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Demmy, T.L., Gu, L., Burkhalter, J.E., Toloza, E.M., D'Amico, T.A., Sutherland, S., . . . Cancer and Leukemia Group B. (2012). Optimal management of malignant pleural effusions (results of CALGB 30102). Journal of the National Comprehensive Cancer Network, 10(8), 975-982.

Study Purpose

The objective of the study was to compare tunneled pleural catheter drainage (TCD) to bedside talc pleurodesis (TP) via chest catheter for efficacy in controlling symptomatic unilateral malignant pleural effusions (MPE).

Intervention Characteristics/Basic Study Process

Randomized patients received one of two methods (TP or TCD) for pleural drainage then were followed up for 60 days. For the TP procedure, a single dose of 4–5 g of sterile talc slurry in 100 mL of saline was infused into the pleural space with a chest catheter. Placement was confirmed on a chest x-ray. Talc was administered within 36 hours of tube placement. The tube remained clamped for two hours for talc distribution. When the chest drainage decreased to 150 mL/24 hours, pleurodesis was assumed and the tube was removed. TP was performed on an inpatient basis. For TCD, catheters were drained daily with drainage bottles. No more than 1,000 mL were drained at a time, other than during the initial drainage. A chest x-ray was taken within 36 hours of initial drainage and the patient, a caregiver, or a visiting nurse drained the catheter daily after that. The catheter was removed when the drainage volume was less than 30 mL each day over three consecutive days. TCD is generally an outpatient procedure.

Sample Characteristics

  • The sample was comprised of 57 patients aged 6067 years.
  • Of the 57 patients, 45%–55% were males and 39%–61% were females.
  • Patients had a performance status of 0 to 2 with no active pleural infection, talc allergy, or other indications to talc use.
  • Lung cancer (62%) and breast cancer (12%) were the most common malignancies.
  • The study originally planned 530 total patients for 90% power to detect differences in efficacy between the two methods of pleural drainage.
  • Trapped lung was not recommended for randomized therapy, as TCD may be a better therapy option.

Setting

The study was conducted in 21 comprehensive cancer centers—17 cases were conducted at one instution, and 1–7 cases were conducted at each of the other institutions.

Phase of Care and Clinical Applications

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

Study Design

The study was a prospective, randomized phase III trial.

Measurement Instruments/Methods

  • Lung re-expansion was determined by the treating physician using serial chest x-rays.
  • Condensed Memorial Symptom Assessment Scale form (specific elements: performance status, dyspnea scale, physical function, social life, and overall quality of life) measured quality of life and specific symptoms or functionality.

Results

  • No statistical differences in lung expansion were noted between the two treatment arms, but it improved from baseline in both cases.
  • The odds ratio for TCD success was five times higher than TP, and patients with good expansion experienced better success (odds ratio, 5; 95% CI, 1–25; P = .053).
  • Pleurodesis occurred in 86.2% of patients treated with TP, compared with 68.0% of those treated with TCD (P = .1883).
  • Therapy-related complications were low but were higher in the TCD arm.
  • Recurrent dyspnea was seen only in TP cases, and dyspnea was statistically better in patients treated with TCD (8.7 vs. 5.9; P = .036) even after adjusting for baseline dyspnea score, initial drainage, gender, inpatient status, and performance status at baseline.
  • No relationship was seen between baseline dyspnea score and lung expansion at any of the three points; however, 30-day dyspnea-free exercise and all quality-of-life measures correlated significantly with lung expansion.

Conclusions

  • TCD is preferred for patients with complicated effusions or when the lung may be trapped.
  • Although TCD prolongs therapy, this added duration may maintain lung expansion and improve quality-of-life parameters.
  • Lung expansion may be an unreliable indicator of the benefits of pleural drainage.
  • TCDs in this study may more predictably relieve dyspnea.
  • The study had to be closed early because patients had a strong preference for treatment (inpatient vs. outpatient) and refused randomization.

Limitations

  • The study had a small sample size of less than 100 patients.
  • The study had a risk of bias because of no blinding and its sample characteristics.
  • Accrual was far less than anticipated due to patient preferences interfering with patient consent to randomization.
  • Refusals to participate may have influenced the final study population, as evidenced by lower-than-anticipated success of talc pleurodesis intervention.
  • The study does not describe that “malignant effusion” was validated cyopathologically.

