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Yon, J.H., Choi, G.J., Kang, H., Park, J.M., & Yang, H.S. (2014). Intraoperative systemic lidocaine for pre-emptive analgesics in subtotal gastrectomy: A prospective, randomized, double-blind, placebo-controlled study. Canadian Journal of Surgery, 57, 175–182. 

Study Purpose

To assess the effect of intravenous lidocaine infusion in patients who received a subtotal gastrectomy

Intervention Characteristics/Basic Study Process

One group of patients received an intravenous lidocaine infusion preoperatively and throughout surgery, and the other group received normal saline.

Sample Characteristics

  • N = 36  
  • MEAN AGE = 62.8 years (range = 57–72 years)
  • MALES: 63%, FEMALES: 37%
  • KEY DISEASE CHARACTERISTICS: Patients undergoing subtotal gastrectomy for early gastric cancer between May 2012 and March 2013
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients who weighed less than 45 kg or more than 100 kg

Setting

  • SITE: Single site
  • SETTING TYPE: Inpatient
  • LOCATION: Chung-Ang University in Seoul, Korea

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Double-blinded, placebo-controlled, randomized study

Measurement Instruments/Methods

  • Visual Analog Scale (VAS) for pain
  • Administration frequency of patient-controlled analgesia (PCA)
  • Measured amount of consumed fentanyl, postoperative nausea and vomiting, length of hospital stay, time to return to regular diet, and patient satisfaction at discharge

Results

The VAS pain scores (p < 0.05) and administration frequency of PCA (p < 0.05) were significantly lower in the lidocaine group until 24 hours after surgery, and fentanyl consumption (p < 0.05) was significantly lower in this group until 12 hours postoperatively compared to the placebo group. The total amount of consumed fentanyl (p = 0.007) and the total administration frequency of PCA (p = 0.003) were significantly lower in the lidocaine group than the control group.

Conclusions

In this study, intravenous lidocaine infusion preoperatively and throughout surgery reduced pain during the postoperative period after subtotal gastrectomy.

Limitations

  • Small sample (< 100)
  • Findings not generalizable

Nursing Implications

Nurses should be aware of the benefits of intravenous lidocaine infusion during certain surgical procedures, including subtotal gastrectomy, so they can advocate for the use of this intervention for their patients.

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Yokoyama, K., Ikeda, O., Kawanaka, K., Nakasone, Y., Inoue, S., Tamura, Y., & Yamashita, Y. (2014). Pain control in patients with hepatocellular carcinoma treated by percutaneous radiofrequency ablation: Comparison of the efficacy of one-shot and continuous intravenous fentanyl delivery. Acta Radiologica, 55, 1219–1225. 

Study Purpose

To determine if the continuous IV infusion of fentanyl during radiofrequency ablation for hepatocellular carcinoma provided better analgesia than medicating via IV bolus before and after the procedure

Intervention Characteristics/Basic Study Process

Eighty-three patients were divided into two groups. Group 1 was given bolus doses of IV fentanyl pre- and postradiofrequency ablation, and group 2 was given a continuous infusion IV fentanyl. The doses were fairly equivocal. The patients were permitted to have IV diazepam if needed during the procedure. It was noted that not all patients used diazepam, and the median doses of diazepam differed significantly between the two groups (Group 1: 7.8 mg, SD = 5.8 mg; Group 2: 4.3 mg, SD = 5.2 mg).

Sample Characteristics

  • N = 86  
  • AGE RANGE = 61–80 years
  • MALES: 58 patients, FEMALES: 25 patients
  • KEY DISEASE CHARACTERISTICS: Hepatocellular carcinoma with no metastases or vascular invasion; single tumor up to 5 cm or up to three tumors each less than 3 cm 
  • OTHER KEY SAMPLE CHARACTERISTICS: Fifty-seven had hepatitis C; seven had hepatitis B; four had both hepatitis B and C; 15 had nonviral hepatitis

Setting

  • SITE: Single site    
  • SETTING TYPE: Inpatient    
  • LOCATION: Kumamoto, Japan

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Elder care  

Study Design

Prospective trial

Measurement Instruments/Methods

  • Visual Analog Scale (VAS)

Results

The data indicated that the median VAS score was 4 (SD = 1.8) in group 1 and 3.4 (SD = 1.9) in group 2. The findings were deemed statistically insignificant (p = 0.63). Thirteen patients experienced major toxicities from either the fentanyl or the diazepam (apnea and respiratory depression with decreased oxygen saturation).

