To assess the effectiveness of retreatment with radiotherapy for painful bone metastases

Data were collected from medical records. Only evaluable patients with pain response documentation were included in the analysis. Information from records was used to categorize pain because no numerical pain scores were recorded. For patients with available data, the pain response proportion was calculated. For those with no response data, it was assumed that these were nonresponders for the calculation of a worst-case scenario.

• N = 247
• MALES: 57%, FEMALES: 43%
• KEY DISEASE CHARACTERISTICS: Various tumor types
• OTHER KEY SAMPLE CHARACTERISTICS: Overall, 56% of patients had multiple bone metastases, and the most frequent sites were spine, pelvis, and hips.

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

• PHASE OF CARE: Late effects and survivorship
• APPLICATIONS: Palliative care 

Retrospective, descriptive study

Not applicable

Overall, 66% of evaluable patients indicated responses with decreases in pain. In the worst-case analysis, the overall response rate was 43%. The use of systemic analgesia (overall response [OR] = 0.39, p = 0.037) and prior pain response to radiotherapy (OR = 1.01, p = 0.049) were predictors of response to repeat radiotherapy. Patients who had an initial response were more likely to respond to retreatment, and those having used systemic therapy were less likely to respond. The toxicities experienced were all grades 1 and 2, including nausea and vomiting, fatigue, diarrhea, and skin reactions. In 4% of patients, a pathologic fracture at the retreated site was reported, and one patient developed radiation-induced femoral head necrosis requiring a total hip replacement. For the initial treatment, it was reported that 13% of patients received no pain medication, and 43% had only levels 1 and 2 analgesia according to the World Health Organization analgesic ladder.

The findings of this study suggested that retreatment with radiation therapy for bone metastases can be effective for pain reduction. Prior response to radiation therapy for pain suggested better odds that retreatment would produce a response.

• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment) 
• Unintended interventions or applicable interventions not described that would influence results
• Measurement/methods not well described
• Measurement validity/reliability questionable
• Other limitations/explanation: No information was provided regarding whether any bone modifying agents were used. The initial analgesia used was low, and it was not clear if pain was maximally treated.

Patients who have initial pain responses to radiation therapy for bone metastases may benefit from repeat radiotherapy.

To examine changes in dyspnea through a randomized trial of high-flow oxygen (HFO) and bilevel positive airway pressure (BiPAP) in patients with cancer

Patients were randomized using a computer-generated randomization scheme in a 1:1 ratio to receive either two hours of HFO followed by a washout period and then two hours of BiPAP or two hours of BiPAP followed by a washout period followed by two hours of HFO. Data on dyspnea were collected every 10 minutes after the first intervention for as much as one hour. Patients participated in the second intervention if their dyspnea level was ≥ baseline dyspnea level minus one or  ≥ 3/10 after one hour.

• N = 30
• AVERAGE AGE = 61 years (range = 29–79 years)
• MALES: 47% (n = 14), FEMALES: 53% (n = 16)
• KEY DISEASE CHARACTERISTICS: Lung 43% (n = 13), head and neck 3% (n = 1), genitourinary 3% (n = 1), gastrointestinal 10% (n = 3), breast 17% (n = 5), other 23% (n = 7); cancer stage metastatic 87% (n = 26) and local 13% (n = 4); causes of dyspnea were pulmonary parenchymal lesions 70% (n = 21), pleural effusions 50% (n = 15), lymphangitic carcinomatosis 7% (n = 2), and other noncancer causes; not already on home supplemental oxygen 70% (n = 21); majority of participants (93%) on supplemental oxygen at the time of enrollment with a median of 3 L per minute and an average oxygen saturation of 95% (SD = 4%). 
• OTHER KEY SAMPLE CHARACTERISTICS: Inclusion criteria: average intensity of dyspnea at rest over the past week ≥ 3/10 on a numeric rating scale despite the use of supplemental oxygen, life expectancy of more than one week, and English-speaking; exclusion criteria: hemodynamic instability, acute respiratory distress with impending intubation, delirium (Memorial Delirium Assessment Scale > 13/30), Glasgow Coma Scale < 8/15, contraindications to BiPAP, or noncancer-related dyspnea with supplemental home oxygen before hospitalization