Nursing Implications

  • TCD and TP are both common strategies to manage malignant pleural effusion.
  • Similar lung expansion appears to be able to be achieved with both techniques in patients with uncomplicated pleural effusion, and the selection of method may be based upon patient preference.
  • Nurses should ensure that patients are thoroughly informed of therapeutic options to make the best decision for their circumstances.
  • In cases in which patients experience distress form dyspnea at baseline, they may experience better symptom relief with the TCD method of managing malignant pleural effusions.
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Demiris, G., Oliver, D.P., Wittenberg-Lyles, E., & Washington, K. (2011). Use of videophones to deliver a cognitive-behavioural therapy to hospice caregivers. Journal of Telemedicine and Telecare, 17, 142–145.
 

Study Purpose

To test the feasibility of delivering problem-solving therapy via videophones

Intervention Characteristics/Basic Study Process

Videophones were installed for caregivers, and in an initial visit, caregivers were asked to review and prioritize common concerns. Three follow-up intervention calls were scheduled from days 5–16 of the hospice admission. Counseling via the videocalls was done to encourage caregivers to be creative and identify alternative solutions to stated problems, predicting consequences and developing an action plan, and trying out and evaluating the effect of the actions implemented. A final call was done to assess caregiver perceptions of the intervention. Calls were supervised to assure treatment fidelity.

Sample Characteristics

  • N = 42   
  • MEAN AGE = 62 years
  • MALES: 19%, FEMALES: 81%
  • CURRENT TREATMENT: Not applicable
  • KEY DISEASE CHARACTERISTICS: All were in hospice; no disease characteristics were reported.

Setting

  • SITE: Single site   
  • SETTING TYPE: Home    
  • LOCATION: Washington

Phase of Care and Clinical Applications

  • PHASE OF CARE: End-of-life care
  • APPLICATIONS: Palliative care

Study Design

Quasiexperimental

Measurement Instruments/Methods

  • Caregiver Quality of Life Index (CQLI)
  • Problem Solving Inventory (PSI)
  • State-Trait Anxiety Inventory (STAI)
  • Technical quality of video calls instrument

Results

Caregivers reported lower anxiety scores after the intervention (p = 0.04). No significant changes occurred in other measures. Eighty-nine percent of attempted calls were successful, and the average technical quality was 48 out of a possible score of 50. Average call duration was 38 minutes (range = 18–84 minutes). Average usefulness of the intervention was rated as 4.8 by caregivers out of a possible score of 5.

Conclusions

The use of video calls to deliver psychoeducational interventions was generally feasible and well received by caregivers. The intervention was associated with a reduction in anxiety levels.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Measurement/methods not well described
  • Intervention expensive, impractical, or training needs
  • Unclear how measurement instruments were completed
  • Equipment for video calls may not be readily available.
  • Type of patients and disease characteristics were not provided.

Nursing Implications

This study showed that the delivery of an intervention via video call was feasible and had benefit in terms of anxiety reduction for caregivers. Since the time of this study, technology has advanced, and it is more likely that video conferencing can be provided via the Internet. This can be a practical method for providing interventions to caregivers.

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Demiris, G., Parker Oliver, D., Wittenberg-Lyles, E., Washington, K., Doorenbos, A., Rue, T., & Berry, D. (2012). A noninferiority trial of a problem-solving intervention for hospice caregivers: In person versus videophone. Journal of Palliative Medicine, 15, 653–660. 

Study Purpose

To compare the effectiveness of problem-solving therapy delivered via videophone versus face-to-face sessions

Intervention Characteristics/Basic Study Process

Caregivers were randomized to the experimental or face-to-face sessions for the intervention. Three videophone calls or sessions were done during 5–18 days after hospice admission. The intervention involved addressing problems initially identified by caregivers, visualization of effective problem solving, positive self-talk, brainstorming approaches to problems, setting goals and solutions, planning action, and evaluating effectiveness of actions taken. A final exit interview was conducted to elicit caregiver perceptions of the intervention. A manual for the intervention was used, all face-to-face visits and videophone calls were audio recorded, and a 10% random sample of recording was evaluated for treatment fidelity.

