Hardy, J., Quinn, S., Fazekas, B., Plummer, J., Eckermann, S., Agar, M., … Currow, D.C. (2012). Randomized, double-blind, placebo-controlled study to assess the efficacy and toxicity of subcutaneous ketamine in the management of cancer pain. Journal of Clinical Oncology, 30, 3611–3617.
To determine whether ketamine, delivered subcutaneously with dose titration over five days, has greater clinical benefit than placebo when used in conjunction with opioids and standard adjuvant therapy in the management of cancer pain
This was a multisite, inpatient study conducted in Australia.
This was a randomized, double-blinded, placebo-control study.
Ketamine was only associated with improvement in worse pain compared to placebo, and it was associated with more adverse events and psychotoxicity.
Ketamine as an adjunct to opioids to manage chronic refractory cancer pain only appeared to affect worst pain rating and may cause adverse effects and increase psychotoxicity. Incidence of adverse events with ketamine infusion adjunctively with opioids in the management of refractory pain should be reevaluated when considering the patient population of advanced cancer.
Harding, M. (2015). Effect of nurse navigation on patient care satisfaction and distress associated with breast biopsy. Clinical Journal of Oncology Nursing, 19, E15–E20.
To evaluate how nurse navigation affected care satisfaction and distress among women who were undergoing breast biopsy. Specifically, were there significant differences in women undergoing breast biopsy with and without nurse navigators?
No significant between-group differences were noted in depression. Lower scores were shown for anxiety (significance p < 0.05) among patients who had navigation. There was no difference in overall satisfaction with care though there was an association between satisfaction and distress: that is, women with more satisfaction reported less distress. The population with nurse navigators shows stronger relationship-based characteristics. Significant differences were shown in five categories (accessibility, communication, finances, interpersonal manner, and time) for the navigated population and in two categories (accessibility, general satisfaction) for the non-navigated or usual care population.
Nurse navigation increased satisfaction with care. General satisfaction measured significantly higher in the non-navigated sample when compared to the navigated group. Distress screening followed by interventions of emotional support, education, and facilitating communication between and among providers are roles nurses can fulfill to improve satisfaction outcomes and lower distress levels.
Train nurse navigators in addressing key areas of patient-center interface: accessibility to care, communication among providers, financial support, interpersonal manner, time with care provider, and technical quality. Nurse navigators have knowledge and skill to manage care of women undergoing needle biopsy and, thereby, improve general satisfaction in specific areas.
Harding, C., Harris, A., & Chadwick, D. (2008). Auricular acupuncture: A novel treatment for vasomotor symptoms associated with luteinizing-hormone releasing hormone agonist treatment for prostate cancer. British Journal of Urology International, 103, 186–190.
To evaluate the role of auricular acupuncture (AA) in men receiving luteinizing-hormone releasing hormone (LHRH) analogues for prostate cancer on hot flash incidence and severity
The study enrolled 60 consecutive men with prostate cancer who were receiving on LHRH agonist treatment. Their median age was74 years, and they received weekly AA for 10 weeks.
Patients recorded the frequency of hot flash episodes during the day and at night at 0, 4, and 10 weeks. Participants were asked to grade the intensity of their hot flashes on a 0–6 scale, with 6 representing maximum intensity, and they recorded these data at 0, 4, and 10 weeks.
95% of patients reported a decrease in the severity of symptoms, from a mean of 5.0 to 2.1 (Student’s test, p < 0.01).
Limitations of this study included using a convenience sample and absence of a control group.
Harding, R., Higginson, I.J., Leam, C., Donaldson, N., Pearce, A., George, R., . . . Taylor, L. (2004). Evaluation of a short-term group intervention for informal carers of patients attending a home palliative care service. Journal of Pain and Symptom Management, 27, 396–408.
To promote self-care by combining informal teaching with group support in a short-term, closed, multiprofessional group
A single group facilitator introduced multiprofessional input from a changing weekly speaker during six 90-minute weekly sessions.
Groups were capped at 12 caregivers and initially focused on patient issues. Transportation for caregivers and a patient-sitting service were provided when necessary.
Four groups were delivered with peer supervision to ensure consistency of the intervention.
The sample (N = 73) was adult, informal, unpaid caregivers of patients receiving palliative care (86% of patients had a cancer diagnosis).
A prospective, observational, comparative (no randomization) design was used between those who accepted the intervention (n = 36) and those who declined the intervention but agreed to data collection in the first wave (n = 37), with limitations in group assignment.
The intervention was not found to affect outcomes for any measures at postintervention (eight weeks) or follow-up (five months).
