Mahendran, R., Lim, H.A., Tan, J.Y., Chua, J., Lim, S.E., Ang, E.N., & Kua, E.H. (2015). Efficacy of a brief nurse-led pilot psychosocial intervention for newly diagnosed Asian cancer patients. Supportive Care in Cancer, 23, 2203–2206.
To determine if psychosocial interventions, led by nurses instead of mental health professionals, for patients newly diagnosed with cancer in Singapore could help ease distress, minor psychiatric morbidity, and psychosocial worry
This quasiexperimental study researched the benefits of a six-month nurse-led psychosocial intervention program for patients with newly diagnosed with cancer receiving chemotherapy. The program consisted of 20- to 30-minute sessions with a nurse and occurred monthly for two visits and bimonthly for two more visits. Participants were offered this intervention along with their treatment. Training of the oncology RNs at the National Cancer Institute in Singapore included personal training by a psychiatrist and a psychologist on psychoeducation for managing stress, sleep hygiene, anxiety, and depression and included resources, deep breathing exercises, muscle relaxation, and inspirational self-talk. Patients also received counseling, supportive therapy, and printed/audio education to encourage practice at home. The RN training also included simulated one-on-one sessions with feedback on performance. Demographic and medical data were collected. Primary outcomes were measured by questionnaires at baseline and at six months.
PHASE OF CARE: Active antitumor treatment
One hundred twenty-one participants were recruited. Seventy (58%) chose to participate, and the rest received treatment as usual (TAU). Sixty-three (90%) participants completed the four nurse-led sessions and were available at six months for reassessment. No significant demographic difference was reported between the intervention and TAU groups at baseline. No significant demographic difference existed between those followed up with and those lost to follow-up, but those lost to follow-up did have higher anxiety and depression scores at baseline. The intervention group had significantly increased distress, anxiety, and depression scores and lower EQ-5D scores at baseline. The intervention group participants had significantly reduced distress (p = 0.001), anxiety (p < 0.001), and depression (p < 0.001) scores, as well as greatly improved quality of life over time. Participants receiving TAU also showed a decline in anxiety and depression over time, with essentially stable distress scores.
A six-month intervention of psychoeducation, counseling, and behavior technique teaching improved participants’ distress, quality of life, anxiety, and depression.
Maestri, A., De Pasquale Ceratti, A., Cundari, S., Zanna, C., Cortesi, E., & Crino, L. (2005). A pilot study on the effect of acetyl-L-carnitine in paclitaxel- and cisplatin-induced peripheral neuropathy. Tumori, 91, 135–138.
Patients were treated with acetyl-L-carnitine (ALC) 1 g per day via IV for at least 10 consecutive days. Cisplatin neuropathy was characterized as numbness, tingling, loss of vibration sensation, and diminished proprioception.
The study was conducted from April 2000 to December 2002.
Of the 26 patients, 19 (73%) showed at least one grade of CIPN improvement, and all cisplatin-treated patients showed at least one grade of CIPN improvement. In addition, one patient with World Health Organization grade 2 neuropathy had complete resolution of neuropathy after 11 days of treatment. For paclitaxel-treated patients, 8 of 12 (67%) showed one grade improvement, as did 8 of 10 (80%) in the combination paclitaxel and cisplatin treatment group. The remaining patients had stable CIPN.
Maemondo, M., Masuda, N., Sekine, I., Kubota, K., Segawa, Y., Shibuya, M., … PALO Japanese Cooperative Study Group. (2009). A phase II study of palonosetron combined with dexamethasone to prevent nausea and vomiting induced by highly emetogenic chemotherapy. Annals of Oncology, 20, 1860–1866.
To evaluate the safety, efficacy, and pharmacokinetics of palonosetron, in combination with dexamethasone in patients receiving highly emetogenic chemotherapy (HEC)
Patients were randomized to 1 of 3 single doses of palonosetron, IV bolus (0.075, 0.25, or 0.75 mg), before administration of HEC. Subjects also received dexamethasone (12–16 mg IV on day 1, 8 mg on day 2, and 4–8 mg on day 3). All patients were hospitalized at least one day after palonosetron administration. Patients were followed up to five days. Patients used a diary to record episodes of vomiting, degree of nausea, and use of rescue medication.
The study was conducted at multiple sites in Japan.
All patients were in active treatment.
This was a randomized, double blind, dose-ranging study.
