Koller, A., Miaskowski, C., De Geest, S., Opitz, O., & Spichiger, E. (2013). Results of a randomized controlled pilot study of a self-management intervention for cancer pain. European Journal of Oncology Nursing, 17, 284–291.
To evaluate the PRO-SELF© Plus Pain Control Program in a German population to determine effect sizes and feasibility
Participants received six visits and four phone calls from an intervention nurse, who taught them effective ways to self-manage their pain, including how to set pain goals, how to titrate prescribed analgesics, how to communicate with their physician, and how to identify management strategies to achieve their pain goals. They also received nurse coaching on their recent successes and failures, as well as individualized information about their medications during each visit and phone call.
Neither average nor worst pain scores demonstrated statistically significant group-by-time interaction effects between the intervention and control group over the 10-week or 22-week period. The difference in the knowledge scores between the intervention and control groups was statistically significant. A large percentage of participants did not complete the study for various reasons.
This study was the first to adapt a U.S.-developed pain intervention for a German audience. It did increase pain self-management knowledge and determine effect sizes for pain intensity scores.
The nursing intervention piece of this trial can have a great effect on the participants. In the U.S. and German trials, the nursing interventions were able to have an effect on fear of addiction, fear of tolerance, physical dependence, and the patients' understanding of taking their medications on a schedule.
Kolden, G.G., Strauman, T.J., Ward, A., Kuta, J., Woods, T.E., Schneider, K.L., . . . Mullen, B. (2002). A pilot study of group exercise training (GET) for women with primary breast cancer. Feasibility and health benefits. Psycho-Oncology, 11, 447–456.
A group exercise training (GET) intervention was delivered in a structured format three times per week for 16 weeks. The one-hour GET training sessions emphasized physical activities that promote aerobic fitness, strength, and flexibility. The warm-up period lasted 10–15 minutes, the aerobic training phase lasted 20 minutes, and the resistance training and cool-down phase lasted 20 minutes. Exercise intensity and duration were prescribed on an individual basis using the results from baseline fitness assessments. Two exercise physiologists provided each session. Data were collected at baseline, week 8, and week 16.
A quasi-experimental design was used.
BDI, PANAS, and HRSD were significantly improved from baseline to week 16. There was no statistically significant change in anxiety, as measured by STAI, after the exercise intervention. At baseline, participants were not experiencing high levels of distress.
Anxiety levels were not changed significantly from this exercise program, although other health benefits were reported.
Koike, K., Terui, T., Nagasako, T., Horiuchi, I., Machino, T., Kusakabe, T., . . . Ishitani, K. (2016). A new once-a-day fentanyl citrate patch (Fentos Tape) could be a new treatment option in patients with end-of-dose failure using a 72-h transdermal fentanyl matrix patch. Supportive Care in Cancer, 24, 1053–1059.
To assess effectiveness of a once-a-day fentanyl patch for patients receiving a 72-hour patch that does not last for 72 hours
Patients identified as having end-of-dose failure with a 72-hour fentanyl patch were identified and converted to the once-a-day patch according to manufacturer recommendations. In the evening of the switch day, the new patch was applied immediately after removing the 72-hour patch. Treatment for breakthrough pain was adjusted according to the fentanyl dose, and immediate-release morphine or oxycodone was used for breakthrough pain. If patients were on anti-inflammatories, they remained on this medication. Patients recorded study data daily. Of the patients, 15.6% had the 72-hour patch changed to use every 48 hours. Mean frequency of daily rescue doses for breakthrough pain were analyzed.
Of the patients with suspected end-of-dose failure, 84% were switched to the once-a-day patch. The rest had patches switched at 48 rather than 72 hours. On the last day of the 72-hour patch, mean daily dosing for breakthrough pain was 3.61; on the third day after the switch, the mean daily dosing was 1.18 (p < 0.05). Adverse events occurred in 18% of patients with the new patch, including local skin irritation and sensitivity. Of the patients with shortened interval to 48 hours, three showed a decrease in pain score, two showed no change, and two showed increased scores. After the switch to the once-a-day patch, 61% showed more than a 30% reduction in average pain.
Patients switched to the once-a-day fentanyl patch had a reduction in average pain scores and a reduction in rescue medications needed.
Differentiating between breakthrough pain and end-of-dose pain medication failure is important. This study suggests that these may not always be well determined. Study findings suggest that a once-a-day fentanyl citrate patch may be more effective for pain control than the usual 72-hour fentanyl matrix, particularly in patients with end-of-dose failure. This study is limited by its design and sample size. Further well-designed research is warranted.
