Skip to main content

Schreck, U., Pausen, F., Bamberg, M., & Budach, W. (2002). Intraindividual comparison of two different skin care conceptions in patients undergoing radiotherapy of the head-and-neck region: Creme or powder? Strahentherapie und Onkologie, 178, 321–329.

Study Purpose

To assess differences between skin care with cream or powder formulations and protocols during radiation therapy

Intervention Characteristics/Basic Study Process

Twelve patients receiving radiation therapy to the head and neck region were randomly assigned to treat one side of the neck with cream and the contralateral side with powder. Highly detailed treatment regimens were defined, including cleaning and care for each type of skin problem that might be encountered. Care included a variety of topical treatments and dressings. All wound dressings and visible cream were removed before each radiation therapy session.

Sample Characteristics

  • The study sample (N = 12) was comprised of patients with cancer of the head and neck region.
  • Eleven patients received adjuvant radiation therapy; eight patients received conventional fractionated radiation therapy up to  60 Gy, 2 up to 50, and all received 50–72 Gy.

Setting

The study took place at the University of Tuebingen in Germany.

Study Design

The study used a quasi-experimental design.

Measurement Instruments/Methods

  • Objective and subjective assessment and photo documentation were performed at therapy onset and weekly during therapy.
  • Skin dermatitis was scored weekly beginning with onset of therapy using a standard form based on skin toxicity scales.
  • Patient questionnaires scored feeling of local warmth, tension, itch, pain, and general discomfort on a four-point scale
  • Patient preference was considered.

Results

Because of the small sample size, analysis was limited to description. No relevant differences were observed between the two treatment options according to the objective and subjective assessment criteria.

Conclusions

Onset and degree of acute skin reactions and differences in symptom relief between the two treatments could not be demonstrated.

Limitations

  • The sample size was small, with less than 30 participants.
  • The trial was not strictly comparing cream and powder treatments (moist desquamation provided for dressings on the cream side and methyl violet solution and Bepanthen cream on the powder side). Complex protocol defined with use of many different treatments further complicates ability to draw any conclusions in the study.
  • Validity and reliability of patient scoring was not noted.
Print

Schover, L.R., Jenkins, R., Sui, D., Adams, J.H., Marion, M.S., & Jackson, K.E. (2006). Randomized trial of peer counseling on reproductive health in African American breast cancer survivors. Journal of Clinical Oncology, 24, 1620–1626.

Study Purpose

The study evaluated a peer counseling program to improve sexual function, increase knowledge about reproductive health, and decrease menopausal symptoms and infertility-related distress for African American breast cancer survivors.

Intervention Characteristics/Basic Study Process

Participants were randomly assigned to immediate counseling or a three-month waitlist. Three peer counselors conducted a three-session intervention using a detailed workbook

Sample Characteristics

The study enrolled  a convenience sample of 60 African American women MD Anderson Center.

Measurement Instruments/Methods

The study used the Breast Cancer Prevention Trial Menopause Symptom Checklist.

Results

Women had fewer problems with hot flashes with counseling. Knowledge of reproductive issues improved significantly from baseline to three-month follow-up (p < .0001), as did emotional distress (p < .0047), and menopause symptoms (p < .0128). Sexually dysfunctional women became less distressed (p < .0167).

Limitations

This was a small convenience sample, and there was a short follow-up time (3 months). Hot flashes were not the primary focus of the study.

Print

Schoot, R.A., van Ommen, C.H., Stijnen, T., Tissing, W.J., Michiels, E., Abbink, F.C., . . . van de Wetering, M.D. (2015). Prevention of central venous catheter-associated bloodstream infections in paediatric oncology patients using 70% ethanol locks: A randomised controlled multi-centre trial. European Journal of Cancer, 51, 2031–2038.

