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Würtzen, H., Dalton, S.O., Elsass, P., Sumbundu, A.D., Steding-Jensen, M., Karlsen, R.V., . . . Johansen, C. (2013). Mindfulness significantly reduces self-reported levels of anxiety and depression: Results of a randomised controlled trial among 336 Danish women treated for stage I–III breast cancer. European Journal of Cancer 49,1365–1373.

Study Purpose

To test, in a randomized controlled study, the effect of a structured eight-week group mindfulness-based stress-reduction program on anxiety and depression among women with breast cancer

Intervention Characteristics/Basic Study Process

The mindfulness-based stress-reduction program consisted of eight weekly two-hour group sessions. The program included guided meditation, yoga and psychoeducational advice on stress and stress reactions, and group dialog about the integration of mindfulness practice into daily life. Three experienced clinical psychologists provided the program. The control group received usual care. Data were collected before randomization and at 6 and 12 months after the intervention.

Sample Characteristics

  • The study reported on 336 female patients (168 in the experimental group, 168 in the control group).
  • Mean patient age was 54.14 years (SD = 10.30 years).
  • Patients had stage I–III breast cancer (97% had stage I or II).
  • Recruitment was of patients who had received surgery within 3–18 months. Patients underwent various treatments during the study.

Setting

  • Multisite
  • Outpatient setting
  • Hospitals associated with University of Copenhagen, Denmark

Phase of Care and Clinical Applications

  • Patients were undergoing active antitumor treatment.
  • The study has clinical applicability for elder care and palliative care.

Study Design

A randomized controlled trial design was used.

Measurement Instruments/Methods

  • Symptom Checklist-90 Revised (SCL-90-R), Danish version: 13 items relating to the depression subscale and 10 items relating to the anxiety subscale
  • Center for Epidemiologic Studies Depression Scale (CESD): 21 items focusing primarily on cognitive and affective, rather than physical, manifestations of depression

Results

  • At baseline, researchers noted no difference between groups in regard to clinical or demographic characteristics, depression, or anxiety.
  • After intervention, analysis revealed a statistically significant between-group difference regarding CESD scores (p = 0.001). At six months, analysis revealed a significant between-group difference regarding anxiety scores (p = 0.05) and for both depression measures (SCL-90-R, p = 0.01; CESD, p = 0.03). After 12 months, researchers noted a significant difference between groups in regard to SCL-90-R depression and CESD scores. After 12 months, intention-to-treat analyses showed differences between groups in levels of anxiety (p = 0.0002) and depression (SCL-90-R, p < 0.0001; CESD, p = 0.0367).
  • The intervention was more effective for those with higher levels of anxiety and depression at baseline.

Conclusions

The mindfulness-based stress-reduction program was effective in reducing anxiety and depression over time in the patients studied. The intervention was most effective for those who had higher levels of anxiety and depression at baseline.

Limitations

  • The study had risk of bias due to lack of appropriate attentional control.
  • Key differences between the sample groups could have influenced results.
  • The intervention is expensive, impractical to implement, and presents training needs.
  • Researchers paid insufficient attention to the control group and provided no blind.
  • Patients may have been at different time points in relation to treatment (e.g., chemotherapy, radiation treatment). This may decrease the reliability of study findings.

Nursing Implications

The intervention appears to be effective. It does, however, require that the facilitator receive special training, which is an extra cost, and the intervention may be difficult to implement in the practice setting. The study does not address whether the effectiveness of the intervention varies with phase of care. As with other types of intervention, the mindfulness-based stress-reduction program appeared to be most effective for patients who had higher levels of anxiety and depression at the beginning of treatment, suggesting that appropriate patient selection for such an intervention can be beneficial. This study was limited by the lack of attentional control; providing attention alone may positively affect the anxiety and depression of patients with cancer.

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Wu, M.F., Hilsenbeck, S. G., Tham, Y. L., Kramer, R., Elledge, R. M., Chang, J. C., & Friedman, L. C. (2009). The efficacy of sertraline for controlling hot flashes in women with or at high risk of developing breast cancer. Breast Cancer Research and Treatment, 118(2), 369-375.

Study Purpose

The study evaluate the efficacy of sertraline for controlling hot flashes in women with or at high risk of breast cancer.

