (SD = 4.03 years); treatments included surgery, chemotherapy, radiation, and hormonal therapy
  • OTHER KEY SAMPLE CHARACTERISTICS: Mean education was 15.14 years (SD = 3.53 years); 90% white/European

Setting

  • SITE: Single site    
  • SETTING TYPE: Tertiary cancer center    
  • LOCATION: Calgary, Canada

Phase of Care and Clinical Applications

  • PHASE OF CARE: Long-term survivorship (at least one month since active, primary treatment)

Study Design

  • Randomized, partially blinded, noninferiority trail
 

Measurement Instruments/Methods

  • Insomnia Severity Index (ISI)
  • Daily sleep diaries
  • Actigraph GT1M
  • Calgary Symptoms of Stress Inventory
  • Profile of Mood States (POMS)
  • Dysfunctional Beliefs and Attitude About Sleep (DBAS)

Results

Of 327 patients screened, 111 were assigned randomly (CBT-I, n = 47; MBSR, n = 64). MBSR was inferior to CBT-I for improving insomnia severity immediately after the program (p = .35), but MBSR demonstrated noninferiority at follow-up (p = .02). Sleep diary-measured sleep latency (minutes to fall asleep) was reduced by 22 minutes in the CBT-I group and by 14 minutes in the MBSR group at follow-up. Similar reductions in wake after sleep onset (in minutes) were observed for both groups. Total sleep time increased by 0.60 hours for CBT-I and 0.75 hours for MBSR. CBT-I improved sleep quality (p = .001) and dysfunctional sleep beliefs (p = .001), whereas both groups experienced reduced stress (p = .001) and mood disturbance (p = .001).

Conclusions

Although MBSR produced a clinically significant change in sleep and psychological outcomes, CBT-I was associated with rapid and durable improvement and remains the best choice for the nonpharmacologic treatment of insomnia.

Limitations

  • Risk of bias (no appropriate attentional control condition)
  • Findings not generalizable
  • Other limitations/explanation: The most notable limitation is the differential attrition observed between groups. Although the reasons are unknown, participant preference may have contributed to the significant attrition in the MBSR group compared with CBT-I because how learning meditation and yoga could contribute to sleep improvements may be less obvious to participants not already inclined to choose MBSR. The findings are not generalizable to a more racially diverse population (90% white/European). The absence of a no-treatment control group prevents an exploration of alternate explanations for change over time. The additional six hours of contact time received by participants in the MBSR group raises the possibility of even greater relative improvement for the CBT-I group if it had been matched for time. Treatment integrity was not formally assessed; however, the research was designed to minimize risk of treatment contamination, and measures were taken throughout the study to promote fidelity.

Nursing Implications

Noninferiority of MBSR only was demonstrated at the five-month follow-up, suggesting that although MBSR may produce clinically significant improvements with time, the treatment effects of CBT-I are rapid and durable. Thus, CBT-I remains the treatment of choice for patients with cancer who have insomnia.

Print

Garland, S.N., Johnson, J.A., Savard, J., Gehrman, P., Perlis, M., Carlson, L., & Campbell, T. (2014). Sleeping well with cancer: A systematic review of cognitive behavioral therapy for insomnia in cancer patients. Neuropsychiatric Disease and Treatment, 10, 1113–1124. 

Purpose

STUDY PURPOSE: To review the efficacy of cognitive behavioral therapy (CBT) on sleep and psychological outcomes in patients with cancer and cancer survivors

TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: PubMed, MEDLINE, PsycINFO
 
KEYWORDS: insomnia; cancer; sleep disturbances; cognitive; cognitive behavioral therapy
 
INCLUSION CRITERIA: CBT tailored for insomnia was used as the intervention; the target population was patients with cancer; measure of sleep was included as a treatment outcome.
 
