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Hacking, B., Wallace, L., Scott, S., Kosmala-Anderson, J., Belkora, J., & McNeill, A. (2013). Testing the feasibility, acceptability and effectiveness of a 'decision navigation' intervention for early stage prostate cancer patients in Scotland: A randomised controlled trial. Psycho-Oncology, 22, 1017–1024. 

Study Purpose

To determine if decision-making support (called decision navigation) was feasible, acceptable, and effective among patients newly diagnosed with prostate cancer with the aim of evaluating confidence in making treatment decisions, certainty in decisions made, and changes in mood and adjustment

Intervention Characteristics/Basic Study Process

Decision navigation involved two primary components, a list of questions to support the question and answer process and audio recordings and summaries to improve information recall.

Sample Characteristics

  • N = 113  
  • MEAN AGE = 67.2 years (control), 65.4 years (intervention
  • MALES: 100%   
  • KEY DISEASE CHARACTERISTICS: Inclusion criteria were early-stage, newly diagnosed primary prostate cancer, pending cancer management decision, and referral to a urology specialist for consultation.
  • OTHER KEY SAMPLE CHARACTERISTICS: All participants were Caucasian males. There were no significant differences between the control and intervention group.

Setting

  • SITE: Single site    
  • SETTING TYPE: Outpatient    
  • LOCATION: Western General Hospital in Edinburgh, Scotland

Phase of Care and Clinical Applications

  • PHASE OF CARE: Diagnostic
  • APPLICATIONS: Elder care  

Study Design

Randomized, controlled trial

Measurement Instruments/Methods

Seven instruments were used:
  1. Baseline demographics survey for age, education, employment, living arrangements, and ethnicity
  2. Decisional Self-Efficacy (DSE) is an 11-item scale that measures confidence in decisions. It was administered at baseline, after the consultation planning appointment, after the consultation, and after six months. 
  3. Decisional Conflict Scale (DCS) is a measure of certainty about decisions. It was administered after the consultation and after six months. 
  4. Decision regret (RS) was measured at six months.
  5. Mental Adjustment to Cancer Scale (MAC) has subscales that measure fighting spirit or hopelessness-helplessness, anxiety, and fatalism. It was administered at baseline and six months after consultation. 
  6. Hospital Anxiety and Depression Scale (HADS) was administered at baseline and six months after the consultation. 
  7. Decision Preparation Measure (DPM), a five-item rating scale, was administered after the consultation planning appointment and after six months to evaluate the use of the intervention and to confirm final treatment choice. 

Results

DSE scores were significantly (p = 0.011) higher for the intervention group after the consultation and at six months. Intervention group DSE scores showed significant (p = 0.008) improvement at six months postconsultation. 
 
DCS scores were significantly (p = 0.047) lower in the intervention group after consultation, and approached significance after six months. DR scores were significantly (p = 0.36) lower in the intervention group.
 
DN significantly increased the confidence of the intervention group in making treatment decisions and for certainty about the right decision. When tested after six months, DN intervention patients reported continued confidence and certainty about the decisions made (approaching a significant effect), and showed significantly (p = 0.036) less regret about decisions after six months. There was no impact on anxiety, depression, or mental adjustment to cancer. Participants had low baseline scores for depression, anxiety, and mental adjustment to cancer. DN evaluation ratings indicated that consultation planning assisted \"a great deal\" or \"quite a bit.\"

Conclusions

The intervention was not shown to have an impact on anxiety or depression symptom scores.

Limitations

  • Risk of bias (no blinding)
  • Findings not generalizable
  • Intervention expensive, impractical, or training needs
  • Subject withdrawals ≥ 10%  
  • Other limitations/explanation: Although the sample size was 113 participants, only 53 were in the control group and 62 were in the intervention group (less than 100 in each group), limiting this study's generalizability. There are training needs regarding the specific and individualized list of questions provided in anticipation of the consultation. It is possible that the physicians could become accustomed to the questions on the list, therefore increasing the amount of information given to the patient without interaction? Ninety-nine patients refused to participate in the study, and 10 patients withdrew.