Sample Characteristics

  • N = 126   
  • MEAN AGE = 59.6 years
  • MALES: 25%, FEMALES: 75%
  • OTHER KEY SAMPLE CHARACTERISTICS: Most were Caucasian and highly educated. Fifty-nine percent of caregivers were adult children of the patient and, in the majority of cases, the patient resided with the caregiver.

Setting

  • SITE: Single site   
  • SETTING TYPE: Multiple settings    
  • LOCATION: Washington

Phase of Care and Clinical Applications

  • PHASE OF CARE: End-of-life care
  • APPLICATIONS: Palliative care

Study Design

Noninferiority, randomized, two-group trial

Measurement Instruments/Methods

  • Caregiver Quality of Life Index-Revised (CQLI-R)
  • State-Trait Anxiety Inventory (STAIS); a six-point change was selected for measurement of noninferiority.
  • Problem Solving Inventory (PSI)

Results

Anxiety reduced significantly in both groups (p < 0.0001). The difference in the video group was not inferior to that in the face-to-face group, and the actual change in anxiety score was greater in the video group. No changes or differences occurred between groups in other study measures.

Conclusions

Delivery of problem-solving therapy, a cognitive behavioral therapy approach, by videophone was not inferior to delivery by face-to-face sessions.

Limitations

  • Risk of bias (no blinding)
  • Subject withdrawals ≥ 10% 
  • Participants mainly lost to follow-up because of patient death

Nursing Implications

The findings showed that a problem-solving intervention was effective to reduce stress in informal caregivers of patients in hospice, and the delivery of the intervention by videophone was not inferior to delivery by face-to-face sessions. Delivery of these types of interventions with technology can be a practical alternative to traditional methods of intervention.

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Demiral, S., Beyzadeoglu, M., Sager, O., Dincoglan, F., Uysal, B., Gamsiz, H., . . . Turker, T. (2015). Evaluation of transforming growth factor-β2 for radiation-induced diarrhea after pelvic radiotherapy. Tumori, 101, 474–477. 

Study Purpose

To evaluate the use of transforming growth factor (TGF)-β2-enriched formula for amelioration of radiation-induced diarrhea for patients undergoing pelvic RT

Intervention Characteristics/Basic Study Process

There were three groups. Patients in group one were supported with TGF-β2-enriched formula from the first day of RT until at least one month after treatment completion. They used diphenoxylate-atropine tablets after the onset of diarrhea. Patients in group two started on diphenoxylate-atropine tablets and TGF-β2-enriched formula typically in the second week of  RT. They used TGF-β2-enriched formula for a period of at least one month after treatment completion. Patients in the third group received diphenoxylate-atropine tablets and feeding formulas (other TGF-β2-enriched formula) after onset of diarrhea, typically in the second week of  RT. They used TGF-β2-enriched formula for a period of at least one month after treatment completion. Diarrhea was measured weekly.

Sample Characteristics

  • N = 86  
  • AGE RANGE: 35–77 years
  • NUMBER OF MALES: 67  
  • NUMBER OF FEMALES: 19
  • KEY DISEASE CHARACTERISTICS: Malnourished patients undergoing RT for pelvic cancers

Setting

  • SITE: Single site    
  • SETTING TYPE: Outpatient    
  • LOCATION: Gulhane Military Medical Academy, Ankara, Turkey

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Retrospective analysis

Measurement Instruments/Methods

  • Common Terminology Criteria for Adverse Events (CTCAE) version 4

Results

Patients receiving nutritional supplementation with TGR-β2-enriched formula (group one and two) experienced a lower median number of diarrhea episodes (p < 0.003) at all time points, and grade 2/3 diarrhea was also lower in these groups. Onset of diarrhea was typically the second week in all the groups. There was no statistical significance is diagnosis in the three groups. The number of patients with grade 2 diarrhea decreased after the second week of RT in groups one and two, and these patients did not experience grade 2 diarrhea one month after RT. However, the number of grade 2 diarrhea increased in group three after the second week of RT.

Conclusions

Patients receiving nutritional supplementation with TGF-β2-enriched formula had a decreased number of grade 2 and grade 3 diarrhea episodes compared to those receiving other nutritional supplements.