• SITE: Single site  
• SETTING TYPE: Inpatient  
• LOCATION: MD Anderson Cancer Center

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

Randomized, open-label study with a parallel design and an optional second intervention

• Numeric Rating Scale (NRS), a measurement of dyspnea on a 0–10 scale
• Modified Borg Scale (MBS), an assessment scale for dyspnea
• Global symptom evaluation
• Memorial Delirium Assessment Scale (MDAS)
• Glasgow Coma Scale (GCS)

HFO and BiPAP were found to alleviate dyspnea and improve physiologic parameters. The results of this study justify larger randomized, controlled studies to validate these findings. The authors of this study proposed that HFO and BiPAP be examined separately.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Other limitations/explanation: Multiple statistical comparisons were conducted. Baseline arterial blood gas and a measurement of oxygen saturation while on room air were not conducted.

Dyspnea is one of the most common symptoms for patients with cancer. This study shows that HFO and BiPAP may alleviate dyspnea. These devices are safe for patients to use. Larger randomized, controlled clinical trials are needed to confirm the findings of this study.

To study the feasibility of a randomized, controlled trial exploring the effects of fentanyl on breakthrough dyspnea, walking distance, vital signs, and adverse events in patients with cancer

• N = 20  
• MEDIAN AGE = 55 years (range = 27–75 years) (mean age was 55 years in the fentanyl group 54 years in the placebo group)
• MALES: 45% (n = 9), FEMALES: 55% (n = 11)
• KEY DISEASE CHARACTERISTICS: Breast (5), gastrointestinal (1), genitourinary (3), gynecologic (2), lung (4), and sarcoma (5); other diseases were chronic obstructive pulmonary disease, heart failure, asthma, and bronchiectasis
• OTHER KEY SAMPLE CHARACTERISTICS: Patients were included if they had a cancer diagnosis, were aged 18 years or older, had average intensity breakthrough dyspnea of three or more on a 10-point Numeric Rating Scale, spoke English or Spanish, were ambulatory with or without an assistive device, had a Karnofsky Performance Status of 50% or more, and were on a stable dose of strong opioids with a MEDD of 30–580 mg. Patients were excluded if their dyspnea scores at rest were seven or more out of 10, they used more than 6 L per minute of supplemental oxygen, they experienced delirium (Memorial Delirium Assessment Scale > 13 out of 30), they were allergic to fentanyl, they had history of substance abuse, they had a recent history of coronary artery disease, and if they had uncontrolled tachycardia or hypertension at the time of assessment.

• SITE: Single site  
• SETTING TYPE: Outpatient  
• LOCATION: Supportive Care Center at the MD Anderson Cancer Center

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

Double-blinded, placebo-controlled, randomized trial

• Numeric Rating Scale (NRS) to measure dyspnea from 0–10 (0 = no shortness of breath and 10 = worst possible shortness of breath)
• Borg scale to assess fatigue level
• Global Symptom Evaluation (GSE) to evaluate change in dyspnea following interventions
• Edmonton Symptom Assessment Scale (ESAS) and Cancer Dyspnea Scale (CDS) at baseline to assess the quality of dyspnea over the previous few days

The prophylactic administration of subcutaneous fentanyl appears to be a safe and well-tolerated method for reducing dyspnea, fatigue, and respiratory rate while also enhancing physiologic function and activity levels among patients with cancer. However, the generalizability of these findings are limited because of the small sample size.