Conclusions

The findings of this study indicated that there was no statistically significant difference in pain control reported between the two groups studied.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Unintended interventions or applicable interventions not described that would influence results
  • Other limitations/explanation: Patients from both groups were offered valium when needed, and the doses varied significantly. Pain was assessed retrospectively three hours after the procedure. Per the terminology in the article, the first 41 patients were assigned to group 1, and the next 42 patients were assigned to group 2. No information was available regarding home medications, specifically of any short- or long-acting analgesic use, which could have had an effect on patients' VAS scores.

Nursing Implications

This study did not establish compelling evidence that a continuous infusion of fentanyl during radiofrequency ablation and embolization provided significantly better analgesia than the conventional IV boluses pre- and post procedure. I also feel the limitations of the study are significant enough to state that the study should not be used for PEP.

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Yim, V., Ng, A., Tsang, H., & Leung, A.Y. (2009). A review on the effects of aromatherapy for patients with depressive symptoms. Journal of Alternative & Complementary Medicine, 15(2), 187–195.

Purpose

To complete a systematic review of the effects of aromatherapy on patients with symptoms of depression

Search Strategy

  • Databases searched were CINAHL, PubMed, MEDLINE, PsyInfo, and Cochrane Library.
  • Search keywords were aromatherapy, scent, fragrance, essential oil, depression, depressive disorder, and depressive symptoms. All retrieved reports were of peer-reviewed studies, in English, published 2000–2008.
  • A study was included if it referred to the clinical application of aromatherapy as the treatment of patients with some kind of clinical condition or patients suffering from symptoms of depression.
  • A study was excluded if it referred to the chemistry of essential oils or if it was published as a dissertation.
     

Literature Evaluated

  • The total number of studies retrieved was 48.
  • Two studies were of patients with depression; one, of postnatal mothers; three, of patients with cancer.
  • Two studies were randomized controlled trials (RCTs), three were not RCTs, and one was quasiexperimental.
  • The evaluation method consisted of a systematic review by two graduate students in a master’s degree program in occupational therapy. The graduate students extracted the data.

Sample Characteristics

  • The final number of studies included was six.
  • The total sample size was 387. The sample range across studies was 5–288.
  • Two studies evaluated the effectiveness of aromatherapy on patients with depression, three studied secondary depressive symptoms in patients with cancer, and one focused on postnatal depression. All studies discussed the effectiveness of aromatherapy massage on depressive symptoms.
     

Phase of Care and Clinical Applications

Authors did not mention the phase of care.

Conclusions

Aromatherapy has an alleviation effect on the mood of patients with depressive symptoms; however, there is a notable lack of studies on the use of aromatherapy by people with depression. Almost all the studies use aromatherapy massage and not aromatherapy alone, so whether the effects are from the aroma intervention, the massage intervention, or a combination of the two remains unclear.

Limitations

Of the six studies, the sample size of three included eight participants or fewer. The size of the others was 36, 42 and 288, respectively. In addition to being small, the samples did not necessarily include cancer patients. These studies were inconsistent and used various oils for the aromatherapy.

Nursing Implications

The evidence is insufficient to support recommendations for the use of aromatherapy for the treatment of depression. Aromatherapy may, however, be used as complementary and alternative therapy for depression and be considered as a treatment for depression in patients with secondary depression arising from chronic medical conditions.

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Yildirim, Y.K., Cicek, F., & Uyar, M. (2009). Effects of pain education program on pain intensity, pain treatment satisfaction, and barriers in Turkish cancer patients. Pain Management Nursing, 10, 220–228.