Limitations

  • Small sample (less than 100)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)

 

Nursing Implications

Patients receiving nutritional supplementation with TGR-β2-enriched formula with diphenoxylate-atropine supplementation while receiving RT may reduce the incidence of diarrhea, but further studies are needed.

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Demiralp, M., Oflaz, F., & Komurcu, S. (2010). Effects of relaxation training on sleep quality and fatigue in patients with breast cancer undergoing adjuvant chemotherapy. Journal of Clinical Nursing, 19, 1073–1083.

Study Purpose

To investigate the effect of progressive muscle relaxation (PMR) training on sleep quality and fatigue in Turkish women with breast cancer undergoing adjuvant chemotherapy.

Intervention Characteristics/Basic Study Process

Following the eligibility assessment and obtaining informed consent, patients in the PMR group were invited to a private practice room for relaxation training. Patients in the PMR group were given PMR therapy in addition to chemotherapy and routine nursing services at the outpatient unit. Patients in the control group had chemotherapy and routine nursing services without PMR therapy. PMR therapy was performed in 25- to 30-minute sessions on the first and fifteenth days of each chemotherapy cycle. Patients in the intervention group were given a CD and encouraged to do exercises every day at home.

Sample Characteristics

  • The sample was comprised of 27 women (PMR group, n = 14; control group, n = 13).  
  • Age ranged from 25 to 65 years.
  • To participate, patients had to be recently diagnosed with breast cancer, be undergoing adjuvant chemotherapy for the first time, and have no metastases or recent psychological treatments. 
  • All patients were living in the city where the research was performed and were literate in Turkish.

Setting

The study was conducted in the outpatient unit of the medical oncology department of the Gulhane Military Medical Academy in Turkey.  

Phase of Care and Clinical Applications

Patients were undergoing the active treatment (chemotherapy) phase of care.

Study Design

The study used a prospective, repeated-measures, quasiexperimental design with a control group.

Measurement Instruments/Methods

  • Sociodemographic and clinical characteristics
  • Pittsburgh Sleep Quality Index (PSQI)
  • Piper Fatigue Scale (PFS)

Results

The PMR group experienced a greater increase in improved sleep quality and a greater decrease in fatigue than the control group. Mean sleep efficiency, sleep distrubances, and total PSQI scores were significantly lower in the control group (p < 0.05). Total fatigue scores were significantly better in the experimental group compared to the control group (p = 0.014).

Conclusions

The findings suggested that PMR training may improve sleep quality and fatigue in patients with breast cancer undergoing adjuvant chemotherapy.

Limitations

  • The study had a small sample size.
  • The article included no discussion or measurement of adherence to home PMR; therefore, the intervention dose is unknown.
  • There was no discussion of therapist experience or education.
  • Information was lacking about therapist training or strategies to maintain intervention fidelity.
  • The study had no random assignment or attentional control.

Nursing Implications

PMR training given by a nurse may improve sleep quality and fatigue in patients with breast cancer. It is important to start relaxation training just before chemotherapy to decrease the frequency and severity of sleep problems and symptoms, such as fatigue during chemotherapy.

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DeMille, D., Deming, P., Lupinacci, P., & Jacobs, L. (2006). The effect of the neutropenic diet in the outpatient setting: A pilot study. Oncology Nursing Forum, 33, 337–343.

Study Purpose

The study examined adherence to neutropenic diet and whether differences existed in rates of hospital admissions for febrile episodes and positive blood cultures between patients who adhered to the neutropenic diet and those who did not.

Intervention Characteristics/Basic Study Process

Data collected at 6 and 12 weeks.

 

Sample Characteristics

  • The study started with 28 participants; 23 completed the study.
  • Participants' age range was 33–67 years.
  • Patients had a wide range of diagnoses (except acute leukemia and HIV). Patients with acute leukemia and HIV were excluded.
  • Adult patients were eligible to be included if they were to receive chemotherapy associated with a high degree of neutropenia and were not being treated with colony-stimulating factors (CSFs).

Setting

Outpatient cancer center

Measurement Instruments/Methods

  • Rates of hospital admissions for febrile episode
  • Rates of positive blood culture

Questionnaires were developed to document demographic and medical variables as well as baseline knowledge of food safety and the neutropenic diet. Adherence to restrictions of the neutropenic diet was measured via self-report based on “yes” or “no” questions and a food-use questionnaire. The 6- and 12-week evaluations measured dietary adherence as a self-reported subjective statement with “yes” or “no” responses.