EXCLUSION CRITERIA: Not described

Literature Evaluated

TOTAL REFERENCES RETRIEVED: Not reported
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Not reported

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 12
  • SAMPLE RANGE ACROSS STUDIES = 10–260
  • TOTAL PATIENTS INCLUDED IN REVIEW = 1,153
  • KEY SAMPLE CHARACTERISTICS: Most studies in breast cancer, but a few in mixed diseases

Phase of Care and Clinical Applications

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

Results

Four of four uncontrolled trials showed a positive significant effect of CBT on sleep problems. Of eight RCTs, five showed a positive significant effect and three showed no difference between groups. One of these compared CBT to mindfulness-based stress reduction rather than usual care. One study showed no long-term effectiveness. Review of the evidence shows overall efficacy of CBT in patients without cancer. The intervention has been delivered effectively in person, individually or in groups, telephonically, and via the internet or videos.

Conclusions

The majority of evidence shows that CBT has a positive effect on sleep-wake disturbance in patients with cancer. The most effective duration, timing, and “dose” is unclear, but this approach appears to be effective when delivered with varied methods.

Limitations

  • This review does not provide a full report of search results or any method of quality evaluation of the studies included.  
  • Reports individual study findings, but does not really synthesize and draw conclusions across studies

Nursing Implications

Evidence supports the effectiveness of CBT for sleep problems in patients with cancer, and this approach appears to be provided effectively in very practical ways, such as through videos and websites. At present, as reported in this review, CBT is seen as the treatment of choice for insomnia in patients with cancer. Future research for comparative effectiveness of various interventions for sleep disturbances is needed.

Print

Garland, S. N., Tamagawa, R., Todd, S. C., Speca, M., & Carlson, L. E. (2013). Increased mindfulness is related to improved stress and mood following participation in a mindfulness-based stress reduction program in individuals with cancer. Integrative Cancer Therapies, 12, 31–40.

Study Purpose

To examine the effects of a mindfulness-based stress-reduction therapy (MBSRT) on stress and mood disturbances and to examine the relationship of improved mindfulness and mood changes.

Intervention Characteristics/Basic Study Process

Hospital staff referred patients to the study or patients self-referred to the study. MBSRT consisted of eight weekly sessions and a six-hour silent retreat held after the sixth session. Classes taught participants about the mind-body connection, principles of mindfulness, and yoga practice. Patients were encouraged to share experiences to generate support from group members. All were given CDs with guided meditation exercises, and all received a program manual. Patients were encouraged to practice meditation and mindful movement at least 45 minutes per day. Patients who did not attend at least five sessions were excluded from the analysis.

Sample Characteristics

  • The sample was comprised of 268 patients.
  • Mean age was 53.8 years.
  • The sample was 15.7% male and 84% female; 71% were married or partnered.
  • Patients were diagnosed with breast, hematologic, and colon cancer.
  • Average time from diagnosis was zero years, indicating participation close in time to diagnosis.

 

Setting

  • Single site
  • Outpatient
  • Canada

Phase of Care and Clinical Applications

Patients were undergoing the transition phase after active treatment.

Study Design

The study used a pre-/posttest design.

Measurement Instruments/Methods

  • Mindfulness Attention Awareness Scale (MAAS)
  • Five Facet Mindfulness Questionnaire (FFMQ)
  • Calgary Symptoms of Stress Inventory (C-SOSI)
  • Profile of Mood States (POMS) Questionnaire

Results

  • The level of mindfulness increased significantly over the course of the program (p < 0.001). 
  • Improvements in stress and mood outcomes were noted, with effects of at least small to moderate size.
  • Change was observed in tension-anxiety (d = 0.52), depression (d = 0.44), and fatigue (d = 0.37) (p < 0.001). 
  • The study revealed no significant or strong correlation between mindfulness change and mood change.

Conclusions

The findings supported the use of MBSRT approaches for managing the symptoms of anxiety, depression, and fatigue.

Limitations

  • The study had risks of bias:  the sample consisted mostly of self-referred participants, suggesting that participants may have been predisposed to find therapy effective; and the study lacked a control group, blinding, random assignment, and appropriate attentional control condition. The lack of a control condition is particularly important because anxiety, depression, and fatigue can improve over time with no intervention.
  • The findings were not generalizable.
  • Baseline anxiety and depression scores were not reported, so it is not known if patients had any initial significant mood problems.
  • The authors stated that patients who did not attend at least five sessions were excluded from the analysis, but the authors did not report how many patients, if any, were excluded; therefore, the drop-out rate and final sample size were unclear.
  • The fact that the study revealed no significant correlations between change in mindfulness scores and mood changes may suggest that the mindfulness aspect of the intervention may not be the main effective component—the component may have been yoga or the support group sessions.