Palonosetron at doses of 0.25 mg and 0.75 mg was shown to be effective in preventing chemotherapy-induced nausea and vomiting (CINV) in the acute phase in patients treated with HEC. CR rates in the delayed phase were less than 60% overall.
Increasing the dose of palonosetron on day one could contribute to better control of CINV during the delayed and overall phases of HEC.
Maeda, I., Miyashita, M., Yamagishi, A., Kinoshita, H., Shirahige, Y., Izumi, N., . . . Morita, T. (2016). Changes in relatives' perspectives on quality of death, quality of care, pain relief, and caregiving burden before and after a region-based palliative care intervention. Journal of Pain and Symptom Management, 52, 637–645.
To explore the effect of a previously developed Japan Outreach Palliative Care Trial of Integrated Regional Model (OPTIM) intervention on palliative care outcomes (quality of patient death and dying, family views on patient quality of care and pain control, and caregiver burden) in hospital, home, and palliative care unit settings
The OPTIM intervention focused on enhancing Japanese regional medical providers’ palliative knowledge and skills via distributions of manuals and interactive workshops and incorporating palliative care teams in educational outreach to community patients and families. The intervention also focused on holding interdisciplinary palliative care conferences and providing consumer-based information and programs on palliative care to improve regional oncologic comfort. Patients and caregivers from 23 hospitals and home-care clinics completed four questionnaires in a mailed survey sent before and following the intervention.
Pre-/postdesign
Significant differences (p < 0.01) were reported in quality of patient care in the home, palliative care unit, and hospital, with highest quality of care in the home. Overall, quality of care improved significantly (p = 0.04) from preintervention to postintervention in hospitals. Similar improvements at a significant level (p = 0.012) occurred in the quality of death and dying in hospitals, although this place had the lowest score at baseline compared to palliative care units and the home. No significant differences in patient pain relief occurred pre- and postintervention, nor did caregiver burden significantly increase postintervention in any of the three settings of patient death. Quality of care measures in the hospital and in some measure domains in the palliative care unit increased significantly postintervention (p < 0.05).
Caregiver quantitative feedback postintervention showed the most improvement in quality of care and of death and dying in hospitalized patients, with additional improvement in palliative care units deemed as high quality by caregivers preintervention. Caregivers consistently viewed home care as highest in quality pre- and postintervention. Family burden of care did not increase in the three settings related to the intervention. With most patient deaths in hospitals in Japan and many countries, additional efforts to improve hospital quality of care may smooth the transition of dying patients to their homes for improved family well-being.
Current emphasis on the delivery of high quality care to patients and their families in a variety of end-of-life settings mandates nursing attention to the feedback of patients who are terminally ill and their caregivers to meet that goal. Additional research and evidence from clinical practice offer opportunities to gain that feedback to improve care at the end of life for patients with cancer and their families.
Maeda, Y., Ohune, T., Nakamura, M., Yamasaki, M., Kiribayashi, Y., & Murakami, T. (2004). Prevention of irinotecan-induced diarrhoea by oral carbonaceous adsorbent (Kremezin) in cancer patients. Oncology Reports, 12(3), 581–585.
To examine the effectiveness of two interventions, AST-120 and oral alkalization, to ameliorate diarrhea after treatment with irinotecan
The study reported on 13 Japanese patients with cancer receiving 60–100 mg/m2 irinotecan every 1–2 weeks, alone or as part of a combination regimen. The control group consisted of 7 patients, the AST-120 group consisted of 4 patients, and the oral alkalization group consisted of 4 patients. One patient in each of the two intervention groups served as his or her own control, having received prior irinotecan with no prophylaxis.
This was a nonrandomized trial.
Patients recorded the number of bowel movements but not the volume.
Although further study is necessary regarding the effect of oral AST-120 on plasma concentrations of irinotecan-related compounds, it is speculated that the absorption of irinotecan or SN-38 from the intestinal lumen is small, if any, and the remaining irinotecan-related compounds in the intestinal lumen cause diffuse mucosal damage in irinotecan treatments.
Maeda, Y., Ohune, T., Nakamura, M., Yamasaki, M., Kiribayashi, Y., & Murakami, T. (2004). Prevention of irinotecan-induced diarrhoea by oral carbonaceous adsorbent (Kremezin) in cancer patients. Oncology Reports, 12(3), 581–585.