Adherence was verified via eight questions targeting specific points of the food safety aspects and diet restrictions covered in the instruction. Patients’ degree of difficulty in following the diet was assessed using Likert scales with four response choices. Patients were questioned regarding hospital admissions; however, the researchers verified all admission information via chart review. The instrument designed to collect information was developed specifically for this study to assess the major aspects of the neutropenic diet for food safety and the diet instructions as given to patients. Content validity was established by review of the tool by a multidisciplinary team.

A chart review was conducted post-treatment to validate self-reported medical information and verify neutropenia (i.e., absolute neutrophil count [ANC] less than 1,000/mm3). The chart review was reviewed by a multidisciplinary team for content validity.

Fisher’s exact test was used to analyze proportions between the groups.

Results

30% of patients were noncompliant with the neutropenic diet.

No differences were found in the rate of febrile hospital admissions (per patient report and confirmed by chart review) and positive blood cultures between those patients who adhered to the neutropenic diet and those who did not.

Limitations

  • Reports of whether patients adhered to a neutropenic diet were done by patients via a survey at 6- and 12-week intervals, which may have decreased the accuracy of self-reported data.
  • No randomization of patients was done. The convenience sample compared patients who were compliant with a neutropenic diet with patients who were noncompliant.
  • It was a small outpatient study in one setting; therefore, results cannot be generalized.
  • Content validity of the tool was established at the institution. Reliability was not tested.

Nursing Implications

Of note, this study underscores the time spent for diet education, the question of appropriate content of diet education regarding food restrictions, and the difficulty adhering to diet requirements.

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Demers, M., Dagnault, A., & Desjardins, J. (2013). A randomized double-blind controlled trial: Impact of probiotics on diarrhea in patients treated with pelvic radiation. Clinical Nutrition (Edinburgh, Scotland), 33(5), 761–767. 

Study Purpose

To determine the effectiveness of the probiotic Bifilact® (Lactobacillus acidophilus LAC-361) on moderate and severe treatment-induced diarrhea in patients with pelvic cancer undergoing therapy, with a secondary objective to assess whether Bifilact® decreased or delayed the need for antidiarrheal medication, reduced intestinal pain, decreased hospitalization, lowered the interruption of radiotherapy treatments or doses of both radiotherapy and chemotherapy, and improved the overall well-being of patients during treatment

Intervention Characteristics/Basic Study Process

Patients were divided into three groups: prostatic cancers, gynecologic cancers without chemotherapy, and gynecologic or rectal cancers with chemotherapy. Then, using double-blind procedures, patients were block-randomized by blocks of two, four, or six patients according to random permutations. A second random block using a higher probiotic dosage was added after an interim analysis. New, random lists were generated for each stratum with a 3:1:1 ratio (higher dose, standard dose, placebo). Nutritional intervention was enacted with a diet teaching to control dietary lipids and providing recommendations on fiber and carbohydrate intake. Yogurt consumption was encouraged.

Sample Characteristics

  • N = 246  
  • MEAN AGE = Placebo 60.6 years; standard-dose 61.4 years; high-dose 62.0 years
  • MALES: Placebo 63; standard-dose 72; high-dose 66, FEMALES: Placebo 37; standard-dose 28; high-dose 34
  • KEY DISEASE CHARACTERISTICS: Prostate, endometrium, cervix, and rectum
  • OTHER KEY SAMPLE CHARACTERISTICS: Surgery placebo 35%; standard-dose 39%; high-dose 30%; chemotherapy placebo 56%; standard-dose 54%; high-dose 45%

Setting

  • SITE: Single-site    
  • SETTING TYPE: Outpatient    
  • LOCATION: L’Hôtel-Dieu de Québec University Health Center, Canada

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Prospective, single-center, placebo-controlled, randomized, double-blinded trial

Measurement Instruments/Methods

  • World Health Organization (WHO) scale of abdominal pain
  • National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI, CTCAE) version 3.0 
  • Fecal incontinence NCI scale version 3.0 stool consistency
  • An adapted Bristol Stool Scale (BSS) was used to facilitate use by patients: grade 1 = normal stools (BSS 1–4); grade 2 = soft stools, in pieces (BSS 5–6), and grade 3 = liquid stools, no shape (BSS 7). 
  • Patients undergoing chemotherapy received a weekly complete blood count. If a patient's neutrophil count was ≤ 1.5 x 109/L, study agent was discontinued.
  • A log book was kept for symptom documentation, stools, and medications such as antidiarrheals. 
  • The European Organization for the Research and Treatment of Cancer's Quality of Life Questionairre C30 (EORTC, QLQ-C30) was completed at baseline, after radiation therapy was completed, and two weeks later.

