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Lai, T.K., Cheung, M.C., Lo, C.K., Ng, K.L., Fung, Y.H., Tong, M., & Yau, C.C. (2011). Effectiveness of aroma massage on advanced cancer patients with constipation: A pilot study. Complementary Therapies in Clinical Practice, 17, 37–43.

Study Purpose

To evaluate the effectiveness of aroma massage in the treatment of constipation, as well as its impact on quality of life (QOL).

Intervention Characteristics/Basic Study Process

Patients were randomized to one of three groups: aroma abdominal massage, plain abdominal massage, or control. Fifteen- to 20-minute massages were offered daily for five consecutive days by the principal investigator and four other trained investigators. Patients completed questionnaires on days 1 and 5. Patients were withdrawn from the study if they required increased use of laxatives, had symptoms such as shortness of breath or fatigue, or were transferred or discharged from the hospital.

Sample Characteristics

  • The study reported on a sample of 32 patients.
  • Patient age ranged from 32 to 82 years. Most patients were aged 51 to 60 years.
  • The sample was 75% male and 25% female.   
  • Most patients (56%) had lung cancer.
  • Karnofsky performance scale index ranged from 40 to 80. Most patients' scores were from 40 to 50.

 

Setting

  • Single site
  • Inpatient
  • Hong Kong
     

Phase of Care and Clinical Applications

  • Patients were in the end-of-life phase of care.
  • The study has clinical applicability to end-of-life and palliative care.

Study Design

This was a randomized controlled trial.

Measurement Instruments/Methods

  • Constipation Assessment Scale (CAS)    
  • McGill Quality of Life questionnaire for Hong Kong Chinese (MQOL-HK)

Results

  • In the aroma massage group, constipation improved with a mean score of 1.46 at day 5 compared to mean scores of 1.55 in the plain massage group and 6.63 in the control group.
  • Patients in the aroma massage group reported improved physical domain, more support, and generally improved QOL compared to the other groups.

Conclusions

Constipation is a common, preventable problem in patients with cancer. Nurses should have knowledge of alternative nonpharmacologic approaches to help patients manage this side effect.

Limitations

  • The sample size was small (fewer than 100).
  • Generalizability of the results is limited bcause of the small sample size. In addition, too many patients withdrew from the control group to draw an accurate conclusion.

Nursing Implications

Nurses play a vital role in the treatment and prevention of constipation.

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Lai, H.L., Li, Y.M., & Lee, L.H. (2012). Effects of music intervention with nursing presence and recorded music on psycho-physiological indices of cancer patient caregivers. Journal of Clinical Nursing, 21, 745–756.

Study Purpose

To compare the effects of music intervention with nursing presence (MINP) and the effects of recorded music (RM) on various psychological and physiologic indices among caregivers of patients with cancer. The recorded indices included the incidence of depression and anxiety, sleep, blood volume pulse (BVP) amplitude, and the low/high frequency ratio component of heart rate variability (HRV).

Intervention Characteristics/Basic Study Process

Participants were seated on a comfortable chair in their own homes. A photoplethysmograph was worn on the left-hand middle finger to continuously monitor BVP amplitude and HRV.

The intervention groups were MINP versus RM. Interventions were alternated between MINP and RM with an interval of one week between each intervention. Each intervention took place in the participant’s home for 30 minutes and generally after dinner according to participant preference. In the MINP intervention, participants were told to imagine they were attending a concert. During MINP, the primary researcher was present and played music on the erhu (Chinese violin) and recorder without any verbal communication or interruption. The live music included diverse pieces such as Japanese, Chinese, Taiwanese, English, and Czech music. Music selections were well known by participants and expected to create immediate enjoyment, and all had similar musical characteristics and quality. Rhythm ranged from 60–80 beats, and the tempo was slow. In the RM intervention, participants were left alone to listen to 30 minutes of the same music selections prerecorded on a CD. The music volume was adjusted to a comfortable level before the session. Study measurement was obtained pre and post each intervention.

Sample Characteristics

  • The sample was comprised of 34 female caregivers of patients with cancer.
  • Caregiver mean age was 44.9 years (SD = 9.03).
  • Caregivers cared for patients with head and neck, lung, hematologic, gastrointestinal, or genitourinary cancers.
  • Caregivers' relationship to the patient was 38% spouse, 38% parent, and 23% child.
  • The majority of the sample had completed high school, were married, were employed, liked live music, and did not play a musical instrument.

Setting

  • Outpatient
  • Home setting
  • Taiwan, Republic of China

Phase of Care and Clinical Applications

  • Transition phase (patients diagnosed with cancer less than one year ago)
  • Late effects/survivorship; anxiety; nursing presence

Study Design

A randomized, crossover, controlled trial design was used.