Nursing Implications

The findings suggested that a stress-reduction intervention involving group support, yoga, and mindfulness may help patients manage the symptoms of anxiety, depression, and fatigue. The various study limitations prevented firm conclusions from being drawn.

Print

Gardner, A., Mattiuzzi, G., Faderl, S., Borthakur, G., Garcia-Manero, G., Pierce, S., & Estey E. (2008). Randomized comparison of cooked and noncooked diets in patients undergoing remission induction therapy for acute myeloid leukemia. Journal of Clinical Oncology, 26, 5684–5688.

Study Purpose

This study was an evaluation of whether a diet including fresh fruits and vegetables increased the risk of infection in adult patients with cancer who were receiving induction chemotherapy for either acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS) in a protective environment.

Intervention Characteristics/Basic Study Process

Patients were randomized to either a “raw group” (n = 75) that was allowed a general diet including fresh fruits and vegetables or to a “cooked group” (n = 78) that was restricted to a low-microbial diet of all cooked food but no fresh fruit or vegetables. Patients remained in a protective environment from the initiation of induction chemotherapy until recovery of the absolute neutrophil count (ANC) over 500 mcl.  

Patients received routine antimicrobial prophylaxis with levofloxacin, valacyclovir, and an antifungal agent (itraconazole, voriconazole, or lipid amphotericin B).

Granulocyte–colony-stimulating factor was not used routinely.

Endpoints for the study were pneumonia, bacteremia, major infection, fever of unknown origin, and death.

Sample Characteristics

  • A total of 153 patients were in the study.
  • Patients were all newly diagnosed with either AML or MDS and received induction chemotherapy in a protective environment (with a high-efficiency particulate air-filtered room).
  • Median age of the patients in the raw group was 63 years.
  • Median age of the patients in the cooked group was 64 years.
  • The most frequent chemotherapy used was cytarabine.
  • One-third of the new patients (n = 53) refused to participate in the study and were placed in a nonrandomized group. They stayed on the low-microbial diet and were given a separate consent for chart review.

Setting

A single institution

Measurement Instruments/Methods

The statistical design was the Bayesian multiple outcome design of Thall and Sung. The X2 or Kruskal-Wallis test was used to compare various pretreatment characteristics.

Results

There was no statistically significant difference in the rate of infection, pneumonia, fever of unknown origin, or overall survival between the raw and cooked groups. A significantly higher rate of bacteremia was found in the raw group; however, the authors noted that most of the organisms responsible for the baceteremia were not of enteric origin.

The median number of days with an ANC less than 500 mcl was 20 days in the cooked group and 21 days in the raw group.
The median number of days with an ANC less than 100 mcl was 15 in the cooked group and 16 in the raw group.

  • Major infection rates: raw group: 35%; cooked group: 29% (p = 0.6)
  • Pneumonia rates: raw group: 5%; cooked group: 15% (p = 0.06)
  • Bacteremia or fungemia rates: raw group: 23%; cooked group: 9% (p = 0.03)
  • Fever of unknown origin rates: raw group: 36%; cooked group: 51% (p = 0.07)
  • Rate of infection or fever of unknown origin: raw group: 76%; cooked group: 87% (p = 0.09)
  • No significant difference existed in the rate of enteric organisms cultured from blood in either group (p = 0.12).
  • Survival rates: raw group: 61%; cooked group: 56%; non-randomized: 64%
  • Survival in all three groups was as expected in older patients with newly diagnosed AML or MDS.

Conclusions

A diet that includes raw fruits and vegetables did not increase the risk of infection or death in patients with MDS or AML treated with remission induction chemotherapy in a protective environment when compared to a diet that restricted raw fruits and vegetables.