Study Purpose

To investigate the effect of a pain education program on pain intensity, satisfaction with pain treatment, and barriers to pain management

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to a group that received the education program or to a control group. Patients in the education group received written materials and an educational slide program. They received a booklet covering the same content as the other components. Content included the definition of pain; a list of its causes; discussion of pain-related pharmacologic treatment, side effects, myths, and misconceptions (e.g., misconceptions about addiction, drug dependence, tolerance); noncompliance; and nonpharmacologic pain treatment and pain assessment. The initial session took 30–40 minutes and was provided to each patient individually, in his or her hospital room. The education session was repeated after three and seven days, as needed. Patients in the control group received standard care and answers to relevant questions but did not receive specialized education. Assessments were done at baseline and at weeks 2, 4, and 8.

Sample Characteristics

  • The sample was composed of 40 patients.
  • Of all patients, 85% were over age 60.
  • Of all patients, 55% were male and 45% were female.

 

Setting

  • Single site
  • Inpatient
  • Turkey

Phase of Care and Clinical Applications

Phase of treatment: active treatment

Study Design

Randomized controlled study

Measurement Instruments/Methods

  • McGill Pain Questionnaire 
  • Numeric rating scale
  • Barriers Questionnaire, Revised

Results

  • Compared to controls at weeks 2, 4, and 8, patients in the education group had a significant decrease in mean scores regarding present pain (p < 0.001), least pain (P < 0.05), and satisfaction with pain treatment (p < 0.001).
  • At the end of week 2, the barriers score decreased significantly in the education group, dropping from 2.12 to 1.29; in the control group, the barriers score decreased from 2.3 to 2.28 (p < 0.001). Compared to controls, patients who received the education had lower barrier scores, in subscales regarding use of analgesics (p = 0.023) and communication related to pain (p = 0.000).

Conclusions

Pain education was helpful in reducing pain intensity; education improved satisfaction with pain management and reduced barriers to pain management.

Limitations

  • The study had a small sample, with fewer than 100 patients.
  • The study had a risk of bias due to no attentional control or blinding.
  • Authors provided no information regarding analgesic use or changes in analgesics over the course of the study. Such changes could have influenced results.
  • The individual education session was to have been repeated every 3–7 days as needed. However, authors did not state how many sessions were repeated.
  • Whether patients were in the hospital for the duration of the study, in a controlled environment, is unclear.

Nursing Implications

Findings suggest that pain education is effective at reducing pain intensity, increasing patient satisfaction, and reducing barriers to pain management. Specifically addressing misconceptions about analgesic use and the need to communicate regarding the pain experience can be expected to help reduce barriers to effective pain management by means of analgesics. Patients' active involvement in their own pain management can improve the quality of this aspect of care.

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Yesilbalkan, O. U., Karadakovan, A., & Göker, E. (2009). The effectiveness of nursing education as an intervention to decrease fatigue in Turkish patients receiving chemotherapy. Oncology Nursing Forum, 36, E215–E222.

Study Purpose

To determine whether a nurse-led educational intervention decreased the perception of fatigue in patients diagnosed with gastrointestinal (GI) cancers who were receiving chemotherapy for the first time and to determine if improvement in fatigue resulted in improvement in quality of life (QOL).

Intervention Characteristics/Basic Study Process

Patients received an individual educational intervention at baseline, on the tenth day after the first cycle of chemotherapy (T1), and 10 days after the second cycle (T2) based on the results of their fatigue assessments. The education program consisted of:  one-to-one education, which consisted of training and counseling about fatigue assessment and management. It was delivered by the researcher. The intervention was designed to improve patients’ knowledge of causes of fatigue and to provide them with strategies to decrease severity, including self-monitoring of fatigue levels, advice on energy conservation, distraction, increasing mobility and activity, stress management, relaxation methods, and management of factors known to cause fatigue.

Sample Characteristics

  • In total, 35 patients (57% women) receiving chemotherapy for GI cancer were included.
  • Mean age was 49 years (standard deviation = 10.12).
  • Patients had GI cancer.
  • Of the patients, 91% were married.