• Small sample (< 30)
• Findings not generalizable
• Intervention expensive, impractical, or training needs
• Other limitations/explanation: The statistically insignificant improvement of dyspnea and fatigue among patients in the placebo arm was attributable to a placebo effect. According to the authors, a placebo effect within the context of this study may have been caused by a reporting bias, interviewer bias, or period/training effects. This suggests a need for the standardization of patient encounter experience and the stratification of baseline dyspnea levels. Also, routine subcutaneous administration may not be practical, and it requires some degree of training. The authors suggested rapid-onset fentanyl via transmucosal or intranasal routes as more practical alternatives.

To implement and evaluate an evidence-based practice change to encourage exercise for fatigue

The Iowa Model of Evidence-Based Practice Change was used to guide implementation and measure impact on patient outcomes and care processes. An intervention to implement physical activity for patients to combat fatigue was selected. Activity kits for patients were developed, and included information on the benefits of physical activity, activity logs, instructions for workouts, as well as strategies to improve sleep, and nutrition. A pedometer and resistance bands were also provided. A nurse made regular connections with patients to encourage physical activity. Fatigue assessment was done at clinic visits at baseline and three months later. Results from the physical activity group were compared to those of patients receiving usual care.

• N = 45  
• AGE: Not provided
• MALES (%): Not provided, FEMALES (%): Not provided

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

PHASE OF CARE: Multiple phases of care

Prospective cohort comparison

Brief Fatigue Inventory (BFI)

Patients who received the activity intervention experienced a significant reduction in fatigue (p = 0.0006) and increase in general activity (p = 0.0066).

The intervention to improve physical activity was effective to improve fatigue.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no random assignment) 
• Risk of bias (no appropriate attentional control condition)
• A single DNP was involved in encouraging patients to continue physical activity, so if this type of practice change would be effective without the consistent follow-up of an individual is unclear.

The findings showed that the use of the activity kit and follow-up in this study was effective in increasing physical activity and reducing fatigue in patients with cancer.

To examine the effectiveness of an inpatient group psychoeducational intervention for caregivers of patients receiving inpatient palliative care

Five education group sessions were delivered using a standardized method, the components and conduct of which were developed by authors in the pilot study that preceded the current study. Each was 90 minutes, and they focused on five topics: what palliative care is, the typical role of family caregivers (CGs), available support services to help CGs, preparing for the future, and self-care strategies for CGs. Caregivers were also given the opportunity to arrange individual meetings with designated multidisciplinary team members based on their needs. CGs were referred formally to family meetings if needed.

• N = 126 in T1, 107 in T2   
• AGE = 57 years
• MALES: 33.3%, FEMALES: 66.7%
• CURRENT TREATMENT: Other
• KEY DISEASE CHARACTERISTICS: Adults receiving palliative care, patients with various advanced cancers
• OTHER KEY SAMPLE CHARACTERISTICS: Adults aged older than 18 years, CGs of adults with cancer receiving palliative care, English speakers, adults willing to be recognized as a patient's primary CG. Those with significant emotional distress were excluded.

• SITE: Multi-site   
• SETTING TYPE: Inpatient    
• LOCATION: Australia

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

Pre-/postdesign

• Family CGs’ needs measured with the Family Inventory of Needs (FIN)
• Preparedness for CG role measured by the Preparedness for Caregiving Scale (PREP)
• Competence for the CG role measured by the Caregiver Competence Scale (COMP)
• General Health Questionnaire (GHQ) to determine if CGs were emotionally eligible to participate.
• All measures had an alpha greater than 0.87.
• Measurement occurred before the educational intervention and after three days.

• Significant (p = 0.028) but small effect (0.22) on FIN, indicating improvement in met needs
• Significant (< 0.001), moderate effect (0.43) on preparedness
• No significant change in general health or competence
• A significant difference between those who declared a religious affiliation (improved GHQ scores) and those who had no religion

The educational intervention showed a small to moderate effect on reducing CGs' unmet needs and improved their sense of preparedness. The intervention did not affect CGs’ competence, although a trend of improvement was observed. The intervention did not improve CGs’ psychological well-being (secondary outcome—intervention was not geared to improve psychological well-being).

• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Unintended interventions or applicable interventions not described that would influence results
• Questionable protocol fidelity
• Subject withdrawals ≥ 10%
• Thirteen of the 52 educational sessions 1:1 rather than group

Educational interventions improved CGs' sense of preparedness and decreased their sense of unmet needs. They may help improve CGs’ competence.

To evaluate changes in family caregiver distress between the referral of a patient with advanced cancer to palliative care and eight weeks after patient death based on caregiver involvement in a theoretically- and home-based one-on-one psychoeducational intervention

Family caregivers of patients with advanced cancer enrolled in home-based palliative care services in Australia were randomized to usual care (control) or one of two experimental groups that received usual care and one of two versions of a psychoeducational intervention. One intervention included one home visit and three phone calls, and the other included two home visits and two phone calls to meet rural access issues with some caregivers. Caregivers received written information in a piloted tested guidebook to prepare for the caregiver role, and trained family caregiver support nurses (FCSNs) used intervention manuals to provide consistency in developing and implementing plans to meet family role and caregiver psychological well-being and educational needs. Caregiver distress was measured within a two-week period of patient referral to palliative care (baseline, time 1), one week after the four-week intervention (time 2), and eight-weeks after patient death (time 3).

• N = 298  
• MEAN AGE = Females; 59 years, males; 61.7 years (range = 22–88 years)
• MALES: 30%, FEMALES: 70%
• KEY DISEASE CHARACTERISTICS: English-speaking adult primary family caregivers of patients with advanced cancer enrolled in home-based palliative care
• OTHER KEY SAMPLE CHARACTERISTICS: Exclusion criteria included caregivers of patients with nonmalignant diagnoses or a defined poor functional status

• SITE: Multi-site    
• SETTING TYPE: Home    
• LOCATION: Three states in Australia

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

Randomized, controlled trial with two arms (two versions of intervention)

• General Health Questionnaire (GHQ): 12 items with a history of established reliability and validity

The study sample included 86% urban caregivers. Diverse patient and caregiver factors caused a 42% caregiver attrition rate between time 1 and time 3 that affected the measurement of caregiver psychological well-being at eight-weeks after patient death. Almost 80% of caregivers provided care to a spouse or parent and lived with the patient an average of six years. There was a significant effect for age (p < 0.001) and gender (p < 0.04), and a close significance of time (p < 0.06), but no significant interaction of time with intervention. Younger and female caregivers had worse (higher) GHQ scores, and an overall analysis indicated that the intervention ameliorated a usual rise in caregiver distress after patient death but did not fully prevent an insult to caregivers' psychological well-being.

Psychological distress decreased by eight weeks after patient death among the caregivers of patients with advanced cancer enrolled in palliative care services if caregivers received a psychoeducational intervention involving one home visit and three phone calls.

• Unintended interventions or applicable interventions not described that would influence results: Authors acknowledged the inconsistency of caregiver support services as part of palliative care services, which would have affected FCSN effect with identified intervention
• Subject withdrawals ≥ 10%

Trained FCSNs exert a powerful role in assisting the caregivers of patients with advanced cancer during the dying process, preventing the complications of prolonged grief. The implementation and evaluation of theoretically-based interventions, tailored to caregiver needs and sociocultural context, can support the efficient multidisciplinary team delivery of care to promote caregiver well-being.

To examine the effects of a four-step, nurse-led, in-person and phone-based psychoeducational intervention on psychological distress, perceived unmet needs, preparedness, competence, and positive emotions among family caregivers of patients with advanced cancer

Family caregivers of patients with advanced cancer enrolled in home-based palliative care services in Australia were randomized to usual care (control) or to a four-step intervention. Caregivers received a written instruction manual on preparation for the caregiving role and a home visit from a family caregiver support nurse (FCSN), who later developed a personalized care plan for the family’s needs in conjunction with the local palliative care team and educated the caregiver on indicated topics. The FCSN followed up by phone to assess needs and to evaluate the continued appropriateness of the care plan, and reinforced relevant educational and psychosocial coping topics, including attempts to assist the caregiver to identify positive aspects of the caregiving experience. Discussion to prepare for the patient’s death and bereavement was conducted during a second home visit, and a written summary of key strategies and resources for caregiving and coping was provided at the intervention’s conclusion.