Intervention Characteristics/Basic Study Process

The study was organized by periods:

  • Week 1: baseline
  • Week 2: single-blind placebo run-in; those reporting hot flash score reductions of greater than 50% were then excluded.
  • The remaining women received placebo or sertraline 25 mg/day and titrated weekly as needed to a maximum of 100 mg/day for weeks 3–6.

Sample Characteristics

The study enrolled women aged 18 or older with personal or family history of carcinoma in situ or invasive breast cancer with reported hot flashes and a weekly hot flash score of greater than 15.

  • N = 57 (randomized eligible) 
  • N=53 (run-in phase)
  • N=46 (assigned treatment)
  • N = 41 completed treatment

Mean participant age was 55.8 years, and 95% had abreast cancer diagnosis.

Exclusion criteria included: progressive metastatic breast cancer, documented history of medication or treatment noncompliance, acute suicidal or homicidal ideation, any unstable clinically significant psychiatric condition including major depressive disorder, or concomitant use or use within 14 days of a monoamine oxidase inhibitor or another antidepressant drug, history of intolerable adverse reaction to sertraline, reduction of a weekly hot flash score by greater than 50% after placebo run-in.

Setting

A university cancer center hosted the study.

Study Design

The study was randomized, double-blind, placebo-controlled.

Measurement Instruments/Methods

Participants maintained a hot flash diary to record the number and severity of hot flashes per day.

Results

Hot flash frequencies and scores suggested greater decline, but not statistically significant, in the sertraline-treated group compared with the placebo group.

Limitations

The study was limited by its small sample size with reported insufficient statistical power to detect modest differences in hot flashes between groups. Study design did not take into account the possibility of pharmacokinetic interaction between sertraline and tamoxifen

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Wu, C.E., & Liaw, C.C. (2012). Using aprepitant as secondary antiemetic prophylaxis for cancer patients with cisplatin-induced emesis. Supportive Care in Cancer, 20, 2357–2361.

Study Purpose

To evaluate the efficacy aprepitant as an additional antiemetic among individuals who failed to obtain nausea and vomiting relief from 5-HT3 antagonists and dexamethasone while receiving cisplatin-based chemotherapy

Intervention Characteristics/Basic Study Process

Physician and nurse investigators recorded patients' nausea and vomiting episodes daily while they were hospitalized. If discharged, patients their symptoms daily for up to 6 days.

Sample Characteristics

  • The study reported on 257 patients.
  • Median age was 62 years with a range of 26–82.
  • the sample was 70% male and 30% female.
  • Cancer diagnoses were genitourinary (54.6%), gastrointestinal (20.2%), head and neck (13.2%), breast (3.9%), lung (3.5%), and other (6.6%).
  • All patients had no prior exposure to cisplatin-based chemotherapy, and 97% of patients were chemotherapy naïve.

Setting

The study was conducted at a single inpatient site in Taiwan.

Phase of Care and Clinical Applications

All patients were in active antitumor treatment.

Study Design

This was a prospective, descriptive study.

Measurement Instruments/Methods

  • Vomiting was measured on a four-point scale of complete response, major response, minor response, or failure. 
  • Nausea was measured on a four-point scale of none, mild, moderate, or severe.
  • The acute phase was defined as day 1 of chemotherapy infusion, and the delayed phase was defined as days 2–6.

Results

  • In cycle 1, 19% of patients reported acute and delayed nausea and vomiting. 
  • In cycle 2, 40 of 49 patients with CINV received aprepitant, and 98% experienced complete protection from acute vomiting, 93% from acute nausea, 65% from delayed vomiting, and 60% from delayed nausea.
  • In cycle 3, 35 of 40 patients with CINV received aprepitant, and 100% experienced complete protection from acute vomiting, 100% from acute nausea, 77% from delayed vomiting, and 71% from delayed nausea.
  • Adverse events associated with aprepitant for each cycle were hiccups (n = 5) and constipation (n = 4).

Conclusions

Aprepitant is an effective additional agent for CINV with minimal side effects; however, the medication should not routinely be used because only a small percentage of patients need an additional antiemetic.

