Kroz, M., Fink, M., Reif, M., Grobbecker, S., Zerm, R., Quetz, M., . . . Gutenbrunner, C. (2013). Multimodal therapy concept and aerobic training in breast cancer patients with chronic cancer-related fatigue. Integrative Cancer Therapies, 12, 301–311.
To investigate the feasibility and effects of a multimodal intervention for fatigue compared to home-based aerobic exercise
Individuals selected which intervention they wanted—home exercise or the multimodal intervention. The multimodal intervention included psychoeducation, including mindfulness-based techniques, sleep education regarding sleep hygiene, restriction and stimulus control, eurythmy therapy involving mind-body exercises, and medicine-oriented painting therapy. Those in the exercise group were asked to carry out 30-minute sessions three to five times weekly. Those in the multimodal group had 225 minutes of activity once weekly over 10 weeks, led by specialists in that therapy. Baseline and follow-up study measures were obtained within three weeks prior to starting the study and within three weeks after completion.
Those in the multimodal group showed a significant reduction in physical fatigue (p = .0342, mean change = -2.1). Those in the multimodal group had a significant improvement in global sleep quality (p = .041, mean change = -2.0).
A multicomponent intervention was seen to be feasible and had a positive impact on rating of physical fatigue and global sleep quality.
A holistic multicomponent approach to manage patient fatigue and sleep disruption may have greater benefit than interventions that only incorporate exercise. Further research is needed to determine what type and intervention components are most effective.
Kroiss, R., Fentiman, I.S., Helmond, F.A., Rymer, J., Foidart, J.M., Bundred, N., … Kubista, E. (2005). The effect of tibolone in postmenopausal women receiving tamoxifen after surgery for breast cancer: A randomised, double-blind, placebo-controlled trial. BJOG, 112, 228–233.
The study assessed the effects of tibolone versus placebo in postmenopausal women receiving tamoxifen, measuring effects on hot flashes, endometrium, and serum lipid and lipoproteins.
Women were randomized to receive 20 mg/day tamoxifen plus 2.5 mg/day tibolone or placebo.
Seventy (70) post-menopausal women less than or equal to 75 years of age (mean age: 58. I years) with Stage IIB or less started on tamoxifen postoperatively. Sixty-seven (67) patients completed the study. I
This was an outpatient, multicenter trial.
The trial was a double-blind, randomized, placebo-controlled, multicenter, pilot study.
The trial's primary end point was frequency and severity of hot flashes at three months. Daily hot flash diaries were used to assess frequency and severity of hot flashes. The Landgren scale assessed intensity of hot flashes and sweats. Patients completed a questionnaire to assess interference of hot flashes and sweats with everyday life. Endometrial biopsies were taken at 6 and 12 months. Monthly diaries assessed the incidence of bleeding or spotting throughout the study. Serum lipid profiles were assessed.
Daily diaries showed no change in the daily number of hot flashes with either tibolone or placebo (p = 0.219) after three months. There was a significant reduction in the severity of hot flashes with tibolone verses placebo (-0.4 versus 0.2, p = 0.031). The Landgren scale showed a mean change in the number of hot flashes of –0.6 with tibolone and +1.1 with placebo after 12 months (p = 0.022). Endometrial biopsies were normal and vaginal bleeding similar in both groups. Significant decrease in triglycerides ( 23% versus 1.4%) and HDL (12% versus 19%) with tibolone versus placebo after 12 months were noted.
The study was limited by its small sample size with less than 100 participants.
The effect of tibolone on recurrence of breast cancer is unknown.
Krohn, M., Listing, M., Tjahjono, G., Reisshauer, A., Peters, E., Klapp, B.F., & Rauchfuss, M. (2011). Depression, mood, stress, and Th1/Th2 immune balance in primary breast cancer patients undergoing classical massage therapy. Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer, 19(9), 1303–1311.
To investigate the short- and long-term effects of classical massage therapy on cytokine responses and the Th1/Th2 ratio, depression, mood, and perceived stress in patients with primary breast cancer; to evaluate the relevance of classical massage therapy in the context of oncologic care
Authors randomized 34 women into two groups. The massage group received a 30-minute classical massage twice per week for five weeks. The control group received standard medical care only. Time points in the study were before intervention, at the end of the five-week intervention period, and at six weeks after the intervention. At these time points, participants completed several measurement instruments, and investigators took blood samples to determine cytokine concentrations and the Th1/Th2 ratio.
Unspecified
Randomized controlled trial
Massage therapy is an efficient treatment for reducing depression in breast cancer patients. Insignificant results concerning immunologic parameters, stress, and mood indicate that further research is needed to determine psychological and immunologic changes associated with massage therapy.
Massage therapy may be an effective intervention to offer to patients who struggle with depression. Additional studies should evaluate the effectivenss of this intervention as well as its effect on immunologic parameters, stress, and mood.
Kroenke, K., Theobald, D., Wu, J., Norton, K., Morrison, G., Carpenter, J., & Tu, W. (2010). Effect of telecare management on pain and depression in patients with cancer: A randomized trial. JAMA: The Journal of the American Medical Association, 304(2), 163–171.