Harding, R., Higginson, I.J., Leam, C., Donaldson, N., Pearce, A., George, R., . . . Taylor, L. (2004). Evaluation of a short-term group intervention for informal carers of patients attending a home palliative care service. Journal of Pain and Symptom Management, 27(5), 396–408.
A short-term, closed, multiprofessional group aimed to promote self-care by combining informal teaching with group support.
A single group facilitator introduced multiprofessional input from a changing weekly speaker during six, 90-minute weekly sessions. Groups were capped at 12 caregivers.
The group initially focused on patient issues, and transportation for caregivers and a patient-sitting service were provided when necessary.
A total of four groups were delivered with peer supervision to ensure consistency of the intervention.
The study design was a prospective, observational, comparative (no randomization) between those who accepted the intervention (n = 36) and those who declined the intervention but agreed to data collection in the first wave (n = 37); limitations existed in group assignment.
The intervention was not found to affect outcomes for any measures at post-intervention (eight weeks) or follow-up (five months).
Harding, R., List, S., Epiphaniou, E., & Jones, H. (2012). How can informal caregivers in cancer and palliative care be supported? An updated systematic literature review of interventions and their effectiveness. Palliative Medicine, 26, 7–22.
To update and evaluate intervention studies and current state of the science regarding support for caregivers in a systematic review
Group interventions were studied most often, although only two of the studies included reported a statistically significant benefit compared to controls. The next largest group of studies investigated one-on-one psychological interventions. Two of these showed a positive effect for patient/carer dyads. Overall findings were equivocal, with about the same number of studies showing significant improvement with the intervention as those showing no change or difference between groups. The nature and timing of interventions varied greatly across studies included.
The authors identified seven categories of interventions: (a) one-on-one psychological, (b) dyad psychological, (c) palliative care/hospice (delivery), (d) informational/training, (e) respite, (f) group intervention, and (g) physical.
Given the limitations, differences in the nature of interventions reviewed, and inconsistencies of findings across studies, this review does not provide strong support for any particular type of intervention.
This summary has limited guidance due to lack of synthesis to actually guide practice. There were also inconsistencies between the inclusion and exclusion criteria and the studies reported; not all have clear implications to cancer, affect active information caregivers, or measure caregiver outcomes.
Harding, R., & Higginson, I.J. (2003). What is the best way to help caregivers in cancer and palliative care? A systematic literature review of interventions and their effectiveness. Palliative Medicine, 17, 63–74.
MEDLINE, CancerLit, PsycInfo, and CINAHL databases using the search terms carer(s), caregiver(s), palliative, and cancer were used.
Twenty-two articles reported interventions for adults actively providing informal care to noninstitutionalized patients with cancer and patients receiving palliative care. Only six of the interventions had been evaluated: Two used a randomized, controlled trial design, three used single group design (two prospective, one retrospective), and one was evaluated by facilitator feedback.
The sample was comprised of caregivers from palliative or cancer care populations.
Problem-solving and education interventions led to overall improved caregiver burden, although the improvement was not significant; however, significant improvements were seen in a subsample of burdened caregivers (at baseline). Home nursing and respite care services improved caregiver satisfaction, quality of life, physical and emotional stress or distress, pain, health, and sleep in a few studies. Problem solving and education are likely to be effective in reducing caregiver burden.
Hardikar, W., Cranswick, N., & Heine, R.G. (2007). Macrogol 3350 plus electrolytes for chronic constipation in children: A single-centre, open-label study. Journal of Paediatrics and Child Health, 43, 527–531.
To evaluate the safety and efficacy of macrogol 3350 plus electrolytes in the treatment of chronic constipation in children.
All children received macrogol 3350 plus electrolytes for 12 weeks. Children aged 2 to 6 years received one sachet daily on days 1 and 2, one sachet twice daily on days 3 and 4, and one sachet three times daily on day 5. Children aged 7 to 11 years received one sachet twice daily on days 1 and 2, and two sachets twice daily on days 3, 4, and 5. After day 5 and until the end of the study, the dosage was titrated according to fecal form. The dose was increased by one sachet per day in the event of continued hard stools or no bowel movement, and decreased by one to two sachets per day in the event of loose stools or diarrhea.
The mean duration of treatment was 75.5 days, during which time the participants took an average of 1.3 sachets (6.9 g) of macrogol plus electrolytes per day.
Royal Children’s Hospital, Melbourne, Australia
This was an open-label, nonrandomized study.
Longitudinal studies are needed to determine the long-term outcome of successful treatment of chronic constipation during childhood.