Nursing Implications

Dedicated decision support for patients preparing for treatment consultation involves patients, increases confidence in asking questions during the consultation, and increases certainty about decisions made. Research to evaluate the effectiveness and cost reduction potential of DN for people with other cancer diagnoses is important. Although decision support interventions are essential to assist patients in decision making, these approaches alone may not be sufficient to manage symptoms of depression and anxiety.

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Ha, K., & Choi, S. (2014). The effect of a PNF technique program after mastectomy on lymphedema patients’ depression and anxiety. Journal of Physical Therapy Science, 26, 1065–1067. 

Study Purpose

To examine the effects of exercise with proprioceptive neuromuscular facilitation (PNF) on depression and anxiety in women with postmastectomy lymphedema

Intervention Characteristics/Basic Study Process

Subjects performed the exercises for 30 minutes, three times weekly, for 16 weeks. Subjects were divided into three groups, a PNF plus super lizer group (which received light radiation as well), a PNF plus manual lymphatic drainage (MLD) group, and a PNF alone group. All groups received the same exercises. Study measures were obtained every four weeks.

Sample Characteristics

  • N = 52  
  • MEAN AGE 52.5 years
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Patients were selected from those who showed lymphedema following mastectomy.

Setting

  • SITE: Single-site    
  • LOCATION: Republic of Korea

Study Design

Three-group trial with a repeated-measures design

Measurement Instruments/Methods

  • Beck Depression Inventory (BDI)
  • Beck Anxiety Inventory (BAI)

Results

Although there was a group-by-time interaction effect on the results, depression scores declined significantly in all groups with no significant difference between the groups after 16 weeks. Anxiety scores also declined in all groups with no differences between them. At the end of the study, scores were lowest in the PNF plus MLD group. Scores declined more in this group over time.

Conclusions

The findings of this study are inconclusive regarding the impact of PNF exercise on depression and anxiety in women with lymphedema following a mastectomy.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment) 
  • Measurement validity/reliability questionable
  • Other limitations/explanation: Repeated-measures design has inherent testing potential as a threat to validity

Nursing Implications

Exercise and MLD have previously been shown to be of benefit for women with lymphedema, and exercise has been shown to be beneficial in terms of reducing anxiety and depression in patients with cancer. It is not clear whether the specific PNF technique in exercise has any greater benefit. This study had several design limitations.

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Gutzmer, R., Becker, J.C., Enk, A., Garbe, C., Hauschild, A., Leverkus, M., . . . Homey, B. (2011). Management of cutaneous side effects of EGFR inhibitors: Recommendations from a German expert panel for the primary treating physician. Journal der Deutschen Dermatologischen Gesellschaft, 9, 195–203.

Purpose & Patient Population

To describe the underlying mechanisms, clinical presentation, severity grading (according to National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], version 4.0), and strategies to prevent and manage epidermal growth factor receptor inhibitor (EGFRI)-associated skin side effects, emphasizing evidence-based practice.

The type of patients addressed was adults receiving an EGFRI, including monoclonal antibodies (e.g., cetuximab, panitumumab) and tyrosine kinase inhibitors (e.g., erlotinib, gefitinib, lapatinib).

Type of Resource/Evidence-Based Process

In this expert opinion article, a panel of German dermatologists met in June 2009 in Frankfurt am Main, Germany, to generate mutual recommendations on the management of cutaneous side effects of EGFRIs. Those recommendations were passed after an internal revision in July 2010. The authors stated the basis of the recommendations was the physicians’ long-term personal experiences with affected patients.

Databases searched were not reported.

Search keywords were EGFR, cutaneous side effects, and papulopustular exanthema.

Studies were included in the review if they were published up to April 2010.

Exclusion criteria were not reported.

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Guidelines & Recommendations

General and Preventive Measures for All Patients Receiving EGFRI Therapy:

  • Give patient education regarding various cutaneous side effects, usual time points for manifestation, and positive correlation between early occurring papulopustular exanthems and therapy success and general measures. 
  • The following advice was recommended for preventive skin care procedures for all patients receiving therapy with EGFRIs:
    • Avoid frequent hand washing; daily, long showers; or frequent, long baths.
    • Use mild bath or shower oils or syndets (no soap).
    • Use moisturizers or urea-containing skin care products (e.g., ointment, cream) without fragrances or other skin irritants (no lotion or gel).
    • Avoid sun-tanning parlors, and consistently use sun protection products (light exposure factor > 20) or clothing protection from ultraviolet radiation.
    • Avoid skin contact with irritants such as solvents, disinfectants, and polishes.
    • Avoid activities that mechanically stress the skin (e.g., garden work, carrying heavy objects, hot hair drying).
    • For adequate treatment of preexisting skin diseases, refer to a dermatologist.