Results

229 patients were analyzed. For the primary endpoint among all groups, there was no difference in the effectiveness of the probiotic Bifilact® (Lactobacillus acidophilus LAC-361) on moderate and severe treatment-induced diarrhea. At the 60-day point, there were more patients without moderate and severe diarrhea in the standard-dose group (35%) compared with the placebo group (17%) (hazard ratio of 0.69, p = 0.04). The postsurgical group with patients taking the standard dose had fewer patients without very severe diarrhea compared to the placebo group (97% and 74%, respectively) (p = 0.03). While undergoing therapy, the average number of bowel movements per day during treatment was less than three soft stools (p = 0.80), and the median level of abdominal pain was < 1 based on the NCI scale (p = 0.23).

Conclusions

Bifilact®, when administered in standard doses to patients with pelvic cancer undergoing therapy, may reduce the risk of radiation-induced grades 2–4 diarrhea towards the end of the treatment. While receiving radiation therapy, a standard dose of probiotics may reduce radiation-induced grade 4 diarrhea in patients who had prior surgery.

Limitations

  • Key sample group differences that could influence results

Nursing Implications

Nurses may want to consider offering counseling and education regarding probiotics as a potential alternative approach to reducing radiation-induced diarrhea.

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De Marinis, F., Eberhardt, W., Harper, P.G., Sureda, B.M., Nackaerts, K., Soerensen, J.B., . . . Tredaniel, J. (2009). Bisphosphonate use in patients with lung cancer and bone metastases: Recommendations of a European expert panel. Journal of Thoracic Oncology: Official Publication of the International Association for the Study of Lung Cancer, 4(10), 1280–1288.

Purpose & Patient Population

To review current evidence regarding the use of bisphosphonates for the treatment of lung cancer and to provide European recommendations for practice

Type of Resource/Evidence-Based Process

An expert panel of European clinical oncologists and lung cancer specialists reviewed available evidence regarding the use of bisphosphonates for the treatment of lung cancer and developed recommendations based on the evidence and clinical experience. The International Association for the Study of Lung Cancer published the resulting report. Authors did not provide specific search description, cite the process of review, or present evidence.

Guidelines & Recommendations

The report made the recommendations that follow.

  • Initial staging of lung cancer should include assessment for bone metastases.
  • In caring for patients with lung cancer with bone involvement, clinicians must consider bisphosphonate as a treatment. Such treatment will delay and prevent further bone metastases, help prevent skeleton-related events, and relieve pain.
  • Clinicians should add bisphosphonates to the treatment of those who develop bone metastases.
  • Comprehensive dental examination should precede treatment with bisphosphonates.
  • Treatment with bisphosphonates should continue as long as feasible, in the absence of severe adverse effects.
  • Bisphosphonate treatment, in combination with chemotherapy, is generally well tolerated and may produce synergistic effects.
  • Zoledronic acid is recommended for the treatment of patients with lung cancer and bone metastases.

Nursing Implications

The International Association for the Study of Lung Cancer recommends the use of bisphosphonates in general and zoledronic acid in particular for patients, with all types of lung cancer, who have bone metastases. Nurses should be aware of potential adverse events of this treatment, though it is generally well tolerated. Because bisphosphonate treatment is associated with osteonecrosis, patients should have a comprehensive dental examination and prophylaxis before starting bisphosphonate treatment. Nurses should also be aware of the potential renal effects of bisphosphonate, especially on patients whose renal function has deteriorated as the result of other nephrotoxic drugs, dehydration, renal impairment, or lack of adherence to the recommended infusion schedule for bisphosphonate.