Study Purpose

To determine if 70% ethanol catheter locks can prevent central line–associated bloodstream infections (CLABSI) in pediatric patients with cancer

Intervention Characteristics/Basic Study Process

Patients were randomised to receive either 70% ethanol or 100 IU/ml heparin locks. Locks were used only when needed, no more than weekly if not accessed, and at least every six weeks. Catheter insertion and care were done according to international guidelines. Patients were stratified according to type of catheter, port-a-cath or broviac type, and type of disease. Two hours after the lock solution was used, the catheter was flushed with saline and the CVC was closed with heparin.

Sample Characteristics

  • N = 237
  • MEAN AGE = 8.8 years
  • AGE RANGE = 1–18 years
  • MALES: 57%, FEMALES: 43%
  • OTHER KEY SAMPLE CHARACTERISTICS: 94% had single-lumen catheters. The majoirty of them (51%) were placed in the right jugular vein.

Setting

  • SITE: Multi-site  
  • SETTING TYPE: Not specified  
  • LOCATION: Netherlands

Phase of Care and Clinical Applications

  • APPLICATIONS: Pediatrics

Study Design

  • Single-blind randomized, controlled trial

Measurement Instruments/Methods

  • Central line–associated bloodstream infection (CLABSI) defined as pathogen cultured from at least one blood culture and fever, chills, or hypotension and a common skin organism from at least two culture drawn on separate locations

Results

The total number of catheter days were 20,916 in the ethanol group and 19,915 in the heparin group. In the ethanol group, 10% of patients developed a CLABSI, compared to 19% in the heparin group (hazard ratio [HR] = 0.52, p = 0.05). CLABSI incidence per catheter days was 0.77/1000 in the ethanol group and 1.46/1000 in the heparin group (p = 0.039); however, when corrected for type of catheter, there was no significant difference between groups. Patients with internalized catheters had significantly lower risk of CLABSI (HR = 0.22, p < 0.001). Survival curve analysis at 100 days showed lower CLABSI rate in the ethanol group (p = 0.038). There was no difference between groups in the number of positive blood cultures. There was no difference in hospital days related to infection. Patients in the ethanol group reported nausea, taste alteration, and dizziness during the time of infusion or lock flushing. A larger proportion of those in the ethanol group withdrew from the study (p = 0.031).

Conclusions

Although authors concluded that ethanol locks reduced CLABSI rate, there was no difference when analyzed according to type of catheter, whether indwelling or not. It appears that the type of catheter may be more important for CLABSI prevention.

Limitations

  • Key sample group differences that could influence results
  • Measurement/methods not well described
  • Subject withdrawals ≥ 10%  
  • No information about proportion of study groups that had indwelling catheters
  • There were high catheter days in the ethanol group.
  • Timing of study measures was not provided.
 

 

Nursing Implications

Findings of this study are not conclusive regarding the efficacy of two-hour ethanol CVC locks, though results are somewhat promising. Further research is needed with clear differentiation of indwelling catheter versus broviac catheters in analysis. This study used a dwell time of two hours for the ethanol lock; the optimum dwell time is unclear.

Print

Schoot, R.A., van Dalen, E.C., van Ommen, C.H., & van de Wetering, M.D. (2013). Antibiotic and other lock treatments for tunnelled central venous catheter-related infections in children with cancer. Cochrane Database of Systematic Reviews, 6, CD008975.

Purpose

STUDY PURPOSE: To investigate antibiotics or other lock treatments in comparison to a control intervention for the treatment of central venous catheter (CVC)-related infections in children with cancer

TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: CENTRAL (2011), MELINE/PubMed (1945–August 2011), and EMBASE/Ovid (1980–August 2011); reference lists from relevant articles and conference proceedings (SIOP, 2006–2010; American Society of Clinical Oncology, 2006–2010; Multinational Association of Supportive Care in Cancer, 2006–2011; American Society of Hematology, 2006–2010; and International Society on Thrombosis and Haemostasis, 2006–2011); and scanned ISRCTN for ongoing trials

KEYWORDS: See appendices attached.

INCLUSION CRITERIA: Randomized controlled trials (RCTs) and controlled clinical trials (CCTs) comparing one lock treatment with another, or with systemic antibiotics alone, to treat CVC-related infections in children with cancer; cohort studies also were included for adverse events.