Limitations

  • A risk of bias exists because no control group, blinding, or random assignment was used in this study. For example, while patients were hospitalized, the investigators collected their own data and, when patients were discharged, patients' providers were asking for the data.
  • Key sample group differences could have influenced results.
  • Measurement and methods were not well described, and measurement validity and reliability were questionable.
  • Findings are not generalizable to other populations. The sample was primarily patients who were chemotherapy naïve, which may have influenced the overall rates of CINV.
  • Although categories remained consistent for the measurement of nausea and vomiting, consistency in data collection (e.g., time of day), which may have influenced results, was not described. 
  • Validity and reliability of the measurements was not described, and inter-rater evaluation was not performed to ensure consistency of measurement. 
  • Delayed nausea and vomiting was defined as days 2–6 after chemotherapy, which is not typical timing for a delayed measurement.
  • The generalizability of these findings is limited because it was a single institution study; furthermore, these findings are generalizable only to patients receiving cisplatin-based chemotherapy.
  • Adverse events were reported in the results but the authors did not state how this information was obtained.

Nursing Implications

Nurses need to assess for CINV throughout chemotherapy and advocate for additional antiemetic therapy when needed. Aprepitant is an effective additional antiemetic medication for relief of CINV among patients receiving cisplatin-based chemotherapy.

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Worthington, H.V., Clarkson, J.E., Bryan, G., Furness, S., Glenny, A.M., Littlewood, A., … Khalid, T. (2011). Interventions for preventing oral mucositis for patients with cancer receiving treatment. Cochrane Database of Systematic Reviews (Online), 4(4), CD000978.

Purpose

To evaluate the evidence for prophylactic agents in management of oral mucositis in patients with cancer receiving treatment

Search Strategy

Databases searched were MEDLINE, CANCERLIT, Embase, CINAHL, Latin American and Caribbean Health Sciences Literature (LILACS), System for Information on Grey Literature in Europe (SIGLE), and the Cochrane Database.

An extensive list of search terms and strategies used per database was provided in the article.

Studies were included in the review if they

  • Were randomized controlled trials (RCTs).
  • Compared an intervention to a placebo or no treatment.

Literature Evaluated

A total of 383 references were retrieved. Risk of bias was evaluated according to the Cochrane Handbook for Systematic Reviews of Interventions. Studies were categorized as low, unclear, or high risk of bias. Studies were labeled using the GRADES system for evaluating quality of evidence.

Sample Characteristics

  • The final number of studies included in the review was 131.
  • The total sample size across all studies was 10,514 with an across-study sample range of 12–301. 
  • Studies involved a variety of cancers and patients receiving chemotherapy, radiation therapy, or both.

Phase of Care and Clinical Applications

  • Patients were in the active antitumor treatment phase of care.
  • This study has clinical applicability to pediatrics.

Results

  • Only 8% of studies included were seen to have a low risk of bias. 
  • Studies included a variety of treatments such as acyclovir, allopurinol rinse, aloe vera, amifostine, antibiotic paste, systemic antibiotics, axulene, benzydamine, beta carotene, chamomile, chewing gum, Chinese herbs, chlorhezidine, cryotherapy, epidermal growth factor, glutamine, granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GM-CSF), histamine gel, honey, hydrolytic enymes, indigo wood root, intestinal trefoil factor, keratinocyte growth factor, laser, anti-inflammatory drugs, oral care, pentoxifylline, pilocarpine, polymixin/tobramycin/amphotericin (PTA), traumeel, sucralfate, zinc sulphate, and povidone iodine. 
  • From all analyses, at least moderately strong evidence of benefit was found for cryotherapy (RR = 0.74, 95% confidence interval [CI] 0.57–0.95, p = 0.02) for any mucositis and for keratinocyte growth factor (RR = 0.82, 95% CI 0.71–0.94, p = .0005) for any mucositis. 
  • Weak and unreliable evidence for potential benefit was found with aloe vera, amifostine, glutamine, G-CSF, honey, laser, polymixin/tobramycin, amphotericin lozenges, and sucralfate.
  • A substantial body of evidence showed no benefit of chlorhexidine.

Conclusions

Findings support the benefits of cryotherapy and keratinocyte growth factor. The low quality of evidence in most of the other interventions points to the need for ongoing, well-designed research in this area. The presentation of findings in many publications made meta-analysis impossible.

Limitations

The rationale for the authors' summaries of findings was not entirely clear. Similar RR ratio results with similar evidence quality levels were identified differently in terms of potential benefit. Although the review was inclusive and extensive, interpretation of results was inconsistent. High heterogeneity existed in most interventions, and most studies were either at high or unclear risk of bias with low GRADES scoring. Studies did not always differentiate between mucositis and candidiasis, which would affect recommendations.