• The sample was comprised of 161 family caregivers (70% female, 30% male).
• Mean age of family caregivers was 59 years (range = 22–88 years).
• Family caregivers cared for patients with advanced cancer who were enrolled in a home-based palliative care service.
• Family caregivers were excluded if they were younger than age 18, unable to understand English, or if the patient for whom they cared had a nonmalignant diagnosis or poor functional status. (indicative of impending death).

• Multisite 
• Home setting
• Three palliative care services in Australia

• End-of-life care phase
• Palliative care

 A randomized, controlled, two-arm trial design was used.

• General Health Questionnaire (GHQ) (12 items) – to measure psychological distress
• Caregiver Competence Scale (4 items)
• Preparedness for Caregiving Scale (8 items)
• Family Inventory of Need–part/scale B (20 items)
• Rewards for Caregiving Scale (10 items)

No significant improvements were noted in the primary outcome, psychological distress, as measured by GHQ. Caregivers (especially older ones) who received both home visits scored higher for preparedness for caregiving (p = 0.035) compared to the control group, although the effect size was small (0.29 for the two-visit group). Caregiver competence scores were also significantly improved in the two-visit group compared to the controls (p = 0.04), but not for decrease in unmet needs or perceived positive aspects of caregiving postintervention.

The primary outcome of the study, decrease in psychological distress, was not met.

• The intervention may be expensive, impractical, or require training needs*.
• Subject withdrawals were 10% or greater.
• Though improvements in caregiver preparedness and competence were noted in the subjects in the intervention group that remained in the study long enough to receive both scheduled home visits, the attrition rate over the four-week period was high, limiting the potential recipients. Whether scores were significant in the two-visit recipients because of the intervention effect alone or due to characteristics of the patients/caregivers who were able to/chose to remain throughout is unknown.
• Other limitations/*explanation: The authors noted a suboptimal accrual rate (40% of those eligible) with many refusals, indicating a potential selection bias by the caregivers. Attrition was 42% between time 1 and time 2, without a clear etiology, although a trend for those caregivers related to a patient with declining functional status to withdraw was noted.

This intervention, although previously piloted, theoretical, and evidence-based, was relatively labor intensive, involving personalized care planning with several reassessments by a study nurse outside of the established palliative care service. The authors noted that, on occasion, recommendations made by the FCSN to address unmet needs were unable to be acted upon by local staff due to inadequate resources, and this may have impacted the lack of significant change in scores. Additionally, a high attrition rate was noted, especially among the subgroup possibly most in need of extra support: caregivers with rapidly declining patients. Future work to support this group is needed.

To examine the effects of a psycho-educational intervention on the reported levels of preparedness, mastery, self-efficacy, competence, rewards, and anxiety among caregivers of patients receiving home-based palliative care for advanced cancer in comparison to caregivers receiving standard care

The intervention was psycho-educational in nature and was delivered by intervention nurses through two intervention home visits and one intervention follow-up phone call. In addition to the interaction with the nurse, caregivers were given a caregiving guidebook and an audiotape. The guidebook provided easy-to-access information about caring for a dying person, and the audiotape contained a structured relaxation exercise and featured reflections from other carers who also reviewed self-care strategies. The control group received the usual care (24-hour access to phone advice, emergency visits, and prescheduled home visits from nurses, physicians, and other health professionals).

• The sample (N = 106) included 54 intervention group participants and 52 control group participants.
• Mean age of participants was 60.78 years (SD = 13.98), with a range of 21–84 years.
• The sample was 34.9% male and 65.1% female (as calculated by the reviewer).
• All patients were receiving palliative care.
• Eligibility criteria for the caregivers included a minimum age of 18 years and be living with a patient with cancer receiving palliative care, be English speaking, and be free of psychiatric illness that could impede ability to complete the study requirements.