Setting

  • Single site
  • Outpatient chemotherapy unit of a large University Hospital in Izmir, Turkey

Study Design

The study used a descriptive, quasiexperimental design.

Measurement Instruments/Methods

  • Baseline demographics
  • Fatigue and QOL were assessed using the Brief Fatigue Inventory (BFI), Piper Fatigue Scale (PFS), and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).
  • Instruments were administered before the first cycle of chemotherapy, at T1, and at T2.
  • Pre- and posttest analyses were conducted using t-tests.
  • Relationships among variables were examined by calculating Pearson correlation coefficients with a statistical significance of p = 0.05.
  • Variables included subjective reports of patients’ fatigue and QOL.

Results

Patients’ mean fatigue scores showed a statistically significant decrease, and their EORTC QLQ-C30 scores were better at T1 and T2 compared with baseline.

Conclusions

Nurse-led educational interventions have the potential to reduce fatigue in patients with GI cancers receiving chemotherapy for the first time.

Limitations

  • The exclusion criteria limited the number of patients; the study had a small sample size.
  • The sample only included patients with GI cancers in a single center in Turkey.
  • No power calculation was performed.
  • No control group was used.
  • The findings could be culturally specific.
  • These limitations prevented generalization. 

Nursing Implications

The administration of chemotherapy should be preceded by a formal fatigue assessment and the provision of individually tailored educational interventions to reduce the severity of fatigue and improve QOL.

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Yeo, W., Mo, F.K., Suen, J.J., Ho, W.M., Chan, S.L., Lau, W., … Zee, B. (2009). A randomized study of aprepitant, ondansetron and dexamethasone for chemotherapy-induced nausea and vomiting in Chinese breast cancer patients receiving moderately emetogenic chemotherapy. Breast Cancer Research and Treatment, 113, 529–535. 

Study Purpose

To compare the efficacy of an aprepitant-based antiemetic regimen and a standard antiemetic regimen for the prevention of chemotherapy-induced nausea and vomiting (CINV) in Chinese patients with breast cancer receiving a first cycle of moderately emetogenic chemotherapy (MEC) and to compare patient-reported quality of life (QOL) among all patients

Intervention Characteristics/Basic Study Process

Chemotherapy naïve patients with breast cancer receiving adjuvant AC chemotherapy were assigned to either an aprepitant-based regimen (day 1: 125 mg aprepitant, 8 mg ondansetron, and 12 mg dexamethasone before chemotherapy and 8 mg ondansetron 8 hours later; days 2-3: 80 mg aprepitant four times a day) or a control arm (day 1: 8 mg ondansetron and 20 mg dexamethasone before chemotherapy and 8 mg ondansetron 8 hours later; days 2-3: 8 mg ondansetron twice daily).

Sample Characteristics

  • The sample consisted of 124 participants.
  • Mean age (range) for the aprepitant group was 46.5 years (32–66 years) and, for the control group, 48.5 years (26–68 years).
  • All of the patients were female (100%).
  • Diagnoses were 94% invasive ductal carcinoma, 1.6% invasive lobular carcinoma, and 5% other.
  • Cancer stages were 22% stage I, 50% stage II, 18% stage IIIa, and 9% stage IIIb.
  • Patients had to be ethnic Chinese females older than 18 years with a life expectancy of four months or more and a Karnofsky score of 60 or more.
  • Both groups had slight differences in history of motion sickness and vomiting during pregnancy.

Setting

The study was conducted at a single site in China.

Phase of Care and Clinical Applications

All study participants were in active treatment.

Study Design

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

Measurement Instruments/Methods

  • Patient diaries were used to monitor the antiemetic efficacy for 120 hours following chemotherapy infusion. Vomiting episodes and the use of rescue therapy were recorded on days 1–6, and daily nausea ratings (based on a visual analogue scale [VAS]) were recorded on days 2–6.
  • The Functional Living Index, an emesis questionnaire (Chinese version), was completed immediately after the patients completed the diary on day 6. It contained nine items in both the nausea and vomiting domains.
  • Adverse events were collected according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTAE).
  • Data on nausea, vomiting, and the use of rescue medication were collected with self-report diaries, and patient QOL assessment was self-administered.

