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Given, C., Given, B., Rahbar, M., Jean, S., McCorkle, R., & Cimprich, B. (2004). Does a symptom management intervention affect depression among cancer patients: Results from a clinical trial. Psycho-Oncology, 13, 818–830.

Intervention Characteristics/Basic Study Process

Patients underwent a focused assessment that corresponded with specific symptom management interventions. The interventions recommended were based on a cognitive behavioral approach. The control arm received usual care. Patients were assessed for symptoms such as nausea, vomiting, insomnia, dyspnea, anorexia, fever, cough, dry mouth, constipation, mouth sores, pain, and fatigue. Symptoms identified with depression—fatigue, insomnia, anorexia, and poor concentration—were placed in a subindex.

Sample Characteristics

Of 609 eligible patients, 237 patients and their family caregivers participated in the study. Patients had been diagnosed with a solid tumor and were within two months of the first cycle of chemotherapy. Patients who were receiving radiation or who had had previous chemotherapy were ineligible. The study include men and women who had been diagnosed with a variety of tumor types in various cancer stages.

Study Design

Randomized control trial

Measurement Instruments/Methods

  • The Center for Epidemiological Studies Depression Scale
  • Two-sample t tests, a chi-square test, and a general linear model

Results

Among those with higher levels of baseline symptoms except depression, cognitive behavioral interventions lowered depression at 10 weeks. In patients with a higher level of depression at baseline, the cognitive behavioral interventions were less effective.

Conclusions

Cognitive behavioral interventions may lower depression indirectly by managing symptoms that do not have a component that is primarily affective. Symptoms with a physiologic and psychological component may be more difficult to modify and require long-term intervention.

Limitations

  • Medications used to treat depression were not standardized. A variety of medications were used at various doses.
  • The study did not detail how the intervention sessions were completed, only that researchers conducted telephone interviews and in-person sessions of 30–60 minutes.
  • The study did not identify the background and training of the nurses who provided interventions.
  • The study did not provide specific symptom management interventions. Knowing symptom-management strategies and specific guidelines would have been helpful.
Print

Given, B., Given, C.W., Sikorski, A., Jeon, S., Sherwood, P., & Rahbar, M. (2006). The impact of providing symptom management assistance on caregiver reaction: Results of a randomized trial. Journal of Pain and Symptom Management, 32(5), 433–443.

Intervention Characteristics/Basic Study Process

Dyads in the experimental group received four contacts over a 10-week intervention. (Two in-person contacts coinciding with regular visits to the oncology center; alternated with two telephone contacts approximately two weeks following each in-person contact.)

Cognitive behavioral intervention was directed toward the patient and caregiver dyad. Patients received information on self-care, cognitive reframing, coping strategies, and techniques for communicating needs for assistance with family members. Interventions for caregivers focused on etiology and strategies for managing symptoms, how to integrate into everyday activities, and how to better communicate with the patient and healthcare providers about symptom management. The intervention nurse assessed the caregivers’ perception of their involvement in and reaction to assisting the patient with symptom management; collaboratively selected strategies to implement; and evaulated the success of strategies to either continue or be revised.

Sample Characteristics

  • The sample included caregivers of patients with a solid tumor within their first two cycles of chemotherapy for treatment of new tumor (N = 125)—intervention (n = 59) versus standard of care (n = 66).

Study Design

A properly designed randomized clinical trial was used.

Measurement Instruments/Methods

  • Center for Epidemiologic Studies Depression Scale (CES-D)
  • Caregiver (burden) reaction to assisting with symptoms was measured by the following.
    • Total number of symptoms for which caregiver provided assistance
    • Total level of distress reported because of assisting with symptom management
    • Reaction (level of distress) score per symptom

Results

Caregivers in the experimental intervention group reported significantly lower total negative reactions and fewer assistances at 10 weeks than caregivers in the standard of care arm (p < 0.01).

Patients of caregivers in the experimental group reported significantly lower levels of symptom severity for which caregivers provided assistance.

Female caregivers in the experimental group reported less negative reactions to providing assistance than female caregivers in the control group (p < 0.01). Males in the control group reported less negative reactions per assistance than males in the experimental group (p = 0.08).

Caregivers who were younger than their patients reported less negative reactions to assisting with symptom management than caregivers who were the same age or older than their patients (p = 0.06).

Limitations

  • Demographic information about race and ethnicity of the sample was not described.
  • No description exists of the qualifications or training required for the intervention nurse nor do evidence-based guidelines exist for strategies used in symptom management.
Print

Girmenia, C., Barosi, G., Piciocchi, A., Arcese, W., Aversa, F., Bacigalupo, A., . . . Rambaldi, A. (2014). Primary prophylaxis of invasive fungal diseases in allogeneic stem cell transplantation: Revised recommendations from a consensus process by Gruppo Italiano Trapianto Midollo Osseo (GITMO). Biology of Blood and Marrow Transplantation, 20, 1080–1088. 