Measurement Instruments/Methods

  • Visual analog scale (VAS): Sleep assessment measured (a) ease of getting to sleep, (b) perceived quality of sleep, (c) ease of awakening from sleep, and (d) daytime function. No reliability or validity information was provided.    
  • Taiwanese Depression Scale: Has criterion-related validity with the Center for Epidemiologic StudiesDepression scale and discriminate validity (93.2%); Cronbach’s alpha for the current study at pretest was 0.73. 
  • State-Trait Anxiety Inventory: Cronbach’s alpha for the current study was 0.78.
  • BVP amplitude
  • Low frequency (LF)/high frequency (HF) ratio
  • VAS was also used to assess music evaluation of participants’ subjective experience associated with the musical pieces (i.e., enjoyment, harmony, friendliness, and peacefulness); two-week test-retest reliability in an earlier study was 0.73.

Results

Both MINP and RM interventions had significant beneficial effects on anxiety, depression, and BVP amplitude (p < 0.0001). A treatment effect across different time points was observed in BVP amplitude and LF/HF ratio in both groups, indicating that MINP and RM both have beneficial effects on BVP and LF/HF ratio. There were no significant differences between the two music interventions in terms of participant evaluation of enjoyment and peacefulness, but participants evaluated RM as being more harmonious than live music, and MINP with live music and nurse presence as more friendly. Participants preferred Chinese music, then followed mostly by Czech music. Regarding the four aspects of sleep measured, MINP was found to affect only \"ease of getting to sleep” (p < 0.0007).

Conclusions

Both music interventions were beneficial on psychological indices, with a reduction in anxiety and depression scores and a long-term dose effect on BVP. Intervention worked well for a sample having moderate degrees of anxiety and, in some cases, clinical depression in prestudy assessment and for a sample of women who liked Chinese and folk music.

Limitations

  • The sample was small, limiting generalizability. 
  • The study had no researcher blinding.
  • The study had single time point pre/post measures and was short-term (no range follow-up or impact).
  • The sample was all female.
  • The sample enjoyed the music used in the intervention and scored high on a pretest self-rated anxiety scale to increase receptivity to the intervention.

Nursing Implications

Music, either live with the nurse present or recorded for 30 minutes, may be beneficial in reducing anxiety and depression in women with cancer as well as their caregivers. Nurses can encourage the use of music as a way of reducing stress throughout the cancer journey. Listening to music appreciated by the caregiver may enhance coping early in the caregiving cycle and prevent negative effects during challenges of cancer treatment and survivorship. Music prescription is an inexpensive intervention and useful for caregivers who prioritize music as part of their culture.

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Lai, N.M., Lai, N.A., O'Riordan, E., Chaiyakunapruk, N., Taylor, J.E., & Tan, K. (2016). Skin antisepsis for reducing central venous catheter-related infections. Cochrane Database of Systematic Reviews, 7, CD010140.

Purpose

STUDY PURPOSE: To evaluate skin antisepsis in reducing catheter-related bloodstream infections (BSIs), catheter colonization, morbidities, and mortality

TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy

DATABASES USED: Cochrane Collaboration, MEDLINE, EMBASE, CINAHL, and clinical trial registries
 
INCLUSION CRITERIA: Randomized, controlled trials comparing skin antiseptic regimens with another regimen, placebo, or no antisepsis
 
EXCLUSION CRITERIA: Crossover studies, studies involving catheters for hemodialysis

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 574
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Cochrane Risk of Bias Tool and GRADE categorization. Most studies were deemed to be of low or very low quality.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 12 studies included in meta-analysis 
  • TOTAL PATIENTS INCLUDED IN REVIEW: 2,011
  • SAMPLE RANGE ACROSS STUDIES: 50–420
  • KEY SAMPLE CHARACTERISTICS: Included studies in pediatric patients. Most studies included patients in intensive care units.

Phase of Care and Clinical Applications

PHASE OF CARE: Not specified or not applicable

Results

Analysis of chlorhexidine versus povidone iodine showed a relative risk of 0.064 (p = 0.05) in favor of chlorhexidine for the outcome of BSI. No significant difference existed between these two methods for all-cause mortality. Chlorhexidine was associated with less catheter colonization (RR = –0.08, p = 0.0003). Few studies compared the use of alcohol, octenidine, hydrogen peroxide, and silver.

Conclusions

The findings suggest that skin antisepsis with chlorhexidine is most effective in reducing BSI; however, the overall quality of the evidence is very low to moderate.

Limitations

Mostly low quality/high risk of bias studies

Nursing Implications

Chlorhexidine is generally more effective than povidone iodine or alcohol for skin antisepsis as part of catheter care for reducing catheter-related BSIs and catheter colonization.

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Laffin, N., Smyth, W., Heyer, E., Fasugba, O., Abernethy, G., & Gardner, A. (2015). Effectiveness and acceptability of a moisturizing cream and a barrier cream during radiation therapy for breast cancer in the tropics. Cancer Nursing, 38, 205–214. 