Results

  • In the overall timeframe (0–120 hours) in cycle 1, no significant differences in symptoms were found.
  • The requirement of rescue medication appeared to be less in the aprepitant group than the control group (11% versus 20%; p = 0.06).
  • No significant difference was found in the median time to first vomiting and nausea domain.
  • Both treatment arms were generally well tolerated.

Conclusions

The addition of aprepitant to ondansetron and dexamethasone for CINV did not have a definitive superiority over the existing regimen in Chinese patients with breast cancer; however the addition of aprepitant reduced the requirement of rescue medication and resulted in significantly better QOL.

Limitations

  • Cultural and traditional Chinese medicine influences may have influenced the study outcomes.
  • No reporting was given on of how often patients needed to take the rescue therapy, metoclopramide, which may have influenced outcomes.
  • Limited generalizability of study findings exists because of the homogenous sample population.
  • The standard “control” regimen only included dexamethasone on day 1.

Nursing Implications

The addition of aprepitant to ondansetron and dexamethasone for CINV in Chinese patients with breast cancer receiving MEC may have some effect in improving QOL and reducing the requirement for rescue medication.

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Yeom, C. H., Jung, G. C., & Song, K. J. (2007). Changes of terminal cancer patients’ health-related quality of life after high dose vitamin C administration. Journal of Korean Medical Science, 22, 7–11.

Intervention Characteristics/Basic Study Process

Patients were given an intravenous administration of 10 g of vitamin C twice daily with a three-day interval and an oral intake of 4 g of vitamin C daily for one week. Outcomes were assessed at baseline and at the end of the intervention.

Sample Characteristics

  • The sample was comprised of 39 patients with terminal cancer.
  • Mean age was 53.5 years.
  • The ratio of males to females was 20:19.
  • Patients had varied diagnoses, the most common being stomach cancer.
  • All patients were at stage IV, and 12 patients experienced a recurrence of their cancers.

Setting

Department of Family medicine, Myungji-Hospital, Kwandong University College of Medicine

Phase of Care and Clinical Applications

Patients were undergoing the end of life phase of care.

Study Design

The study was a prospective, nonrandomized trial.

Measurement Instruments/Methods

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

Results

The vitamin C intervention significantly improved fatigue in patients after one week of treatment, as mean fatigue scores dropped from 52 (standard deviation [SD] = 24) to 40 (SD = 19) (p < 0.001).

Limitations

  • The study lacked a control group.
  • When given high doses of vitamin C, patients have the risk of developing hemolysis and, therefore, should be screened for deficiency before receiving treatment.
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Yeo, T. P., Burrell, S. A., Sauter, P. K., Kennedy, E. P., Lavu, H., Leiby, B. E., & Yeo, C. J. (2012). A progressive postresection walking program significantly improves fatigue and health-related quality of life in pancreas and periampullary cancer patients. Journal of the American College of Surgeons, 214, 463–475.

Study Purpose

To evaluate the effects of a home-based walking program in postresection patients on cancer-related fatigue, physical function, and quality of life.

Intervention Characteristics/Basic Study Process

Consenting patients were randomly assigned to the walking group or usual care group while in the hospital after surgery. Baseline measures were obtained either in the physician's office prior to surgery or in the hospital. Patients in the intervention group were given a prescription for a graduated walking program and were asked to record the number of minutes or approximate distance walked and any adverse symptoms in a weekly diary. They also received monthly telephone calls to assess their current status and adherence to walking and remind them to mail in their diary information. The intervention group was given a modified “Every Step Counts” booklet, modified to cover a six-month period recommending increasing brisk walking time to 20 minutes in the second month and to 25 to 30 minutes in the third month. Patients in the usual care control group did not receive monthly calls but received one follow-up call at three months. Outcome measures were assessed via the follow-up telephone calls in all groups.