Nursing Implications

This article suggests strong support for use of cryotherapy and keratinocyte growth factor for mucositis prevention. It suggests possible benefit from aloe vera, amifostine, IV glutamine, G-CSF, honey, laser, and antibiotic lozenges. Sucralfate may reduce the severity of mucositis. These findings should be interpreted with caution, given the relatively low quality of overall evidence and high heterogeneity across studies included in meta-analysis, as well as the fact that treatments and sample characteristics were highly varied.

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Worthington, H.V., Clarkson, J.E., & Eden, O.B. (2004). Interventions for treating oral mucositis for patients with cancer receiving treatment. Cochrane Database of Systematic Reviews (Online), 2, CD001973.

Search Strategy

Database searched were Cochrane Oral Health Group's Trial Register, CENTRAL, MEDLINE, and EMBASE. Reference lists from relevant articles were searched, and the authors of eligible trials were contacted to identify trials and obtain additional information. Most recent search was conducted in August 2003.

Literature Evaluated

A total of 25 randomized, controlled trials comparing agents prescribed to treat oral mucositis were evaluated.

Sample Characteristics

  • A total of 1,292 patients were involved in the 25 studies.
  • All patients were receiving chemotherapy, radiotherapy, or both.

Results

In one trial of 44 patients, a mouthwash of 300 mg allopurinol dissolved in water was compared to placebo. Patients rinsed with the mouthwash for one minute, four to six times per day. The study showed improvement but had a moderate risk of bias and weak evidence.

In another study of 80 patients with head and neck cancer and radiation-induced mucositis, patients were given immunoglobulin (10 mL on day 0, 5 mL on day 2, 5 mL on day 4) or placebo of 10% human albumin given at the same dosages and times. Both groups received nystatin. Patients who received immunoglobulin showed improvement; however, evidence was weak.

Conclusions

According to the authors, “There is weak and unreliable evidence that allopurinol mouthwash, vitamin E, immunoglobulin, or human placental extract improve or eradicate mucositis. There is no evidence that patient-controlled analgesia is better than the continuous infusion method for controlling pain; however, less opiate was used per hour, and duration of pain was shorter for patient-controlled analgesia. Further, well-designed, placebo-controlled trials assessing the effectiveness of allopurinol mouthwash, immunoglobulin, human placental extract, other interventions investigated in this review and new interventions for treating mucositis are needed.”

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Wootten, M. (2004). Morphine is not the only analgesic in palliative care: Literature review. Journal of Advanced Nursing, 45(5), 527–532.

Search Strategy

DATABASES USED: CINAHL and MEDLINE

KEYWORDS: Cancer pain, pain management, and morphine; reference list from search articles 1990–2000

INCLUSION CRITERIA: Only articles using strong opioids (e.g., morphine, methadone, ketamine, fentanyl)

Literature Evaluated

COMMENTS ON LITERATURE USED: Most articles were anecdotal or case studies. A total of 16 articles fit inclusion criteria.

Sample Characteristics

FINAL NUMBER STUDIES INCLUDED = 16

KEY SAMPLE CHARACTERISTICS: Patients with cancer using strong opioids; no true sampling

Conclusions

The evidence does show encouraging results with use of fentanyl, methadone, and ketamine. Transdermal fentanyl is recommended for those with stable pain because it is difficult to titrate quickly. All of these strong opioids were well tolerated and seemed to be comparable to morphine.

Limitations

Most of the evidence available is anecdotal.

Nursing Implications

More research is needed in this area.

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Woo, J.H., Park, H.S., Kim, S.C., & Kim, Y.H. (2013). The effect of lumbar sympathetic ganglion block on gynecologic cancer–related lymphedema. Pain Physician, 16, 345–352.

Study Purpose

To study treatment effect of lumbar sympathetic ganglion block (LSGB) on patients with lymphedema secondary to gynecologic cancer treatment who did not respond to conservative treatment, defined as complex decongestive physiotherapy or manual lymphatic drainage, compression therapy, exercise, and skin care.

Intervention Characteristics/Basic Study Process

Fluoroscopy-guided LSGB was performed on stage II lower limb lymphedema patients three times at two-week intervals. Thigh and calf measurements were measured upright at first visit and two weeks post-LSGB.

Sample Characteristics

  • N = 18 
  • AGE RANGE = 32–79 years
  • MALES: 0%, FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: 12 participants with stage II lower leg lymphedema; four participants with endometrial cancer; two participants with ovarian cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: All participants underwent radiotherapy, and 17 underwent bilateral pelvic lymph node dissections.