Study Purpose

To compare the effectiveness of Cavilon Durable Barrier Cream (Cavilon) and 100% Pure Sorbolene Cream (Sorbolene) for the prevention of moist desquamation in patients with breast cancer receiving radiation in a tropical setting, and to explore patient preference of the two products

Intervention Characteristics/Basic Study Process

Patients applied Cavilon or Sorbalene to intact skin at least twice daily from day 1 of treatment until 4 weeks post completion of treatment. Nurse assessment of skin reactions occurred weekly during treatment, with final skin assessment via telephone one month after completion of the treatment. If moist desquamation occurred, cream was stopped and dressings were applied, which was standard practice.

Sample Characteristics

  • N = 245 completed radiation, 218 competed radiation and follow-up interview  
  • MEAN AGE = 55.5 years (SD = 11.6 years)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Breast cancer with treatment to the breast (173 patients) or to the chest wall (72 patients)
  • OTHER KEY SAMPLE CHARACTERISTICS: All patients received 42 Gy/16 fractions to the breast or 50 Gy/25 fractions to the chest wall. Bolus was applied to 70.8% of patients with treatment to the breast wall and 6.9% of patients with treatment to the breast. Bra size, BMI, smoking status, and classification of skin type were obtained at the time of patient consent to participate.

Setting

  • SITE: Single site    
  • SETTING TYPE: Not specified    
  • LOCATION: Townsville Cancer Centre, Queensland, Australia

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

Patients were stratified by breast or chest wall radiation with random allocation to barrier (Cavilon) or moisturizing (Sorbolene) cream.

Measurement Instruments/Methods

Skin type was determined by using the validated Fitzpatrick Skin Type Scale. Weekly skin assessment was completed using the Common Terminology Criteria and Adverse Events (CTCAE), version 4, scoring criteria. Acceptability of cream was determined by a five-question acceptability survey.

Results

Cavalon was found to significantly reduce moist desquamation during treatment in patients with chest wall radiation (p = 0.047). Participants preferred Cavalon over Sorbolene during treatment (p = 0.02), but no statistical difference in preference of cream existed at follow-up. At the end of treatment, 15% of patients had moist desquamation, and 26% of patients self-reported moist desquamation at telephone follow-up. With pooled data of breast and chest wall treatment, no significant difference existed between skin treatment groups experiencing moist desquamation during treatment and at follow-up. Statistically significant risk factors for moist desquamation were larger breast cup size, i.e., larger than a C cup (p = 0.003); higher BMI (p = 0.01); and prior chemotherapy (p = 0.04). No statistical significance existed with skin type, smoking, or effects of tropical weather measured by the Fitzpatrick scale.

Conclusions

A high incidence for moist desquamation existed in patients receiving radiation for breast cancer, particularly in patients receiving radiation to the chest wall.

Limitations

  • Risk of bias (no blinding)
  • Key sample group differences that could influence results
  • Measurement validity/reliability questionable
  • Intervention expensive, impractical, or training needs
  • Patients and nurses could not be blinded to different creams because of differences in texture, smell, and amount needed for application.  
  • The sample size for breast treatment was not reached, which may have influenced statistically significant differences in that strata. The sample size for chest wall treatment was sufficient.  
  • While higher BMI was found to be a risk factor for the development of moist desquamation, the authors did not define or quantify the BMI that was associated with the toxicity.
  • Despite education, possible inconsistencies in nurse grading based on assessment criteria were acknowledged.
  • Patient self-reporting at four weeks post treatment completion is a known limitation.
  • Barrier cream would be three times the cost of moisturizing cream without use of grant money, a potential factor for ongoing use.

Nursing Implications

Nurses should discuss risk factors that pertain to patients when educating on the skin effects of radiation. As many patients develop moist desquamation following completion of treatment, discharge information and management plans are needed.

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Lacouture, M.E., Mitchell, E.P., Piperdi, B., Pillai, M.V., Shearer, H., Iannotti, N., . . . Yassine, M. (2010). Skin toxicity evaluation protocol with panitumumab (STEPP), a phase II, open-label, randomized trial evaluating the impact of a pre-emptive skin treatment regimen on skin toxicities and quality of life in patients with metastatic colorectal cancer. Journal of Clinical Oncology, 28, 1351–1357.

Study Purpose

To examine the difference in incidence of specific grade 2 or higher skin toxicities of interest between patients with metastatic colorectal cancer in preemptive and reactive skin treatment groups during a six-week treatment period that included epidermal growth factor receptor inhibitors (EGFR-Is).

Intervention Characteristics/Basic Study Process

Eligible patients were randomly assigned to preemptive or reactive skin treatment arms. The chemotherapy regimen schedule was a random assignment stratification factor.

The preemptive skin treatment regimen was administered beginning on day –1 (one day before the administration of the first panitumumab dose) and continued through weeks 1 to 6.

