The study evaluated soy phytoestrogens for the treatment of hot flashes in breast cancer survivors.

After a baseline documentation week, women received four weeks of either soy tablets or placebo. They then crossed-over to the opposite for the last four weeks. The soy product was formulated in 600 mg tablets. Participants took one tablet three times per day (150 mg of isoflavones day), an amount similar to that consumed with three glasses of soy milk.

Participants included 177 women with a history of breast cancer; 149 participants (84%) provided useable efficacy data for the entire nine weeks of the study.

All participants were randomized in a double-blind crossover design to one of two groups (soy or placebo) and crossed-over after four weeks. Participants were stratified according to age, duration of hot flashes, and the average daily hot flash frequency using a dynamic allocation procedure that balances marginal distributions. They were also stratified by current tamoxifen or raloxifene use (yes or no).

The instrument was a daily questionnaire documenting hot flashes frequency, intensity, and perceived side effects.

The soy product did not alleviate hot flashes in breast cancer survivors. No toxicity was observed. These data failed to suggest any patient preference for the soy compound over the placebo preparation.

Optimal daily dose of soy required to recognize a clinical response may be questioned. Data related to estimated intake of 150–200 mg daily in the Asian diet endorsed the choice of 150 mg/day. Experience from conventional HRT suggests that length of time on the soy isoflavones (four weeks) may be too short to elicit a clinical response. Study durations of less than three months have been excluded from overviews of the effects of HRT.

To reduce anxiety caused by chemotherapy (not the diagnosis)

The intervention was reflexology foot massage in hospitalized patients undergoing their second or third cycle of chemotherapy (30-minute foot massage on both feet by an RN student). The Spielberger State-Trait Anxiety Inventory was administered before and after reflexology and 24 hours post-reflexology.

The study reported on a sample of 30 patients: 15 in the control group and 15 in the reflexology foot massage group.

Italian research hospital

Spielberger State-Trait Anxiety Inventory

There was an average decrease of 7.9 points on the state-anxiety scale in the treatment group (p < 0.0001) after the short time frame (immediate decrease in anxiety).

• The study had a small sample size.
• The sample was not randomized, and patients were not categorized by cancer diagnosis, stage, or presence of metastasis.
• The study used a specially trained reflexology practitioner.

• FINAL NUMBER STUDIES INCLUDED = 4
• TOTAL PATIENTS INCLUDED IN REVIEW = 94 
• KEY SAMPLE CHARACTERISTICS: All four studies reviewed the application of leuprolide acetate (LA) at varying doses and timing in premenopausal females undergoing bone marrow transplant (44) or stem cell transplantation (30), or who were at risk of bleeding due to hematologic malignancy or therapy-induced thrombocytopenia (20).

PHASE OF CARE: Active antitumor treatment

In the four studies reviewed, the administration of LA in premenstrual women with hematologic malignancy at risk of bleeding demonstrated efficacy in reducing episodes of uterine bleeding. The route of administration (IV, IM, or SQ) did not appear to have an effect upon efficacy. Efficacy was improved when LA was administered at least two weeks prior to the onset of thrombocytopenia.

Leuprolide acetate administration to premenopausal women at risk of uterine bleeding demonstrates efficacy in the prevention of uterine bleeding. In addition, there was no documentation of adverse effects from the hormone.

The number of studies and participants included was small (4 and 94, respectively). In addition, there was not a randomization of participants.

Uterine bleeding in premenopausal females undergoing therapy for hematologic malignancy poses a significant risk. Administration of LA has the potential to mitigate this. There is a place for further research to define dose, administration, and timing of administration.

• FINAL NUMBER STUDIES INCLUDED = 10
• TOTAL PATIENTS INCLUDED IN REVIEW = 1,582
• SAMPLE RANGE ACROSS STUDIES: 23–631 patients

Four studies examined modafinil, and six evaluated used methylphenidate. The meta-analysis showed that methylphenidate reduced fatigue significantly (SMD = –0.28, p = 0.0005) and had no impact on sleep quality. Modafinil did not demonstrate a significant reduction in fatigue. Adverse effects were reported in 6.5% of patients getting methylphenidate, and no differences in study dropouts related to side effects existed between those on methylphenidate and those receiving placebo. The analysis showed no significant difference in risk of adverse events between those receiving either drug and those on placebo.