One strength of the study is that the sample was a population of high-risk patients who had an ANC less than 500 mcl for a median of 20 days. In comparison, patients with solid tumors treated with chemotherapy are at low risk for infection, and the patients that experience neutropenia generally have an ANC less than 500 mcl less than seven days. Because this study demonstrated an absence of efficacy of the low-microbial diet in high-risk patients; it is unlikely to be of benefit in low-risk patients with a much shorter duration of neutropenia. However, further research is warranted to confirm the findings in other populations of neutropenic patients.

Limitations

  • The study was done at a single institution.
  • The study was conducted with patients in a protective environment, and patients were treated routinely with prophylactic antimicrobial agents. Therefore, findings are not generalizable to outpatients, patients cared for in non-protective environments, or patients not treated with prophylactic antimicrobial agents.
  • The rates of infection and death were the same between study groups; however, the rate of bacteremia was significantly higher in the raw group. Although the incidence of bacteremia was higher in the raw group, the authors reported that a substantial part of the difference reflected isolation of organisms not resident in the gut; the presence of such organisms would not be expected to be influenced by cooking of fruits and vegetables. In addition, the incidence of fever of unknown origin was higher in the cooked group, suggesting that some cases of bacteremia in the cooked group were not identified.
Print

Gardani, G., Cerrone, R., Biella, C., Galbiati, G., Proserpio, E., Casiraghi, M., … Lissoni, P. (2007). A progress study of 100 cancer patients treated by acupressure for chemotherapy-induced vomiting after failure of pharmacological approach. Minerva Medica, 98(6), 665-668.

Study Purpose

To confirm the potential therapeutic efficacy of PC6 stimulation by acupressure in patients with cancer experiencing chemotherapy-induced nausea and vomiting (CINV) after failure with pharmacologic approaches

Intervention Characteristics/Basic Study Process

PC6 acupoint was stimulated by acupressure with a button (P6 nausea control Sea-Band®) for eight hours per day at home, starting before the onset of chemotherapy, and for at least three days after chemotherapy.

Sample Characteristics

The study consisted of 100 consecutive patients with metastatic solid tumors admitted to receive chemotherapy for advanced disease.

Patients were included in the study if they had

  • Histologically proven metastatic solid tumor.
  • Measurable lesions.
  • No double tumor or brain metastasis.
  • No previous chemotherapy for metastatic disease.
  • No concomitant illnesses other than cancer.
  • Grade 3 or 4 vomiting.
  • No response to conventional antiemetic therapies.

Setting

The study was conducted in Italy.

Measurement Instruments/Methods

World Health Organization criteria were used.

Results

Overall, 68% of patients achieved control of emesis.

No significant differences in efficacy were observed in relation to tumor histotype.

The percentage of efficacy varied in relation to type of chemotherapy. The lowest results were observed in patients treated with anthracyclines, whereas more benefit was seen in patients with other chemotherapy agents. However, the efficacy achieved was greater than 50% in the treatment of vomiting because of anthracyclines.

Conclusions

The study confirmed the efficacy of acupressure in the treatment of CINV with a larger number of patients than previously studied. Acupressure appears to be effective in reducing vomiting experienced as a result of most commonly used chemotherapy agents.

Limitations

  • Only vomiting was measured; nausea was not.
  • This population was heterogeneous with different tumor types and chemotherapy agents.
  • Antiemetics before and after chemotherapy were not described.
  • No specific exclusion criteria were listed.
  • Several questions arose related to the intervention: who taught the patients how to use the Sea-Bands; what training did that person have; and how, when, and who evaluated the effectiveness of the intervention.
Print

Garcia, M.K., Cohen, L., Guo, Y., Zhou, Y., You, B., Chiang, J., . . . Wang, M. (2014). Electroacupuncture for thalidomide/bortezomib-induced peripheral neuropathy in multiple myeloma: A feasibility study. Journal of Hematology and Oncology, 7, 41-8722-7-41. 

Study Purpose

To evaluate the safety and initial efficacy of acupuncture for the treatment of thalidomide and bortezomib-induced chronic peripheral neuropathy (PN)

Intervention Characteristics/Basic Study Process

Standardized acupuncture medication and equipment was used by two licensed acupuncturists three times per week for four weeks (one week of rest; two times per week for four weeks). Both upper extremities and both lower extremities had the same point sites of treatment. After participants experienced a sensation of numbness, tingling, or warmth at the needle insertion site, an electrical stimulation was applied bilaterally for 20 minutes after completion of 80% of treatment sessions.