Koh, C.E., Young, C.J., Young, J.M., & Solomon, M.J. (2008). Systematic review of randomized controlled trials of the effectiveness of biofeedback for pelvic floor dysfunction. British Journal of Surgery, 95, 1079–1087.
To determine whether biofeedback improves outcomes for patients with pelvic floor dysfunction (PFD), and to assess the relative effectiveness of different types of biofeedback therapy.
Databases searched were CINAHL, Embase, Medline, PsycINFO, Evidence-Based Medicine Reviews (EBMR), and the Cochrane Database. References of retrieved articles also were hand searched.
Search keywords were constipation, anismus, dyssynergia, obstructive defecation, rectocele, rectal intussusception, rectal prolapse, and biofeedback.
Studies were included in the review if they
Studies were excluded from the review if they reported on pediatric cases.
The initial searching provided 5,028 references. Study selection and screening for inclusion criteria provided a final set of seven studies. Study quality was evaluated by two reviewers.
Additional, better-designed studies are needed in this area to determine efficacy. Future studies should compare different biofeedback modalities to identify the most effective approaches.
Kohli, S., Fisher, S.G., Tra, Y., Adams, M.J., Mapstone, M.E., Wesnes, K.A., … Morrow, G.R. (2009). The effect of modafinil on cognitive function in breast cancer survivors. Cancer, 115(12), 2605–2616.
The study's primary aim was to examine the effect of modafinil on persistent fatigue after treatment. Its secondary aim was to examine the effect of modafinil on cognitive function of patients with breast cancer.
In phase 1, participants were given 200 mg of modafinil daily for four weeks. Participants with a positive response in phase 1 were randomized to phase 2. In phase 2, participants continued to receive 200 mg of modafinil orally once per day or a placebo for four weeks. Repeated measures were completed at baseline (week 0), week 4, and week 8. Participants were stratified by treatment type: chemotherapy, radiation, or both chemotherapy and radiation.
The study took place at the University of Rochester Medical Oncology Clinic in New York.
The study was a prospective, open-label clinical trial.
Approximately 70% of the participants in the active treatment group had an improvement in continuity of attention from baseline to after treatment (week 8), compared with 52% in the placebo group; however, this difference was not statistically significant (p = 0.19).
In phase 1, modafinil had a significant effect on speed of memory (p = 0.0073) and quality of episodic memory (p = 0.0001). No significant effect in continuity of attention, quality of working memory, or power of attention was observed during this phase.
In phase 2, those who continued modafinil demonstrated significantly greater improvement in cumulative speed of memory (p = 0.029), quality of episodic memory (p = 0.0151), and continuity of attention (p = 0.0101).
Modafinil significantly improved some cognitive functioning, including speed of memory and episodic memory, but failed to demonstrate improvement in working memory.
Kohara, H., Ueoka, H., Takeyama, H., Murakami, T., & Morita, T. (2005). Sedation for terminally ill patients with cancer with uncontrollable physical distress. Journal of Palliative Medicine, 8(1), 20-25.
The objective of this study was to investigate the influence on consciousness of sedative drugs to relieve severe physical distress refractory to standard interventions.
The study was a retrospective review of medical records of 124 consecutive patients admitted to a single palliative care unit between January and December 1999 to evaluate the use of sedation, defined as “a medical procedure to palliate patient symptoms refractory to standard therapy by intentionally dimming consciousness.\" Nocturnal sedation was excluded.
This single-site study was conducted in an inpatient setting in Japan.
This study contributes descriptive information about the use of terminal sedation (midazolam and opioids) for symptom control and the influence sedation has on the level of consciousness during the last days of life. In this study, patients receiving sedation were significantly drowsier and less responsive only during the last three days of life. What is not known from this study, although it is implied, is the degree of symptom control achieved by this intervention.
Limitations of this study included
This is helpful, descriptive, and low-level evidence about the use of terminal sedation to control symptoms. No measurement of dyspnea relief was included in the report, although it implies that sedated patients were not in distress.
Kohara, H., Ueoka, H., Aoe, K., Maeda, T., Takeyama, H., Saito, R., . . . Uchitomi, Y. (2003). Effect of nebulized furosemide in terminally ill cancer patients with dyspnea. Journal of Pain and Symptom Management, 26(4), 962–967.
The objective of the study is to assess the effect of nebulized furosemide (20 mg) on dyspnea uncontrolled by standard therapy in patients with terminal cancer.
Patients inhaled 20 mg of furosemide diluted with 3 ml of normal saline through an ultrasonic nebulizer over 10 minutes.