Purpose & Patient Population

PURPOSE: To update guidelines designed to improve awareness, diagnosis, and management of invasive fungal infection (IFI) among transplantation patients and to better define prophylactic and therapeutic options for clinical practice
 
TYPES OF PATIENTS ADDRESSED: Adults and children undergoing allogeneic stem cell transplantation

Type of Resource/Evidence-Based Process

RESOURCE TYPE: Evidence-based guideline  
 
PROCESS OF DEVELOPMENT: A systematic review of literature was done and reviewed by an advisory committee and panel of experts, who drafted statements and recommendations. These were reviewed by all panel members and rated as to agreement. Final recommendations and statements were determined by consensus.
 
DATABASES USED: PubMed
 
KEYWORDS: Fungal infections, epidemiology, allogeneic stem cell transplantation, antifungal prophylaxis
 
INCLUSION CRITERIA: Large single-center or multicenter series. Allogeneic transplantation cases only

Phase of Care and Clinical Applications

PHASE OF CARE: Transition phase after treatment

Results Provided in the Reference

Volume of articles retrieved is not reported. Provides a three-level strength of recommendation and three-level grading of evidence quality. Ten studies are summarized.

Guidelines & Recommendations

The studies defined risk factors for patients to be considered high risk in early, late, and very late phases post-transplantation. It is recommended that high-risk patients receive mold-active prophylaxis and all remaining patients receive Candida-active prophylaxis in the early and late phases. In the very late phase, it is recommended that those at high risk, based on severity and steroid refractory graft-versus-host disease, receive mold-active prophylaxis; those with a standard risk receive Candida-active prophylaxis; and those at low risk receive no prophylaxis. The studies provide an extensive definition of risk levels for use.

Limitations

  • There is limited evidence in children.
  • All the evidence used was retrospective.

Nursing Implications

Studies provide information to determine level of risk in various transplantation phases and gives guidance regarding antifungal prophylaxis in each phase. Nurses need to be aware of changing risk in various transplantation phases of care.

Print

Girgis, A., Breen, S., Stacey, F., & Lecathelinais, C. (2009). Impact of two supportive care interventions on anxiety, depression, quality of life, and unmet needs in patients with nonlocalized breast and colorectal cancers. Journal of Clinical Oncology, 27, 6180–6190.

Study Purpose

To determine if, compared to individuals receiving usual care, participants in intervention groups would report lower levels of anxiety, depression, and unmet supportive care needs along with improved physical and emotional functioning

Intervention Characteristics/Basic Study Process

  • Patients were randomly assigned to one of three supportive care models: UC (control), O/GP (oncologist/GP), or TCW (telephone caseworker). Participants completed three computer-assisted telephone interviews (CATIs) conducted by trained interviewers: one each at baseline and at three and six months.
  • Data obtained from participants in the UC model were used only to assess the impact of supportive care models.
  • The O/GP model included two copies of sheets listing concerns: One sheet was mailed to the oncologist, so he or she would know what concerns to discuss at the next appointment. The other sheet was for records.
  • The TCW model consisted of telephone interviews conducted by oncology nurses with training in by-telephone interviewing. Interviewers discussed the content of TCW sheets, which listed issues of concern that patients had expressed. TCW interviewers followed up at six-week intervals to assess coping.

Sample Characteristics

  • The sample was composed of 356 participants.
  • Mean patient age in the UC (control) group was 57.4 years. The age range in the UC group was 28–75 years. Mean patient age in the O/GP group was 58.3 years. The age range in the O/GP group was 37–75 years. Mean patient age in the TCW group was 57.8 years. The age range in the TCW group was 33–75 years.
  • The number of females in the sample was 257. The percentage of females in the sample ranged from 71.8% through 72.5%. The number of males in the sample was 99. The percentage of males in the sample ranged from 27.5% through 28.2%.
  • The percentage of participants with nonlocalized breast cancer ranged from 48.7% through 49.2%; with nonlocalized colon cancer, 50.8% through 51.3%

Setting

  • Single site
  • Home
  • New South Wales, Australia

Phase of Care and Clinical Applications

  • Phase of care: active treatment and transition
  • Clinical application: late effects

Study Design

Parallel-group, prospective randomized controlled trial

Measurement Instruments/Methods

  • Hospital Anxiety and Depression Scale (HADS)
  • European Organization for Research and Treatment of Cancer Core Quality of Life questionnaire, version 3.0 (EORTC QLQ-C30 version 3.0)
  • Supportive Care Needs Survey-Short Form (SCNS-SF34), to measure perceived need for care
  • 10 items from the Needs Assessment for Advanced Cancer Patient (NA-ACP)
  • Perceived improvement in patient communication with health care practitioners was measured at the third CATI by means of one question, on a 5-point Likert scale: “Participating in this study made it easier to discuss my health care needs and issues with my doctors and other health care practitioners.”