Sample Characteristics

  • N = 19  
  • AGE RANGE = 46–79 years
  • MALES: 74%, FEMALES: 26%
  • KEY DISEASE CHARACTERISTICS: Multiple myeloma 95%; amyloidosis 5%; for peripheral neuropathy (PN), all patients had symptoms in upper and lower extremities
  • OTHER KEY SAMPLE CHARACTERISTICS: PN treatment, pain management, and prior therapy were allowed. Dose ranges and the number of months since last dose were recorded. Participants had Eastern Cooperative Oncology Group statuses < 2. Patients were allowed to remain on the same medication regimens for PN and pain. Minor adjustments to medications were allowed.

Setting

  • SITE: Single-site
  • SETTING TYPE: Outpatient
  • LOCATION: MD Anderson Cancer Center in Houston, TX, United States

Phase of Care and Clinical Applications

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

Study Design

Nonrandomized, pilot feasibility, safety and efficacy study with a quasi-experimental design

Measurement Instruments/Methods

The National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) were used to evaluate for PN prior to beginning the study. The General Functional Assessment of Cancer Therapy (FACT-G) and the Brief Pain Inventory Short Form (BPI-SF) were used to evaluate patient-reported outcomes and baseline and at weeks 4, 9, and 13 during the study. Objective measurements (coin test, button test, walking test, postural stability/fall risk) and bilateral tibial and sural sensory nerve conduction tests were conducted at baseline and at week 13. The FACT and Gynecologic Oncology Group-Neurotoxicity (GOG-NTX) scales were used to assess the primary thee endpoints for PN at baseline and at weeks 4, 9, and 13. Evaluable patients completed 80% of the study medication.

Results

BPI-SF scores significantly improved in regard to pain severity with the worst pain occurring at 24 hours at all time points with large effect sizes in weeks 9 and 13. There was a significant improvement in BPI-SF pain interference in weeks 9 and 13 with a moderate effect size. FACT and GOG-NTX scores showed significant improvement in weeks 4, 9, and 13. Timed motor function tests from baseline to one month after the beginning of the study showed significant improvement. There was no statistically significant difference for fall risk, and nerve conduction studies demonstrated no change.

Conclusions

This feasibility, safety, and efficacy trial of electroacupuncture in 19 patients experiencing bortezomib- or thalidomide-induced PN demonstrated significant improvements in patient-reported outcomes for pain severity and interference according to the BPI-SF, FACT and GOG-NTX scores, and objective timed motor function tests from baseline to 13 weeks. No safety issues were reported.

Limitations

  • Small sample (< 30)
  • Baseline sample/group differences of import
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Risk of bias (sample characteristics)
  • Unintended interventions or applicable interventions not described that would influence results
  • Key sample group differences that could influence results
  • Measurement/methods not well described
  • Measurement validity/reliability questionable
  • Findings not generalizable
  • Treatment group differences: Previous medications were 84% bortezomib versus 16% thalidomide. 68% of patients experienced grade 2 PN while 32% experienced grade 3 PN. At baseline, PN occurrences were 74% male and 26% female. 58% of patients were taking pregabalin and 32% were taking gabapentin; 41% of patients were taking opioids. The frequency of pain medication use during treatment was not measured. The nerve conduction studies that were performed were not reported. The method of assessment was not well described. The reliability and validity of tools was not reported.

Nursing Implications

The use of electroacupuncture requires additional study in large, randomized, controlled trials to establish safety, benefits, the duration and sustainability of benefits, and treatment recommendations as an adjunct therapy for bortezomib- and thalidomide-induced PN.

Print

Garcia, M. K., McQuade, J., Haddad, R., Patel, S., Lee, R., Yang, P., . . . Cohen, L. (2013). Systematic review of acupuncture in cancer care: a synthesis of the evidence. Journal of Clinical Oncology, 31, 952–960.

Purpose

To evaluate the effectiveness of acupuncture for symptom control in patients with cancer.

