Deng, G., Rusch, V., Vickers, A., Malhotra, V., Ginex, P., Downey, R., . . . Cassiletha, B. (2008). Randomized controlled trial of a special acupuncture technique for pain after thoracotomy. The Journal of Thoracic and Cardiovascular Surgery, 136(6), 1464-1469.
Deng, G., Vickers, A., Yeung, S., D’Andrea, G.M., Xiao, H., Heerdt, A.S., … Cassileth, B. (2007). Randomized, controlled trial of acupuncture for the treatment of hot flashes in breast cancer patients. Journal of Clinical Oncology, 25, 5584–5590.
Compare the immediate and long-term effects of true acupuncture versus sham acupuncture on hot flash frequency in women with breast cancer
The study included 72 women with breast cancer experiencing three or more hot flashes per day.
Patients were randomly assigned to receive either true or sham acupuncture.
The primary outcome measurement was hot flash frequency. Participants completed a hot flash diary for one day at days 7, 14, 21, 28, and 35.
The mean number of hot flashes per day was reduced from 8.7 to 6.2 in the true acupuncture group. The mean number of daily hot flashed was reduced from10.0 to 7.6 in the sham group. The true acupuncture was associated with 0.8 fewer hot flashes per day when compared to the sham at six weeks. This difference was not statistically significant. During the cross-over phase, participants in the sham group who received true acupuncture reported a further reduction in the frequency of hot flashes. The overall reduction in hot flash frequency persisted for up to 6 months after the completion of treatment.
The study was limited by a reliance on self-report instruments and recall. No physiologic measurements were used. The study may not have been of a sufficiently long duration and employed a modest sample size.
Deng, G., Chan, Y., Sjoberg, D., Vickers, A., Yeung, K.S., Kris, M., . . . Cassileth, B. (2013). Acupuncture for the treatment of post-chemotherapy chronic fatigue: a randomized, blinded, sham-controlled trial. Supportive Care in Cancer, 21, 1735–1741.
To determine if acupuncture reduced cancer-related fatigue (CRF) more effectively than did sham acupuncture.
Patients were randomized to an acupuncture or sham control group. Treatments were given once a week over six weeks. In the acupuncture group, a total of 14 needles were inserted at defined points during each session. The needles were stimulated manually and retained for 20 minutes. Sham needles, used in the control group, were blunt-tipped, moved up inside their handles when pressed against the skin, and did not penetrate the skin. In the control group, sham needles were applied in the same number and using the same technique as were the needles in the acupuncture group. Outcome measures were obtained at two weeks and at one week prior to the start of interventions and again at 42 and 49 days after completion.
Patients were undergoing the transition phase after initial treatment.
The study was a double-blind, randomized, sham-controlled trial.
The study showed that acupuncture had no effect on the symptoms of fatigue, anxiety, or depression.
The study did not demonstrate that acupuncture had an effect on fatigue, anxiety, or depression. The study contributes to a growing body of research that shows conflicting results regarding the effectiveness of this intervention for the management of fatigue. It has been shown that symptoms such as fatigue and anxiety tend to decline over time among patients with cancer. It is unclear if the timing in this study affected the results; symptoms may have declined with or without the intervention.
Demmy, T.L., Nwogu, C., Solan, P., Yendamuri, S., Wilding, G., & DeLeon, O. (2009). Chest tube-delivered bupivacaine improves pain and decreases opioid use after thoracoscopy. The Annals of Thoracic Surgery, 87(4), 1040–1046; discussion 1046–1047.
To compare, in thorascopy patients, the efficacy of intrapleural bupivacaine versus that of PCA fentanyl
All patients underwent a thorascopic operation during the study. Afterward, the F group received IV fentanyl (F) by means of patient-controlled analgesia (PCA). The IB group received intermittent intrapleural bolus delivery of bupivacaine plus fentanyl. The CB group received continuous intrapleural delivery of bupivacaine plus fentanyl.
PCA fentanyl was given as 40 mcg/hour basal rate with 30 mcg every 10 min as needed to a 160 mcg/hour maximum. Patients in the IB group received an initial bolus of 0.25% bupivacaine and the same PCA fentanyl dosage as the fentanyl-only group. If the fentanyl escalation was insufficient, the patient was prescribed additional 50 mcg boluses as needed. Patients in the CB group received 5 ml/hour continuous infusion bupivacaine via chest tube as well as PCA fentanyl. In the CB group, if fentanyl escalation was insufficient, 15–30 mg ketorolac was administered intervenously.
Nurses obtained baseline pain measures at the first postoperative complaint of pain and request for additional analgesia. Pain was also measured at 6, 12, 18, and 24 hours after the operation.
Nonblinded prospective randomized controlled trial
Administering local anesthetic through a chest tube catheter can reduce fentanyl consumption and pain after a thoracoscopy.
Intrapleural bupivacaine can be used to reduce pain after a thoroscopy; however, this approach may require ongoing adjustment and dosage escalations to achieve sufficient pain control. Intrapleural infusion may reduce total opioid consumption and attendant side effects; however, the study evidenced no differences in terms of prevalence or severity of effects. The most appropriate and effective doses of intrapleural bupivacaine remain unclear. Authors note that the continuous intrapleural infusion approach is much more costly than the other interventions. Whether study findings warrant the increased cost is unclear.
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.