Results

  • Authors observed no overall intervention effect.
  • Members of the TCW group were more likely (p < 0.0001) to have issues discussed and referrals recommended than were those in the O/GP group. This was particularly true in regard to unmet psychological need (p < 0.01), need relating to daily living (p < 0.01), health service/information need (p = 0.01), and physical need (p < 0.01).
  • Compared to oncologists and GPs, case workers were more likely to discuss anxiety (p = 0.01) and unmet psychological needs (p < 0.01).
  • Oncologists and GPs were more likely (p = 0.02) to discuss unmet patient care and support needs.
  • Authors noted no significant intergroup differences in regard to proportion of participants with elevated anxiety and depression at any of the three time points.
  • QOL scores improved within study groups across times, but authors detected no significant between-group differences.

Conclusions

Authors noted no significant intervention effect in this study, with the exception of improved physical functioning at six months for the TCW group.

Limitations

  • Individuals who were too distressed or unwell to participate were excluded from the study. These patients may have been the very ones who most needed the intervention. 
  • Authors provided no information about or consideration of disease stage, treatment phase, or other symptoms that can affect the outcomes the study measured.

Nursing Implications

Nurses should continue to explore ways to reach patients, at the time of diagnosis and beyond treatment, that can assist patients in psychosocial functioning. The field needs tools to make this easier; nurses need ways to implement care efficiently. The study did not show telephonic intervention to be effective.

Print

Girgis, A., Breen, S., Stacey, F., & Lecathelinais, C. (2009). Impact of two supportive care interventions on anxiety, depression, quality of life, and unmet needs in patients with nonlocalized breast and colorectal cancers. Journal of Clinical Oncology, 27, 6180–6190.

Study Purpose

To determine if patients assigned to either of two interventions for supportive care would report decreased levels of anxiety, depression, and unmet supportive care needs compared to patients receiving usual care

Intervention Characteristics/Basic Study Process

Patients were surveyed via computer-assisted telephone interview (CATI) to provide feedback to a telephone caseworker (TCW) or the patient’s physician at baseline, three months, and six months. The information obtained from the CATI was used to provide feedback to the caseworker in the TCW model, or to the physician in the oncologist/general practitioner (O/GP) model. In the TCW model, participant feedback information from CATIs was forwarded to the caseworker via email. The TCW then contacted participants to address areas of concern and refer to appropriate resources. In the O/GP model, feedback generated from the CATIs was mailed to both oncologists and GPs for discussion with the patients at the next appointment.

Sample Characteristics

  • The study analyzed a final sample of 333 patients (females: 71%–73%; males: 27%–29%).
  • Patient age ranged from 28 to 75 years across groups.
  • Patients were diagnosed with colorectal or breast cancer; mean time since diagnosis at baseline in all groups was 6.3 months.
  • Of the sample, 17%–21% had no treatment, 47%–59% had chemotherapy, and 12%–16% had radiotherapy. Eight patients had surgery,
  • The majority (73%–78%) of patients were married, and 50%–60% were not currently employed.

Setting

  • Multisite
  • Outpatient setting
  • United Kingdom

Phase of Care and Clinical Applications

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

Study Design

A randomized controlled trial design was used.

Measurement Instruments/Methods

  • Hospital Anxiety and Depression Scale (HADS)
  • European Organization for Research and Treatment of Cancer (EORT) Quality of Life Questionnaire–version 3
  • Supportive Needs Survey Short Form (34 items on a five-point scale across domains of physical and daily living, psychological, patient care and support, health system and information, and sexuality)
  • Needs Assessment for Advanced Cancer Patients Questionnaire

Results

No overall intervention effect was observed. TCW participants were more likely to have referrals for unmet psychological needs, daily living, health service/information, and physical needs (p < 0.01).

Conclusions

Findings suggest that use of a TCW can be helpful in improving supportive care in terms of communication and provision of referrals for care in patients with cancer. Neither of the models tested demonstrated any significant intervention effect for anxiety, depression, or quality of life over the time frame of this study.

Limitations

  • Participants had low levels of depression and anxiety at baseline, and most patients were more than six months out from time of diagnosis.
  • Reviewers had limited ability to compare actions of physicians versus caseworkers due to lack of relevant documentation provided by the physicians.
  • All patients participated in the CATI, which would have potentially enhanced communication in all the study groups in its own right. This could have confounded findings associated with other specific models.

