RESOURCE TYPE: Evidence-based guideline

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

Not clearly listed in article. Article focused on the consensus points and education points. Prior to those sections, a general section regarding the literature was included.

• BTCP is not the same as background pain or end-of-dose pain.
• Assess pain for evidence of BTCP using algorithm such as the one by Davies et al. Recommend assessment of pain using 1–10 scale. Studies of the outcomes in patients who are assessed and managed using the assessment tools needs to be completed.
• Manage pain by considering the cause of the pain. Optimize control of background analgesia and background pain before trying to treat BTCP.
• The most common approach to manage BTCP in Canada includes the use of traditional short-acting opioids.
• Using up to 20% of total daily opioid dose to treat BTCP is reasonable. Consider using different formulations for background and breakthrough pain.
• Transmucosal fentanyl formulations are beneficial over traditional methods. Pharmacologic properties of the fentanyl formulation should be matched with the characteristics of the BTCP. Never use transmucosal fentanyl formulations in opioid-naïve patients. Injectable fentanyl and sufentanil can be used sublingually or intranasally in the inpatient setting; not recommended in outpatient setting.
• Concerns regarding opioid abuse and dependence should not prevent clinicians from using opioids in patients with a life expectancy less than three months.

• Developed for use in Canada and may not be generalizable to areas outside Canada

Understanding BTCP is vital for nurses to adequately manage pain. Nurses need to be aware of the available guidelines since they are usually at the sharp end of managing pain. With this knowledge, nurses can educate patients and families regarding the proper use of medications to manage pain, specifically BTCP.

RESOURCE TYPE: Expert opinion

• DATABASES USED: None
• INCLUSION CRITERIA: None
• EXCLUSION CRITERIA: None

PHASE OF CARE: Active antitumor treatment

Expert opinion

Literature review of common checkpoint inhibitors adverse events. No quality review provided.

Further education needs to be available on the toxicity profile related to immune checkpoint inhibitors, and obtaining a detailed personal and family history of autoimmune diseases, other comorbidies, concurrent medications, PE, and medications of patients is important prior to starting therapy.

To evaluate the effectiveness of guaraná in fatigue and depression in 36 patients with breast cancer undergoing adjuvant radiotherapy.

Patients were randomized to 75 mg guaraná daily or placebo for two weeks, and then switched to the opposite treatment for the last two weeks of radiotherapy. Randomization was centralized by a pharmacist.

• The final sample size was 36 patients.
• Mean age was 59 years for the experimental group and 57 years for the control group.
• All participants were women.
• Patients were diagnosed with early stage breast cancer for which adjuvant radiotherapy was indicated.

Patients were recruited at Faculdade de Medicina da Fundação do ABC.

The study was a randomized, controlled crossover trial.

• Patients completed the Chalder Fatigue Scale, the Brief Fatigue Inventory (BFI), and the Beck Depression Inventory (BDI) Scale II.
• These assessments were conducted immediately before first radiotherapy, at switching, and right before the start of the last radiotherapy treatment.

No significant differences existed between the two groups on any of the scales. In addition, no side effects were reported from the guaraná.

This study showed no effect from guaraná on fatigue for this population.

The study used patients who reported no fatigue at the beginning of the study.

A currently fatigued population may be worth exploring with guaraná. Patients using guaraná for fatigue should be educated about the research findings.

To present physiotherapy modalities applied for lymphedema therapy through a systematic literature review

Databases searched were Latin American and Caribbean Literature (LILACS), PubMed, and SciELO, covering periods from 1981–2009, 1951–2009, and 2001–2004, respectively. Also, data from physiotherapy textbooks were surveyed. Search keywords were post mastectomy lymphedema, physiotherapy upper limb lymphedema, complex decongestive physiotherapy, and manual lymphatic drainage. Inclusion and exclusion criteria were not described.

No description was provided of the total number of studies reviewed initially, of how identified articles were assessed, or hwo studies were selected and evaluated. 