Caregiver profile: The majority of caregivers (74.8%) were Australian-born, and 74.3% self-identified as Christians. Thirty-one (31.7%) of participants had professional or university education, and 34.6% did not complete high school education. The caregivers were giving care to their patient for a mean length of time of 16.3 weeks (SD = 5). The majority (87.6%) of participants expressed that they were involved in the care because they wanted to, not because they had to, and 43.4% had at least three friends or family members assisting them in providing care. About half of participants had to stop or reduce their work in order to be able to provide care for their patient. Caregivers of patients who were identified as Eastern Cooperative Oncology Group level 4 (completely disabled and confined to bed at all times) were excluded from participating when identified at screening.                                                                                                                                                                    

Patient profile: Patients cared for by caregivers had advanced cancer and were admitted to home-based palliative services within a week before recruitment. The mean age of patients was 69.14 years (SD = 13.46), with a range of 31–92 years. About half (48.1%) were confined to bed almost 50% of the time, and 11.3% were completely disabled and confined to bed all the time. The majority of patients (66.7%) were spouses or partners of caregivers; the rest were either parents of caregivers (16%) or their offspring (7.6%).   

• Multisite
• Home setting through palliative care centers
• Two community (home-based) palliative care services in Melbourne, Australia

• End-of-life care phase
• Pediatrics; elder care 

The study design was a controlled trial with random assignment of participants to intervention versus control group. Data were collected at multiple times using self-reported questionnaires.

• Preparedness for Caregiving Scale (8 items): This scale has good reliability (0.86–0.92). The reliability coefficient in the current study was checked and was above 0.70 according to the authors. The tool was used to assess the perceived level of readiness for the caregiving role among participants.
• Caregiver Competence Scale (4 items): This scale has good reliability (0.74). The reliability coefficient in the current study was checked and was above 0.70 according to the authors. The tool was used to assess the perceived level of adequacy to give care among participants.
• Rewards of Caregiving Scale: The authors selected 10 of the 15 original items. This scale has good reliability (0.77–0.94). The reliability coefficient in the current study was checked and was above 0.70 according to the authors. The tool was used to assess the perceived benefits of giving care among participants.
• Hospital Anxiety and Depression Scale (14 items): Cronbach’s alpha value was above 0.70 but was not specifically stated; however, it was mentioned that this tool has been widely used to screen for depression and anxiety among the terminally ill and that it was used previously with caregivers of patients with cancer. The authors chose 11 as the cutoff score to make determination about participants’ anxiety and depression.
• “Mastery” scale: This scale has 6 items from the original Caregiver Appraisal Scale (Lawton et al., 1989), which has 12 items. The 6-item scale has a poor reliability (0.59–0.61); the reliability coefficient in the current study was not reported, but because it was low, the authors mentioned that this scale was excluded.
• Self-efficacy instrument: This tool has two subscales: (a) caregiver self-care efficacy (Cronbach’s alpha 0.76) and (b) problem-solving self-care efficacy (Cronbach’s alpha 0.83). The tool has good reliability for the two subscales, but the reliability coefficients in the current study were above 0.70. The authors reported that they made changes in two  items to make them appropriate for the study.

The intervention and control group were compared to identify any significant differences between them, but none were detected.

Only 12 participants in the intervention group and 15 in the control group filled out the data questionnaires at all three time points. However, the number of participants who completed the data at times 1 and 2 was 75 (35 in the control and 40 in the intervention group), and at times 1 and 3 was 45 (25 in the control and 20 in the intervention group).