Clinical and experimental data suggest that four major alterations occur in the skin of patients treated with EGFR-Is: follicular and interfollicular inflammation, bacterial superinfection, dry skin, and sensitivity to ultraviolet (UV) radiation. The rationale for selection of the preemptive skin regimen was based on those four alterations. The preemptive skin treatment regimen comprised the following.

  • Skin moisturizer applied to the face, hands, feet, neck, back, and chest daily in the morning on rising (rationale: restore the permeability barrier and treat dry skin)
  • Sunscreen (para-aminobenzoic acid [PABA] free, sun protection factor [SPF] ≥ 15, UVA and UVB protection) applied to exposed skin areas before going outdoors (rationale: prevent UV radiation–induced skin toxicity)
  • topical corticosteroid (1% hydrocortisone cream) applied to face, hands, feet, neck, back, and chest at bedtime (rationale: instituted against cutaneous inflammation and pruritus)
  • Semisynthetic tetracycline (doxycycline 100 mg BID) (rationale: anti-inflammatory and antibacterial properties)

The reactive skin treatment regimen comprised any treatments the investigator deemed necessary for the management of emergent skin toxicity and could be administered anytime during weeks 1 to 6. Patients randomly assigned to the reactive skin treatment group were not prohibited from using skin moisturizer or sunscreen at any time during the treatment if they chose to do so.

All patients were monitored weekly from weeks 1 to 7 for compliance with the randomized skin treatment regimen and for skin toxicity assessment.

Sample Characteristics

  • The study reported on a sample of 95 patients.
  • The sample was 67% male and 33% female in the preemptive skin treatment group, and 55% male and 45% female in the reactive skin treatment group.

Setting

  • Multi-site
  • Outpatient
  • United States

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

This was a phase 2, multicenter, open-label, randomized clinical trial.

Measurement Instruments/Methods

  • Protocol-defined skin toxicities of interest included pruritus, acneform dermatitis, skin desquamation, exfoliative dermatitis, paronychia, nail disorder, skin fissures, skin laceration, pruritic rash, pustular rash, skin infection, skin ulceration, and local infection.
  • Dermatology Life Quality Index (DLQI): Assessed patient-reported quality of life (QOL) at screening, weeks 2 to 7, and the week 13 or 14 visit, depending on the skin treatment schedule. The DLQI comprises 10 simple questions to assess QOL in patients with skin disorders. The DLQI is scored on a scale from 0 to 30, where higher scores indicate more QOL impairment.
  • Patient diary: Throughout the skin treatment period, patients completed a daily diary of symptoms and treatment compliance. The diary was shared with study personnel at each weekly clinic visit and was used for case report data entry.
     

Results

  • The incidence of protocol-specific grade 2 or higher skin toxicities during the six-week skin treatment period was 29% for the preemptive skin treatment group (23% grade 2 and 6% grade 3) and 62% for the reactive skin treatment group (40.4% grade 2 and 21.3% grade 3) (odds ratio, 0.3; 95% confidence interval [0.1, 0.6]).
  • Acneform dermatitis at any grade occurred in 77% of patients in the preemptive skin treatment group and 85% in the reactive skin treatment group.
  • Incidence of pruritus was similar in both groups.
  • Seventeen percent of patients in the preemptive skin treatment group developed paronychia, compared to 36% in the reactive skin treatment group.

Conclusions

The preemptive skin treatment regimen was well tolerated. The incidence of specific grade 2 or higher skin toxicities during the six-week skin treatment period was lower in the preemptive skin treatment group compared with the reactive skin treatment group.

Limitations

  • The sample size was small (fewer than 100 patients enrolled).
  • The only EGFR-I used to treat patients was panitumumab. Patients who were receiving cetuximab were not included in the study.
  • The study was not blinded.
  • Information was not provided on reactive treatments used for comparison of effectiveness or the stage at which reactive treatments were instituted.
  • Patient compliance results were not reported.

Nursing Implications

The findings supported the importance of establishing a preemptive, comprehensive skin treatment regimen in patients treated with panitumumab to decrease skin toxicities and improve QOL. The skin toxicities are considered a class-based effect; therefore, these results may be generalized to other EGFR-Is.  

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Lacouture, M.E., Anadkat, M.J., Bensadoun, R.-J., Bryce, J., Chan, A., Epstein, J.B., Eaby-Sandy, B., . . . MASCC Skin Toxicity Study Group. (2011). Clinical practice guidelines for the prevention and treatment of EGFR inhibitor-associated dermatologic toxicities. Supportive Care in Cancer, 19, 1079–1095.

Purpose & Patient Population

To develop first-generation, evidence-based recommendations for eight epidermal growth factor receptor inhibitor (EGFRI)-associated dermatologic toxicities: papulopustular (acneform) rash, hair changes, radiation dermatitis, pruritus, mucositis, xerosis, fissures, and paronychia.

The type of patients addressed was those receiving EGFRIs.

