Huisman, M., van den Bosch, M.A., Wijlemans, J.W., van Vulpen, M., van der Linden, Y.M., & Verkooijen, H.M. (2012). Effectiveness of reirradiation for painful bone metastases: A systematic review and meta-analysis. International Journal of Radiation Oncology, Biology, Physics, 84, 8–14.
STUDY PURPOSE: To assess pain response after reirradiation in patients with painful bone metastases not sufficiently responding to initial radiation therapy or exhibiting recurrent pain after initial response
TYPE OF STUDY: Combined systematic review and meta-analysis
DATABASES USED: MEDLINE, EMBASE, and Cochrane Collaboration library
KEYWORDS: Radiotherapy, reirradiation, retreatment, bone metastases, palliative treatment
INCLUSION CRITERIA: All types of studies were allowed. Participants received reirradiation at the initial site of radiation for radiation-refractory metastatic bone pain. Both the initial treatment and retreatment consisted of external beam radiation therapy (EBRT). Reported outcomes were reported at least in response to initial reirradiation, and original research data were reported. If eligibility for inclusion could not be decided based on abstract screening, or if the abstract was not available, the full-text article was reviewed. To qualify for the meta-analysis, the study had to meet additional criteria: outcomes were available on an individual patient level, and the size of the study population was 10 patients or more.
EXCLUSION CRITERIA: Languages other than English, German, French, and Dutch
TOTAL REFERENCES RETRIEVED: 707
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Authors were contacted for missing data. Publication quality was assessed using the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) method. Data extraction and quality assessment was performed independently by two observers.
PHASE OF CARE: Transitional care after initial treatment
APPLICATIONS: Late-effects, survivorship, and palliative care
In this meta-analysis, 264 out of 440 patients achieved either complete or partial response with an overall response rate of 58%. Sensitivity analysis was not feasible. The complete response rate for reirradiation ranged from 16%–28%, and partial response rates were 28%–45%. Pooling was not appropriate due to the low number of studies. The time to response after reirradiation ranged from three to five weeks.
Approximately 60% of patients derived some benefit from the reirradiation of radiation-refractory bone pain. The time to response was three to five weeks. For those receiving reirradiation in a circumstance in which the end of life is near, this method may not be effective. Remission of pain, however, was reported to last anywhere from 15–22 weeks.
Not all studies reported drop-out rates and so an intention to treat analysis was not feasible. If reported, however, drop-out rates ranged from 14%–35%. These rates were attributed to death and symptomatic relief but were not clear, so bias could not be excluded. Further, no randomized, controlled trial has been published on reirradiation treatment for radiation-refractory metastatic bone pain. There is limited evidence on reirradiation effectiveness, study quality is mediocre, and populations are small. Also, the difference in study design, clinical differences between study populations, lack of clinical guidelines for reirradiation, and changes in insight over time contributed to the heterogeneity observed in the included studies. All of these factors again support the need for ongoing investigation of reirradiation for bone metastases and further investigation of palliative care measures to provide optimal relief for patients with painful bone metastases.
Huisman, M., Verkooijen, H.M., van der Linden, Y.M., van den Bosch, M.A., & van Vulpen, M. (2015). Effectiveness of repeat radiotherapy for painful bone metastases in clinical practice: A 10 year historical cohort study. Clinical Oncology, 27, 472–478.
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.
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.
Patients who have initial pain responses to radiation therapy for bone metastases may benefit from repeat radiotherapy.
Hui, D., Morgado, M., Chisholm, G., Withers, L., Nguyen, Q., Finch, C., . . . Bruera, E. (2013). High-flow oxygen and bilevel positive airway pressure for persistent dyspnea in patients with advanced cancer: A phase II randomized trial. Journal of Pain and Symptom Management, 46, 463–473.
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.
Randomized, open-label study with a parallel design and an optional second intervention
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.
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.
Hui, D., Xu, A., Frisbee-Hume, S., Chisholm, G., Morgado, M., Reddy, S., & Bruera, E. (2013). Effects of prophylactic subcutaneous fentanyl on exercise-induced breakthrough dyspnea in cancer patients: A preliminary double-blind, randomized, controlled trial. Journal of Pain and Symptom Management, 47, 209–217.
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
Double-blinded, placebo-controlled, randomized trial
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.
Huether, K., Abbott, L., Cullen, L., Cullen, L., & Gaarde, A. (2016). Energy Through Motion©: An evidence-based exercise program to reduce cancer-related fatigue and improve quality of life. Clinical Journal of Oncology Nursing, 20, E60–E70.
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.
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.
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.
Hudson, P.L., Trauer, T., Lobb, E., Zordan, R., Williams, A., Quinn, K., . . . Thomas, K. (2012). Supporting family caregivers of hospitalised palliative care patients: A psychoeducational group intervention. BMJ Supportive and Palliative Care, 2, 115–120.
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.
Pre-/postdesign
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).
Educational interventions improved CGs' sense of preparedness and decreased their sense of unmet needs. They may help improve CGs’ competence.
Hudson, P., Trauer, T., Kelly, B., O'Connor, M., Thomas, K., Zordan, R., & Summers, M. (2014). Reducing the psychological distress of family caregivers of home based palliative care patients: Longer term effects from a randomised controlled trial. Psycho-Oncology, 24, 19–24.
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).
Randomized, controlled trial with two arms (two versions of intervention)
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.
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.
Hudson, P., Trauer, T., Kelly, B., O'Connor, M., Thomas, K., Summers, M., . . . White, V. (2013). Reducing the psychological distress of family caregivers of home-based palliative care patients: Short-term effects from a randomised controlled trial. Psycho-Oncology. [Epub ahead of print]
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.
A randomized, controlled, two-arm trial design was used.
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.
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.
Hudson, P.L., Aranda, S., & Hayman-White, K. (2005). A psycho-educational intervention for family caregivers of patients receiving palliative care: A randomized controlled trial. Journal of Pain and Symptom Management, 30, 329–341.
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).
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%).
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.
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):
Findings of time 1 to time 3 (n = 45):
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.
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.
Huang, C.J., Hou, M.F., Kan, J.Y., Juan, C.H., Yuan, S.S., Luo, K. H., . . . Hu, S.C. (2015). Prophylactic treatment with adlay bran extract reduces the risk of severe acute radiation dermatitis: A prospective, randomized, double-blind study. Evidence-Based Complementary and Alternative Medicine, 2015, 312072.
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.
PHASE OF CARE: Active antitumor treatment
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.
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.