The study reported on a sample of 15 patients in a palliative care unit with histologic diagnosis of malignant disease and the presence of dyspnea that resists standard treatments.
Uncontrolled, open study
Initial severity of dyspnea was grade 4, assessed with the Hugh-Jones 0–4 classification. Effects were evaluated using the Cancer Dyspnea Scale before treatment and 60 minutes following treatment. Hemoglobin oxygen saturation and heart rate (HR) were measured with a pulse oximeter. Respiratory rate (RR), HR, and arterial blood gas parameters also were determined before and 60 minutes after use of nebulized furosemide. In addition, patients were asked whether they felt relief with the treatment and whether they hoped to continue the treatment.
The study showed that the inhalation of nebulized furosemide alleviated the sensation of dyspnea according to decreased Cancer Dyspnea Scale scores for sense of effort, sense of anxiety, and total dyspnea. However, objective data such as arterial oxygenation (PaO2), arterial partial pressure of carbon dioxide (PaCO2), oxygen saturation, HR, and RR did not change with treatment.
The study had several limitations. It was an uncontrolled, open study and, thus, the results may include a placebo effect from the intervention itself. The assessment of dyspnea was conducted on only two occasions—before and after administration of a single dose. Finally, the sample size was small.
Knols, R., Aaronson, N. K., Uebelhart, D., Fransen, J., & Aufdemkampe, G. (2005). Physical exercise in cancer patients during and after medical treatment: a systematic review of randomized and controlled clinical trials. Journal of Clinical Oncology, 23, 3830–3842.
Databases searched were MEDLINE, CINAHL, Cochrane Library, CANCERLIT, and PEDro through June 2004 to identify randomized, controlled trials and controlled trials (those with a comparison group but without explicit use of randomization for purposes of group allocation).
To be included in the review, the trials had to have examined the effects of physical exercise after surgery or during or after chemotherapy, radiotherapy, and/or hormonal therapy. Only exercise interventions designed to improve endurance or muscular strength were included.
Studies of relaxing exercises (e.g., yoga or tai-chi) were excluded.
The methodologic quality (using the Delphi criteria list—a set of nine criteria for quality assessment of clinical trials) and substantive results of 34 randomized, controlled trials and controlled trials was examined. Of the 34 studies examined, 22 examined the effectiveness of physical exercise during medical treatment, whereas 12 focused on the period after medical treatment.
Outcomes were fatigue, health-related quality of life, symptom distress, psychological distress, body composition, physical exercise capacity (maximal oxygen consumption [VO2] max), self-reported exercise/physical activity level, and other physical performance measures, such as walk time. Various physical exercise modalities were used, differing in type (walking, cycling, swimming, resistive exercises, or combined exercises), intensity (with most programs at 50% to 90% of the estimated VO2 maximum heart rate), frequency (ranging from two times per week to up to two times daily), and duration (ranging from two weeks up to one year). In some studies, the experimental group was compared with a group that received some form of training of a lesser intensity, frequency, and/or duration (e.g., stretching, self-directed exercises, strength exercises, aerobic exercise of a lesser intensity, swimming, behavioral therapy). In other studies, the comparison group did not receive any exercise program or advice, was on a waiting list, or participated in a cross-over trial.
The studies during medical treatment were divided into three subcategories: (1) exercise during breast cancer treatment, (2) exercise during bone marrow and peripheral blood stem cell transplantation, and (3) exercise during medical treatment for mixed solid tumors. The studies after medical treatment were divided into those involving exercise after breast cancer treatment and exercise after medical treatment for other solid tumors. The authors used this strategy to reflect not only differences in cancer diagnosis and the timing of physical exercise programs, but also possible differences in motivation, safety, feasibility and efficacy of exercise. The sample sizes for the intervention groups ranged from 12 to 188 participants.
A clinically significant or statistically significant positive effect of physical activity specifically on fatigue was noted during breast cancer treatment (three studies) or after breast cancer treatment (two studies), and during treatment (three studies) or after treatment (one study) in a mixed solid tumor population. The median quality criteria score on the Delphi list (range 1–7) was four for studies of exercise during and after cancer treatment. Twenty-five of the trials satisfied more than three criteria on the Delphi criteria list. The most commonly observed methodologic problems were with concealment of treatment allocation, blinding of the outcome assessor, and failure to use an intention-to-treat data analysis strategy.
Overall, the authors concluded that the included trials were of moderate methodologic quality, with a trend toward more methodologic rigor in more recent studies.