Search Strategy

Databases searched were MEDLINE, EMBASE, CINAHL, Cochrane Collaboration, Scopus, and PubMed through December 2011.

Search keywords were acupuncture, electroacupuncture, moxibustion, Chinese medicine, Asian medicine, and keywords that included cancer and cancer symptoms.

Studies were included in the review if they

  • Were randomized, clinical trials (RCTs)
  • Involved acupuncture with needle insertion
  • Compared acupuncture to control, placebo, or sham acupuncture.

Studies were excluded from the review if they

  • Compared two active acupuncture forms, acupressure, or other interventions similar to acupuncture that did not involve needle insertion
  • Did not measure the effect of acupuncture on symptoms
  • Were considered gray literature (i.e., not generally accessible).

Literature Evaluated

In total, 3,494 references were retrieved and evaluated according to the Cochrane Handbook for Systematic Reviews of Interventions.

Sample Characteristics

  • The final number of studies included was 41.
  • The authors did not provide the sample range across studies, total number of patients, disease types, or characteristics.

Results

Studies addressed potential management of the following symptoms:

  • Pain:  Eleven RCTs met the criteria for analysis. No large trials reported positive results or were of good quality.
  • Chemotherapy-Induced Nausea and Vomiting (CINV):  Eleven RCTs met the criteria for analysis. One large study with a low risk of bias showed between-group effect sizes for acupuncture versus sham (0.80) and for acupuncture versus usual care (1.10).
  • Fatigue:  Three RCTs met the criteria for analysis. All had high risks of bias, and two had negative outcomes.
  • Hot Flashes:  Seven RCTs met the criteria for analysis. None had a low risk of bias.
  • Anxiety or Depression:  Five of the six RCTs analyzed showed positive results. All five had high risks of bias.
  • Sleep:  Three RCTs met the criteria for analysis, and all three reported positive outcomes and had high risks of bias.

Conclusions

The strongest evidence that the study produced showed that acupuncture may be effective for the management of CINV. The study did not show acupuncture to be efficacious in the treatment of other symptoms.

Limitations

The studies included were of low quality.

Nursing Implications

Available evidence, which was limited, did not support the claim that acupuncture is effective in alleviating various adverse symptoms in adults with cancer. Additional research is needed to determine the efficacy. The findings of this analysis suggested that patients with uncontrolled CINV may be appropriate candidates for acupuncture referral. For the treatment of other symptoms, the efficacy is undetermined.

Print

Garcia, M.K., Driver, L., Haddad, R., Lee, R., Palmer, J.L., Wei, Q., . . . Cohen, L. (2014). Acupuncture for treatment of uncontrolled pain in cancer patients: A pragmatic pilot study. Integrative Cancer Therapies, 13, 133–140.

Study Purpose

To test the hypotheses that acupuncture would be feasible, safe, and effective adjunct for pain management

Intervention Characteristics/Basic Study Process

Patients were recruited from referrals to a pain management center. Patients received individualized acupuncture treatments one to three times per week. Treatments were provided by two licensed and experienced acupuncturists. The points used in the treatments are described, and standard techniques for point location were used. Needles were left in place for about 25 minutes. Electrical stimulation was added at the discretion of the practitioner. Study measures were obtained at baseline and after the last acupuncture session. Patients were dropped from the analysis if pain control medications were changed during the course of the study.

Sample Characteristics

  • N = 41  
  • MEAN AGE = 54 years (range = 33–88 years)
  • MALES: 29%, FEMALES: 71%
  • KEY DISEASE CHARACTERISTICS: Multiple tumor types (breast was most common); patients had varied stages of disease
  • OTHER KEY SAMPLE CHARACTERISTICS: Pain scores were > 4 on a numeric rating scale at study entry, and mean duration of pain management we 31 months. There were varied locations of pain with low back, neck, and shoulder being the most common. Most patients had multiple locations of pain.