Medicinal Prophylaxis of EGFRI Cutaneous Lesions:

  • A few studies on medicinal prophylaxis of papulopustular exanthema have been performed, and their results do not allow for reliable recommendations.
  • Prophylactic treatments included oral tetracycline, minocycline, and doxycycline; topical pimecrolimus; skin moisturizer; and topical sunscreen, glucocorticosteroids, and vitamin K3.

Therapy of the Papulopustular Exanthems on the Face and Trunk:

  • Initiate combined therapy with a topical metronidazole or nadifloxacin-containing ointment and a systemic tetracycline (doxycycline: 50 or 100 mg BID;  minocycline: 50 mg BID; tetracycline: 2–4 x 250 mg daily).
  • Treatment of rash with wound gel containing collagen or lidocaine and topical vitamin K3 is being studied.

Advanced Diagnostics and Therapy for Rash (Usually With a Dermatologist):

  • Obtain microbial diagnostics in papulopustular exanthema.
  • If Demodex mites are detected in the lesions, employ topical metronidazole, a short course of an azelaic acid cream, or a cream containing permethrin.
  • If Pityrosporum yeasts are identified, ciclopirox olamine, clotrimazole, or ketoconazole is recommended.
  • In bacterial superinfection, depending on the antibiogram (usually identification of Staphylococcus aureus), topical therapy with an antiseptic agent (e.g., octenidine) and targeted systemic antibiotic therapy are recommended.
  • For eczematous skin lesions with scaling and pruritus on the trunk, mild-to-moderate potency topical glucocorticosteroids (e.g., hydrocortisone butyrate, methylprednisolone aceponate) are recommended.
  • When clinical features of seborrheic dermatitis or perioral dermatitis are present in the face, pimecrolimus or tacrolimus and a topical antifungal agent (e.g., ciclopirox) may be used.

Therapy of Papulopustular Exanthems on the Scalp:

  • Early treatment with a systemic antibiotic usually offers effective protection from the development of a severe papulopustular rash on the scalp.
  • In patients who develop a superinfection despite administration of a systemic antibiotic, microbiological diagnostics should be performed and therapy based on the antibiogram should be changed to an antibiotic effective against S. aureus (e.g., flucloxacillin).
  • Antimicrobial shampoos may be used.

Treatment Recommendations: Dry Skin and Pruritus:

  • Use of emollients (e.g., urea-containing products), perhaps with the addition of an antiseptic (e.g., triclosan) can be used for dry, sensitive skin.  
  • If marked inflammation exists, a short course of glucocorticosteroid ointment is recommended.
  • If severe inflammation exists, a short course of glucocorticosteroid ointment and an antiseptic is recommended.
  • Topical products containing polidocanol and oral antihistamines can be used on a supplemental basis for dry skin and pruritus.
  • If inflamed skin fissures exist, obtain a referral to a dermatologist.

Treatment Recommendations: Paronychia:

  • In early stages of paronychia, treatment with a topical antifungal agent (e.g., ciclopirox olamine) and a topical antibiotic (fusidic acid) is recommended.
  • In the event of damage to the cuticle, a nail lacquer containing ciclopirox should be applied every two days.
  • Combination of a topical glucocorticosteroid and a disinfectant can be considered.
  • Systemic therapy can include one of the oral tetracyclines, or an oral cephalosporin or quinolone.
  • In advanced or persistent inflammation, the patient should be referred to a dermatologist for further treatment.
  • For severe inflammation, microbiological tests and targeted antibiotic therapy are recommended.
  • Excessive granulation tissue should be removed surgically or with silver nitrate.
     

Nursing Implications

Effective management of frequent cutaneous side effects is important for tumor therapy. The present recommendations developed by a German expert panel are based on a three-step concept.

