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.
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).
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.
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.
The study was a prospective, randomized phase III trial.
To test the feasibility of delivering problem-solving therapy via videophones
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.
Quasiexperimental
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.
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.
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.
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.
To compare the effectiveness of problem-solving therapy delivered via videophone versus face-to-face sessions
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.
Noninferiority, randomized, two-group trial
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.
Delivery of problem-solving therapy, a cognitive behavioral therapy approach, by videophone was not inferior to delivery by face-to-face sessions.
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.
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.
To evaluate the use of transforming growth factor (TGF)-β2-enriched formula for amelioration of radiation-induced diarrhea for patients undergoing pelvic RT
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.
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.
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.
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.
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.
To investigate the effect of progressive muscle relaxation (PMR) training on sleep quality and fatigue in Turkish women with breast cancer undergoing adjuvant chemotherapy.
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.
The study was conducted in the outpatient unit of the medical oncology department of the Gulhane Military Medical Academy in Turkey.
Patients were undergoing the active treatment (chemotherapy) phase of care.
The study used a prospective, repeated-measures, quasiexperimental design with a control group.
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).
The findings suggested that PMR training may improve sleep quality and fatigue in patients with breast cancer undergoing adjuvant chemotherapy.
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.
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.
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.
Data collected at 6 and 12 weeks.
Outpatient cancer center
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.
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.
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.
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.
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
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.
Prospective, single-center, placebo-controlled, randomized, double-blinded trial
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).
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.
Nurses may want to consider offering counseling and education regarding probiotics as a potential alternative approach to reducing radiation-induced diarrhea.
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.
To review current evidence regarding the use of bisphosphonates for the treatment of lung cancer and to provide European recommendations for practice
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.
The report made the recommendations that follow.
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.
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.
To examine the effect of probiotic use for prevention of radiation-induced diarrhea
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.
This study reported on 490 patients receiving adjuvant radiation therapy after surgery for sigmoid, rectal, or cervical cancer.
This was a double blind, randomized, placebo-controlled trial.
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.
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.
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.
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.
To compare melatonin with placebo for impact on appetite in patients with advanced cancer
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.
The study was a double-blind, randomized, placebo-controlled trial.
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.
Melatonin had no effect on appetite or other symptoms in patients with advanced cancer.
Findings of this study do not support the use of melatonin to improve appetite or other symptoms in patients with advanced cancer.