EXCLUSION CRITERIA: Adults included in the analyses, studies focused on infection prevention, use of coated catheters, observational studies, no control comparisons, case report studies, and review studies

Literature Evaluated

TOTAL REFERENCES RETRIEVED = 508

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Two review authors searched the databases and reviewed articles for inclusion criteria. Bias assessment was conducted, and if no agreement was reached, a third party was included in the assessment. Pooled analysis was conducted using Review Manager 5 when studies met methodologic quality and were comparable; otherwise, descriptive summaries were conducted. Comparisons included the creation of forest plots. The comprehensive search of multiple databases, meeting proceedings, and ongoing trials to elicit articles for the evaluation of RCTs, CCTs, and cohort studies was appropriate for this evaluation.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 12 (not all included in all of the analyses)
  • SAMPLE RANGE ACROSS STUDIES = 23–68
  • TOTAL PATIENTS INCLUDED IN REVIEW = 132
  • KEY SAMPLE CHARACTERISTICS: Children with cancer (aged 0–18 years) who incurred a CVC-related infection

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment     
  • APPLICATIONS: Pediatrics

Results

No significant differences were found between the use of ethanol or urokinase lock treatments with systemic antibiotics and systemic antibiotics alone for the outcomes of number cured, number of recurrent CVC-related infections, days until first negative blood culture, number of early removal of CVCs, intensive care unit admissions, or sepsis.

Conclusions

No benefit of urokinase or ethanol lock in addition to systemic antibiotics was found.

Limitations

  • Small sample sizes
  • Short follow-up time
  • Some CVC malfunctioning was reported.
  • No adverse events were reported in the cohort studies.
  • No RCTs or CCTs that used antibiotic lock treatment alone were found in the literature.

Nursing Implications

No added benefit was found in the use of urokinase or ethanol lock treatment in addition to systemic antibiotics for the treatment of CVC-related infections in children undergoing treatment for cancer.

Print

Schofield, P., Gough, K., Lotfi-Jam, K., Bergin, R., Ugalde, A., Dudgeon, P., . . . Aranda, S. (2016). Nurse-led group consultation intervention reduces depressive symptoms in men with localised prostate cancer: A cluster randomised controlled trial. BMC Cancer, 16, 637-016-2687-1. 

Study Purpose

To investigate the benefits of a group nurse-led intervention on psychological morbidity, unmet needs, treatment-related concerns, and quality of life in men with prostate cancer receiving radiotherapy with curative intent

Intervention Characteristics/Basic Study Process

This phase-III, randomized trial assessed the relative benefits of a tailored, group consultation intervention for men receiving curative intent radiotherapy for prostate cancer compared to the best supportive care. The aim was to communicate information about diagnosis, treatment, and side effects, and coaching in self-management. Content and discussion were based on expressed needs and concerns. It included four group consultation sessions and one individual consultation completed by uro-oncology nurse specialists. Survey assessments occurred before treatment, at the end of treatment, and six months postcompletion of treatment. Sessions were tape recorded, and random selections were used to evaluate intervention fidelity.

Sample Characteristics

  • N = 165 included in analysis of primary outcome   
  • MEAN AGE = 67.2 years (intervention), 67.6 years (usual care group)
  • MALES: 100%  
  • CURRENT TREATMENT: Radiation
  • KEY DISEASE CHARACTERISTICS: Low risk prostate cancer for both groups (about 11%), intermediate risk (prostate cancer control group) (42.3%), prostate cancer risk intervention group (41.1%), high risk prostate cancer (about 47% for both groups) 
  • OTHER KEY SAMPLE CHARACTERISTICS: A little less than 80% were married, 82% were from urban areas, about 78% had previous treatment (e.g., prostatectomy, ADT). Included patients aged 18 years or older with prostate cancer

