Rugno, F.C., Paiva, B.S., & Paiva, C.E. (2014). Early integration of palliative care facilitates the discontinuation of anticancer treatment in women with advanced breast or gynecologic cancers. Gynecologic Oncology, 135, 249–254.
To evaluate quality of life, anxiety, depression, and provider-patient communication in patients with breast and gynecologic cancers with advanced disease stopping active treatment based on the care model used (integrated [ICM] compared to traditional [TCM])
Patients who had received anticancer treatment that was discontinued and were followed up only in the palliative care unit were recruited. Consented patients were evaluated by a treating physician using the Communication Assessment Protocol (CAP). The patients then completed the CAP. The CAP was aimed at determining the degree to which patients had been informed about the reality of their diseases. Patients were categorized for group placement for study comparisons. Those who had been evaluated at least once for palliative care were placed in the ICM model (included PC commitment team and active cancer treatment). Those with no prior consult were placed in the TCM model. Patients in both groups completed study assessments.
Prospective, descriptive, two-group comparison
KPS scores ranged from 30–90 (median = 50). Previous treatment included up to eight different lines of systemic palliative treatment (mean = 2.7). There were no group differences between the two care models. The ICM care group had higher global health (p = 0.022), emotional functioning (p = 0.034), and social functioning (p = 0.018), and it had lower insomnia scores (p = 0.027) compared to the TCM group. A smaller proportion of those in the ICM group demonstrated HADS scores at a level indicating clinically relevant anxiety (HADS ≥ 11, p = 0.018). There was no correlation with the number of consultations with the palliative care team. The ICM group experienced significantly fewer communication problems (p = 0.004). The ICM group received less chemotherapy in the last six weeks compared to the TCM (p = 0.001). There was no significant difference between groups in fatigue, anorexia, constipation, pain, or diarrhea. Multivariate analyses showed increased prognostic factors for survival in the ICM group.
Early palliative care may improve quality of life and reduce insomnia and symptoms of anxiety in patients at the end-of-life phase of care.
This study sought to show that offering appropriate and timely palliative care using the ICM model can reduce symptom burden during the transition into advanced disease and death. This study provided little support because of study design flaws. There was limited research on the effects of early palliative care. Additional research is needed to test this model in the United States and focus on integration into practice.
Ruggiero, A., Coccia, P., Arena, R., Maurizi, P., Battista, A., Ridola, V., . . . Riccardi, R. (2013). Efficacy and safety of transdermal buprenorphine in the management of children with cancer-related pain. Pediatric Blood & Cancer, 60, 433–437.
To investigate the safety and efficacy of transdermal buprenorphine in the treatment of chronic cancer pain in children
Patients receiving other analgesics were transitioned to transdermal buprenorphine. The initial dose was 8.75–35 mcg/hour, depending on body weight. Patches were changed every three days. If needed, the dose could be titrated by means of a standard scheme. Study evaluations were done on days 4, 7, 14, 30, 44, and 60. Rescue medication, tramadol 1–2 mg/kg for breakthrough pain, was allowed as needed but not more than twice daily. School-age children self-reported study measures. Parents reported measures related to younger children.
Clinical application: pediatrics
Prospective observational study
Transdermal buprenorphine was effective at treating chronic cancer-related pain in pediatric patients. Patients tolerated the drug well.
Findings suggest that pediatric patients can safely use transdermal buprenorphine and that it is effective at treating the pain of the specified patients. Nurses should be aware that these findings resulted from a study with a very small sample; the findings may not reflect actual frequency of adverse events. Pediatric patients should be closely monitored for adverse events. The side effects of transdermal buprenorphine in children are the effects typical of opioids; care should include a prophylactic approach to side effect management.
Rueda, J. R., Sola, I., Pascual, A., & Subirana Casacuberta, M. (2011). Non-invasive interventions for improving well-being and quality of life in patients with lung cancer. Cochrane Database of Systematic Reviews (Online), 9, CD004282.
The objective of the systematic review was to assess the effectiveness of non-invasive interventions delivered by healthcare professionals in improving symptoms, psychological functioning, and quality of life.