Findings of time 1 to time 2 (n = 75):

• No main effect for group was noticed for preparedness, and no effect for interaction between group and time was noticed either. There was a trend (not significant) for main effect within subjects over time F(1,73) = 3.36, p = 0.071 (ƞ2 = 0.044), indicating that preparedness increased over time.
• No main effect for group was noticed for rewards. There was a significant interaction between group and time, F (1,73) = 8.44, p = 0.005 (ƞ2 = 0.10); this indicated that while the control group showed a decreased sense of rewards between time 1 and time 2, the intervention group showed an increased sense of perceived rewards between the two assessment times. There was a trend (not significant) for main effect within subjects over time, F (1, 73) =  2.84, p = 0.096 (ƞ2 = 0.37).
• No significant effects or trends were noticed for self-efficacy, competence, and anxiety.

Findings of time 1 to time 3 (n = 45):

• No significant main effects between groups were noticed for preparedness, rewards, anxiety, or competence between time 1 and time 3.
• There was a significant main effect within-subjects over time, F (1, 42) = 4.94, p = 0.032 (ƞ2 = 0.11) for competence. This means that participants, irrespective of group, had increased overall sense of competence at time 3 compared to time 1.
• There was a main effect trend (not significant) within-subjects for time noted for anxiety F (1, 43) = 2.77, p = 0.10 (ƞ2 = 0.06), indicating that there was decreased anxiety among participants, irrespective of group, between time 1 and time 3.
• The interaction between group and time was significant in rewards F (1, 43) = 4.68, p = 0.036 (ƞ2 = 0.098). Comparing the means showed that there was decreased average rewards scores among control group participants between time 1 and time 3 and an overall increase of these scores among members of the intervention group. Furthermore, there was a main effect trend (not significant) for “time” within-subjects for rewards F (1, 43) = 3.22, p = 0.08 (ƞ2 = 0.07); this indicates that there was increased sense of reward among participants, irrespective of group, between time 1 and time 3.

Although the study showed that the intervention did not show much effect on most of the assessed caregiver outcomes, it did reveal an unexpected finding. That is, participants in the intervention group showed increased perceived sense of reward over time compared to participants in the control group. The findings suggest that the increased sense of perceived reward may play a role as a coping resource and could potentially have a buffering effect from caregiving burden.
 

• The sample was small (< 30 participants).
• Risk of bias existed (sample characteristics).*
• Findings were not generalizable.* 
• The intervention was expensive, impractical, or required training.*
• Subject withdrawals were ≥ 10%.
• Other limitations/*explanation: The study was done in Australia, which runs a different health system than the United States, and this could have implications. It remains unclear whether the lack of evidence for intervention effectiveness is due to the small numbers of participants or due to lack of variability among participants to start with. It is possible that those enrolled in the intervention and control groups were highly functional and independent individuals who did not need help; the fact that they chose to participate could indicate that they were people who were resourceful and willing to learn more about the caregiving experience. It is possible that those who declined participation are the ones who most needed an intervention.

Attrition of participants in caregiving studies seems to be a significant factor to consider and one that is hard to control.

The sense of reward or maintaining positive emotions by caregivers of patients in palliative care could be used as a resource to help caregivers cope with caregiving burden.

Although the study did not show much impact of the intervention, it supports the notion that giving information to caregivers is important, especially when given at selected times that are based on the caregivers’ needs during the caregiving experience. The “proper” timing for interventions, as well as the “proper” intervention with caregivers, are areas open for research. The need remains to identify the nature of interventions that are needed by caregivers. These needs seem to be variable depending on the healthcare system in which they are delivered, the specific characteristics of the caregivers, and the settings in which potential interventions are delivered.

To evaluate the efficacy of oral treatment with adlay bran extract to prevent severe radiodermatitis

Adlay is an annual cereal crop that has been used in Chinese medicine. Patients were randomly assigned to receive either capsules containing adlay bran extract or placebo (olive oil) twice daily. The dosage was two capsules 500 mg each taken twice daily from the first day to the last day of radiotherapy. Skin assessment was conducted at baseline and at the end of treatment, at 5–6 weeks. Patients were asked not to take anti-inflammatory medications or apply topical agents during the study period. Compliance to study medication was assessed at every follow-up visit.