Setting

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

Phase of Care and Clinical Applications

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

Study Design

Phase-III, two-arm cluster, randomized, controlled trial

Measurement Instruments/Methods

  • Hospital Depression and Anxiety Scale (HADS)
  • Cancer Treatment Scale (CaTS)
  • The Short-Form Supportive Care Needs survey questionnaire (SCNS-SF34-R)
  • Expanded Prostate Cancer Index Composite (EPIC-26)

Results

A higher consent rate existed at one site, but no other statistically significant differences in patient characteristics existed between the two groups. One hundred thirteen (out of 165) participants attended all sessions in the intervention group (p = 0.02). Mixed models analysis indicated that group consultations were statistically more beneficial on depressive symptoms (p = 0.009) and procedural concerns relating to cancer treatment (p = 0.049). Ninety-two percent completed surveys at all three time points. Descriptive analysis showed a slight reduction in depressive symptoms in the intervention group between baseline and the end of radiotherapy; the control (usual care) group reported an increase in these symptoms during the same time period. The difference between groups persisted six months post radiotherapy, although between groups, differences in mean changes was substantially reduced. No significant difference existed in rate of change in anxiety between the intervention group and the usual care group noted from the HADS. Descriptive analysis indicated a reduction in anxious symptoms in both groups at the follow-up assessments. Differences in mean changes from baseline to six months post-radiation also occurred, as it did with depressive symptoms.

Conclusions

Nurse-led group consultations may help address patient education, particularly among men who are experiencing depression.

Limitations

  • Findings not generalizable
  • Participants had a baseline high level of baseline functioning.

Nursing Implications

Nurses must realize the importance of patient education and their role in counseling patients experiencing depression not only during treatment but following treatment as part of survivorship care.

Print

Schofield, P., Jefford, M., Carey, M., Thomson, K., Evans, M., Baravelli, C., & Aranda, S. (2008). Preparing patients for threatening medical treatments: Effects of a chemotherapy educational DVD on anxiety, unmet needs, and self-efficacy. Supportive Care in Cancer, 16, 37–45.

Study Purpose

Primary aim: To evaluate effect of an educational DVD about chemotherapy on pretreatment anxiety, self-efficacy, unmet informational needs, and satisfaction with information received

Secondary aim: To determine if effects differ between those who perceived treatment to be curative rather than palliative

Intervention Characteristics/Basic Study Process

Control group patients received usual care and completed questionnaires before beginning their treatment. Experimental group patients were recruited at a later time. They were given a copy of the DVD to take home to watch, several days before their first treatment. They then completed questionnaires on the first day of chemotherapy treatment. The DVD focused on preparation for chemotherapy and self-management of side effects, including nausea and vomiting, constipation, diarrhea, mucositis, fever and infection, hair loss, infertility, and effects on sexuality and intimacy. Content was evidence-based, derived from a systematic review of the literature to support recommended self-care approaches. Most content was delivered by cancer survivors who also discussed their experiences and the self-care strategies they used to manage side effects. An oncologist and oncology nurse presented medical and nursing information. The DVD was 25 minutes long and had been previously pilot tested. Usual care education consisted of a brief description of the procedure and side effects provided by the patient’s oncologist and a 30-minute education session with a chemotherapy nurse. Analysis was done within curative and palliative care patient groupings.

Sample Characteristics

  • The study reported on a sample of 100 patients.
  • Mean patient age among curative cases was 54 years, and among palliative cases was 56.88 years.
  • The sample was 52% male and 48% female.
  • A variety of cancer diagnoses were represented. The most common types were head and neck, lung, gynecologic, gastrointestinal, and breast cancers.
  • A majority of the sample was employed full- or part-time, and patients were essentially equally distributed across educational levels from less than high school completion to university completion.
  • The majority of patients were married.
  • All patients had not previously received chemotherapy treatment.

Setting

  • Single site
  • Outpatient setting
  • Melbourne, Australia

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

The study used a prospective quasi-experimental design with use of historical controls.