Type of Resource/Evidence-Based Process

In this guideline, topic review committees were formed according to expertise to review the literature and develop guidelines for each dermatologic toxicity. Each review committee comprised three members, with a primary reviewer to present the findings of the committee to the Skin Toxicity Study Group. Each committee reviewed from 17 to 35 articles to formulate the recommended guidelines. Randomized clinical trials were considered the best source. The level of evidence and grade of the recommendation were considered. In the absence of experimental evidence, pertinent studies and case reports were presented in conjunction with expert opinion derived from clinical practice. When available, data were extrapolated from other dermatologic conditions with similar clinical or pathologic characteristics (e.g., xerosis, alopecia, hirsutism, pruritus, paronychia, radiation dermatitis).

Databases searched were Ovid, MEDLINE, and Embase.

Search keywords were rash, hair changes, radiation dermatitis, pruritus, mucositis, xerosis, fissures, paronychia, EGFR inhibitors, and recommendations (this information was not stated directly in the article).

Studies were included in the review if they were published before December 2010. 

Studies were excluded if they were published during or after December 2010.

Phase of Care and Clinical Applications

  • Patients were undergoing the active treatment phase of care.
  • The study has clinical applicability for late effects.

Results Provided in the Reference

Eight tables outlining prophylactic and reactive recommendations were included for papulopustular (acneform) rash, hair changes, radiation dermatitis, pruritus, oral complications, xerosis, fissures, and paronychia.

Guidelines & Recommendations

Papulopustular (Acneform) Rash

Preventive (Weeks 1–6 and 8 of EGFRI Initiation): 

  • Systemic: minocycline 100 mg daily (less photosensitizing) and doxycycline 100 mg BID (preferred in patients with renal impairment)
  • Topical: hydrocortisone 1% cream with moisturizer and sunscreen BID 

Treatment:

  • Systemic: minocycline 100 mg daily (less photosensitizing), doxycycline 100 mg BID (preferred in patients with renal impairment), and isotretinoin at low doses (20–30 mg per day).
  • Topical: alclometasone 0.05% cream, fluocinonide 0.05% cream BID, and clindamycin 1% cream

Hair Changes (Hair Loss)

Preventive:

  • Topical and Systemic: Follow rash recommendations for scarring alopecia.

Treatment:

  • Topical: minoxidil 2% or 5% BID (nonscarring alopecia); class 1 steroid lotion, shampoo, or foam, or antibiotic lotion (scarring alopecia)

Hair Changes (Increased Hair)

Preventive:

  • Support interventions (e.g., patient education)
  • Treatment: eflornithine and lasers (facial hypertrichosis) and eyelash trimming (eyelash trichomegaly)

 Radiation Dermatitis

Preventive:

  • Topical: maintenance of appropriate skin hygiene with gentle cleansing in radiated areas prior to radiation treatment; high-potency topical steroids

 Treatment:

  • Topical: maintenance of appropriate skin hygiene with gentle cleansing in radiated areas prior to radiation treatment, moisturizers, antibacterial moisturizers, drying gel or antiseptics (chlorhexidine), hydrophilic dressings, and antibiotics if infected
  • Systemic: doxycycline
  • Other: blood cultures for fever or signs of sepsis

Pruritus

Preventive:

  • Topical: gentle skin instructions

Treatment:

  • Systemic: antihistamines (first generation, sedating: hydroxyzine and diphenhydramine; second generation, nonsedating: loratadine), anti-epileptic agents (gabapentin or pregabalin), and doxepin
  • Topical: menthol (0.5%–3%), cooling, pramoxine 1%, doxepin, and medium-to-high–potency steroids (triamcinolone acetonide 0.025%, desonide 0.05%, fluticasone propionate 0.05%, and alclometasone 0.05%)

Mucositis

Preventive:

  • Topical: benzydamine, steroids, cryotherapy or ice chips, and low-level laser therapy
  • Systemic: patient-controlled analgesia
  • Other: radiation blocks and intensity-modulated radiation therapy

Treatment:

  • Topical: No topical treatments are recommended.
  • Systemic: doxycycline

Xerosis

Preventive:

  • Topical: bathing techniques: using bath oils or mild moisturizing soaps and bathing in tepid water; regular moisturizing creams
  • Other: Avoid extreme temperatures and direct sunlight.

Treatment:

  • Topical (mild to moderate): emollient creams packaged in a jar or tub that lacks fragrance or potential irritants; occlusive emollients containing urea, colloidal oatmeal, and petroleum-based creams; exfoliants for scaly areas: ammonium lactate 12% or lactic acid cream 12%; urea creams (10%–40%); salicylic acid 6%; zinc oxide (13%–40%)
  • Topical (severe): Use medium-to-high–potency steroid creams (triamcinolone acetonide 0.025%, desonide 0.05%, fluticasone propionate 0.05%, and alclometasone 0.05%).

Fissures

Preventive:

  • Topical: Wear protective footwear and avoid friction with fingertips, toes, and heels.