  • Patient education and general preventive measures
  • Measures that should be initiated as early as possible by the primary treating physician at the first sign of skin lesions
  • Advanced diagnostics and therapy by a specialized dermatologist

Although the article had 36 references, several interventions (especially in rash—advanced diagnostics and therapy, rash—therapy on scalp, measures for dry skin and pruritus, and therapy of paronychias) do not have a specific reference.

Adequate management of cutaneous side effects is necessary for optimal therapeutic benefit and enhanced quality of life. Because of their visibility, cutaneous side effects are experienced by many patients as a psychological burden that can impair quality of life and often endangers compliance with therapy, or leads to a dose reduction or discontinuation. This article provided nurses with practical recommendations for the prevention and management of cutaneous side effects of EGFRIs.  

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Gurion, R., Belnik-Plitman, Y., Gafter-Gvili, A., Paul, M., Vidal, L., Ben-Bassat, I., . . . Raanani, P. (2011). Colony-stimulating factors for prevention and treatment of infectious complications in patients with acute myelogenous leukemia. Cochrane Database of Systematic Reviews, 9, CD008238.

Purpose

The purpose of the article is to assess the influence of colony-stimulating factors (CSFs) on the prevention and treatment of infectious complications in patients with acute myelogenous leukemia (AML).

Search Strategy

The Cochrane Central Register of Controlled Trials, MEDLINE (January 1966 to July 2010), and LILACS (through December 2009) databases were searched, as were ongoing trials and conference proceedings from January 2002 to June 2010 from the European Group for Bone and Marrow Transplantation, the Annual Meeting of the European Hematology Association, the Annual Meeting of the Society for Hematology and Stem Cells, and the Center for International Blood and Marrow Transplant Research (CIBMTR).

Articles included in this review were randomized, controlled trials that compared the addition of CSFs during and following chemotherapy to chemotherapy alone in patients with AML and included age, type of AML (morphology criteria according to the FAB classification), leukemia type (de novo AML, secondary AML, refractory AML, relapsed AML), white blood cell count, platelet count, and treatment stage (induction, consolidation, relapse).

Articles were excluded if they were reporting on trials evaluating the role of CSFs administered for the purpose of stem cell collection and/or priming (e.g., before and/or only for the duration of chemotherapy).

Literature Evaluated

1,421 total references were retrieved.

Following a review of each study by two reviewers, statistical analyses were conducted including relative risk with a 95% confidence interval (CI) for dichotomous data and hazard ratios for time-to-event outcome. Cochrane handbook criteria were used to assess study quality.

Sample Characteristics

  • 19 studies were included in the final review.
  • The total sample size of the combined studies was 5,256.
  • The sample size across studies ranged from 53–803.
  • The patient population was diagnosed with AML (per World Health Organization 2008 classification), were at any stage of treatment following chemotherapy, and were of all ages.
  • The ages varied per study with one pediatric study including patients younger than 16 years old (Nakajima) and another (Lehrnbecher) aged 0–18. Four studies contained patients aged 15–60, six contained patients older than age 55, and eight had patients older than age 15.
  • Chemotherapy regimens also varied and included numerous agents used as induction, consolidation, or salvage therapy, or conditioning regimens for HCT.
  • All patients in the intervention arms of the studies evaluated received CSF (G-CSF or GM-CSF), IV or subcutaneous, started with or following chemotherapy.
  • Those receiving CSF as part of the HCT cell collection or conditioning were excluded.
     

Phase of Care and Clinical Applications

Active treatment

Results

No statistically significant differences were found between patients who received CSF with chemotherapy compared to those who did not. This included no differences in 30 day all-cause mortality (RR = 0.97; 95% CI [0.8, 1.18]) and end of follow-up (RR = 1.01; 95% CI [0.98, 1.05]), overall survival (HR = 1.00; 95% CI [0.93, 1.08]), complete remission (RR = 1.03; 95% CI [0.99, 1.07]), relapse (RR = 0.97; 95% CI [0.89, 1.05]), disease-free survival (HR = 1.00; 95% CI [0.9, 1.13]), decrease in bacteremias (RR = 0.96; 95% CI [0.82, 1.12]) or invasive fungal infections (RR = 1.4; 95% CI [0.9, 2.19]). There was a slight increase in adverse events requiring discontinuation of CSFs in intervention groups compared to controls (RR = 1.33; 95% CI [1.00, 1.56]). Among 17 studies in which duration of neutropenia was reported, in all but one study the duration of neutropenia was significantly shortened with CSFs. Several studies reported a significant shortening of duration of hospital stay with CSFs, while others showed no difference.