The findings showed that methylphenidate was associated with improvement in cancer-related fatigue, with no significantly increased risk of side effects. Modafinil was not associated with any improvement.

• Relatively small number of studies

The findings suggest that methylphenidate is helpful to reduce cancer-related fatigue, with minimal adverse effects. Modafinil was not shown to be beneficial. Nurses need to be aware of the benefits and potential adverse effects when using psychotropic drugs to combat fatigue in patients with cancer.

Evaluate the effects of group cognitive behavioral therapy (CBT) among women with breast cancer and major depression

The intervention was a protocol-driven group intervention, delivered in group meetings weekly for 10 weeks. The content included cognitive restructuring dealing with existential concerns, behavioral activation, focusing on the importance of behavior in improving depressive symptoms, coping with side effects of treatment and pursuing healthy behaviors, and interpersonal communication examining the impact of relationships on mood. The intervention group also received progressive muscle relaxation training. Patients were randomized to the CBT or usual care wait list control group. The control group received an educational booklet. Sessions were audio taped and reviewed by supervisors to ensure treatment fidelity. All interventions were done by the same person. Patients were assessed at baseline, at the end of treatment, and at six months after the intervention.

• N = 54
• MEAN AGE = 50.63 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All had breast cancer—most were stage 0–1. More than 94% had received chemotherapy. More than two-thirds had a psychiatric history and family history of mental illness. All were diagnosed with major depressive disorder. All had completed initial cancer treatment.
• OTHER KEY SAMPLE CHARACTERISTICS: 22.6% had completed at least some college education. About half were currently employed, and approximately 90% were married.

• SITE: Single site    
• SETTING TYPE: Outpatient    
• LOCATION: China

PHASE OF CARE: Transition phase after active treatment

Single-blind randomized controlled trial

• Hamilton Rating Scale for Depression (HRSD)
• Self-Rating Anxiety Scale (SAS)
• Functional Assessment of Cancer Therapy-Breast Self Esteem Scale (SES)

At the end of treatment, a significant improvement was seen in HRSD results in the intervention group compared to controls (p = .00), with a between-groups effect size (ES) of 2.19. At six months, the difference between groups remained significant (p = .00) with an ES of 1.51. HRSD scores declined in all subjects over time. SAS scores declined in all subjects over time. At the end of treatment and at six months, scores were significantly lower in the intervention group (p < .05) with between-groups ES of 0.5 and 0.66, respectively. SES scores were higher in the intervention group but only were significantly different between groups at six months.

Group CBT reduced symptoms of depression and anxiety and increased self-esteem in patients with breast cancer who had major depressive disorder. These effects were maintained to some extent over a six-month period. The greatest effect was seen in reducing depressive symptoms

• Small sample (< 100)
• Risk of bias (no appropriate attentional control condition)  
• Risk of bias (sample characteristics)
• Unintended interventions or applicable interventions not described that would influence results
• Findings not generalizable
• Though they state intent to treat analysis using the last measure carried forward, the sample size used for six months was less than the number who completed the intervention phase of the study. No attentional control condition existed. The sample was limited to Chinese women with mostly early-stage breast cancer who had completed treatment and had a depression diagnosis. No information is provided regarding whether any patients were receiving antidepressants or other relevant medications. Interventions all were provided by a single experienced individual, so findings may not be similar in other situations.

Findings demonstrate that group CBT was effective in reducing symptoms of anxiety and depression among patients with major depressive disorder. Patients with clinically significant depression need to be identified and treated for depression. CBT is one option for management of major depression among patients with cancer.

Objectives were to

• Present evidence that will contribute to the improvement of palliative care at the end of life.
• Answer questions regarding critical elements.
• Identify patients who could benefit from palliative approaches.
• Identify treatment strategies that work for pain, dyspnea, and depression.
• Identify elements important in advance care planning, collaboration and consultation, and assessment and support aspects helpful to caregivers.

Included were patients with any disabling or symptomatic condition at the end of life.