Sample Characteristics

  • One hundred two patients (50% male, 50% female) were included.
  • Seventy-nine patients completed the final six-month postoperative follow-up.
  • Mean age was 66.5 years (range 38–91). 
  • All patients had pancreatic, bile duct, or duodenal cancer, and 93% had undergone pancreaticoduodenectomy with pyloru preservation.
  • Of the patients, 73% underwent adjuvant therapy with chemotherapy, radiation, or both.
  • Patients with stage IV disease were excluded.

Setting

  • Single site
  • Home
  • Philadelphia, PA

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

This was a randomized, controlled trial.

Measurement Instruments/Methods

  • Fatigue visual analog scale (VAS)
  • Pain VAS
  • Medical Outcomes Study (MOS)
  • Short Form 36 Health Survey (SF-36), version 2
  • Eastern Cooperative Oncology Group (ECOG) Performance Status
  • Functional Assessment of Chronic Illness (FACIT) Fatigue subscale

Results

Patients in the exercise group had improved fatigue scores by both VAS and FACIT measures (p < 0.05). Mean change in VAS fatigue score was 1.2, and mean change in the FACIT subscale was 9 points. FACIT scores tended to correlate with disease stage. All patients had a significant reduction in pain. Physical function score changes on the SF-36 were mixed, with the individual subscale score improving more in the exercise group but the composite score improving more in the usual care group. There were no differences between groups in other symptoms observed. Analysis demonstrated a fatigue-related symptom cluster of fatigue, bodily pain, depression, weakness, and anxiety at an average of three months.

Conclusions

Findings supported the benefits of a home-based progressive walking program for patients postsurgical resection.

Limitations

  • The study had risks of bias due to no appropriate control group and no attentional control. 
  • It is unclear if some patients had baseline measures performed pre- or postoperatively; the timeframe of these measures related to the surgical procedure is also unclear.
  • The study report appeared to provide some conflicting information in this area. There was no subgroup analysis between those who received various adjuvant therapies, although the study groups were similar in terms of percentages that had any adjuvant treatment. There was no stratification based on baseline activity levels and physical functioning. There was no information regarding walking adherence or the activity levels of the control group, so it is not really known if there was a difference in actual exercise between groups.

Nursing Implications

Findings suggested that a self-managed home-based walking prescription can be helpful to patients with cancer postoperatively. This study adds to the body of evidence related to exercise and fatigue by using a sample of patients who had diagnoses and treatments not previously studied in this area.

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Yennurajalingam, S., Kang, J.H., Hui, D., Kang, D.H., Kim, S.H., & Bruera, E. (2012). Clinical response to an outpatient palliative care consultation in patients with advanced cancer and cancer pain. Journal of Pain and Symptom Management, 44, 340–350.

Study Purpose

To determine response to pain treatment with outpatient palliative care consultation

Intervention Characteristics/Basic Study Process

Records of consecutive patients referred to an outpatient palliative care consultation program were reviewed for analysis. The palliative care service was provided by an interdisciplinary team led by a board-certified palliative care specialist. Care follows a standardized management plan. Symptoms were evaluated at baseline and follow-up visits. Findings between individuals who had consultation only versus those who had consultation with follow-up were compared.

Sample Characteristics

  • The study reported on a sample of 1,869 patients.
  • Mean patient age was 59.2 years.
  • The sample was 52% male and 48% female.
  • Multiple different disease types were represented. 
  • The most severe symptoms were pain and fatigue.
  • Patients who had consultation only had significantly lower symptom severity scores.

Setting

  • Single site
  • Outpatient setting
  • The University of Texas MD Anderson Cancer Center

Phase of Care and Clinical Applications

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

Study Design

A retrospective, descriptive design was used.

Measurement Instruments/Methods

  • Edmonton Symptom Assessment Scale
  • Pain “responders” defined as those achieving at least a three-point pain severity reduction

Results

More than half (53%) of patients did not achieve a pain response, and 70% of those with moderate to severe pain at the initial visit did not respond to palliative care consultation or still had poor pain control at a follow-up visit. Thirty-two percent of those with mild pain and 27% with moderate pain had worse pain at follow-up. Median time to follow-up visits was 15 days. Factors associated with pain treatment response were baseline pain intensity, fatigue, and total symptom burden at baseline (p < 0.04).