Measurement Instruments/Methods

  • Hospital Anxiety and Depression Scale (HADS)
  • Cancer Behavior Inventory (CBI)–version 2: 33-item scale used to measure self-efficacy
  • Supportive Care Needs Survey (SCNS)–short form: 31 items to assess unmet needs
  • Satisfaction with information assessed with four questions on a five-point Likert scale developed for this study

Results

There were no differences in anxiety or depression scores between usual care and intervention groups. Those who watched the DVD rated themselves as more confident about seeking social support than the usual care group (p = 0.044). There were no differences between groups in any supportive care needs that were unmet. Both curative and palliative patients reported having more psychological needs than any other type of care, and reported sexuality as the least needed area. Those in the intervention group were more satisfied with information they had received (p = 0.026) compared to the control group. There were significant differences between self-perceived curative and palliative patients in confidence for maintaining activity (p = 0.028), stress management (p = 0.044), coping with side effects (p = 0.002), maintaining a positive attitude (p = 0.008), managing emotions (p = 0.005), and seeking social support (p = 0.012).

Conclusions

The intervention appeared to have an influence on aspects of self-efficacy and satisfaction with information received. There were no findings to support an effect on anxiety or depression prior to chemotherapy.

Limitations

  • The study did not have an appropriate control group.
  • A convenience sample was used.
  • The sample size was not sufficiently powered to detect differences in measured outcomes.
  • It is not clear how much information provided in the DVD differed from that provided in usual care by chemotherapy nurses and the oncologist.
  • While the DVD was a different format, differences in content were not clear. It was also not clear from the report if intervention patients received the DVD in addition to usual care, or instead of usual care.

Nursing Implications

Prechemotherapy education is an important part of nursing management of these patients, but there is little evidence to guide the timing, content, format, and style of this type of education. Additional research in this area will be helpful to guide nursing practice. The use of adjuncts to direct face-to-face patient teaching and support by nurses may be helpful in the face of workforce shortages and increasing shifts of patient care to suggest that provision of basic information and orientation to the setting are not sufficient approaches to impact feelings of anxiety. Further study of such approaches can be helpful to determine how to best meet patient needs.

Print

Schnur, J.B., Bovbjerg, D.H., David, D., Tatrow, K., Goldfarb, A.B., Silverstein, J.H., . . . Montgomery, G.H. (2008). Hypnosis decreases presurgical distress in excisional breast biopsy patients. Anesthesia and Analgesia, 106, 440–444.

Study Purpose

To test the hypothesis that presurgical distress would be lower in a group that received hypnosis compared to an attentional control group

Intervention Characteristics/Basic Study Process

On the day of surgery, participants completed data collection instruments prior to study interventions and 15 minutes postintervention. Both the hypnosis and control interventions were standardized to last for 15 minutes. The hypnosis intervention included debunking common misconceptions, giving the patient an opportunity to ask questions, and presentation of a scripted relaxation-based induction, guided imagery, deepening, and surgery-specific suggestions for decreasing pain, nausea, and distress. Patients in the control group spent an equal amount of time with study personnel in sessions of empathic listening and supportive remarks from study personnel. All personnel providing interventions were clinical psychologists with advanced training in use of hypnosis in the medical setting.

Sample Characteristics

  • The study reported on a sample of 90 female patients.
  • Mean patient age was 45.7 years (range = 19–77).
  • All patients were scheduled for excisional biopsy. Almost all patients did not have previous breast cancer; 22.2% had previous excisional biopsy.
  • Of the sample, 64% were Caucasian, and 68.7% had a college or graduate degree.

Setting

  • Single site
  • Outpatient setting
  • New York

Phase of Care and Clinical Applications

Patients were undergoing the diagnostic phase of care.

Study Design

A single-blind, randomized controlled trial design was used.

Measurement Instruments/Methods

  • Profile of Mood States–short version (POMS)
  • Visual analog scale (VAS) for depressed mood, emotional upset, and level of relaxation – 100 mm

Results

Patients in the hypnosis group demonstrated significantly lower general upset (d = 0.85, p < 0.001), depressed mood (d = 0.67, p < 0.002), and anxiety (d = 0.85, p < 0.001), and higher relaxation (d = 0.76, p < 0.001) on VAS and POMS scores.