The guideline was based on a systematic evidence review, done by others, in an Agency for Healthcare Research and Quality evidence report. The guideline does not address nutritional support, complementary and alternative therapies, or spiritual support because evidence related to these areas does not often appear in the literature. Specific procedures for grading the evidence and recommendations are not described.

The guideline was developed for the Clinical Efficacy Assessment Subcommittee of the American College of Physicians. Evidence and recommendations were graded using the clinical practice guidelines grading system (GRADE).

Databases searched were MEDLINE and the Database of Abstract Reviews of Effects (January 1990–November 2005); citations from the review by the National Consensus Project for Quality Palliative Care (2003) also were searched.

Search keywords were cancer, congestive heart failure, and dementia. The full description of search terms is published elsewhere.

The guideline outlines the strength of GRADE recommendations and includes a brief description of the supporting evidence for each recommendation.

Critical Elements for End-of-Life Care: Elements identified are preventing and treating pain and other symptoms; supporting families and caregivers; ensuring continuity of care; ensuring respect for patients as people and informed decision making; ensuring well-being, including consideration of existential and spiritual concerns; and supporting function and duration of survival.

Identifying Patients Who Could Benefit From Palliation: No evidence tools have been validated or effectively shown to predict optimal timing. Decisions should be based on each patient's symptoms and preferences.

Treatment Strategies:

• Pain
  • Evidence is strong in support of the use of nonsteroidal anti-inflammatory drugs, opioids, bisphosphonates, and radiotherapy or radiopharmaceuticals for pain, with bisphosphonates used for bone pain specifically.
  • Insufficient evidence exists to evaluate the usefulness of acupuncture or exercise for pain control.
  • Palliative care teams may be moderately beneficial in providing pain management.
• Dyspnea
  • Evidence shows a valuable effect of morphine.
  • Nebulized opioids show no additional benefit over oral opioids.
  • Evidence regarding the use of oxygen is equivocal.
  • Studies that evaluated facilitated communication or palliative care consultation showed no effect.
• Depression
  • Evidence suggests that long-term use of tricyclic antidepressants, selective serotonin reuptake inhibitors, and psychosocial interventions are beneficial for patients with cancer who are depressed.
  • Evidence is mixed regarding the benefit of guided imagery and exercise in the defined patient population.
  • Evidence showed that care coordination had no effect.

Important Elements for Advance Care Planning: Evidence shows that extensive multicomponent interventions, goal-oriented interviews with palliative care providers, and proactive communication involving skilled discussants can reduce unnecessary services, without causing harm, and increase the use of advance directives.

Collaboration and Consultation: Use and patient-centered outcomes improve when multidisciplinary teams include nurses and social services providers, address care coordination, and use facilitated communication.

Supporting Caregivers: Evidence regarding the effects of palliative care teams for caregivers is mixed.

The following were graded as strong recommendations with moderate quality of evidence.

• Patients with serious illness at the end of life should be regularly assessed for pain, dyspnea, and depression.
• For patients with cancer, clinicians should use therapies with proven effectiveness to manage pain. These therapies include nonsteroidal anti-inflammatory drugs, opioids, and bisphosphonates.
• Clinicians should use therapies with proven effectiveness to manage dypsnea. These therapies include opioids (for unrelieved dyspnea) and oxygen (for the relief of short-term hypoxemia).
• Clinicians should use therapies with proven effectiveness to manage depression in patients with cancer. These therapies include tricyclic antidepressants, selective serotonin reuptake inhibitors, and psychosocial interventions.
• Clinicians should ensure that advance care planning occurs for all patients with serious illness. Such planning includes the preparation of advance directives.

• Several authors had grants from the Agency for Healthcare Research and Quality or pharmaceutical companies.
• Financial support for this guideline was entirely from the American College of Physicians.

The guideline provides clear guidance in several areas of end-of-life care and symptom management and identifies the relevant evidence and strength of the evidence. The guideline may not apply to all patients and is not intended to override clinical judgment. In addition to recommending medication interventions for depression, the guideline recommends psychosocial interventions.

Explore the effectiveness of payayor compared with benzydamine for the prevention and relief of radiation induced mucositis.