Conclusions

Findings show that pain was not effectively controlled in the short-term with this program. Pain intensity can change quickly in the short-term. Standardized care as examined here may be an insufficient way to effectively manage pain.

Limitations

  • The study has risk of bias due to no control group, no blinding, no random assignment, and no appropriate attentional control condition.
  • The study has risk of bias due to the sample characteristics.
  • Unintended interventions or applicable interventions are not described that would influence results.
  • Retrospective descriptive nature of the study is limiting but does provide some information regarding this type of program.
  • It is not known if recommendations made from consultation were implemented, such as any changes in pain medications, etc.

Nursing Implications

This study provides only limited information about effectiveness of outpatient palliative care consultation for pain control; however, it does show that pain can get worse quickly, a large percentage of patients did not have adequate pain control, and the use of standard protocols may not be sufficient. Findings point to the need for aggressive pain management, frequent assessment of pain, and the potential need for very frequent follow-up in initial phases of establishing a pain management plan for the patient in order to quickly achieve pain reduction.

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Yennurajalingam, S., Reddy, A., Tannir, N.M., Chisholm, G.B., Lee, R.T., Lopez, G., . . . Bruera, E. (2015). High-dose Asian Ginseng (Panax Ginseng) for cancer-related fatigue: A preliminary report. Integrative Cancer Therapies, 14, 419–427. 

Study Purpose

To assess the safety and efficacy of high-dose ginseng for cancer-related fatigue

Intervention Characteristics/Basic Study Process

Patients were given a supply of ginseng for 29 days and instructed to take two 400 mg tablets twice daily. Study measures were obtained at baseline, day 15, and day 29.

Sample Characteristics

  • N = 24
  • MEDIAN AGE = 58 years (range = 48–68 years)
  • MALES: 50%, FEMALES: 50%
  • KEY DISEASE CHARACTERISTICS: Genitourinary cancers were most common
  • OTHER KEY SAMPLE CHARACTERISTICS: 87% were currently receiving cancer treatment with either combination chemotherapy or targeted therapies; 33% also were receiving radiation therapy

Setting

  • SITE: Single site  
  • SETTING TYPE: Not specified  
  • LOCATION: Texas

Phase of Care and Clinical Applications

  • PHASE OF CARE: Multiple phases of care
  • APPLICATIONS: Palliative care

Study Design

Prospective observational

Measurement Instruments/Methods

  • Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F)
  • Edmonton Symptom Assessment Scale (ESAS)
  • Hospital Anxiety and Depression Scale (HADS)

Results

There was an improvement in the FACIT fatigue subscale on day 15 (p = 0.004) and day 29 (p = 0.0006) although scores increased between day 15 and 29. Improvement was also seen in the ESAS fatigue scale at both time points (p < 0.001). Appetite improved on day 15 (p = 0.004) and day 29 (p = 0.0097). Sleep was improved on day 15 (p = 0.004) but not on day 29. ESAS scores for anxiety were improved on day 15 (p = 0.002). There were no significant adverse effects attributed to ginseng.

Conclusions

The findings of this study suggest that high-dose ginseng may be helpful in the management of multiple symptoms among patients with cancer.

Limitations

  • Small sample (< 30)
  • Risk of bias (no control group)
  • Risk of bias (no random assignment)
  • Other limitations/explanation: Patients were included and considered evaluable if they took only one dose of ginseng. The number of doses actually taken was not stated, so there is no way to know if symptoms changed over time due to ginseng or not, or in how many patients. For several symptoms, though statistically significant, actual changes in score were very small.

Nursing Implications

Ginseng appears to be safe and may be helpful in the management of multiple symptoms among patients with cancer. This study had multiple design limitations. Additional well-designed studies with larger patient samples are needed to provide sufficient evidence for the meaningful evaluation of efficacy.

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