To examine the effectiveness of two interventions to ameliorate diarrhea after treatment with irinotecan
This was a nonrandomized trial of 13 Japanese patients with various cancers receiving 60–100 mg/m2 irinotecan every one to two weeks, alone or in combination regimens. Patients received one of three interventions. Four patients received AST-120; one of these four had previously received irinotecan with no prophylaxis and thus served as a control. Four patients received the oral alkalization; one of these also had previously received irinotecan with no prophylaxis and thus served as a control. Including these two controls, a total of seven control patients received irinotecan with no prophylaxis.
The number of bowel movements was recorded; however, volume was not recorded.
Oral AST-120 was associated with significantly decreased numbers of daily bowel movements during irinotecan treatment compared to no prophylaxis (p < 0.05). Oral alkalization was effective in ameliorating diarrhea, but the difference was not significant.
Madsen, M.T., Hansen, M.V., Andersen, L.T., Hageman, I., Rasmussen, L.S., Bokmand, S., . . . Gogenur, I. (2015). Effect of melatonin on sleep in the perioperative period after breast cancer surgery: A randomized, double-blind, placebo-controlled trial. Journal of Clinical Sleep Medicine, 12, 225–233.
To conduct a secondary data analysis from the MELODY trial to determine if 6 mg of oral melatonin administered at bedtime pre- and postsurgery would improve objective and subjective sleep outcomes in patients with breast cancer
The original study design was a randomized, double-blind, placebo-controlled trial to test the effect of melatonin on depressive symptoms. Participants randomized to melatonin or placebo taken at bedtime for three days prior to surgery and continued until 12 weeks postoperative. Secondary data points for sleep are described in this article. No baseline sleep assessment was reported, and time points of subjective and objective data collection were preoperative night 2/3, preoperative night 1, postoperative night 1/2/3, postoperative night 4/5/6, and night before histology information, normally two weeks postoperative.
Subjective measures included visual analog scale for subjective sleep quality (0 mm = best possible sleep and 100 mm = worst sleep). The Karolinska sleepiness scale (KS) was used to assess level of sleepiness using nine-point scale (1 = very alert, 10 = very sleepy). No psychometric properties were provided. Objective sleep actigraphy data were guided with a sleep diary for parameters of efficiency, time in bed, total sleep time, wake after sleep onset (WASO), latency, and awakenings. Actigraphy was recorded for the entire study period.
Evaluation of objective sleep outcomes from actigraphy revealed no significant differences for preoperative sleep or wake outcome variables postoperatively and prehistology. Sleep efficiency was higher in the treatment group (p < 0.03). WASO was significantly lower in the postoperative times of 1/2/3 and 4/5/6 in the melatonin group (p < 0.03). No significant differences were found in the subjective measurements (sleep, pain, KSS) preoperatively and postoperatively.
Use of oral 6 mg of melatonin one hour before bed significantly increased efficiency in the three postoperative time points, and WASO decreased during the postoperative time points. However, subjective sleep and pain did not improve. Melatonin use needs to be further evaluated as this study had several limitations.
Nurses need to inquire about pre- and postoperative use of any medications to understand and counsel patients and family members on evidence that would support the use of the medication. Melatonin may be helpful to improve sleep, but additional studies are needed.
Maddocks-Jennings, W., Wilkinson, J. M., Cavanagh, H. M., & Shillington, D. (2009). Evaluating the effects of the essential oils leptospermum scoparium (manuka) and kunzea ericoides (kanuka) on radiotherapy induced mucositis: A randomized, placebo controlled feasibility study. European Journal of Oncology Nursing: The Official Journal of European Oncology Nursing Society, 13(2), 87-93. doi:10.1016/j.ejon.2009.01.002
Determine the effect of essential oil mouth rinse on mucositis onset, pain, and oral symptoms; weight loss
Patients were randomized to treatment, placebo, and control groups. Placebo and intervention groups were given solutions in 25 mL amber bottles with dropper caps. Patients in the treatment group were provided with a 1:1 mix of manuka and kanuka oils; placebo was sterile water. The participants further diluted and gargled for at least 15 seconds, then spit out. Then a fresh prep of same dilution was swallowed. This was started two days before radiation treatment began, and continued until one week after the completion of radiotherapy. Patients were to gargle 30 minutes either before or after eating, smoking,or drinking and before and after each radiotherapy treatment. Control patients did usual care.