Patients were randomized to receive either benzydamine (BZD) hydrochloride (Difflam, 3M, Australia) 15 ml, rinse 3 times daily or glycerin payayor 3 drops, 3-5 times daily. Payayor is an herb that was prepared in a standardized preparation that contains flavinoids and glycosides with sulfur compounds. A single research assistant instructed participants in oral hygiene care, how to use the product, and avoidance of tobacco, alcohol, or other oral products. All patients received normal saline as a mouth cleaning solution. Oral examinations were done weekly until two weeks after treatment.

The sample was comprised of 30 patients. The mean age was 55.66, with a range of 32-62 years. Females 25%, Males 75%.

Diagnosis Information: Cancer of the nasopharnyx, larynx, oral cavity and tonsils. All were scheduled to receive radiation therapy daily 5 times per week, up to 6,000cGy.

Other Key Characteristics: Over 50% had concomitant chemotherapy.

Single site

Outpatient setting: Bangkok, Thailand

Prospective, single, blind, randomized controlled trial

Oral examination 0-4 scale for symptom grading by the patient World Health Organization grading system for oral mucositis. Patient satisfaction 5 point scale.

All patients developed oral mucositis. Time to onset was 1.24 weeks with payayor versus 0.44 weeks with BZD (p < 0.001). Total radiation dose to onset was higher in the payayor group, but was not significantly different from BZD. Mean mucositis severity scores were lower in the payayor group (p < 0.001). There were more treatment delays in the BZD group, with 30% of these due to oral pain. No treatment delays due to oral symptoms were reported for the payayor group. The mean satisfaction score in the payayor group was significantly higher (p < 0.01). Patients in the payayor group described a feeling of increased saliva in the mouth with alleviation of xerostomia symptoms. All symptoms were mild to moderate.

Results support the protective and relief effects of BZD and payayor in patients receiving radiation therapy for head and neck cancer. Payayor was well tolerated and potentially can be more effective for mucositis prophylaxis.

Small sample <100

No discussion of other medications provided for oral pain relief. The sample size was too small to provide appropriate subgroup analysis by radiation dosage or between those who had concomitant chemotherapy or not.

Payayor and BZD are shown to be at least somewhat effective for the prevention of mucositis in patients receiving radiation therapy, prone to oral complications. Findings here warrant further investigation of efficacy in other patient groups and in comparison to other standard treatments in this area. BZD is not yet approved for this use in the United States.

To examine whether providing pre-, post-, or pre-/post-radiotherapy fatigue education and support (RFES) reduced the severity of fatigue at the end of six weeks post radiotherapy.

A 60-minute session was held using a PowerPoint presentation, participant handbook, goal setting sheet, and progress diary. Follow-up telephone calls were made to patients two and four weeks after the session to reinforce the information. Content included radiotherapy processes, side effects, and behaviors to reduce fatigue, such as activity modification, sleep hygiene, and relaxation.

• In total, 91 patients (49% male, 51% female) were included.   
• Mean age was 57.65 years.
• Cancer diagnoses included were breast (34%), prostate (33%), other diagnosis (13%), melanoma (11%), and head and neck (9%).
• Length of radiotherapy was 29.5 days.

• Single site   
• Outpatient
• Radiation oncology department of a major metropolitan hospital in Brisbane, Australia

Patients were undergoing the active treatment phase of care.

The study used a three-group, quasiexperimental, pre/post design.

• Medical Outcomes Study (MOS) Sleep Scale
• Multidimensional Fatigue Inventory (MFI)
• EuroQol-5D (EQ-5D)
• Frenchay Activities Index (FAI)
• International Physical Activity Questionnaire (IPAQ)
• Hospital Anxiety and Depression Scale (HADS)
• Health and Labour Questionnaire (HLQ)
   

Pre-RFES showed no improvement in fatigue compared to no pre-RFES. Post-RFES showed no improvement in fatigue compared to no post-RFES.

Patient-reported fatigue was unaffected by the intervention for any of the time points it was delivered.

• The study had a small sample size, with less than 100 patients.
• No appropriate nonintervention control group was used.