Treatment:

  • Topical: thick moisturizers or zinc oxide (12%–40%) creams; liquid glues or cyanoacrylate to seal cracks, steroids or steroid tape, hydrocolloid dressings, and topical antibiotics; bleach soaks to prevent infection; and zinc oxide

Paronychia

Preventive:

  • Topical: Diluted bleach soaks; avoid irritants.

Treatment:

  • Systemic: tetracyclines, antimicrobials (reserved for culture-proven infection), and biotin for brittle nails
  • Topical: corticosteroids and calcineurin inhibitors
  • Other: silver nitrate chemical cauterization weekly; nail avulsion

Limitations

Recommendations were based on randomized clinical trials with control groups when possible. However, because of the lack of high-quality studies investigating EGFRI-associated dermatologic changes, many recommendations were based on expert opinion and consensus.

Nursing Implications

The authors developed first-generation, evidence-based recommendations for eight EGFRI-associated dermatologic toxicities: papulopustular (acneform) rash, hair changes, radiation dermatitis, pruritus, mucositis, xerosis, fissures, and paronychia. In addition, the authors rated each intervention according to the level of evidence (I–V) and the recommendation grade (A–D). 

The authors proposed that multidisciplinary teams, including radiation and medical oncologists, nurses, dermatologists, pharmacists, oral healthcare providers, and wound care specialists, should assess the occurrence and management of EGFRI-associated dermatologic toxicities. In addition, the Multinational Association for Supportive Care in Cancer (MASCC) EGFRI Skin Toxicity Tool (MESTT) should be used in clinical trials and practice.

Nurses should provide patient education prior to EGFRI therapy to ensure patients can expect, prepare for, and use preventive and treatment approaches to manage the eight toxicities described. In addition, nurses should encourage the multidisciplinary team to collaborate on management of EGFRI-associated dermatologic toxicities.

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Lacouture, M.E., Wolchok, J.D., Yosipovitch, G., Kähler, K.C., Busam, K.J., & Hauschild, A. (2014). Ipilimumab in patients with cancer and the management of dermatologic adverse events. Journal of the American Academy of Dermatology, 71, 161–169. 

Purpose & Patient Population

PURPOSE: To summarizes the efficacy of ipilimumab and safety profile as well as paying special attention to the dermatologic adverse events associated with the drug and management strategies 
 
TYPES OF PATIENTS ADDRESSED: Patients with cancer receiving ipilimumab therapy

Type of Resource/Evidence-Based Process

RESOURCE TYPE: Expert opinion  
 
PROCESS OF DEVELOPMENT: Review of specific dermatologic immune-response adverse events (IRAEs) from phase II and III trials with ipilimumab for patients with melanoma
 
SEARCH STRATEGY: None reported
 
DATABASES USED: Search databases not reported
 
INCLUSION CRITERIA: Pooled analysis of ipilimumab monotherapy clinical trials with patients with metastatic melanoma
 
EXCLUSION CRITERIA: Patients without advanced melanoma

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment
 
APPLICATIONS: Elder care

Results Provided in the Reference

From pooled analysis, 64.2% of patients experienced an IRAEs of any grade, and 17.8% were severe (grade 3 or 4). Dermatologic IRAEs were the most common (44.9% any grade). Most IRAEs develop within the first 12 weeks (five to nine weeks depending on the dose). Ipilimumab rash differs from that of targeted therapies, with ipilimumab rash more closely resembling maculopapular rash. Pruritus with or without rash and can have major impact on quality of life. Ipilimumab appearance, histology, time to onset of IRAEs, grading, and management of skin IRAEs were reviewed.

Guidelines & Recommendations

Guidelines are developed to aid providers to manage IRAEs by early intervention and vigilance. First, determine the severity of the rash or pruritis. For grade 1 or 2 rash, topical corticosteroids and oral antihistamines may be useful. Resume ipilimumab with resolution of rash or with improvement if systemic steroid dose is 7.5 mg of prednisone or less. If grade 3 rash is present, hold ipilimumab and give oral corticosteroids at 1–2 mg/kg/day of prednisone or equivalent. If symptoms improve, healthcare professionals can re-challenge. If symptoms worsen or are evaluated as grade 4, permanently discontinue ipilimumab. Administer corticosteroids at a grade 3 dose and taper for one month if rash improves. For mild or localized pruritus, use topical corticosteroids and antipruritics. For intermittent intense or widespread pruritus, topical corticosteroids and oral antihistamines are indicated. If pruritus is constant, limiting self-care or sleep, use oral antihistamines and corticosteroids and consider gabapentin, pregabalin, mirtazapine, and aprepitant.

Limitations

These are expert opinion guidelines developed from pooled trial data of patients with metastatic melanoma and from evaluating other clinical trial results of ipilimumab. Interventions are not developed from randomized, controlled clinical trials. These guidelines do not differentiate disease type or dose-related IRAEs.