Conclusions

Findings demonstrate that a brief hypnosis intervention reduced symptoms of depression and anxiety and increased relaxation prior to excisional breast biopsy.

Limitations

The study had a small sample, with less than 100 participants.

Nursing Implications

Hypnosis can be an effective intervention to reduce distress prior to breast biopsy. Additional research to determine longer-term effects on post-biopsy patient symptoms is warranted. This intervention was accomplished in 15 minutes, suggesting that hypnosis can be a practical intervention in the clinical setting. This type of intervention does require specific expertise.

Print

Schneider, T., Reimer, P., Storz, K., Klopp, M., Pfannschmidt, J., Dienemann, H., & Hoffmann, H. (2009). Recurrent pleural effusion: Who benefits from a tunneled pleural catheter? The Thoracic and Cardiovascular Surgeon, 57(1), 42-46.

Study Purpose

The objective of this study was to report on the effectiveness of tunneled indwelling pleural catheters (TIPC) in patients with recurrent malignant pleural effusion (MPE) and impaired lung dilatability.

Intervention Characteristics/Basic Study Process

TIPC placement was performed on three groups of patients: those with a trapped lung who were not candidates for pleurodesis, those with recurrent pleural effusion after failed attempts at pleurodesis, and those with poor physical condition/limited lifespan who were not candidates for VATS procedure. Prior to TIPC placement, diagnostic or therapeutic interventions (i.e., pleuracenteses or pleurodesis) were performed on 54 patients to treat the pleural effusion. TIPC placement was performed by a thoracic surgeon as an inpatient procedure for 98 patients in an operating room via local anesthesia or VATS procedure. Following placement, patients and relatives or home care nursing staff were instructed in TIPC care and drainage through specific training, and subsequent drainage of the catheter system was performed three times weekly and afterward based on symptoms (pain or dyspnea) or fluid volume. TIPCs ultimately were removed as an outpatient procedure under local anesthesia when volume at three sequential drainage procedures was less than 50 mL and were drained once a week in an expanded lung by x-ray. Patients were then followed up until February 2008.

Sample Characteristics

  • The study reported on a sample of 100 patients.
  • The mean age was 64 years, with a range of 30-91 years.
  • Of the sample, 52% were males and 48% were females.
  • Key disease characterstics included underlying cancer disease: lung (23), breast (20), mesothelioma (11), ovarian (4), pancreatic (5), cancer of unknown primary (5), other malignant disease (19), nonmalignant due to liver cirrhosis or chronic exudative pleurisy (13).
  • Of the 107 patients undergoing TIPC procedures, 88 patients had malignant disease and 12 had nonmalignant effusions. Seven additional procedures included six contralateral procedures and one ipsilateral procedure.
  • Patients with malignant pleural effusion and fully expandable lungs in good clinical condition were given talc poudrage during VATS procedure instead of TIPC. Also, intraoperative suspicion of pleural empyema was a contraindication for TIPC.

Setting

This single-site study was conducted in an inpatient setting (for TIPC insertion) and outpatient setting (for TIPC removal) in an operating room in Germany.

 

Phase of Care and Clinical Applications

  • Patients were undergoing multiple phases of care.
  • The study has clinical applicability for end-of-life and palliative care.

 

Study Design

The study was a retrospective analysis.