Conclusions

Administration of CSFs is associated with decreased episodes of febrile neutropenia and febrile days; however, it shows no statistically significant benefit of being administered with chemotherapy for improved survival and decreased infection rates. Since hematopoiesis is different in pediatric patients compared to adults (occurring in the bone marrow of long bones and at higher rates in pediatric populations, and in flat bones at slower rates in adults and older adults), benefits may be found in older age groups when using CSF with chemotherapy. Among the studies that had a mean age of patients at 58 years and older (n = 7), six of them showed more favorable outcomes in patients who received CSF.

Limitations

The composite evaluation of all age groups together.

Nursing Implications

Implications for practice based on this study are unfavorable to use CSF for decreased infection rates among all age groups. Further evaluation in older age groups may be warranted.

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Gurdal, S.O., Kostanoglu, A., Cavdar, I., Ozbas, A., Cabioglu, N., Ozcinar, B., . . . Ozmen, V. (2012). Comparison of intermittent pneumatic compression with manual lymphatic drainage for treatment of breast cancer–related lymphedema. Lymphatic Research and Biology, 10(3), 129–135.

Study Purpose

To compare the effects of complete decongestive therapy (CDT) with intermittent pneumatic compression (IPC) and self-lymphatic drainage

Intervention Characteristics/Basic Study Process

Patients were randomized to receive either CDT, consisting of manual lymphatic drainage and compression bandaging, or self-lymphatic drainage and pneumatic compression. Both groups did the same exercises and wore compression garments at the end of therapy. Treatments were done every other day for six weeks. IPC was applied for 45 minutes in each treatment.   Patients did self drainage at home daily for 15 minutes during the study. Study measurements were done at the beginning and end of the six-week study period.

Sample Characteristics

  • N  = 30            
  • MEDIAN AGE = 55
  • AGE RANGE = 31–74
  • MALES: 0%, FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: All participants had breast cancer and lymphedema at study entry. All had level 1 or 2 axillary lymph node dissection and had radiotherapy to the regional lymphatics. 
  • OTHER KEY SAMPLE CHARACTERISTICS: Participants had no prior treatment for lymphedema.

Setting

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

Phase of Care and Clinical Applications

  • PHASE OF CARE: Not available

Study Design

  • Randomized, controlled trial

Measurement Instruments/Methods

  • Diary of self treatments
  • European Organisation for Research and Treatment of Cancer–Ouality of Life Core 30 (EOTRC QLQ-C30)
  • American Shoulder and Elbow Association Quality of Life questions regarding effective use of the arm during the day
  • Stillwell classification for lymphedema
  • Arm circumference measurement

Results

Both groups had significant reduction in arm volumes at one, two and six weeks (p < .001). There were no significant differences between the groups in this change. There were no significant differences between groups in other study measures. Quality of life improved significantly across the study in both groups.

Conclusions

There were no significant differences in lymphedema or associated quality of life between patients receiving CDT or IPC plus self lymphatic drainage. Both approaches were effective in reducing arm lymphedema volumes.

Limitations

  • Small sample (< 100) 
  • Baseline sample/group differences of import
  • Risk of bias (no blinding)
  • Key sample group differences that could influence results
  • Other limitations/explanation: More patients in the CDT group had total mastectomy. No information is provided as to whether patients were completely finished with adjuvant treatment.

Nursing Implications

Findings show that both approaches studied were effective in reducing lymphedema and improving QOL over a six-week period. The study is limited by the small sample size and short period of time for follow-up.

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Gupta, S., Singh, P.K., Bhatt, M.L., Pant, M.C., Gupta, R., & Negi, M.P. (2010). Efficacy of granulocyte colony stimulating factor as a secondary prophylaxis along with full-dose chemotherapy following a prior cycle of febrile neutropenia. Bioscience Trends, 4, 273–278.

Study Purpose

The purpose of the study was to evaluate the feasibility and efficacy of G-CSF secondary prophylaxis in patients with solid tumors undergoing chemotherapy.