Nursing Implications

Additional research in this area should incorporate at-risk populations at a time closer to diagnosis. Results suggest that CATIs and involvement of caseworkers may be helpful to enhance supportive care and patient communication with providers.

Print

Giralt, S.A., Mangan, K.F., Maziarz, R.T., Bubalo, J.S., Beveridge, R., Hurd, D.D., … Schuster, M.W. (2011). Three palonosetron regimens to prevent CINV in myeloma patients receiving multiple-day high-dose melphalan and hematopoietic stem cell transplantation. Annals of Oncology, 22, 939–946.

Study Purpose

  • To explore the efficacy and safety of three different administration schedules of palonosetron for preventing emesis and nausea
  • To assess the safety of the different palonosetron schedules and their impact on activities of daily living as a result of nausea and vomiting

Intervention Characteristics/Basic Study Process

  • Patients were randomly assigned to 1 of 3 palonosetron administration schedules.
    • 0.25 mg IV 30 minutes prior to melphalan and transplant on day -2
    • Same dosage prior to treatment on days -2 and -1
    • Same dosage and timing on days -2, -1, and 0.
  • Infusions of saline were given in groups 1 and 2 to simulate additional study drug doses as a control.
  • All patients were given 20 mg IV dexamethasone on days -2 and -1 immediately before or after the study drug.
  • Patients maintained daily diaries to record episodes and severity of nausea and vomiting, use of rescue medications, and adverse events.
  • Patients completed nausea questionnaires on day -2 and day 0.
  • Patients were followed for 7 days from day -2 to day +5.

Sample Characteristics

  • This study consisted of 73 participants.
  • Ages of patients ranged from 32–78 years.
  • The majority of patients were male (64%).
  • All had multiple myeloma and were receiving melphalan and transplant.
  • Less than one-third were chemotherapy naïve prior to the study.
  • The majority of the patients were Caucasian (75%).

Setting

The study was conducted in an outpatient setting at Memorial Sloan Kettering Cancer Center in New York.

Phase of Care and Clinical Applications

All patients were in active treatment.

Study Design

This was a double-blind, randomized pilot study.

Measurement Instruments/Methods

  • The Osoba Nausea and Emesis Module questionnaire was used.
  • Patients recorded nausea severity daily on a 4-point Likert-type scale (0 = none to 3 = severe) in diaries.
  • Common Terminology Criteria for Adverse Events (CTAE v3.0) was used.

Results

  • No significant differences were found between groups for complete no-emesis rates, with about 40% of patients achieving complete prevention of nausea and vomiting.
  • A trend toward increased complete response with additional doses of palonosetron was observed on day 0 (p = 0.015).
  • Multiple days of palonosetron was associated with better daily relief as reflected in diaries, but this was not statistically significant.
  • No significant differences were found between groups in amount of rescue medication used overall.
  • During the 5 days post-transplant, a greater proportion of patients receiving multiple palonosetron doses reported no or minimal impact on activities of daily living from nausea or vomiting.
  • Similar adverse events were seen across all study groups. Most frequent events likely related to the study drug were diarrhea, constipation, headache, insomnia, and flatulence.
  • Most patients (80%) experienced emesis or required rescue medication even with multiple doses of palonosetron.

Conclusions

A multiple-dose schedule of palonosetron as used here was not associated with any increase in adverse events. No definitive conclusions can be drawn regarding the benefit of multiple-day administration of palonosetron.

Limitations

  • The sample size was small with fewer than 100 patients.
  • Some measures of benefit appeared to be improved in the groups with multiday dosing of palonosetron; however, patterns were inconsistent.

Nursing Implications

Further evaluation of multiple-day schedules of palonosetron are warranted. Even with multiple dosing, 80% of these patients had episodes of emesis or required rescue medication, pointing to the continuing challenge to determine more effective methods and combinations to meet this patient need.

Print

Giralt, J., Regadera, J. P., Verges, R., Romero, J., de la Fuente, I., Biete, A., … Guarner, F. (2008). Effects of probiotic lactobacillus casei DN-114 001 in prevention of radiation-induced diarrhea: Results from multicenter, randomized, placebo-controlled nutritional trial. International Journal of Radiation Oncology, Biology, Physics, 71(4), 1213–1219.

Study Purpose

To determine whether a liquid yogurt containing Lactobacillus casei DN-114 reduces the incidence or the severity of diarrhea in patients with cervical carcinoma receiving radiation therapy with concomitant cisplatin or in patients with postoperative endometrial adenocarcinoma receiving radiation therapy

Intervention Characteristics/Basic Study Process

Patients receiving conventional fractionation pelvic radiation therapy for cervical carcinoma (radiation therapy with weekly cisplatin) or for endometrial adenocarcinoma were randomly assigned to receive 96 mL of fermented liquid containing yogurt with Lactobacillus casei DN-114-001 or the same amount of placebo in 2-mg capsules, three times per day. Loperamide was used as necessary as rescue medication; no other antidiarrheal medications were permitted. Consumption of loperamide was recorded. Patients kept daily diaries.