Measurement Instruments/Methods

  • Diagnostic VATS procedure prior to TIPC placement (54 patients)
  • X-ray performed prior to TIPC removal to assess lung re-expansion
     

Results

Median residence time of TIPC was 70 days (range 2-384 days) in all patients. In 52 procedures, TIPC remained indwelling until patients’ death (median 47 days; range 2-319 days). In these particular patients, further relief of recurrent effusion was achieved by a drainage system, such that no one required repeated investigations (via pleuracenteses or surgical interventions). Sixteen TIPCs remained at the end of the observation period with a median indwelling time of 87 days (range 30-389 days) because they still required relief for recurrent pleural effusion. Thirty-nine TIPCs were removed after a median indwelling time of 80 days after decreased drainage and lung re-expansion. Patients with carcinoma of unknown primary and pancreatic cancer had the worst outcome. Nine patients had their catheters removed following TIPC-related complications (empyema [4], pain [1], accidental dislodgement by patient [2], bronchopleural fistula [1], occlusion of drainage [1], and recurrent effusion requiring TIPC replacement [2]). Six patients died during hospitalization following TIPC placement due to rapid progressive malignant disease.

According to the authors, the three groups that appear to benefit the most are patients with an intraoperative find of a trapped lung in a diagnostic VATS procedure who are not candidates for talc pleurodesis; patients with a history of repeated pleuracenteses or past failed attempts at pleurodesis; and patients with limited life expectancy and reduced clinical condition due to underlying disease.

Conclusions

Tunneled indwelling catheters are useful in the palliative treatment of patients with recurrent malignant and nonmalignant pleural effusions.

Limitations

  • The study had no appropriate control group.
  • Due to the nature of the study, authors were unable to control for patient death during the hospitalization and observation period.
  • Only patients unable to tolerate VATS procedures were included, so results can only be generalized to patients with refractory pleural effusion in the setting of poor physical health.
  • Authors suggest that the insertion of a “not-tunneled pleural mini-catheter” be considered as an alternative intervention. This point, however, seems to contradict the authors’ original conclusion that TIPC will be beneficial for patients with limited lifespan and reduced clinical condition due to underlying disease.

     

Nursing Implications

Though TIPC placement under local anesthesia is less invasive and offers the advantage of very low postoperative mortality rate, it may not be an appropriate intervention for patients with a “very limited lifespan” based on underlying disease. Hence, its use in this population should be considered cautiously, given the procedure's aggressive or semi-aggressive, invasive nature. Patient/caregiver capacity to care for the catheter and perform drainage may influence the appropriateness of this intervention.

Print

Schneider, F., Danski, M.T., & Vayego, S.A. (2015). Usage of Calendula officinalis in the prevention and treatment of radiodermatitis: A randomized double-blind controlled clinical trial. Revista da Escola de Enfermagem da USP, 49, 221–228. 

Study Purpose

To compare Calendula officinalis with essential fatty acids (EFAs) for the prevention and treatment of radiodermatitis among people with head and neck cancers

Intervention Characteristics/Basic Study Process

  • Active control arm: EFAs
  • Experimental arm: Calendula officinalis
  • A pharmacy compounded the treatments and placed them in bottles.
  • Radiation oncology nurses applied 10 ml of treatment on gauze after radiation therapy. Participants reapplied treatment 12 hours later.

Sample Characteristics

  • N = 51 total, n = 27 (control), n = 24 (Calendula)  
  • MEAN AGE: EFA group: 60.44 years (SD = 10.53), Calendula group: 62.38 years (SD = 12.71)
  • MALES (%): Not reported, FEMALES (%): Not reported, but the study included males and females. Most participants were male.
  • KEY DISEASE CHARACTERISTICS: Head and neck cancers
  • OTHER KEY SAMPLE CHARACTERISTICS: All patients were treated with Colbalt-60.

Setting

  • SITE: Single site    
  • SETTING TYPE: Not specified    
  • LOCATION: Radiotherapy department, Curitiba, Parana, Brazil

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

Prospective, random assignment, double-blind, controlled clinical trial

Measurement Instruments/Methods

Radiation Therapy Oncology Group (RTOG) scale for skin toxicity

Results

The proportion of grade 2 radiodermatitis was significantly higher in the EFA group ascompared to the Calendula group (p = 0.012). The EFA group’s Kaplan-Meier survival curve was consistently lower (i.e., fewer survivors) than the Calendula group curve at every point of the survival curve (p = 0.00402). In patients receiving concurrent chemo/radiation therapy, grade 2 dermatitis was more frequent in the EFA group, with grade 1 dermatitis more frequent in the Calendula group (p = 0.0179).