• Nineteen studies were included in the report.
• The sample range across studies was 3–537.
• All samples included women with lymphedema post-breast cancer treatment.

Physiotherapy used for lymphedema treatment includes complex decongestive therapy (CDT), pneumatic compression (PC), high-voltage electrical stimulation (HVES), and laser therapy. Better results are obtained with combined techniques. CDT is the most used protocol, and its association with PC has demonstrated efficacy. The new techniques HVES and laser demonstrate satisfactory results.

CDT has the strongest scientific support. Its application together with PC has demonstrated efficacy, and new techniques with satisfactory results are being studied, such as HVES and laser therapy. Combined physiotherapy techniques produce the most beneficial effects.

Clinicians should select the best combination based on a detailed assessment of individual cases.

To evaluate the effectiveness of guarana in the treatment of the fatigue and depression of patients with breast cancer who are undergoing adjuvant radiation therapy

Guarana, a plant native to the central Amazon, is known for its stimulant properties. The study involved three phases. Investigators randomized patients at the start of adjuvant radiation treatment (RT) to either guarana or placebo (phase 1). Halfway through RT, crossover occurred from placebo to guarana and vice versa (phase 2). Protocol terminated at end of the 28th RT (phase 3) for both groups. Assessments occurred three times, once at the start of each phase. The total time of the trial was 35 days. A dose of 75 mg/day guarana was administrated.

• The sample was comosed of 36 participants. In Group A, 17 participants received guarana first, then switched to placebo. In Group B, 19 received placebo first then switched to guarana.
• Mean patient age in Group A was 59 years; in Group B, 57 years.
• All participants were female and had infiltrating ductal breast cancer. All patients had undergone mastectomy and were receiving adjuvant RT. Authors state that most participants had stage I or II cancer, but they do not provide a table of sample characteristics. 

• Single site
• Outpatient
• Brazil

Active treatment

Double-blind randomized design with crossover

• Chalder Fatigue Scale (CFS)
• Brief Fatigue Inventory (BFI), in Portuguese
• Beck Depression Inventory-II (BDI-II), validated in Portuguese

• Authors reported no statistically significant differences between the guarana- and placebo-treated group, on any of the measures of fatigue or depression.
• Authors reported no significant differences within groups over time or in different treatment arms, placebo or guarana.
• Authors noted no toxic effects of guarana.
• Participants in neither group had significant fatigue or depression at the start of the trial. Showing the improvement of a nonexistent symptom is impossible, according to the so-called floor effect.

Findings did not support the use of guarana for the treatment of depression or fatigue in cancer patients.

• The study had a small sample, with fewer than 30 participants. Conclusions drawn from such a small sample may not be valid.
• The study was likely underpowered in regard to detecting group differences.
• Participants did not demonstrate significant symptoms at baseline. A better course may be to select either patients at risk for fatigue and depression or a sample of individuals already presenting with such symptoms, to see if treatment results in improvement.

Due to the limitations noted, this study does not support valid nursing conclusions.

To investigate if providing tailored information to patients with advanced head and neck cancer decreases patients' symptoms of anxiety and depression

Patients at one study site received the intervention, and patients at another study site did not receive the intervention and were treated as a control group. The tailored information used was a multimedia tool that included a patient booklet; interactive computer software; computer animation describing cancer spread, staging, and surgical procedures; and a take-home DVD. The purpose of the packet was to educate patients about diagnostic and adjuvant procedures, nutrition, and speech and swallowing practice. Another component was a database. The database could receive and store patient input and could print information that could be given to the patient. The intervention was provided at the hospital by a nurse who was available to address patients' questions and concerns. The control intervention was usual care provided by a nurse practitioner who provided verbal information and pamphlets and met with some patients in an ad hoc manner. Data were collected at baseline. Outcomes were assessed at three months and six months.

• The study reported on a sample of 96 patients.
• Mean patient age was 59.8 years. The age range was 19–87 years.
• The sample was 75% male and 25% female.
• All patients had stage III or IV primary or recurrent head and neck cancer.
• Most patients received combination radiation and chemotherapy.
• The education level of the groups varied significantly, with patients in the control group having a much higher level of education.
• About half of the sample was employed.