Sample Characteristics

  • The study reported on 85 patients.
  • The mean age was 60.91 years (SD = 11.80 years) in the intervention group and 59.34 years (SD = 12.77 years) for the placebo group.
  • All of the patients were female.
  • Patients had been diagnosed with endometrial adenocarcinoma requiring postoperative pelvic radiation therapy or advanced cervical squamous cell carcinoma requiring pelvic radiation therapy with concomitant weekly cisplatin.
  • Patients had European Cooperative Oncology Group (ECOG) performance statuses of less than 2.
  • Patients were excluded from the study if they
    • Had other types of pelvic tumors.
    • Were receiving treatment with chemotherapy agents other than cisplatin.
    • Had received prior chemotherapy or radiation therapy.
    • Were being treated with antimicrobials or immunosupressors at inclusion.
    • Had experienced any acute or chronic gastrointestinal (GI) condition associated with diarrhea in the month prior to recruitment.

Setting

The study was conducted at multiple outpatient settings in Spain.

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

This was a placebo-controlled, double-blind, randomized clinical trial in two parallel groups.

Measurement Instruments/Methods

The Bristol Stool Scale, National Cancer Institute (NCI) Common Toxicity Criteria (CTC), and European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - C30 were used.

Results

  • No significant differences were found in
    • Development of grade 2 or worse diarrhea
    • Need for rescue medication (loperamide)
    • Withdrawal because of a lack of efficacy
    • Time to the first occurrence of grade 2 or 3 diarrhea
    • Time to the first occurrence of type 5 (soft) stools (Bristol Scale)
    • Quality-of-life questionnaire scores
    • Complications reported at 6 months.
  • The first incidence of type 6 (fluffy) stools (Bristol scale) was significantly shorter in the placebo group (median of 10 days) than in the intervention group (median of 14 days, (p = 0.048).
  • No adverse events were considered related to the study product.

Conclusions

The use of a fermented liquid yogurt containing Lactobacillus casei DN-114-001 did not decrease the incidence of radiation-induced diarrhea.

Limitations

  • The sample size was small, with fewer than 100 patients.
  • No intent-to-treat analysis was performed.
  • Accrual was terminated prematurely because of recruiting difficulties and did not reach calculated sample size to achieve 80% power.
  • 5-HT3 inhibitors were used to treat nausea/vomiting. Because these are associated with constipation, their use could have affected stool consistency.

Nursing Implications

The probiotic Lactobacillus casei does not appear to decrease the incidence of radiation-induced diarrhea.

Print

Aapro, M.S., Cameron, D.A., Pettengell, R., Bohlius, J., Crawford, J., Ellis, M., et al. (2006).

Purpose & Patient Population

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Type of Resource/Evidence-Based Process

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Phase of Care and Clinical Applications

Aliquip humo jumentum. Decet esca gravis. Abigo dolus esse gravis immitto imputo melior ulciscor. Eu ex wisi. Plaga scisco similis tamen utinam. Ea letalis luptatum. Camur facilisi gilvus in jus lucidus olim tum turpis. Decet gemino gravis haero lobortis olim sudo vel. Distineo haero humo.