Intervention Characteristics/Basic Study Process

Patients in the study required IV antibiotics filgrastim 300 mg per day subcutaneously starting 24–30 hours after the last chemotherapy dose in a subsequent cycle. A total of 8–9 alternate day doses were given. If no other dose limiting toxicity was seen, patients received full chemotherapy dosing with filgrastim support for following treatment cycles. Duration of hospital stay, days on antibiotic therapy, incidence of fever, time to resolve fever, dose reductions or delays, neutrophil recovery time, and incidence of adverse events were recorded. Results compared to findings in the same patients during the previous chemotherapy cycle.

Sample Characteristics

  • The total sample size was 50.
  • Participants had a median age of 47, with a range of 22–75.
  • The most common cancer types were lymphoma and breast cancer.
  • Fifty-eight percent were receiving adriamycin-containing regimens.
     

Setting

Single-site location in India

Phase of Care and Clinical Applications

Active antitumor treatment

Study Design

Prospective, single group, observational study

Measurement Instruments/Methods

No specific measure definitions were provided.

Results

Neutrophil recovery time, duration of fever, duration of antibiotics and duration of hospitalization, cycle delays, and chemotherapy dose reductions declined with each course of chemotherapy. The decrease in all measures was significant across four treatment cycles (p < 0.01).

Conclusions

Study findings provide some support the use of colony-stimulating factor as secondary prophylaxis in patients receiving myelosuppressive chemotherapy. A number of study limitations limit the strength of these findings.

Limitations

  • Small sample (less than 100 participants)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Measurement/methods not described  
  • Measurement validity/reliability questionable
  • The stated sample size varies in the report from 54 to 50, and authors stated that two patients who developed overwhelming febrile neutropenia during the study were eliminated from analysis, demonstrating no intent to treat analysis.
  • No definition of neutropenia for determination of recovery time is provided.

Nursing Implications

This study provides limited evidence supporting the use of colony-stimulating factors as secondary prophylaxis in patients receiving chemotherapy. CSF was given every other day in this trial, adding to the body of evidence in which the frequency of administration varies. Secondary prophylaxis can play an important role in sustaining the treatment dosages of chemotherapy cycles.

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Guo, Y., Jones, D., Palmer, J.L., Forman, A., Dakhil, S.R., Velasco, M.R., . . . Fisch, M.J. (2014). Oral alpha-lipoic acid to prevent chemotherapy-induced peripheral neuropathy: A randomized, double-blind, placebo-controlled trial. Supportive Care in Cancer, 22, 1223–1231.

Study Purpose

To test whether oral alpha-lipoic acid (ALA) could reduce the severity of peripheral neuropathy in patients receiving platinum-based chemotherapy

Intervention Characteristics/Basic Study Process

Prior to randomization, patients were stratified according to prior exposure to platinum-based therapy dosages. Patients were assigned to receive ALA 600 mg oral sustained-release tablets three times per day. Control patients received a matching placebo. Medications were taken continuously for 24 weeks between two days prior and four days after each dose of platinum.

Sample Characteristics

  • N = 70   
  • MEAN AGE = 56 years
  • MALES: 53%, FEMALES: 47%
  • KEY DISEASE CHARACTERISTICS: Gastrointestinal cancers were most common. Dosage of platinum compounds were in excess of 750 mg/m2​.
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients with neuropathy and diabetes mellitus, and those exposed to carboplatin, vincristine, paclitaxel, or docetaxel within the past six months were excluded.

Setting

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

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Double-blind, placebo-controlled RCT

Measurement Instruments/Methods

  • FACT/GOG-NTX (version 4) for neuropathic symptoms
  • Brief Pain Inventory
  • Functional tests—time to button a six-button shirt, 50-foot walk, and coin test

Results

Only 28% in the ALA arm and 30% in the placebo arm completed 24 weeks of the study. Most discontinued the study because of withdrawal of consent and noncompliance. Neuropathy scores increased significantly from baseline in both groups at 24 weeks (p < .001). No differences were observed in study results between groups.  Authors state that attrition was not related to toxicities and that adverse events were comparable between groups.

Conclusions

Findings did not show a beneficial effect of ALA for prevention or reduction of peripheral neuropathy in patients receiving platinum-based chemotherapy.