Databases searched were Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, PsycINFO, AMED, British Nursing Index and Archive, and reference lists from relevant studies.
Search keywords were non-invasive interventions and lung cancer.
Randomized controlled trials and controlled clinical trials were included. The trials included involved
A total of 20 references were retrieved. Two authors independently assessed all the references. Three of 15 studies included in this review were evaluated together in one category labeled “Nursing Interventions to Manage Breathlessness.” Of the three studies that focused solely on breathlessness, two studies previously were evaluated in the 2009 Putting Evidence Into Practice publication.
The final number of studies included was 15. The breathlessness category included 165 patients with lung cancer. The sample range across studies was 22-109.
Patients had lung cancer with refractory breathlessness, the majority of which were not receiving active therapy. Patients received breathlessness rehabilitation, which focused on emotional as well as physical aspects of the symptom, or breathlessness training intervention, described as training in diaphragmatic breathing, pacing, anxiety management, and relaxation.
The three studies found that the intervention was effective in improving the sensation of breathlessness at best and also had beneficial effects on performance status, functional ability, and depression. Due to the stage of disease and limited life expectancy of those diagnosed with advanced lung cancer, rapid deterioration and attrition were seen in one of the studies.
The studies of breathlessness management indicate that nurse-led breathing programs may produce beneficial effects and should be encouraged.
Rozzi, A., Nardoni, C., Corona, M., Restuccia, M.R., Fabi, A., Bria, E., … Lanzetta, G. (2011). Palonosetron for the prevention of chemotherapy-induced nausea and vomiting in glioblastoma patients treated with temozolomide: A phase II study. Supportive Care in Cancer, 19(5), 697–701.
To investigate the efficacy of palonosetron for prevention of chemotherapy-induced nausea and vomiting (CINV) caused by adjuvant temozolomide (TMZ) in patients affected by glioblastoma
After completion of concomitant radiotherapy plus daily TMZ (75 mg/m2) in patients with stable disease or better, 30 minutes before the beginning of the first cycle of adjuvant TMZ (150-200 mg/m2 per day for five consecutive days every 4 weeks), patients received a single IV bolus of 0.25 mg palonosetron. All patients were receiving oral or parenteral dexamethasone (range 2–8 mg/day) with steady doses from at least 14 days before adjuvant TMZ initiation.
Patient diaries were used to record any emetic episodes, nausea, or rescue medication in daily (24-hour) intervals. The daily rates of emesis and nausea were assessed using a Likert-type scale. The primary endpoint was the percentage of patients with complete response (CR), defined as no emetic episodes and no rescue medication during the overall phase (0–168 hours).
This study was conducted at a single-site, outpatient setting at the Clinical Oncology Unit of Istituto Neurotraumatologico Italiano (I.N.I.) in Rome, Italy.
This was a prospective, open phase II study.
Complete response during the overall treatment period (0–168 hours) was observed in 30 patients (91%). Complete response in the 0–120-hour and 121–168-hour phases was observed in 30 patients (91%). Complete control was seen in 29 patients (88%), in 30 patients (91%), and in 29 patients (88%) during the 0–120-hour, 120–168-hour, and 0–168-hour phases, respectively.
The results suggested that a single dose of palonosetron before the initiation of multiple oral doses of TMZ, in patients receiving treatment with steady doses of dexamethasone, provides a high level of protection against CINV throughout the overall phase (0–168 hours). Discerning the affect of dexamethasone on nausea prevention was difficult in this study. Understanding the full impact of this regimen is challenging. A similar study conducted with ondansetron or another oral 5-HT3 RA would be interesting. If oral antiemetics are able to achieve similar results, they may be more cost effective and convenient for patients.
More antineoplastic drugs are being given orally at home. This study looked at the use of an antiemetic regimen used with an oral drug. Studies like this will become increasingly important as oral continuous-dosing drug regimens emerge. Adequate control of nausea and vomiting is essential for oral therapies, because lack of control can lead to patient noncompliance.
Rozans, M., Dreisbach, A., Lertora, J.J., & Kahn, M.J. (2002). Palliative uses of methylphenidate in patients with cancer: A review. Journal of Clinical Oncology, 20, 335–339.