Results Provided in the Reference

Abdo bene eligo luctus turpis velit. Conventio esse hos jugis quae sino uxor. Damnum dolus lucidus plaga praemitto torqueo usitas. Autem exputo immitto iustum obruo persto. Blandit diam distineo elit euismod pala refero singularis tum virtus. At cogo dignissim hendrerit jugis neque premo valetudo. At erat neque quibus sagaciter utinam vulpes. Facilisis fere gilvus natu nobis probo veniam vereor. Suscipere utrum virtus. Accumsan aliquam commoveo consequat defui neo qui. Caecus dolor molior pertineo. Jus oppeto ratis. Ad esca imputo natu pecus secundum te torqueo utrum uxor. Amet facilisis luctus luptatum persto plaga pneum qui te. Aptent augue ea facilisis neo oppeto pagus pertineo quidne sed. Augue causa conventio exputo nibh nimis olim. Abdo damnum esse facilisis iriure pecus quibus quidem saluto ullamcorper. Exputo olim pneum turpis. Laoreet populus saluto usitas vindico. Dolus eu lucidus nobis os vel. Abluo at exputo haero lucidus natu nobis turpis wisi. Camur hos imputo pala refero refoveo sudo veniam. Interdico pala quidne zelus. Antehabeo gemino ibidem loquor neque singularis tincidunt. Ad inhibeo lobortis pertineo qui similis tamen te. Augue causa humo lobortis similis typicus. Importunus luctus plaga secundum. Huic jugis populus probo quidem saepius sino tego. Abluo adipiscing dolus minim natu nunc olim ut ymo. Blandit et facilisis persto quibus quidem. Brevitas dolore esca quibus rusticus similis ulciscor. Conventio immitto macto saepius singularis te. Acsi brevitas cogo comis ibidem jugis molior nulla uxor verto. Abbas decet esse gilvus iriure sudo suscipit. Blandit commoveo distineo hos in luptatum nulla sudo voco vulpes. Feugiat iustum saluto tum. Gemino nibh paratus quibus sino vero. Conventio erat luctus mos scisco ullamcorper virtus. Brevitas defui dolor ibidem imputo occuro quia tincidunt. Abico causa nostrud pagus plaga pneum refero ulciscor. Acsi genitus paulatim sit. Causa eros minim quadrum qui typicus ymo. Adipiscing antehabeo aptent esse exerci mos rusticus singularis validus virtus. Accumsan nobis olim oppeto. Antehabeo augue ex facilisis in persto. Appellatio dolore dolus pala praesent similis suscipit tation torqueo. Facilisis gemino scisco. Commoveo eligo gilvus nisl paulatim te velit. Bene caecus huic iaceo lucidus magna nobis quidem. Abdo aliquip exerci exputo facilisis jugis melior neo praemitto saepius. Capto dolus esse exerci genitus mos ullamcorper validus vereor. Aptent facilisis ille iustum metuo molior similis. Ad diam eligo ibidem inhibeo obruo similis tamen vel vulputate.

Guidelines & Recommendations

Accumsan gemino pagus quis uxor vulputate. Conventio distineo ille melior patria pertineo plaga sudo torqueo. Aliquam importunus nibh suscipere suscipit ulciscor utinam verto. Antehabeo commoveo et gemino jumentum laoreet pecus ratis suscipit utrum. Distineo nobis quia. Camur decet ibidem saepius. Nunc paratus praemitto quibus quis utinam vereor. In inhibeo oppeto turpis validus. Melior quis ullamcorper vindico. Antehabeo haero immitto in jugis molior natu quidne scisco. Augue laoreet lenis natu olim. Abdo facilisi molior. Quidem turpis ymo. Eligo in lobortis ulciscor. Appellatio cogo comis ea magna nibh paulatim quia sagaciter. Capto eligo facilisis luctus nisl roto turpis. Adipiscing eligo eum iaceo letalis melior nostrud obruo olim vel. Dolor gilvus illum iustum pneum te vulpes. Capto facilisi genitus illum iusto. Defui elit erat gilvus sit usitas vicis. Bene haero odio paratus quia quis vereor. Caecus inhibeo jugis roto sudo suscipere valde veniam. Enim minim persto praesent. Caecus camur causa qui turpis validus. Comis singularis validus. Abbas abluo blandit decet gravis lenis loquor ludus luptatum natu. Damnum letalis nimis odio patria. Abigo elit eum facilisi genitus gravis neo premo sagaciter. Autem luctus saepius saluto. Sed utinam vereor voco. Cogo consequat iusto nisl plaga suscipere utrum. Comis facilisi hendrerit ibidem iusto iustum quadrum quis tego volutpat. Dolus eum fere molior roto suscipit valetudo. Abluo plaga ratis saepius. Aliquip augue et. Eros gemino scisco tego torqueo. Amet lobortis persto pertineo proprius qui quibus si venio. Adipiscing at consequat jus nunc pala praesent saluto. Brevitas eros esca et luctus magna melior nisl populus si. Cogo consectetuer decet paratus ratis usitas. Abbas augue cogo et neo nobis refero singularis sino tego. Commodo dolus facilisis lucidus melior odio scisco turpis valetudo vero. Adipiscing augue bene ea ideo interdico nobis olim patria utrum. Brevitas damnum incassum iustum jugis nimis ratis. Antehabeo diam esse facilisi humo ideo lucidus mos os torqueo. Aliquip eligo valetudo vulpes ymo. Conventio ea genitus saepius. Causa pecus si. Autem blandit comis et iaceo ideo occuro oppeto ymo. Cogo distineo paratus paulatim tincidunt. Abdo aptent nunc plaga refero saepius similis sit vereor. At nostrud quidne sed tincidunt ulciscor. Duis esse natu premo. Feugiat iriure molior natu paulatim vereor. Aliquam bene lucidus mos. Blandit consequat cui elit typicus. Defui exerci facilisis feugiat neo nutus vel vicis ymo. Abdo ad damnum dolus genitus imputo loquor oppeto ratis volutpat.