Limitations

  • Small sample (less than 100)
  • Subject withdrawals 10% or greater
  • Other limitations/explanation: Extensive attrition, suggesting that the intervention was not acceptable to patients

Nursing Implications

Findings do not show a benefit of oral ALA for prevention of chemotherapy-induced peripheral neuropathy with platinum-based chemotherapy. Management and prevention of chemotherapy-induced peripheral neuropathy is a challenge that is generally managed by dose reduction or chemotherapy discontinuation, which can reduce effectiveness in treatment of cancer. Few approaches have shown to be effective in preventing or reducing chemotherapy-induced peripheral neuropathy. Ongoing research in this area is needed.

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Guo, S.P., Wu, S.G., Zhou, J., Feng, H.X., Li, F.Y., Wu, Y.J., . . . He, Z.Y. (2014). Transdermal fentanyl for pain due to chemoradiotherapy-induced oral mucositis in nasopharyngeal cancer patients: Evaluating efficacy, safety, and improvement in quality of life. Drug Design, Development and Therapy, 8, 497.

Study Purpose

To evaluate the safety and efficacy of transdermal fentanyl for oral mucositis pain

Intervention Characteristics/Basic Study Process

Transdermal fentanyl was given at a rate of 25 mcg per hour to patients with pain scores greater than five during treatment and increased by 25 mcg per hour to maintain pain scores less than or equal to three on a numeric rating scale. Study assessments were done on days 1, 4, 7, and 10. Patients rated pain daily.

Sample Characteristics

  • N = 78
  • MEDIAN AGE = 41 years (range = 31–52 years)
  • MALES: 75.6%, FEMALES: 24.4%
  • KEY DISEASE CHARACTERISTICS: All participants had nasopharyngeal cancer and were receiving daily radiation therapy of prescribed doses of 70 Gy to the planning target volume. Patients also were receiving chemotherapy of cisplatin with 5-FU or taxol and cisplatin.

Setting

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

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

Open-label, observational trial

Measurement Instruments/Methods

  • Pain numeric rating scale
  • Score for pain, Physical activity levels, Additional pain medication, Additional physician/emergency room visits, Sleep, Mood, and Side effects (SPAASMS)

Results

Mean pain scores declined from 7.41 before treatment to 5.54 (SD = 0.86, p < 0.001) on day 1 and 2.82 (SD = 0.68, p < 0.001) on day 10. Sleep quality was improved after treatment (p < 0.001). The most frequent side effect was nausea and vomiting. No patients discontinued treatment.

Conclusions

Transdermal fentanyl was quickly effective in reducing pain from oral mucositis in this patient population. Pain reduction was associated with improved sleep.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Measurement/methods not well described
  • Other limitations/explanation: The method of sleep quality measurement was not described. The final doses of fentanyl were not reported.

Nursing Implications

The findings of this study demonstrated that transdermal fentanyl was effective in reducing oral mucositis-related pain within one day, and pain scores continued to decline during combined radiation and chemotherapy. They also suggested that adequate pain control in this patient population improves sleep quality and other aspects of quality of life.

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Guo, Z., Tang, H.Y., Li, H., Tan, S.K., Feng, K.H., Huang, Y.C., . . . Jiang, W. (2013). The benefits of psychosocial interventions for cancer patients undergoing radiotherapy. Health and Quality of Life Outcomes, 11, 121.

Study Purpose

Many patients with cancer experience depression and anxiety, with an associated decrease in quality of life, during radiation therapy. The main objective of the study was to determine the benefits of psychosocial interventions for these patients with cancer, concurrent with radiation therapy.

Intervention Characteristics/Basic Study Process

Patients in the intervention group received psychosocial care, which consisted of psychoeducation, cognitive behavioral therapy (CBT), and supportive expressive therapy.

Sample Characteristics

  • N = 178
  • MEAN AGE = 47 years
  • MALES: 42%, FEMALES: 58%
  • KEY DISEASE CHARACTERISTICS: Patients with cancer undergoing radiation therapy
  • OTHER KEY SAMPLE CHARACTERISTICS: 96% of patients had Eastern Cooperative Oncology Group performance status of 1–2, meaning that they were fairly fit. Radiation therapy had to be given with curative intent, not palliative.