Conclusions

Calendula was more efficacious than EFAs for the prevention and treatment of radiation-induced skin toxicity among individuals with head and neck cancers.

Limitations

  • Small sample (< 100)
  • Risk of bias (sample characteristics)
  • Measurement/methods not well described
  • Findings not generalizable
  • Subject withdrawals ≥ 10%
  • The authors did not provide a table listing the demographics of the sample.
  • The participants in the EFA arm were more likely to be orally fed than those in the Calendula arm (92.59% versus 70.83%).
  • The authors reported using chi-square, the Fisher and G Williams test for categorical variables, and Mann-Whitney U and Wilcoxin tests for quantitative variables. However, the authors reported numerous percentages, a few p values, and a Kaplan-Meier curve in the article.
  • The authors used “a team of trained researchers” but did not address inter-rater reliability.
  • The control product (EFAs: sunflower oil, 1% vitamin A, 0.2% vitamin E, and 5% caprylic acid) and the experimental product (Calendula: 4% Calendula oil, 1% vitamin A, and liquid Vaseline) were compounded by the hospital pharmacy. This helped maintain double-blinding but made it more difficult to compare these results with studies conducted by Pommier (2004) and Sharp (2013) because the Calendula products differ in each of the studies.
  • More than 50% of the control group and 42% of the experimental group members withdrew before the end of the study.

Nursing Implications

These results neither negate nor support the current Oncology Nursing Society's Putting Evidence into Practice (PEP) guidelines for the use of Calendula in radiodermatitis.

Print

Schneider, S. M., & Hood, L. E. (2007). Virtual reality: a distraction intervention for chemotherapy. Oncology Nursing Forum, 34, 39–46.

Intervention Characteristics/Basic Study Process

Virtual reality (VR) is a computer-simulated technique during which individuals wear a head-mounted device and become immersed in scenarios through visual and auditory stimuli that they manipulate. Patients wore a VR headset during an intravenous (IV) chemotherapy treatment and chose from the following scenarios:

  1. Deep sea diving
  2. Walking through an art museum
  3. Exploring ancient worlds
  4. Solving a mystery.

Each scenario was long enough to last the entire length of the chemotherapy infusion (45–90 minutes). Patients were free to change scenarios at any time. During the control and VR conditions, patients sat in a reclining treatment chair. In the control condition, patients were free to participate in any activities they chose during treatment, such as watching television, talking with others, or reading. Patients were randomly assigned to receive the VR distraction intervention during one chemotherapy treatment and to receive the control (no intervention) during an alternate matched chemotherapy treatment. Outcomes were assessed at baseline (T1), immediately after chemotherapy (T2), and 48 hours postchemotherapy (T3).

Sample Characteristics

  • The sample was comprised of 123 adults receiving initial chemotherapy treatments.
  • Mean age was 53.97 years (range 32–78).
  • The majority of the patients were female (77%) and Caucasian (91%), and about half had a diagnosis of breast cancer (52%).
  • Patients were excluded if they were younger 18 years, non-English speaking, had evidence of primary or metastatic disease to the brain, or had a history of motion sickness or seizures.

Setting

Outpatient clinic at a comprehensive cancer center in southeastern United States

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

The study used a randomized, crossover, within-subjects design with a:

  1. VR distraction intervention
  2. Control.

Measurement Instruments/Methods

Revised Piper Fatigue Scale (PFS)

Results

The VR intervention did not improve fatigue outcomes. Although the treatment group experienced a greater decline than the control from T1 to T2, the difference did not reach statistical significance.

Limitations

  • The intervention was only used once with each patient, and determining whether patients had enough exposure to VR to produce an effect on symptoms was not possible.
  • In some cases, a stronger “dosage” of VR may be needed.
  • The study was conducted at a single site, and the the study population was homogenous.
  • The study lacked standardized measures to capture satisfaction with VR use during chemotherapy treatment.
Print
Subscribe to