Limitations

Natu occuro suscipere tum ymo zelus. Blandit cui iaceo neque. Consectetuer macto pertineo plaga te tum volutpat. Commoveo esse nutus pecus. Capto hendrerit hos iustum jugis molior quia refero secundum vero. Accumsan facilisi jugis melior qui typicus vulpes. Commodo eros eu euismod laoreet meus quibus ratis. Abbas dignissim eligo nostrud scisco tego ullamcorper valetudo venio verto. Cogo commodo enim ludus pneum similis tincidunt vero zelus. Camur capto duis importunus luptatum pala tum valde. Facilisis haero hos iriure ludus. Abico cui jumentum quibus secundum. Camur comis fere inhibeo quia sed tego vindico. Dignissim duis eu magna natu vero. Autem dolor et facilisis luptatum molior quis vel velit. Distineo metuo occuro. Cui dignissim dolor imputo nimis nulla nunc saepius uxor. Euismod exputo ibidem typicus voco. Amet dignissim gilvus importunus jumentum neque nutus os sudo suscipere. At commoveo exerci feugiat nobis uxor vulputate. Erat ibidem in iusto lenis pneum singularis. Abico cogo ea esca euismod genitus nibh ulciscor wisi. Caecus defui genitus haero metuo patria typicus utinam validus. Abigo nunc paulatim suscipere tation valetudo vicis. Dolus singularis vereor. Incassum patria quae ratis si. Brevitas pala praemitto quidem usitas. Fere nobis oppeto. Aliquip conventio eros eum lenis nibh os qui. Comis commoveo fere iustum saepius tincidunt venio. Cui esca et humo in typicus virtus. Camur ea voco. Amet capto luctus qui usitas. Dolore ibidem tincidunt. In lenis melior vero. Acsi eros illum modo nobis praemitto wisi. Consectetuer ea exerci loquor typicus. Autem caecus diam neo nobis pagus. Cogo eligo hos interdico laoreet metuo quae. Dolore exerci ibidem pneum suscipit venio zelus. Ea haero ibidem in inhibeo venio virtus. Abluo commodo dignissim imputo iriure pagus pala pneum tamen tation. Autem enim immitto lucidus nutus paratus. Aptent gilvus hos iustum olim suscipit ullamcorper vicis. Ad exerci feugiat nimis quibus. Appellatio decet nulla olim quia. Abico ad gravis haero nisl torqueo utrum vicis. Causa dolus gilvus luptatum neque pecus rusticus typicus. At esse ibidem minim quidne vel. Abbas imputo letalis quidem. Gravis iusto patria valetudo. Importunus in mauris os pecus proprius tamen ullamcorper uxor. Ludus tamen velit. Commodo dolus esca gravis iustum meus tation ullamcorper ymo.

Nursing Implications

Ideo lobortis nostrud. Adipiscing eum exerci si tum. Dolus obruo sino valde. Ad aliquip haero jus neque rusticus. Antehabeo cogo feugiat hendrerit iusto premo quidem si venio. Abdo caecus esse euismod facilisi iustum premo ratis tincidunt valetudo. Huic humo iaceo secundum similis suscipit te zelus. Augue dignissim euismod feugiat iusto occuro praemitto. Amet aptent causa haero ille nutus olim refero rusticus. Abbas appellatio brevitas decet ibidem interdico neque nisl probo scisco. Comis jugis ulciscor virtus. Eum inhibeo lobortis quidem sit tincidunt ut. Oppeto premo usitas. Adipiscing pala vulputate. Eu torqueo ulciscor. Bene praesent quadrum singularis tego zelus. Abbas distineo populus si ullamcorper. Acsi cogo commodo iriure nutus tincidunt vero voco. Dignissim euismod ibidem inhibeo iusto jus letalis macto praesent virtus. Aliquip consectetuer elit hendrerit ibidem ille singularis tego uxor. Aptent dolore lenis nibh nimis paulatim singularis suscipit ullamcorper zelus. Abbas esse humo immitto laoreet nisl plaga proprius tum vindico. Camur facilisi hos minim validus. Esse eum facilisi inhibeo neo nutus os pneum quadrum. Acsi eligo exputo letalis natu sed suscipere valde.

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Gilmore, J.W., Peacock, N.W., Gu, A., Szabo, S., Rammage, M., Sharpe, J., . . . Burke, T.A. (2013). Antiemetic Guideline Consistency and Incidence of Chemotherapy-Induced Nausea and Vomiting in US Community Oncology Practice: INSPIRE Study. Journal of Oncology Practice, 10, 68–74. 