 Additional interventions should be considered when attempting to alleviate fatigue in patients receiving radiotherapy.

To evaluate the effectiveness of endoscopic ultrasound–guided (EUS) celiac plexus neuroloysis (CPN) for relief of the pain of chronic pancreatitis or pancreatic cancer

• Databases searched were MEDLINE, databases of PubMed and Ovid journals, Ovid, EMBASE, CINAHL, Database of Abstracts of Reviews of Effects (DARE), ACO Journal Club, and International Pharmaceutical Abstracts.
• Search keywords were endoscopic ultrasound, endoscopic ultrasonography, celiac plexus block, celiac plexus neurolysis, chronic pancreatitis and pancreatic cancer.
• Studies were included if they were studies of EUS CPN used for control of the pain of chronic pancreatitis or unresectable pancreatic cancer.

The search retrieved 1,439 articles relating to 130 studies. Authors chose for analysis eight studies of pancreatic cancer and nine studies of chronic pancreatitis. Of the studies involving pancreatic cancer, four were abstracts.

The total sample size in studies relating to pancreatic cancer was 243 patients. The range of sample size in studies of pancreatic cancer was 10–71. 

Study procedures conformed with the Quality of Reporting of Meta-analysis (QUORUM) statement. Study design conformed to the guidelines of the Meta-analysis of Observational Studies in Epidemiology (MOOSE) group. Authors removed two studies from pooled analysis because the studies contributed to heterogeneity. Pooled analysis of the remaining six studies showed that 80.12% of patients experienced pain relief (95% CI 74.47–85.22). The complication rate associated with the procedure was low. Across all studies, only two patients had diarrhea, which medication resolved. Subgroup analysis showed that bilateral injection of the celiac plexus resulted in better pain relief than did a single injection. The majority of the studies demonstrated reduction in the use of oral opioid agents for pain relief.

Findings demonstrate that EUS CPN may be an important option in management of the pain of pancreatic cancer. The technique is associated with a very low rate of complications. Pain relief is enhanced with bilateral injection of the celiac plexus. The technique was associated with reduction in oral opioid use.

In advocating for patients with pain due to pancreatic cancer, oncology nurses can discuss EUS CPN as an option. The procedure may be especially helpful to patients for whom opioids cause significant side effects.

This study describes an integrated approach that includes a qualified psychotherapist as an active part of the oncology team. The first consultation with the patient included a PhD-level specialist. The oncologist asked the patient for both medical and psychological treatment consent. The psychologist performed psychological evaluations; conducted structured interviews; and measured, observed, and supported patients. One aim of the study was to evaluate feasibility of this integrated approach.

Outcomes measured included anxiety and depression, adaptation and awareness, and subjective perception of medical treatment quality. Outcome data were collected before and after 18 weeks of chemotherapy.

The sample was composed of 98 participants with metastatic or locally advanced colorectal cancer.

• Single site
• Cancer institute
• Rome, Italy

Prospective, nonrandomized design

• Hospital Anxiety and Depression Scale (HADS)
• European Organization for Research and Treatment quality of life questionnaire (EORTC QLQ-C30)

Prior to treatment 30% (29 patients) were found to have psychopathologic disorders. With the total of 294 psychodynamic interviews conducted, the McNemar test showed a significant improvement in terms of adaptation and awareness between pretreatment and 18 weeks. The mean HADS score initially was 4.9 ±2.9 for anxiety and 5.5 ±3.4 for depression, showing no abnormal depression or anxiety. After 18 weeks, the scores for anxiety decreased (p < 0.02). No significant change occurred with depression. At the completion of 18 weeks of therapy, there was a significant increase in the number of patients having a positive experience on health-related quality of life (53% versus 70%), anxiety (49% versus 63%), depression (54% versus 69%), interpersonal relationships (61% versus 79%), free time (61% versus 73%), and positive perception of treatment quality.

The results show the feasibility and some evidence of the benefit of the integrated approach to oncology care. Patients seemed to have a positive inner experience regarding the physician-patient relationship.

• The study was prospective and nonrandomized. It did not include a control group and was conducted at one site only.
• The study did not specify the exact actions of the psychologist.