Setting

  • SITE: Not stated/unknown  
  • SETTING TYPE: Outpatient  
  • LOCATION: Guilin Medical University, Guangxi Province, China

Phase of Care and Clinical Applications

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

Study Design

Patients were randomized to the intervention arm (psychoeducation, CBT, and supportive expressive therapy) or to the control arm. The control group received radiation therapy only.

Measurement Instruments/Methods

  • Zung Self-Rating Depression Scale for symptoms of depression
  • Self-Rating Anxiety Scale
  • European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30.  

An association also was made between intervention and survival.

Results

Patients in the intervention group showed significant improvements in symptoms of depression and anxiety and health-related quality of life. They had better global health status and physical and emotional functioning and less insomnia. No difference was observed between groups in disease-free survival and overall survival.

Conclusions

Psychosocial interventions appear to be a cost-effective approach that can improve a patient’s mood and quality of life during and after radiation therapy.

Limitations

Chinese study (possible cultural implications)

Nursing Implications

This is an important study for oncology nurses, especially radiation therapy oncology nurses, who often feel like they cannot make much impact on their patients' lives, except for checking for toxicities. Nurses have an important role in psychoeducational and supportive therapies. Some very brief strategies being taught regarding CBT and supportive expressive therapy could go a long way in helping many patients.

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Gulluoglu, B.M., Guler, S.A., Ugurlu, M.U., & Culha, G. (2013). Efficacy of prophylactic antibiotic administration for breast cancer surgery in overweight or obese patients: A randomized controlled trial. Annals of Surgery, 257, 37–43.

Study Purpose

To assess the effectiveness of prophylactic antibiotics on prevention of surgical site infection (SSI) and the cost of this effectiveness, as compared to a control without prophylaxis antibiotics in early breast cancer surgery in overweight or obese women

Intervention Characteristics/Basic Study Process

Women randomly were assigned to receive IV infusion of 1 g ampicillin-sulbactam at the start of anesthesia or no prophylactic antibiotics. Patients were followed for 30 days. Outcomes also were compared to a group of women who had a body mass index (BMI) lower than 25 and who did not receive antibiotic prophylaxis.

Sample Characteristics

  • N = 369 (187 in the prophylaxis group, 182 in the control group)
  • AGE = 58 years
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: BMI of 25 or higher; all had nonrecurrent, operable breast cancer

Setting

  • SITE: Single site 
  • SETTING TYPE: Inpatient 
  • LOCATION: Tertiary university hospital in Turkey

Phase of Care and Clinical Applications

  • PHASE OF CARE: Multiple phases of care

Study Design

  • Phase IV, randomized, controlled, parallel-group

Measurement Instruments/Methods

  • SSI was defined as infection within 30 days post-operation with one of the following.
    • Purulent drainage from incision
    • Organisms isolated from incision cultures
    • Localized pain
    • Tenderness
    • Swelling
    • Redness of an incision deliberately opened by the surgeon
  • ASA class

Results

Nine SSIs developed in the prophylaxis group, versus 25 in the control group (p = .002). Patients were matched well according to age, BMI, history of smoking, ASA class, interval between tissue biopsy and randomization, clinical cancer stage, type of breast and axillary surgery, operation time, hospital stay, and post-operation complications. All SSIs were discovered within post-operation week one after discharge, except one. The control group had significantly more SSIs compared to those in the normal-weight comparison group (p = .0007) and higher SSI treatment costs than the prophylaxis group (p = .007). Patients in the control group had more open surgical biopsies than those in the prophylaxis group (p = .004)

Conclusions

The administration of antibiotics at the time of induction for surgery was associated with reduced incidence of SSI among obese women undergoing breast cancer surgery. Costs were lower among those receiving prophylactic antibiotics.

Limitations

  • Risk of bias (no blinding)
  • Risk of bias(sample characteristics)
  • Other limitations/explanation: The control group underwent more biopsies prior to surgery; mastectomy is more common in Turkish culture.

Nursing Implications

Reminding physicians to prescribe pre-operation antibiotics is important. Administration of a dose of IV antibiotics at the time of induction is a current U.S. standard of care and recommendation for SSI prevention. Careful hand washing and clean dressing changes are imperative. These findings also point to the increased risk of infection associated with obesity. Nurses can educate patients regarding risks associated with obesity and assist patients with weight management.

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