Setting

  • SITE:  Single site 
  • SETTING TYPE:  Outpatient 
  • LOCATION: Gynecologic oncology pain clinic at an academic outpatient center

Phase of Care and Clinical Applications

  • PHASE OF CARE: Mutliple phases of care
  • APPLICATIONS: Elder care, palliative care

Study Design

  • Prospective clinical study

Measurement Instruments/Methods

  • Thigh and calf circumference
  • Pain and satisfaction

Results

Thigh and calf circumference reductions were greatest after the third LSGB and totaled 4 cm in thigh and 2 cm in calf. Pain score was also reduced.

Conclusions

This was a very small study measuring an intervention with radiation exposure, and procedure risks appeared to outweigh benefit. No long-term follow-up was noted. The study lacked researcher reliability and validity, with no noted description of thigh and calf measurement tools.

Limitations

  • Small sample (< 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)
  • Risk of bias (sample characteristics)
  • Key sample group differences that could influence results
  • Measurement/methods not well described
  • Measurement validity/reliability questionable
  • Intervention expensive, impractical, or training needs

Nursing Implications

Careful consideration of risk to benefit ratio for patients undergoing LSGB is recommended because this procedure should only be performed under the auspices of research. High-quality controlled research studies with long-term follow-up are needed.

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Wong, K.H., Kuciejewska, A., Sharabiani, M.T., Ng-Cheng-Hin, B., Hoy, S., Hurley, T., . . . Newbold, K.L. (2016). A randomised controlled trial of Caphosol mouthwash in management of radiation-induced mucositis in head and neck cancer. Radiotherapy and Oncology, 122, 207–211.

Study Purpose

To evaluate the efficacy of Caphosol mouthwash in the management of patients with head and neck cancer receiving (chemo)radiotherapy who have radiation-induced oral mucositis (OM)

Intervention Characteristics/Basic Study Process

Prior to receiving (chemo)radiotherapy, patients were randomized 1:1 to receive a standard oral care regimen (control) with or without Caphosol mouthwash. Those patients randomized to Caphosol used it from week 1–6 of radiation and then one week postradiation, at least four times per day, but could be increased up to 10 times per day per the patient or physician discretion. Other interventions for symptom control were allowed during the study. The patients randomized to the control arm received standard OM treatment per the institutions guidelines, which consisted of normal saline rinses at least four times per day, fluoride toothpaste with brushing, and aspirin mouthwash three times per day. Training on the use of Caphosol was provided by EUSA Pharma.

Sample Characteristics

  • N = 215   
  • MEAN AGE = 58.8 years (SD = 10.6)
  • MALES: 74.9%, FEMALES: 25.1%
  • CURRENT TREATMENT: Radiation, combination radiation and chemotherapy
  • KEY DISEASE CHARACTERISTICS: Carcinoma of the head and neck receiving (chemo)radiotherapy
  • OTHER KEY SAMPLE CHARACTERISTICS: Inclusion criteria of 18 years of age or older and a Karnofsky Performance Status greater than 70%. Induction chemotherapy and concomitant platinum-based chemotherapy or cetuximab were allowed at the discretion of the physician. Exclusion criteria were previous radiation therapy to head and neck, baseline OM, and carcinoma of the thyroid and larynx. Patients were stratified by type of radiation therapy (unilateral versus bilateral) and whether or not they were receiving chemoradiation versus radiotherapy alone.

Setting

  • SITE: Single site   
  • SETTING TYPE: Outpatient    
  • LOCATION: Royal Marsden Hospital, UK

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

Phase III, single institution, non-blinded, randomized, controlled trial

Measurement Instruments/Methods

Patients were assessed at baseline and prospectively every week for six weeks during radiation therapy and until four weeks postradiation therapy. Physicians trained on the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, performed the scoring of radiation-induced adverse events. Quality of life was assessed at baseline, week 4 of radiation therapy, week 4 of postradiation therapy, and week 8 of postradiation therapy using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core Model (EORTC QLQ-C30), version 3.0, and the Quality of Life Questionnaire Head and Neck Module (QLQ-HN35).