• Multisite 
• Setting not specified
• Montréal, Canada

Active antitumor treatment

Nonrandomized controlled trial

• Distress Thermometer
• Hospital Anxiety and Depression Scale (HADS)

Over time, anxiety was lower in the intervention group (p = 0.001), and there was a significant group-by-time effect (p = 0.025). Anxiety did not decline in the control group over time. Over time, depression declined in both groups (p = 0.001), and there were no group differences in depression. Findings were grouped by low, borderline, and high anxiety levels according to HADS results. In the low-anxiety group, patients reported lower levels of anxiety over time than did controls (p = 0.003). In the borderline group, there were no significant differences between study groups. Among those who had clinical levels of anxiety at baseline, patients had lower levels of anxiety at three months (p = 0.014) and six months (p = 0.005). Among those with clinical depression in the control group, depression initially increased at three months and then decreased toward baseline,

Findings demonstrate that the providing information can have an effect on anxiety. It cannot be determined if the nature of the multimodal intervention was a critical factor or whether providing information in any form would be helpful, since there was no random patient assignment and patients in the control group received information in an inconsistent, ad hoc manner.

• The study had a small sample size, with fewer than 100 participants.
• The study had baseline sample and group differences of import.
• The study had a risk of bias due to no control group, no blinding, no random assignment, and no appropriate attentional control condition.
• Baseline data were obtained after the intervention was given.

Findings suggest that providing information to patients may help reduce patients' anxiety but not their symptoms of depression. This study used a package of information; such a package may be a practical means of ensuring that the information patients receive is consistent. Multiple limitations in this study prevent the drawing of firm conclusions about the effectiveness of the method studied.

To perform a systematic review of evidence related to the use of mind-body therapies to address various symptoms of depression

• Databases searched were PubMed, EMBASE, CINAHL, PsycINFO, Current Contents, Web of Science, and Web of Knowledge.
• Searched keywords were MeSH terms for depression, complementary therapies, mind-body therapies, biofeedback, hypnosis, autogenic training relaxation, meditation, imagery, yoga, relaxation therapy, mindfulness, and multiple terms for yoga and tai chi.
• Studies were included if they used a validated depression-scoring system and monitored for changes over time and if the study used any type of control comparison.
• Studies were excluded if they did not last at least two weeks and if they had a sample size of more than 30 participants.

• Investigators retrieved 2,864 references.
• Authors used the Scale for Assessing Scientific Quality of Investigations, modified for use in studies of complementary and alternative medicine.

• The final number of studies analyzed was 90. Eight studies included patients with cancer.
• Across studies, the size of samples included in analysis was 30–298. In studies including patients with cancer, sample size was 38–191. The total number of patients in studies that included patients with cancer was 561.
• Studies including patients with cancer involved mainly breast cancer patients.

Among studies that included patients with cancer, six studies involved yoga and one examined relaxation and guided imagery. Among the yoga studies, three showed positive results with yoga alone or in combination with other supportive therapies, two showed negative results, and the results of one were equivocal. Relaxation and guided imagery were associated with postive results. Across all studies involving various medical illnesses, 74% associated mind-body therapies with positive results.
 

Mind-body therapies appear to be effective in reducing symptoms of depression.

• Authors eliminated studies with relatively low quality scores. How these exclusions affected the final sample is unclear.
• Most studies did not include any attentional control conditions, and authors noted that attention alone could have produced positive results. (Individualized attention is often lacking in mainstream medicine.)
• Many studies involved multiple modalities, so gauging the effect of any single intervention is difficult.
• Authors used various types of instruments to measure depression. Because the level of depression involved is unclear, one cannot tell if benefit was derived by patients with clinically relevant symptoms.

The individualized attention provided to patients via mind-body therapies may be beneficial in reducing symptoms of depression.

The objective of the study is to identify the benefit of home oxygen therapy on breathlessness within a palliative care program.