DATABASES USED: MEDLINE
COMMENTS ON LITERATURE USED: Articles published from 1966–2000 related to methylphenidate use in patients with cancer or in palliative care
FINAL NUMBER STUDIES USED = 49
The evidence in the review found that methylphenidate is useful for the treatment of depression in a variety of malignancies, with more than 80% improvement in depression and side effects in less than 20%.
Roy, I., Fortin, A., & Larochelle, M. (2001). The impact of skin washing with water and soap during breast irradiation: A randomized study. Radiotherapy and Oncology, 58, 333–339.
To evaluate the impact of washing breast skin with soap and water during radiation therapy on the intensity of acute skin toxicity
Patients were randomized prior to receiving radiation into two groups. In group 1, skin within the treatment field was not allowed to be washed. In group 2, skin within the treatment field could be washed with Dove® or Ivory® soap and water. Patients were not to apply any other materials unless prescribed by a physician. Topical treatment was prescribed for 87% of non-wash patients and 80% of wash patients for a mean duration of 18.2 and 17.6 days, respectively. The topical agents prescribed were topical corticosteroids, eosin, Burow’s solution, and Biafine®. Patients were requested not to tell physicians if they were washing the irradiated area or not. Skin toxicity was independently scored by the author and radiation oncologist.
The study took place at an institution in Quebec, Canada.
The study used a randomized, blinded, controlled trial design.
In group 1, 57% had grade 2 or higher skin toxicity. In group 2, 36% had grade 2 or higher skin toxicity (p = 0.04). Mean time to maximal toxicity score achieved was not different between the groups. Maximal erythema score was not significantly different between the two groups. Incidence of moist desquamation was significantly higher in group 1 (p = 0.03). Dry desquamation (one month after treatment) was experienced by 74% of patients in group 1 compared with 56% of patients in group 2. The difference was not significant. Variables in univariate model significantly associated with acute skin toxicity included group 1, chemotherapy as part of treatment regimen, concomitant chemotherapy, presence of hot spots on dosimetry, and increased patient weight.
Allowing patients to wash irradiated skin did not result in any increased skin toxicity.
Rottmann, N., Dalton, S.O., Bidstrup, P.E., Wurtzen, H., Hoybye, M.T., Ross, L., . . . Johansen, C. (2012). No improvement in distress and quality of life following psychosocial cancer rehabilitation. A randomised trial. Psycho-Oncology, 21, 505–514.
To evaluate the effectiveness of a residential rehabilitation course for patients with cancer in decreasing psychological distress
Patients who had completed cancer treatment were randomly assigned to receive either usual care or a six-day residential psychosocial course. Those in the residential group had weekly rehabilitation courses in groups of 20. Course activities included education, supportive talks, physical activity, relaxation, massage, social activities, peer discussions, and dietary instruction. At the end of the course, individuals created a personal action plan to reinforce what was learned. Data were collected at baseline and at 1, 6, and 12 months after completion of the intervention.
Transition phase of care after initial treatment
Randomized controlled trial
At one-month time point, findings revealed significantly more improvement in anxiety (p = 0.03), total mood disturbance (p = 0.04), emotional role function (p = 0.02), and cognitive functioning (p = 0.0009) in the control group. At the six-month time point, a significantly improved outcome for the control group was also found for depression (p = 0.005) as well as sustained improvement in anxiety (p = 0.003), total mood disturbance (p = 0.02), emotional role function (p = 0.04), and cognitive functioning (p = 0.03).
The residential rehabilitation course studied did not have a positive effect on anxiety, depression, or cognitive functioning. In this study, the control group improved more over time than those who received the intervention.
This study suggests that an intensive residential program for cancer survivors, as examined, was of no benefit.
Roth, A. J., Nelson, C., Rosenfeld, B., Scher, H., Slovin, S., Morris, M., . . . Breitbart, W. (2010). Methylphenidate for fatigue in ambulatory men with prostate cancer. Cancer, 116, 5102–5110.
To test the potential benefit of psychostimulants in managing fatigue in men with prostate cancer.