Harder, H., Parlour, L., & Jenkins, V. (2012). Randomised controlled trials of yoga interventions for women with breast cancer: A systematic literature review. Supportive Care in Cancer, 20, 3055-3064.
STUDY PURPOSE: To examine physical and psychological benefits of yoga interventions in women with breast cancer
TYPE OF STUDY: Systematic Review
DATABASES USED: MEDLINE, PsychINFO, the Cochrane Library, Embase, CINAHL, AMED, Web of Science, and Scopus
KEYWORDS: Yoga, breast cancer, and breast neoplasm
INCLUSION CRITERIA: Yoga intervention; women with breast cancer; a randomized controlled trial design (RCT); the studies were original full reports; and the studies were published in peer-reviewed journals.
EXCLUSION CRITERIA: Studies that investigated complementary and alternative medicines or exercise interventions; conference abstracts
TOTAL REFERENCES RETRIEVED: Eighteen RCTs met the inclusion criteria out of 274 initial data. The 274 initial articles returned were reduced to 132 after duplicates were removed. Further reductions occurred due to multiple publications of the same data or the same outcome measures; same studies or continuation of same studies also were removed from review.
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Physiotherapy Evidence Database (PEDro Scale) was used to rate methodological quality of RCTs. It is a 10-item scoring system that evaluates internal validity (random allocation; concealment of allocation; similarity of groups at baseline; blinding of participants, therapists, and assessors; adequate follow-up and undertaking an intention-to-treat analysis) and statistical information. A total score below 4 was considered to be of “poor” methodological quality; between 4 and 5 was considered to be of “fair” quality; 6 to 8 was considered to be of “good” quality; and 9 or 10 was considered to be of “excellent” quality. Two reviewers independently rated each study.
PHASE OF CARE: Active antitumor treatment and transition phase after active treatment. Twelve studies were conducted during treatment; six were conducted post-treatment (two months to six years); two were conducted during mixed time periods during and after treatment (mean time since diagnosis or treatment = 1.7–6.5 years).
APPLICATIONS: Elder care and palliative care
This review does not specifically focus on depression and anxiety. Only studies with patients with breast cancer were included for this review. Thus, only several studies with depression or anxiety as outcome variables were included in the final review. None of the studies were found to have excellent design (e.g., small sample size and lack of long-term follow-up).
The intervention may be beneficial, yet its specific effect on depression and anxiety should be further examined. Also, the intense, duration, and practical issues (e.g., who provided the intervention, who paid the cost) should be considered. Nurses can conduct large-sample, long-term studies of the efficacy of yoga using instruments that measure change scores and calculating sufficient power to detect group differences.
Harada, K., Ferdous, T., Horinaga, D., Uchida, K., Mano, T., Mishima, K., . . . Fukunaga, M. (2016). Efficacy of elemental diet on prevention for chemoradiotherapy-induced oral mucositis in patients with oral squamous cell carcinoma. Supportive Care in Cancer, 24, 953–959.
To evaluate effects of an elemental diet for prevention of radiotherapy or chemotherapy-induced oral mucositis in patients with oral cancer
Data were collected from medical record review. All patients received 2 Gy per day, fives days per week to the oral cavity for a total dose of 60-70 Gy with or without concurrent chemotherapy. 80 g of elemental diet powder was dissolved in 300 ml of water for patients to swish around in the mouth and swallow once daily. All patients were to follow a similar regimen of oral brushing, gargling with 4% azulene sodium sulfonate and water, lidocaine gargle, NSAIDs, and/or opioids as needed for pain. Data were compared between those who had received the elemental diet versus individuals who had not.
Mulivariate analysis showed that use of the elemental diet (p = 0.004) and no concurrent chemotherapy (p = 0.004) were significant factors to predict the grade of mucositis observed. For those getting RT only, the incidence of grade 3 or 4 mucositis was lower in the group who had the elemental diet, but the difference was not statistically significant. For those getting both chemotherapy and radiation therapy (n = 49 patients), rates of more severe mucositis were 79.2% among controls and 40% in the elemental diet group (p = 0.005).
Having patients swish and swallow an elemental diet preparation appeared to reduce the severity of oral mucositis in patients with oral cancer getting combined radiation and chemotherapy.
Administration of an elemental diet preparation as used here might have a protective effect to reduce severity of oral mucositis in patients with oral cancer getting combined radiation and chemotherapy. This is a low-risk type of intervention that warrants further investigation. Prospective, well-designed trials are needed to establish efficacy.