Data were collected (from face-to-face clinical encounters) from a consecutive cohort of 5,862 patients seen by a regional community palliative care program. Patients who were prescribed home oxygen concentrators by referral to palliative care for symptomatic breathlessness were the population of interest. Breathlessness was assessed before and one week after oxygen prescription and before and two weeks after oxygen prescription as a way to explore benefits of home oxygen on an extended time frame.

Four hundred and thirteen patients were included for analysis and were found to have data collection points during the week before and at least one week after home oxygen prescription, and 230 comprised available breathlessness scores during the week before and at least two weeks after home oxygen prescription. The average age was 69.69 years, with a median age of 72 years and a range of 0-108 years. The sample was comprised of 2,552 (43.4%) females and 3,310 (56.6%) males. Of the sample, 5,386 (91.9%) identified with cancer diagnoses. Of the 413 patients included for analysis, 384 (93.1%) identified cancer diagnoses as their “life-limiting illness.\" Patients were prescribed home oxygen concentrators after referral to palliative care for symptomatic breathlessness.

The study was conducted in an inpatient setting at Silver Chain Hospice Care Service (SPHCS), a regional community palliative care program covering all the metropolitan area of Perth, Western Australia.

Descriptive, retrospective

Symptom Assessment Scale (SAS)-0-10 scale, although the anchors for each end of the scale for dyspnea were not identified

No significant improvement in SAS was observed one week after oxygen prescriptions (mean = 5.1, SD = 2.6, median = 5, range = 0-10, P value = 0.28). Where data were available for 230 individuals on home oxygen therapy, mean SAS dyspnea score was 5.4 (SD = 2.5, median = 4, range = 0-10), and no significant improvement in breathlessness scores was noted two weeks after use of home oxygen (mean = 5.2, SD = 2.5, median = 5, range = 0-10, P = 0.35). Sub-group analysis based on primary underlying diagnosis associated with breathlessness for people prescribed home oxygen showed no remarkable difference among individual response rates.

No significant clinical improvement in breathlessness was observed among this palliative care population.

The study had no group without oxygen for comparison. Pulse oximetry and dyspnea rating were not consistently measured after application of oxygen therapy, allowing only for assumed or indeterminable benefits of oxygen therapy. Authors reported that the sample size as too small for the differences in the primary cause of breathlessness to be fully explored. Generalizability was broadly reflective of palliative care patients admitted on a referral basis in “resource-rich” community settings and may not reflect the experience of individuals not referred for symptom management support. The post-hoc analysis design presents limitations in data selected to report and the use of a uni-dimensional measure of breathlessness that may not reflect the complete experience or distress the symptom causes in some individuals.

More data and studies regarding the symptomatic benefits of home oxygen therapy and the relationship between hypoxemia, breathlessness, changes in functional status, and the way in which oxygen is prescribed are needed.

Each participant took one placebo and a 24 hour-dose of sustained-release morphine daily, 12 hours apart. For one week participants took the active dose in the morning; for one week they took the active dose in the evening. For each participant, the study lasted 17 days. The time of administration was randomized in double-blind manner. The study was completed over 12 months.

The sample was composed of 42 people with advanced cancer who were suffering from opioid-responsive pain and who were taking stable opioid doses. Twenty-six of the 42 completed the study, providing adequate power (80%) for analysis.

Patients in the sample were in five regional palliative care programs in Australia.

Randomized multisite double-blind, placebo-controlled crossover equivalence and effectiveness study that comprised broad inclusion criteria

• 100 mm visual analog scale (VAS), to measure pain during the last two days (steady state) in both arms of the study (Investigators collected pain scores every four hours while the patient was awake.)
• VAS and categorical scales, to measure other pain parameters, quality of sleep, nausea, vomiting, constipation, confusion, and somnolence

• Mean VAS: morning dosing = 16 mm; evening dosing = 14 mm (p = 0.76, difference of adjusted means = 2 mm, 95% CI –2, 6). Data indicate no significant differences in pain control, pain during day, pain-disturbing sleep, or with breakthrough medication use.
• In regard to nausea, authors noted a significant treatment difference but no period or sequence effect. Authors observed no difference, associated with morning or evening administration of morphine, in use of antiemetics.
• Authors observed no significant treatment, period, or sequence effects regarding side effects other than nausea.
• Ten participants indicated a preference for a time period; eight preferred evening administration of morphine.

