To determine whether use of intradermal acupuncture needles is superior to sham acupuncture in the treatment of acute and chronic pain after thoracotomy

Patients were stratified according to use of epidural anesthesia and then randomized to receive acupuncture or a sham technique. Within 2 hours before the operation and before induction of anesthesia, 9 intradermal acupuncture needles were inserted on each side of the spine corresponding to BL-12 to BL-19 acupuncture points and to an extra point. These needles had the appearance of miniature thumbtacks, and a ring at the end of the needle keeps it from entering the skin completely. Needles were exchanged for new ones 1 week after initially placed. The duration of acupuncture was 4 weeks, with different needles removed at different time-points. Patients in the control group underwent the same procedure, except that dummy studs were used that had the same appearance and ring, but no needle. Sham studs were placed at areas to prevent tactile stimulation of acupuncture points. Pain was measured at days 10, 30, 60 and 90 post surgery.

Sample Size: 106 Mean age = 64, range = 57-72 Females: 51% Males: 49% Patients had cancer and were scheduled for unilateral thoracotomy that did not involve the chest wall, esophagectomy or extrapleural approaches. No other disease related information is provided. Patients were excluded if they had previous acupuncture or platelet counts 20,000.

Single site, Other Memorial Sloan Kettering

Randomized controlled trial

Brief Pain Inventory Medication Quantification Scale for opioid use

There were no differences between groups for any pain measures at any of the follow-up time points.

Acupuncture as used here does not appear to be effective for the management of acute or chronic thoracotomy related pain

No information was provided regarding any background chronic pain among the sample, which may have also affected findings. Authors point out that the needles used here were shorter than those used in other studies. It is not clear how these factors and needle placement affect results.

Findings suggest that perioperative acupuncture does not effectively prevent or reduce pain associated with the operation. Acupuncture techniques in terms of needle types, placement, frequency of replacement etc., vary among providers of this treatment. These aspects increase the complexity of research in this area.

DOI Link: doi:10.1200/JCO.2007.12.0774

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.

DOI Link: doi: 10.1007/s00520-013-1720-z

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.

• The study reported a sample of 74 patients (82% female, 18% male).
• Mean patient age was 53.5 years (range 45–59).
• Patients had multiple tumor types, and more than half had breast cancer.
• All had completed a course of chemotherapy at least 60 days prior to the study.

• Single site
• Outpatient
• Memorial Sloan Kettering Cancer Center, New York City, NY

Patients were undergoing the transition phase after initial treatment.

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

• Brief Fatigue Inventory (BFI)
• Hospital Anxiety and Depression Scale (HADS)
• Functional Assessment of Cancer Therapy-General (FACT-G)

• At least 87% of participants completed all sessions.
• In both groups, total fatigue scores declined by approximately one point between baseline and follow-up.
• There were no differences between groups.
• Neither HADS nor FACT-G measures showed significant differences between groups.

The study showed that acupuncture had no effect on the symptoms of fatigue, anxiety, or depression.

• The study had a small sample size, with less than 100 participants.
• The drop-out rate was greater than 24%.
• The authors performed an intention-to-treat analysis, but they did not report their exact procedures.

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.

DOI Link: doi:10.1016/j.athoracsur.2008.12.099

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.

• The sample was composed of 30 patients.
• In the F group, mean patient age was 56 years. In the IB group, mean patient age was 61 years. In the CB group, mean patient age was 60.
• Of all patients, 56.6% were female and 43.3% were male. All patients underwent, during the study, thorascopic operations to achieve nonanatomic lung resections. Of all patients, 80% had cancer.

• Single setting
• Inpatient
• Roswell Park Cancer Institute, Buffalo, New York

Nonblinded prospective randomized controlled trial

• Visual analog pain score (VAPS)
• Amount of fentanyl used

• During the first six hours, authors noted a statistically significant difference (p = 0.01) among groups in total fentanyl consumed. Patients in the intrapleural infusion groups had lower consumption.
• At six hours, three patients in the fentanyl-only group were not able to bring pain to an acceptable level (p = 0.04).
• Compared to the F group, more patients in both intrapleural groups required dose escalation. The continuous bupivacaine group contained the highest proportion of patients needing escalation (p = 0.08).
• Authors noted no differences in the proportion of patients whose pain improved from baseline, and the highest pain severity scores were similar across groups.

Administering local anesthetic through a chest tube catheter can reduce fentanyl consumption and pain after a thoracoscopy.

• The study had a small sample size, with fewer than 100 patients.
• Patients' relatively brief length of stay suggests that cases involved may have been carefully selected, subjecting the sample to bias.

 

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.

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 sample was comprised of 57 patients aged 60–67 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.

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.

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

The study was a prospective, randomized phase III trial.

• 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.

• 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.

• 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.

• 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.

• 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.

DOI Link: doi: 10.1258/jtt.2010.100503

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.

• 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.

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

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

Quasiexperimental

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

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.

• 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.

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.

DOI Link: doi: 10.1089/jpm.2011.0488

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.

• 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.

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

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

Noninferiority, randomized, two-group trial

• 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)

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.

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

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.

DOI Link: doi: 10.5301/tj.5000328

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.

• 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

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

• PHASE OF CARE: Active antitumor treatment

• Retrospective analysis

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

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.

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

 

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.

DOI Link: doi: 10.1111/j.1365-2702.2009.03037.x

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 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.

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.

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

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.

• 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.

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.

DOI Link: doi: 10.1188/ONF.06.337-343

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.

 

• 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).

Outpatient cancer center

• 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.

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.

• 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.

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.