Setting

  • SITE: Single-site    
  • SETTING TYPE: Outpatient    
  • LOCATION: Texas

Phase of Care and Clinical Applications

  • PHASE OF CARE: Mutliple phases of care
  • APPLICATIONS: Palliative care 

Study Design

Single-arm prospective trial

Measurement Instruments/Methods

  • Brief Pain Inventory (BPI)
  • MD Anderson Symptom Inventory (MASI)

Results

The average number of treatments was eight (range = 2–10) over five weeks excluding drop-outs. 71% of patients received auricular acupuncture and 71% received electroacupuncture. Pain severity and interference scores declined significantly (p < .0011) using the BPI. A significant reduction in both of these aspects was also seen with the MASI (p < .002). Intent-to-treat analysis using the replacement of missing values with group means showed the same results. For 44% of patients, pain medications remained the same as those at baseline. Fewer patients required opioids at follow-up compared to baseline, and the prevalence of use of other medications for pain such as nonopioid analgesics, antidepressants, and other adjuvant medications declined. 87% of patients stated that the course of acupuncture treatment met their expectations very or extremely well. There were no adverse effects of acupuncture reported.

Conclusions

Findings suggest that the use of acupuncture as an adjunctive therapy for chronic pain management is feasible, is safe, and can be beneficial in reducing pain.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Unintended interventions or applicable interventions not described that would influence results
  • Subject withdrawals ≥ 10%  
  • Other limitations/explanation: Although it was stated that patients were not to have pain medication changed during the study, substantial changes in various medications occurred and were reported. There was a 21% drop-out rate with about 40% of these due to changes in pain medication.

Nursing Implications

Findings suggest that acupuncture treatment as an adjunctive pain management approach can be beneficial for some patients. Interpretation of findings is difficult due to the individualization of the treatment regimen, study design limitations, and the likelihood that there is a placebo effect with acupuncture. For those patients who wish to try acupuncture for pain management, it appears to be feasible and safe when provided by appropriate practitioners.

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Garcia, S. (2014). The effects of education on anxiety levels in patients receiving chemotherapy for the first time: An integrative review. Clinical Journal of Oncology Nursing, 18, 516–521. 

Purpose

PURPOSE: To synthesize evidence regarding the effectiveness of education for decreasing anxiety in patients receiving chemotherapy for the first time

TYPE OF STUDY: General review, semisystematic

Search Strategy

DATABASES USED: MEDLINE, CINAHL, ProQuest nursing and allied health source, Joanna Briggs Institute Clinical Online Network of evidence for care and therapeutics, Cochrane collaboration, and the National Guidelines clearing house
 
KEYWORDS: Patient education, health promotion, education intervention, chemotherapy, cancer, anxiety, treatment, management, and prevention
 
INCLUSION CRITERIA: Adult population; peer reviewed articles; and English language
 
EXCLUSION CRITERIA: Patients receiving radiation therapy or oral chemotherapy

Literature Evaluated

TOTAL REFERENCES RETRIEVED: Not reported
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: The AGREE II, Critical Appraisal Skills Program, Joanna Briggs Institutue Meta-Analysis of statistics assessment and review instrument, and the Joanna Briggs narrative opinion and text assessment and review instrument

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 10 articles
  • TOTAL PATIENTS INCLUDED IN REVIEW = N/A (not all resources included were research studies or systematic reviews)
  • SAMPLE RANGE ACROSS STUDIES: N/A
  • KEY SAMPLE CHARACTERISTICS: Three references were related to patients receiving chemotherapy for the first time. Other references included general practice guidelines and expert opinions.

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Results

Three sources were guidelines, two were pilot studies, one was an evidence summary review, one was a systematic review, and one was an expert opinion. Most sources were of poor or fair quality. Not all the studies actually measured anxiety; some measured patient satisfaction. There was no differentiation made between the provision of educational and informational written materials and the provision of psychoeducation or cognitive behavioral therapy interventions.

Conclusions

This review provides minimal actual evidence regarding the effectiveness of educational interventions.

Limitations

A limited number of actual studies were included, and those included did not all address or measure anxiety.

Nursing Implications

Patient education prior to receiving chemotherapy is an essential aspect of patient care in providing an informed and empowered patient. The impact of education alone on anxiety is not clear, and this article does not provide substantial evidence or synthesis to clarify this potential effect of educational interventions.

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