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Delia, P., Sansotta, G., Donato, V., Frosina, P., Messina, G., De Renzis, C., & Famularo, G. (2007). Use of probiotics for prevention of radiation-induced diarrhea. World Journal of Gastroenterology, 13(6), 912–915.

Study Purpose

To examine the effect of probiotic use for prevention of radiation-induced diarrhea

Intervention Characteristics/Basic Study Process

The experimental group received high-potency probiotics (VSL#3 in one sachet) three times per day beginning on the first day of radiation therapy until the end of scheduled cycles. The VSL #3 sachet contained 450 billions/gm of viable lyophilized bacteria, including 4 strains of lactobacilli (Lactobacilli casei, L. plantarum, L acidophilus, and L. delbruekii subsp. Bulgaricus); 3 strains of Bifidobacteria (B. longum, B. breve, and B. infantis) and 1 strain of Streptococcus salivarius subsp. thermophilus.

The control group received an identical-appearing placebo.

Sample Characteristics

This study reported on 490 patients receiving adjuvant radiation therapy after surgery for sigmoid, rectal, or cervical cancer.

Study Design

This was a double blind, randomized, placebo-controlled trial.

Measurement Instruments/Methods

Efficacy endpoints included incidence and severity of radiation-induced diarrhea, the number of bowel movements (BMs) per day, and the time from start of study until need for loperamide.

Endpoints (clinical symptoms, use of medications, and any adverse events) were reviewed with patients weekly during scheduled radiation therapy treatments and again one month after completion.

Results

  • In all, 97.5% of patients in the placebo group and 99.1% of patients in the experimental group completed study.
  • More patients in the placebo group had radiation-induced enteritis and colitis (p < 0.001).
  • The placebo group experienced more severe toxicity (grade 3 or 4) (p < 0.001) and had a higher mean daily number of BMs (p < 0.001).

Conclusions

Use of a probiotic lactic-acid producing bacteria is a safe, easy, feasible approach to preventing radiation-induced diarrhea after surgery for abdominal and pelvic cancer.

Limitations

  • Severity was assessed using World Health Organization (WHO) standards whereas other studies use National Cancer Institute (NCI) standards.
  • This study looked only looked at prevention of radiation-induced diarrhea. 
  • The study did not address safety in patients who are neutropenic.

Nursing Implications

Probiotic lactic-acid-producing bacteria is safe for use in patients receiving radiation treatment, and it is not associated with bacteremia, sepsis, or septic shock. Lactobacilli lowers the production of proinflammatory cytokines and other effectors of inflammation and tissue injury. Probiotic bacteria upregulates the innate immune response in the gut and protects against invasive organisms. Further studies are needed on different probiotic preparations and mixtures.

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Del Fabbro, E., Dev, R., Hui, D., Palmer, L., & Bruera, E. (2013). Effects of melatonin on appetite and other symptoms in patients with advanced cancer and cachexia: A double-blind placebo-controlled trial. Journal of Clinical Oncology, 31, 1271–1276.

Study Purpose

To compare melatonin with placebo for impact on appetite in patients with advanced cancer

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to receive 20 mg melatonin or identical placebo daily for 28 days. Study assessments were done at baseline and at four weeks. Patients were stratified according to whether or not they were currently receiving antitumor treatment.

Sample Characteristics

  • The study reported on a sample of 48 patients.
  • Mean patient age was 60 years, with a range of 32–86 years.
  • The sample was 56% female and 44% male.
  • All patients had locally recurrent or metastatic disease.

Setting

  • Multisite
  • Outpatient setting
  • Texas

Study Design

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

Measurement Instruments/Methods

  • Edmonton Symptom Assessment Scale
  • Functional Assessment of Chronic Illness TherapyFatigue (FACIT-F)
  • FACIT subscale questionnaire
  • Toxicity questionnaire
  • Bioimpedance for body composition and weight
     

Results

There were no significant differences between groups in symptoms or change in symptoms at four weeks. There were no differences in change in body weight or body composition. Thirty-three percent of patients were lost to follow-up.

Conclusions

Melatonin had no effect on appetite or other symptoms in patients with advanced cancer.

Limitations

  • The study had a small sample size, with less than 100 patients.
  • Patient withdrawals were 10% or greater.

Nursing Implications

Findings of this study do not support the use of melatonin to improve appetite or other symptoms in patients with advanced cancer.

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