Nursing Implications

Quality of life and optimal therapy for patients receiving these new therapies are dependent on vigilance and early detection for interventions. Patient and healthcare providers need to be instructed to recognize findings for improved outcomes early. Mechanisms for patients to report their experiences should be outlined early.

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Labourey, J. L. (2007). Physical activity in the management of cancer-related fatigue induced by oncological treatments. Annales de Réadaptation et de Médecine Physique, 50, 445–459.

Search Strategy

PubMed was searched to identify English or French language reports of randomized or controlled studies and meta-analyses concerning the benefits of physical activity in patients receiving cancer treatment. The dates encompassed by the search process were not specified.

Literature Evaluated

Eleven randomized or controlled studies that had evaluated the effects of physical exercise on cancer-related fatigue as one of their primary or secondary objectives were identified for analysis. Varied patient-reported outcome measures were used to evaluate fatigue, including the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), Piper Fatigue Scale, Functional Assessment of Cancer Therapy-Fatigue (FACT-F), or the Profile of Mood States (POMS) Fatigue-Inertia subscale. Studies evaluated aerobic exercise, strength training, or a combination of both. Supervised and home-based exercise interventions were studied, and the duration of exercise treatment ranged from only the duration of hospitalization to several months.

Sample Characteristics

  • The groups represented in these studies included survivors of breast cancer and individuals with prostate cancer, multiple myeloma, mixed solid tumors, lymphomas, breast cancer, and colon cancer.
  • In total, 718 patients were represented across these studies, most without metastases.
  • Age ranged from 18 to 77 years.
  • Participants were either undergoing active cancer therapy or had completed therapy.
  • Most study samples were small, with less than 50 participants.

Results

Of the seven studies of exercise during active cancer therapy, five studies (all with less than 25 patients) found no significant differences in fatigue across the treatment period. A sixth study in a highly selected population of patients hospitalized for stem cell transplant noted that fatigue increased significantly in the control group but remained steady in the exercise group. The seventh study of men with prostate adenocarcinoma on hormone therapy and receiving strength training noted a statistically significant improvement in fatigue in patients receiving the strength training intervention.

In the posttreatment setting, three studies with small samples suggested that exercise (aerobic exercise of low or moderate intensity) or a motivational counseling intervention to increase home-based exercise and a small study in patients with breast and colon cancer who were three to 15 months posttreatment showed significant improvement in fatigue as a result of either low- or moderate-intensity exercise, compared to controls. An additional study in patients who had completed chemotherapy or surgery within the past month showed an improvement in aerobic fitness in the intervention group but a statistically significant increase in fatigue.

Conclusions

Taken together, these results suggested that there is no clear evidence that exercise during active treatment improves fatigue outcomes, although it may have a favorable effect on cardiorespiratory conditioning. The results of this review point to the possibility that a minimum of rest or mild activity is needed to promote some initial recovery from treatment-related fatigue before residual fatigue is addressed, but current studies provide no guidance on how long the interval should be between the end of chemotherapy and the start of exercise for therapeutic purposes.

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Kwong, K.K. (2004). Prevention and treatment of oropharyngeal mucositis following cancer therapy: Are there new approaches? Cancer Nursing, 27(3), 183–205.

Search Strategy

Database searched was MEDLINE (1993–2003) for randomized, controlled trials evaluating mucositis interventions.

Literature Evaluated

A total of 50 randomized controlled trials were presented. Other trials and papers were referenced.

Sample Characteristics

  • Sample sizes ranged from 10–222.
  • Patients were treated with chemotherapy, radiotherapy, and bone marrow transplantation.

Conclusions

The author concluded that most agents require more study.

  • Evidence for cryotherapy and bolus 5-fluorouracil was strong.
  • Sucralfate studies produced conflicting results and included varying doses and administration frequencies, making comparisons difficult. Most studies indicated no difference in severity or duration. The validity and reliability of the data were questioned because of the measurement scales used.
  • Similarly, studies of cytokine-like agents used different doses, making comparisons difficult.
  • Moderate evidence suggested that benzydamine is effective in relieving mouth pain caused by radiation-induced mucositis in patients with head and neck cancer. The agent requires additional investigation and study for chemotherapy-induced mucositis.
  • Large studies of chlorhexidine mouthwashes have failed to show significant findings; however, the studies may have had inadequate sample sizes, as power analyses were not performed.
  • Povidone-iodine showed significant reduction in onset, incidence, total duration, and worst grade of mucositis for patients with head and neck cancer undergoing radiation with carboplatin in two studies. Both studies had sample sizes of 40. Given these sample sizes and specific populations, generalizability of the findings was restricted.
  • Oral hygiene protocols were shown to reduce the duration and severity of mucositis; however, the content of the protocols was not proven.

Limitations

The author noted the problem of variation in study protocols, insufficient sample sizes, and a lack of consensus regarding the scoring system for mucositis.

Nursing Implications

The author noted the need to include psychotherapeutic interventions and management and pointed out the lack of a quality-of-life tool for mucositis.