The sample was comprised of 19 patients. Intervention n = 6, placebo n = 6, control n = 7. The mean age was 68.9, with a range of 45-81 years. Females active = 1; placebo = 4, males active = 5, placebo = 2, control = 7.
Diagnosis Information: all head and neck cancer; all undergoing non-palliative radiotherapy to the oropharyngeal area.
Other Key Characteristics: Mean radiation dose across groups ranged from 5933-6200 cGy.
Single site: Outpatient setting New Zealand; large center with 7-9% of new patients with head and neck dx/year
Randomized placebo double-blind controlled trial
Patient diary: pain score, medication use, oral symptoms, 10 point visual analogue score (pain) RTOG 0-4 scale; body weight post-discharge survey (dry mouth/cough; altered taste and appetite; excess secretion/nausea and vomiting rating on scale of 0-10)
All patients developed some mucositis. The active gargle group went the longest time before a reaction occurred (p = 0.05). Onset of pain was reported to be delayed in the treatment group; only 1% of patients had a weight decrease in the treatment group compared to a 5.2% loss in the control group and a 4.1% loss in the placebo group.
Because this was a feasibility study, there is no statistical analysis of the results. The results support the hypothesis that these oils may provide a positive effect on the development of mucositis, pain, and nutritional outcomes.
Small sample <30. Need for participants to adhere to gargling; frequent performance of intervention; multiple clinicians evaluated mucositis.
Further research is needed to determine the overall benefit of this intervention.
Madan, P.D., Sequeira, P.S., Shenoy, K., & Shetty, J. (2008). The effect of three mouthwashes on radiation-induced oral mucositis in patients with head and neck malignancies: A randomized control trial. Journal of Cancer Research Therapies, 4(1), 3–8.
The effect of three test mouthwashes and a control were studied.
1. 0.12% chlorhexidine
2. 1% povidone-iodine
3. salt/sodium bicarbonate
4. plain water (control)
Coloring agents, sweeteners, and flavoring agents were added to the mouthwashes so that all had identical color and taste. All were alcohol free.
Patients rinsed mouths with 10 ml of mouthwash BID for six weeks. Patients swished for about two minutes and expectorated, then abstained from eating or gargling for 30 minutes.
The study was comprised of 20 patients in each arm of study.
Adult patients with stage II–IV head and neck malignancy scheduled to receive RT of 60 Gy or higher, delivered in 30 fractions over a six-week period.
At least one-third of oral cavity mucosa was included in the radiation field.
Powered for 20 subjects in each arm; 76 completed.
The median age was 54.25–58.2 years.
More men participated than women.
July 2003–January 2004
Double-blind, placebo-controlled, randomized clinical trial
Compliance was assessed weekly by checking the level of mouthwash left in bottles.
Mucositis WHO– single examiner
Primary endpoint of study was the end of week 6.
Significant difference in mean mucositis scores was observed among all four groups. Post hoc analysis for repeated measure showed a statistically significant difference between the povidone group and control group (p = 0.013) at the end of week 1.
At the end of week 2, povidone, chlorhexidine, and salt/soda groups differed significantly from the control group.
At the end of week 4, significant differences also were observed between the povidone and salt/soda groups (p = 0.16).
At the end of week 5, significant differences were observed between all test groups and the control group. Differences also were observed within test groups.
At the end of week 6, a slightly different trend was observed. Significant differences were observed between the povidone group and all other groups; difference in mucositis among other groups was not statistically significant.
Although the volume of solution used was checked weekly, data does not indicate compliance.
No data is available regarding treatment delay.
Macmillan, M.S., Wells, M., MacBride, S., Raab, G.M., Munro, A., & MacDougall, H. (2007). Randomized comparison of dry dressings versus hydrogel in management of radiation induced moist desquamation. International Journal of Radiation Oncology, Biology, Physics, 68, 864–872.
To evaluate the effect of a hydrogel or dry dressing on the time to healing of moist desquamation after radiation therapy
Participants were randomly assigned to either dry dressing or no dressing (Tricotex) or hydrogel (intrasite) dispenser at the beginning of radiation therapy. Patients received the same instruction of skin care and were provided with simple soap. Patients were instructed to use their dressing from the onset of moist desquamation, if it occurred.
The study took place at multiple sites in Scotland.
The study used a randomized controlled trial design.
The study does not support the routine use of hydrogel in the care of patients with moist desquamation and suggests that the healing times are prolonged, without any improvement in patient comfort.