This study suggests that once-daily sustained-release morphine can be administered, to people with significant opioid-responsive pain and advanced cancer, with equal overall effect in the morning or the evening.

The findings regarding nausea may be a statistical rather than a clinical finding—a Type I error. Of the 42 randomized patients, 16 withdrew. Nine withdrew from the am-pm arm and seven withdrew from the pm-am arm. In the am-pm arm, three cited efficacy as the reason for withdrawal. In the pm-am arm, one cited efficacy as the reason for withdrawal. The difference in withdrawals, am-pm vs. pm-am, was not significant (p = 0.97). Authors questioned whether the study should have been powered to show a smaller difference, though the patients were already optimized on opioids.

Patients in the study population suffered typical end-of-life pain. Future researchers should define a subgroup (e.g., those with poorly controlled pain, those on high doses of opioids, those who are still trying to function at work). Other than in regard to nausea, secondary measures indicated no differences relating to administration time. Future research could assess effects on sleep patterns, quality of life, activities of daily living, and fatigue.

To determine if 15 minutes of therapeutic massage is associated with reduction in patient-expressed levels of pain, fatigue, and emotional and physical distress during hospitalization

Patients were recruited over a three-year period. The same social worker assessed the four domains of distress evaluated; assessments were done pre- and postmassage. All patients served as their own controls. Before the massage, the massage therapist asked the patient which parts of the body to massage. The most frequently chosen area was feet and legs or back, neck, and shoulders. The massage therapist provided each patient with a 10–15 minute Swedish massage. A CD player provided the same music to all patients.

• The sample was composed of 251 patients.
• Mean patient age was 59.4 years. The age range was 20–80 years.
• The percentage of male patients was 30.3%. The percentage of female patients was 69.7%.
• The sample included a broad distribution of cancer sites.
• Of all patients, 68.9% were white, 29.1% were Black; 2% self-identified as belonging to an ethnic group.

• Single site
• Inpatient
• University hospital in Georgia, United States

Observational

The study used MacDonald’s scale, modified, for patient evaluation of massage therapy (rating on a 1–5 point Likert scale, Cronbach's alpha = 0.850).

Authors found significant reductions relating to each of the four dimensions measured. Mean pain scores declined (p = 0.000, effect size = 0.7270), fatigue scores declined (p = 0.000, effect size = 0.714), physical distress declined (p =.000, effect size = 0.756), and emotional distress declined (p = 0.000, effect size = 0.6810). Posthoc analysis did not reveal that the main effect was affected by interactions with possible covariates.

Results demonstrated that massage therapy was associated with reduction of physical and emotional distress, pain, and fatigue in a broad range of hospitalized patients.

• The study did not have an appropriate control group.
• The authors noted that a large proportion of patients refused to participate. Males were more likely to refuse participation than females. This suggests that some patients have preconceptions about massage or privacy concerns regarding human touch. The study may have a risk of bias due to selection bias.
• Postintervention assessments were performed immediately after the intervention. They do not reflect how long perceived benefits lasted.
• The sample consisted of hospitalized patients, but authors provided no information about phase of care or whether patients were hospitalized for comorbid conditions.

Nurses must consider the possibility that patients have preconceptions or privacy concerns regarding massage therapy. Authors suggested that some patients might be more comfortable with the intervention if it were called a back rub rather than a massage. Nurses in settings that offer massage should incorporate information about the intervention and allow patients to discuss their preconceptions and concerns. Findings suggest that a brief massage can relieve distress during hospitalization. Nurses should consider reinstituting the back rub as a standard nursing intervention.