• N = 110
• MEAN AGE = 51.6 years 
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All had breast cancer. The radiation therapy dose was 50–50.4 Gy administered in 1.8–2 Gy fractions five days per week. Those who had received breast-conserving surgery (BCS) were given an additional boost dose.
• OTHER KEY SAMPLE CHARACTERISTICS: Of the participants, 87% had received BCS. The mean body mass index was 22.6.

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

PHASE OF CARE: Active antitumor treatment

• Placebo-controlled, double-blind, randomized, controlled trial

• Radiation Therapy Oncology Group (RTOG) criteria for skin grading

In the adlay bran group, 5.5% had grade 0, 49.3% had grade 1, 34.2% had grade 2, and 11% had grade 3 radiodermatitis at the end of treatment. In the placebo group, 0% had grade 0, 24.3% had grade 1, 67.6% had grade 2, and 8.1% had grade 3 skin reaction. No patients developed grade 4 dermatitis. The overall lower severity of radiodermatitis in the adlay bran group was significant (p = 0.006). The majority did not have any adverse effects, and no serious adverse reactions were seen. Regression showed that higher body mass index and use of the adlay bran intervention were predictive of radiation dermatitis severity.

Patients receiving oral adlay bran extract had overall lower severity of skin reaction from radiation therapy.

• Unintended interventions or applicable interventions not described that would influence results
• Results of compliance assessment were not reported.

The findings suggest that prophylactic oral adlay bran extract may have a protective effect to reduce the severity of radiation dermatitis. This substance has been used in traditional Chinese medicine for centuries and is believed to have anti-inflammatory and antioxidant properties. Adlay bran may have potential for the prevention of severe radiodermatitis. Further studies are needed to determine the optimal dosage and duration of administration.

To examine the evidence on manual lymphatic drainage (MLD) in the prevention or management of limb edema in postsurgical women with breast cancer

• Databases searched were PubMed, EMBASE, CINAHL, SCOPUS, Cochrane Central Register, ClinicalTrials.gov, and PEDro.
• Search keywords were MeSH terms for manual lymph drainage, breast cancer, and lymphedema.
• Studies were included in the review if they were randomized controlled trials or quasi-experimental and evaluated the outcome of MLD for prevention or management of lymphedema. All studies involved patients with breast cancer.
• Studies were excluded from the review if they included patients who did not have axillary lymph node excision or clinical outcomes were not clearly stated.

The literature search retrieved 170 references. Authors independently evaluated methodological quality in terms of blinding, attrition, and use of intention-to-treat analysis. No specific tool for evaluation was described.

• Ten studies were included in the review.
• The total sample size was 536 patients, with a range of 24–158.
• Age ranged from 25–77 years.
• All patients had undergone axillary lymph node excision for breast cancer.

Patients were undergoing multiple phases of care.

Some trials focused on prevention and others involved treatment of lymphedema. Nine studies were included in meta-analysis. Findings showed a risk ratio of 0.063 (95% CI 0.14, 2.83, p = 0.54). High heterogeneity existed. Standard mean difference (SMD) findings showed no benefit of MLD, with SMD = 75.12 (95% CI -9.34, 159.58). Findings showed that the addition of MLD to other individual components of complete rehabilitation such as compression bandaging does not show a significant benefit in reducing arm volume. Overall published reports of MLD show conflicting results. No significant differences were found in the incidence of lymphedema between patients treated with MLD or not.

MLD does not add significant benefit for prevention or management of lymphedema in patients with breast cancer.

• High heterogeneity existed between studies. 
• Several trials were small.
• Only half of the studies reported adequate randomization. 
• In most studies, data collectors were not blinded.

Findings suggest that MLD as an adjunctive treatment is not effective in preventing or managing arm lymphedema in women with breast cancer who have had axillary lymph node excision.