Patients were randomly assigned to receive methylphenidate or placebo for up to six weeks. Methylphenidate was started at 5 mg once daily and titrated upward by 5 mg every two to three days to a maximum of 30 mg/day. The physician or research nurse was in contact with each patient at least twice weekly for dosage and patient safety evaluation. Study data were collected at the time of study entry and at the end of the six-week study period.
This was a randomized, double-blind, placebo-controlled, intervention study.
Of the eligible patients screened, 54% declined to participate. Of the patients in the methylphenidate group, 31% were discontinued due to increased blood pressure, and another 16% were removed due to tachycardia. The methylphenidate group showed significant reduction in BFI fatigue scores from 5.13 to 2.19 (p = 0.01). The placebo group also showed significant reduction in scores (p = 0.02). There was a difference between groups in the changes in fatigue during the study, with those in the methylphenidate group showing greater reduction in fatigue (p = 0.07; d = .80). There were no significant differences between groups in depression, anxiety, quality of life, or measures of cognitive function. The separation of study drug and placebo effects emerged at weeks 3 and 6.
The results suggested that methylphenidate was associated with a decline in fatigue; however, it was also associated with substantial cardiovascular side effects in almost half of the patients. A significant placebo effect was also observed.
Psychostimulants may be helpful to some patients in managing fatigue, but their use should be accompanied by close monitoring of potential side effects.
Rostock, M., Fischer, J., Mumm, A., Stammwitz, U., Saller, R., & Bartsch, H. H. (2011). Black cohosh (Cimicifuga racemosa) in tamoxifen-treated breast cancer patients with climacteric complaints - a prospective observational study. Gynecological Endocrinology, 27(10), 844-848.
The purpose of this study was to evaluate the dosage, effectiveness, and tolerability of an isopropanolic extract of black cohosh (Cimicifuga racemosa) in patients with breast cancer taking tamoxifen and reporting menopausal symptoms.
The study drug, Remifenin, was dosed at 2 tablets by mouth per day (40 mg black cohosh total) for 4 weeks but then participants could self-escalate the dose per patient preference (20, 40, 60, or 80 mg) and continue daily tablets for up to 6 months (mean 134 days). Participants were assessed at baseline and again 3- and 6-months later (90 and 180 days later). A subset of 4 patients also took St. John’s Wort.
Prospective, longitudinal, non-randomized study
There was a significant reduction in menopause rating scale scores, total scores, and subscales of vegetative-somatic and psychic symptoms at 1, 3, and 6 months of treatment. The overall MRS II score significantly decreased from 17.6 to 13.6 between baseline and last observation (p<0.001). Two of the three symptom subscales also decreased significantly (vegetative-somatic and psychic both p<0.01). However, the was no evidence of effectiveness for urogenital symptoms. Symptoms that were initially most intense such as hot flashes, sweating, and sleep disturbances improved most during the observation period.
The effectiveness of black cohosh extract for treatment of menopausal symptoms among women taking adjuvant tamoxifen is still unclear. Daily use over at least 4 weeks may result in reduced hot flashes and sleep disturbances. The drug was well tolerated in the small sample; however, it is unclear what the ideal dosing is for therapeutic benefit.
Limitations of the study included:
Black cohosh could be studied in a randomized trial but this study does not provide any efficacy information in relation to placebo.
Rossi, D., Alessandroni, P., Catalano, V., Giordani, P., Fedeli, S.L., Fedeli, A., . . . Catalano, G. (2007). Safety profile and activity of lower capecitabine dose in patient with metastatic breast cancer. Clinical Breast Cancer, 7, 857–860.
To evaluate the effectiveness of oral pyridoxine as prophylactic therapy for Palmar-Plantar Erythrodysesthesia (PPE)
The first 15 patients were treated without prophylaxis with oral pyridoxine. The following 20 patients were given oral pyridoxine 300 mg per day for 56 days.
In group 1, 33% developed PPE—one patient developed grade 3, and four patients developed grade 2 PPE. In group 2, 40% developed PPE—three patients developed grade 3, and five patients developed grade 2 PPE.
Prophylactic use of vitamin B6 may not be useful with biweekly administrations at low dose (15–20 mg/m2) because of low frequency of PPE documented with this particular schedule.