Knijn N., Tol, J., Koopman, M., Werter M.J., Imholz, A.L., Valster, F.A., . . . Punt C.J. (2011). The effect of prophylactic calcium and magnesium infusions on the incidence of neurotoxicity and clinical outcome of oxaliplatin-based systemic treatment in advanced colorectal cancer patients. European Journal of Cancer, 47, 369–374.
The purpose was to assess the effect of calcium and magnesium infusions on incidence of neurotoxicity and clinical outcomes in patients treated in a phase III trial (CAIRO2) with oxaliplatin-based chemotherapy.
Patients who had been treated in an randomized clinical trial for advanced colorectal cancer with either capecitabine, oxaliplatin, and bevacizumab or the same regimen with the addition of cetuximab were retrospectively divided into two groups: those who had received calcium and magnesium infusion at least during the first oxaliplatin cycle and those who did not receive calcium and magnesium during cycle 1. To evaluate the impact on prevention, incidence of neurotoxicity was defined as early (occurring during the first six cycles) or late (present at the last cycle).
The study was conducted in multiple outpatient facilities in Norway.
The study was a retrospective analysis of trial data.
Sample sizes were varied between groups, with 551 having received calcium and magnesium and 181 who did not. Incidence of any grade neurotoxicity was 85% in those who received calcium and magnesium and 92% in those who did not (p = 0.02), and incidence of grade 2 or higher was not significantly different between groups. Early neurotoxicity of any grade occurred more often in those who did not receive calcium and magnesium (91% versus 81%, p = 0.0002). In addition, no significant difference were noted between groups in incidence of grade 2 or higher early toxicity. All grade late neurotoxicity was lower in those who were in the calcium and magnesium group; however, incidence of grade 2or higher late toxicity was no different between groups. No difference was noted in survival or response rates between study groups.
Findings suggest that calcium and magnesium infusion may be helpful in the prevention of neurotoxicity with oxaliplatin; however, findings do not show a clear difference in more severe toxicity of grade 2 or higher.
The findings suggest the potential effect of calcium and magnesium infusions in the prevention of neurotoxicity; however, the findings do not show any difference in terms of prevalence of higher grade neurotoxicity. Additional research in this area is needed with more definitive outcome measures.
Kmetec, A., & Hajdinjak, T. (2013). Evaluation of safety and analgesic consumption in patients with advanced cancer treated with zoledronic acid. Radiology and Oncology, 47, 289–295.
To evaluate zoledronic acid treatment in patients with advanced cancer and metastases to bone, in regards to safety and effectiveness (as measured by serum value of calcium, concurrent analgesic use, reported bone pain, and pathological bone fractures)
An observational clinical study was conducted that monitored patients with cancer receiving monthly zoledronic acid treatment for 12 months. At each visit, pain status was evaluated using a visual analog scale (VAS), as well as by monitoring prescribed analgesics. Lab values were obtained, and skeletal events (pathological bone fractures, spinal cord compression, or concurrent therapy to palliate bone lesions) were recorded. Monthly doses of zoledronic acid were prescribed and infused according to each disease’s treatment guidelines.
At each monthly visit, measurements were taken as follows.
The percentage of patients on analgesics decreased in the multiple myeloma group from 57%–24%. In the group with prostate cancer, this percentage increased from 70%–88%. Pain VAS scores decreased by 22% in the patients with prostate cancer and by 97% in those with multiple myeloma. Hypocalcemia was recorded in 4% of all participants. Thirty-one skeletal events were reported by 10 patients (rate of 8%).
Zoledronic acid as treatment for patients with multiple myeloma may account for diminished concurrent use of analgesics for the same group over the annual period observed. Patients receiving zoledronic acid treatment concurrently with analgesics experienced a reduction in all types of skeletal events. This does appear to be an effective treatment for patients diagnosed with prostate cancer, specifically in terms of prophylactic treatment with bone metastases, as it has shown a decrease in skeletal events and pathological fractures. It is not effective for palliation of pain symptoms for patients with pancreatic cancer, as analgesic use increased for this group of patients.
Nurses work with patients to identify and communicate concerns to treatment providers at the earliest possible onset. The results of this study indicate a need for nurses to continue to evaluate, educate, and assist patients to communicate concerns to providers for the purpose of pursuing earliest possible interventions that provide the maximum effectiveness and best possible outcome for quality of care provided and quality of life resulting from that care for each patient. These findings reiterate an area for nursing attention when evaluating patients with pain issues at all stages of disease from initial diagnosis to progression, end-stage, and palliative care.