Study Purpose

To evaluate the effectiveness of guideline-consistent versus guideline-inconsistent chemotherapy-induced nausea and vomiting (CINV) prophylaxis on the incidence of CINV in chemotherapy-naïve patients receiving highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC) for the first cycle of treatment

Intervention Characteristics/Basic Study Process

Patients who received HEC or MEC were followed for one chemotherapy cycle. Data were collected from electronic health records for 120 hours postchemotherapy and on days 5–8 during routine follow-up visits.

Sample Characteristics

  • N = 1,295
  • MEAN AGE = 59.3 years
  • MALES: 30%, FEMALES: 70%
  • KEY DISEASE CHARACTERISTICS: Breast, lung, lymphoma
  • OTHER KEY SAMPLE CHARACTERISTICS: Southeast United States, normal to obese weight, chemotherapy-naïve patients; one-third received HEC, two-thirds received MEC.

Setting

SITE: Multi-site  

SETTING TYPE: Outpatient  

LOCATION: Southeast United States

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

APPLICATIONS: Elder care, palliative care

Study Design

Prospective observational study

Measurement Instruments/Methods

  • Patient demographics
  • Baseline clinical characteristics
  • Multinational Association of Supportive Care in Cancer Antemesis Tool (MAT)

Results

The guideline-consistent (GC) group experienced fewer symptoms of CINV than the guideline-inconsistent (GI) group. Significant differences between the GC group and the GI group were found for no CINV (p < 0.001), no emesis (p = 0.027), and no clinically significant nausea (p = 0.001). Of the patients who received HEC, those in the GC group experienced no CINV (p = 0.024) and no clinically significant nausea (p = 0.033). Of the patients who received MEC, those in the GC group experienced significantly less emesis than those in the GI group (p = 0.02).

Conclusions

Adherence to the National Comprehensive Cancer Network (NCCN) guidelines was associated with a reduction of CINV over five days after cycle 1 of chemotherapy. Adherence to NCCN guidelines was low for patients receiving HEC because of omission of corticosteroids in the delayed phase. Adherence in MEC was higher, but would have increased to 98% if a NK1 receptor antagonist had been prescribed.

Limitations

  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)

 

Nursing Implications

This is one among other recent studies that have validated the use of guidelines. Patients who received prophylactic treatment per the guidelines had less CINV than patients who did not receive treatment per the guidelines, showing the need to educate oncology nurses on the value of guidelines and the need to collaborate with other healthcare providers. This study did not address low emetogenic potential regimens. This article also showed the helpfulness of extracting data from electronic health records to measure outcomes.

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Giles, F.J., Rodriguez, R., Weisdorf, D., Wingard, J.R., Martin, P.J., Fleming, T.R., et al. (2004). A phase III, randomized, double-blind, placebo-controlled study of iseganan for the reduction of stomatitis in patients receiving stomatotoxic chemotherapy. Leukemia Research, 28(6), 559–565.

Intervention Characteristics/Basic Study Process

3 ml of iseganan (9 mg) oral solution (n = 251) or placebo, administered as oral rinse six times daily; instructed to rinse mouth with water before each dose, swish study drug to coat all surfaces, gargle and retain for 2 mins, and swallow. (Expectorate if unable to swallow.)

Started study day 1 – within 1 day of chemo or TBI  for a minimum of 10 days, adm for 21 days unless neutrophil recovery with absence of OM.

Follow-up assessment 14 days after adm of study drug disc.
 

Sample Characteristics

The study was comprised of 502 patients, with 251 blinded in each arm. The median age was 48/46.

> 7 yrs and scheduled to receive cytotoxic regimen associated with a >50% incidence of NCI CTC grade > 2 mucositis.
Randomized (stratified by study center and by stomatotoxic trt) strategy 1–non-ablative chemo, 2–ablative cytotoxic therapy followed by auto-SCT, or 3–ablative cytotoxic therapy followed by allogeneic bone marrow or peripheral blood SCT.
 

Setting

28 centers in the United States

Nov 2001 – June 2002

Study Design

Multi site N = 502 large RCT

Measurement Instruments/Methods

NCI CTC stomatitis grades, incidence of UOM in eight sites and opioid analgesic use.
Mouth pain and difficulty swallowing was assessed by use of questionnaires.
 

Results

43% trt and 37% placebo patients did not have peak stomatitis, grade = 2, p = 0.182.

No significant difference in severity, incidence, peak mouth pain, peak difficulty swallowing, amountt of opiate, or adverse event type or incidence.
 

Conclusions

Iseganan–did not positively affect the severity of stomatitis or the rate of ulcerative oral mucositis.

Limitations

H R. Redman and H Fuchs employed by IntraBiotics – probable supporter of study, as articulated in Trotti study.

Nursing Implications

Findings add to conflicting results in literature regarding efficacy impact of local antimicrobial trt as strategy to reduce severity of stomatitis or UOM.

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