Results

Primary endpoint:
  • Incidence of grade 3 or higher OM during and up to eight weeks after radiation therapy. This study showed no benefit in the incidence of OM (64.1% Caphosol versus 65.4 control, p = 0.839).
Secondary endpoints:
  • Duration of grade 3 or higher OM; no difference
  • Incidence and duration of pharyngeal mucositis; lower incidence and shorter duration but NCS
  • Incidence and duration of severe dysphagia; lower incidence and shorter duration but NCS
  • Incidence and duration of severe radiation-induced pain; lower incidence and shorter duration but NCS
  • Patient-reported quality of life; no difference

Conclusions

In this large study, prophylactic Caphosol mouthwashes with standard OM treatment did not show a benefit versus standard OM treatment alone in reducing the incidence of OM or shortening the duration of OM in patients receiving (chemo)radiotherapy for head and neck cancer.

Limitations

  • Risk of bias (no blinding)
  • Key sample group differences that could influence results
  • Findings not generalizable
  • Patients were not stratified by primary site of disease; therefore, patients who were at high risk were not evenly distributed between treatment groups.
  • The number of completed quality of life questionnaires were significantly lower than predicted, possibly because of the length and the toxicities patients were experiencing later in the study.
  • Patients did not adhere to the prescribed use of Caphosol during the entire study period because of taste, nausea, or perceived lack of benefit.
  • Single site—not generalizable

Nursing Implications

No evidence suggests that this intervention would benefit the type of patients studied. The cost of Caphosol would not be warranted, and its use could actually negatively affect patients because of the poor taste and potential for nausea.

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Wong, R., & Wiffen, P.J. (2009). Bisphosphonates for the relief of pain secondary to bone metastases. Cochrane Database of Systematic Reviews 2009(4).

Purpose

To determine the effectiveness of bisphosphonates as a treatment for pain in patients with bone metastases

Search Strategy

  • Databases searched were MEDLINE, CANCERLIT, the Cochrane Library, and the Oxford Pain Relief Database.
  • Keywords searched were bisphosphonates, diphosphonates, multiple myeloma, and bone neoplasm.
  • Studies were included if they
    • Reported on patients with bone metastasis.
    • Were randomized controlled trials (RCTs).
    • Were reports of bisphosphonate use.
    • Were full research reports (no abstracts).
    • Included pain or analgesic use as an outcome measure.

Literature Evaluated

The initial search identified 85 studies, of which 30 met inclusion criteria. Study quality was evaluated using the Jadad scale. Five studies included pain as a primary endpoint.

Sample Characteristics

The final sample of 30 studies included 3,582 patients. Types of diagnoses included breast and prostate cancer, multiple myeloma, and other types of primary tumors.

Results

  • Drugs studied included etidronate, clodronate, and pamidronate. In 22 of the 30 studies, additional hormone therapy or chemotherapy was used.
  • Proportion of patients with pain relief: Across eight studies, pooled data showed significant pain relief with treatment (OR = 2.37, 95% CI 1.61–3.5).
  • Average pain score effects: Seven studies showed a general trend in favor of treatment, though data were insufficient to allow pooled analysis. Differences between treatment and control groups ranged from –0.037 through –0.53. Most studies used a visual analog scale measurement.
  • Analgesic consumption:
    • Three studies showed no differences between groups.
    • Three studies showed less increase in analgesic consumption with treatment.
  • Adverse effects:
    • Twenty-four studies reported nonsignificant increases in nausea and vomiting.
    • Three studies reported an adverse effect that necessitated discontinuation of therapy.
    • Other effects reported were abdominal pain, allergic response, and hypocalcemia.

Conclusions

Results of this review suggest that one of six patients treated with a bisphosphonate will receive modest pain relief. Results suggest that 1 of 11 patients treated with a bisphosphonate will experience side effects severe enough to justify discontinuing bisphosphonate treatment. Overall, data were insufficient to allow investigators to recommend the use of a bisphosphonate to achieve an immediate effect. Findings show that the maximum response to bisphosphonate-related pain management can be observed by four weeks.

Limitations

  • Study results do not provide information about effects beyond 12 weeks.
  • Most studies used insufficient, unvalidated pain outcome measures.

Nursing Implications

Bisphosphonates appear to help reduce the pain of bone metastases in some patients. Long-term efficacy is unclear. The effects of bisphosphonates on pain appear to be at the maximum at four weeks of use. Effects appear to be stable up to 12 weeks. Efficacy after 12 weeks has not been studied. Studies reviewed in this investigation reported little data; the result is the inability to analyze results quantitatively across studies. Future research should incorporate valid pain measures and report results.