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Kwiatkowski, F., Mouret-Reynier, M.A., Duclos, M., Leger-Enreille, A., Bridon, F., Hahn, T., . . . Bignon, Y.J. (2013). Long term improved quality of life by a 2-week group physical and educational intervention shortly after breast cancer chemotherapy completion. Results of the 'Programme of Accompanying women after breast Cancer treatment completion in Thermal resorts' (PACThe) randomised clinical trial of 251 patients. European Journal of Cancer, 49(7), 1530–1538.

Study Purpose

Determine the effectiveness of an intensive intervention (i.e., two weeks at a SPA centre involving exercise, physiotherapy, and dietary education) on overall quality of life, weight, nutrition, and physical activity in women who recently had completed treatment for non-metastatic breast cancer

Intervention Characteristics/Basic Study Process

The intervention included a two-week stay at a SPA centre with a daily routine of physical training (i.e., two hours daily under the supervision of a physiotherapist, which included walking, strength training, and aquaexercise), dietary education with cooking lessons and provision of healthy meals, and aesthetic care, massage, etc. Dietary consultations every six months for three years also were incorporated into standard follow-up care.

Sample Characteristics

  • N = 222
  • MEAN AGE: Intervention group: 51.8 years (SD = 8.7 years), control group: 52.3 years (SD = 10.1 years)
  • MALES: 0%, FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: The stage of cancer is not reported; it's described only as invasive and non-metastatic. A description of disease characteristics is not reported. Subjects had completed treatment (chemo and/or radiation) for breast cancer less than nine months prior to study enrollment. The majority of patients received chemotherapy and radiation therapy, and more than two-thirds of the sample were on hormonal therapy; a minority (less than 15%) were on trastuzumab as well.
  • OTHER KEY SAMPLE CHARACTERISTICS: No significant differences were seen between the treatment and control group, except for a statistically significant difference in smoking history, in that a greater percentage of the treatment group reported a history of smoking.

Setting

  • SITE: Not stated/unknown 
  • SETTING TYPE: Other 
  • LOCATION: This is a French study. The intervention occurred at three different SPA centres, also mentioned as “thermal centres.” From where the sample was recruited is not reported.

Phase of Care and Clinical Applications

PHASE OF CARE: Transition phase after active treatment

Study Design

Prospective, randomized, repeated measures (baseline, 6, 12, 18, and 24 months after intervention) two-group clinical trial

Measurement Instruments/Methods

  • Short Form 36 Health Survey (SF-36) as quality-of-life measure
  • Hospital Anxiety and Depression Scale (HADS)
  • Adapted Leeds Sleep Evaluation Questionnaire
  • Ricci & Gagnon questionnaire for physical activity
  • Questionnaire for sitting time and impedancemetry for body composition

Results

Statistically significant differences were seen between groups on the SF-36 measure at six months, but these differences did not persist in any dimension at year one except for a difference in vitality at one year between groups. Although data were collected on weight/body mass index, diet, and sleep, results for these variables are not reported (except to note no significant differences in sleep between the groups). The plots/trends in quality of life over time (at 6, 12, 18, and 24 months) look very similar for both groups, except for a significant upward trend at six months for the intervention group. The correlation was stronger between HADS depression and SF-36 quality of life. In the SPA group, an overall decrease was seen in anxiety compared to baseline scores (p = 0.0005). No significant difference was seen in the anxiety scores between the SPA and control groups at six months. Depression decreased in both groups but to a greater degree in the SPA group. A significant difference was seen between the SPA group and control group in terms of depression scores. What the “control” or comparison group was or what care was given to them is not clear.

Conclusions

As reported, patients with non-metastatic breast cancer did not appear to derive significant benefit (improved quality of life as measured by the SF-36) from a two-week SPA intervention in terms of improving quality of life and reducing anxiety and depression.

Limitations

This unrealistic intervention (two-week SPA stay) does not seem sustainable. Furthermore, if this “intensive” intervention did not demonstrate significant impact on quality of life or anxiety, except for depression, then the “cost” of such an intensive intervention is not worth the benefit. When exactly the intervention occurred is not reported relative to timing of completion of breast cancer treatment except to say “within nine months,” but this is an important variable/covariate because time since treatment completion (and intervention) might impact study results. Importantly, unclear is how subjects were screened or that only a “distressed” group was enrolled. The report that global SF-36 scores at study inclusion were 56 and 54 respectively (treatment and control groups) indicates that this is not a very “stressed” group, as evidenced by SF-36. The higher the scores on the SF-36, the better the quality of life. These scores at study inclusion are right at the midpoint range of 0%–100%; thus, a possible floor effect is at play. Overall, this is not a very well developed or reported study.

Nursing Implications

No real meaningful nursing implications are drawn from this study. The intervention seems unrealistic and unsustainable and did not impact outcome measures as predicted, except for depression.

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