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Wong, S.L., Leong, S.M., Chan, C.M., Kan, S.P., & Cheng, H.W. (2015). The effect of using an electric fan on dyspnea in Chinese patients with terminal cancer: A randomized controlled trial. American Journal of Hospice and Palliative Care. Advance online publication.

Study Purpose

To measure the effect of using electrical fans as a nonpharmacologic nursing treatment to relieve dyspnea among Chinese patients with progressive cancer

Intervention Characteristics/Basic Study Process

The study used a single-blinded trial whereby the participants, dyspneic patients with advanced cancer, were allocated randomly to either the experimental group or the control group. For ethical reasons, both groups were given the same nursing or medical interventions when dyspnea transpired, which included oxygen therapy, rescue medications, and semi-Fowler's positioning. The participants in the experimental group received the fan therapy when dyspneic, which involved the use of an electrical fan directed to the face with a low flow rate for five minutes. Baseline demographics, medical diagnosis, hemoglobin levels, and drug treatments were recorded before the intervention was made. Furthermore, clinical parameters including a numeric rating scale (NRS), respiratory rate (RR), and SpO2 were taken before and after each use of the fan therapy.

Sample Characteristics

  • N = 30   
  • AGE = Adults
  • MALES: 47%, FEMALES: 53%
  • CURRENT TREATMENT: Other
  • KEY DISEASE CHARACTERISTICS: The main cancer diagnosis of the participants was carcinoma of the lung.
  • OTHER KEY SAMPLE CHARACTERISTICS: Other diagnoses included colorectal, stomach, breast, and prostate cancers as well as lymphoma. Of the patients, 96.7% required chronic oxygen therapy during the study. All patients were Chinese. Inclusion criteria included patients capable of expressing that they had dyspnea and baseline dyspnea level on numeric rating scale (NRS) of 3 or higher. Excluded patients had a fever or acute shortness of breath, and were mentally incompetent or unwilling to participate.

Setting

  • SITE: Single site   
  • SETTING TYPE: Inpatient    
  • LOCATION: Hospice and Palliative Care Center of Kiang Wu Hospital, China

Phase of Care and Clinical Applications

  • PHASE OF CARE: End-of-life care
  • APPLICATIONS: Elder care, palliative care 

Study Design

  • Randomized, control trial

Measurement Instruments/Methods

  • Verbal NRS from 0–10 signifying “no shortness of breath” to “very severe shortness of breath.” Patients were shown a colored picture with words and figures along with numbers on the rating scale, and respondents either pointed to picture or stated a number aloud. 
  • Finger pulse oximeter indicating the SpO2 and RR

Results

In the experimental group, participants' self-reported breathlessness score was 6.13 and 4.6 before and after intervention, respectively, demonstrating a 1.53 improvement after the intervention (p < 0.01). However, other measurement parameters comprising the RR and SpO2 exhibited no significant improvement (p > 0.05). After recording the second assessment postintervention for the experimental group, the control group was given the fan therapy. No substantial change in self-reporting, RR, and SpO2 was noted.

Conclusions

The results of this randomized, control trial showed a significant improvement in self-reporting of breathlessness among the participants in the intervention group using fans. Since dyspnea is a subjective symptom, self-report in improvement of dyspnea demonstrates a positive outcome despite no improvement in RR or SpO2.

Limitations

  • Small sample (< 100)
  • Risk of bias (no appropriate attentional control condition)
  • Measurement/methods not well described
  • Measurement validity/reliability questionable
  • Subject withdrawals ≥ 10% 
  • Subjects all were Chinese, so results may not be generalizable to the general population.
  • The authors concluded that the control group did not demonstrate improvement in dyspnea when offered the fan later because it was not offered immediately; this would need to be further tested prior to making that assumption.

Nursing Implications

These findings shed light on new interventions that nurses could use to alleviate dyspnea in their patients with cancer. In addition, because the intervention is cheap and practical (no needed training), it could be one of the most ideal interventions for a nurse to use. Further studies incorporating larger and culturally diverse sample sizes are recommended for validation. People of Chinese heritage may ascribe to the belief that, in Chinese medicine, a “cold pathogen” may attack and harm the body; as a result, they may be concerned that prolonged exposure to fan therapy may give them a cold or a headache; therefore, they may be resistant to its use for reasons not related to efficacy in mitigating dyspnea.

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