To determine whether centralized telephone-based care management cued by automated symptom monitoring can improve depression and pain in patients with cancer
In this study, called the Indiana Cancer Pain and Depression Trial, centralized telecare management was conducted by a nurse-physician specialist team that worked in concert with automated home-based symptom monitoring. The means of monitoring was interactive voice recording or Internet. A nurse care manager assessed symptom response and medication adherence, provided pain- and depression-specific education, and made treatment adjustments according to evidence-based guidelines. Intervention patients received scheduled calls (at baseline, at 1 week, and at 4 and 12 weeks) and received calls when automated monitoring indicated problems in symptom management. Control group received usual care. Data were collected at baseline and at months 1, 3, 6, and 12.
Randomized controlled trial
This study showed that centralized telecare management with automated symptom monitoring may be a feasible approach for geographically dispersed urban and rural oncology practices. This approach may be effective in improving the pain and depression of cancer patients.
Lack of control of the type of cancer treatment and of the time lapse since treatment might have affected study findings.
Cost will be involved in training the care manager and in the hiring of trained personnel. The cost-effectiveness of the collaborative care model needs to be further examined. Findings suggest that telecare management used with automatic systems cued by patient problems can be an effective approach.
Kroenke, K., Theobald, D., Wu, J., Norton, K., Morrison, G., Carpenter, J., & Tu, W. (2010). Effect of telecare management on pain and depression in patients with cancer: A randomized trial. JAMA, 304, 163–171.
To determine whether centralized telephone-based care management and automated symptom monitoring can reduce depression and pain in patients with cancer
Participants in the intervention group received centralized telecare management, conducted by a nurse-physician specialist team, and automated home-based symptom monitoring by means of interactive voice recording or Internet. The control group received usual care. Data were collected at baseline and at months 1, 3, 6, and 12.
Random controlled trial with double blinding, with stratified randomization by symptom type (pain only, depression only, or both pain and depression)
The intervention may be effective at reducing pain and depression. The intervention proved to be a feasible care approach for geographically dispersed urban and rural oncology practices.
Lack of control over type of cancer treatment and over the time lapse since treatment might have affected study findings.
Cost will be involved in training the care manager and in hiring trained personnel. The cost-effectiveness of the collaborative care model needs to be further examined. Studies show mixed results regarding effect of by-telephone patient management; further work in this area is warranted. Use of technology may be a viable approach to ongoing patient support.
Krischer, M.M., Xu, P., Meade, C.D., & Jacobsen, P.B. (2007). Self-administered stress management training in patients undergoing radiotherapy. Journal of Clinical Oncology, 25, 4657–4662.
The intervention was a self-administered stress management training (SSMT) program for patients treated with radiation therapy. The usual care only (UCO) intervention included the usual psychosocial care typically provided at the institution where patients were receiving treatment. Participants in the SSMT program met individually with a nurse for approximately five minutes to receive instructional materials and explanations. The instructional materials consisted of a 15-minute prerecorded videotape, a 12-page booklet, and a 35-minute prerecorded audiotape titled “Active Relaxation,” which taught paced breathing, active relaxation, and positive thinking with guided imagery instructions. Data were collected at baseline and weeks 1, 2, and 3.
Multiple centers in South Florida
A randomized controlled trial design was used.
SSMT is effective only in those patients receiving radiotherapy with initially higher levels of psychological distress at baseline.
Special training needs include the creation of the SSMT tool (instructional materials, video tables, and audiotapes).
Intervention requires screening for psychological distress.
Kris, M.G., Hesketh, P.J., Somerfield, M.R., Feyer, P., Clark-Snow, R., … Grunberg, S.M. (2006). American Society of Clinical Oncology guideline for antiemetics in oncology: Update 2006. Journal of Clinical Oncology, 24(18), 2932–2947.
To update the 1999 American Society of Clinical Oncology (ASCO) guideline for antiemetics in oncology
The update committee reviewed studies identified through a literature search.
Databases searched were MEDLINE, the National Library of Medicine, and the Cochrane Collaboration Library (1998-Feb. 2006).
Studies were included if they were phase II and III randomized, controlled trials.
The search identified the following studies.
Additional materials provided to the committee were
Kress, H.G., Von der Laage, D., Hoerauf, K.H., Nolte, T., Heiskanen, T., Petersen, R., . . . Jensen, N.H. (2008). A randomized, open, parallel group, multicenter trial to investigate analgesic efficacy and safety of a new transdermal fentanyl patch compared to standard opioid treatment in cancer pain. Journal of Pain and Symptom Management, 36(3), 268–279.
To compare, in clinical practice, the effect and safety of a new matrix fentanyl patch (Fentanyl Improved Transdermal [FIT]) patch) to oral and other transdermal opioid treatment
Patients were randomly assigned to either FIT patch or standard opioid treatment via oral or transdermal route. Morphine was the only rescue medication allowed. Patients could receive radiotherapy and chemotherapy as well as nonpharmacologic and pharmacologic pain management therapies. Patients randomized to FIT therapy switched from existing regimens to FIT therapy by means of standard conversion ratios. Patients had an initial screening visit and four additional visits. Each evening each patient assessed his or her pain and recorded the pain rating in a diary. Adverse events were monitored in follow-up visits through the 30-day trial period and for one week longer. Patients assessed adverse events on a four-point scale and recorded the rating.
Randomized open-label parallel-group design
Results showed no differences, in terms of pain management or adverse effects, between the new transdermal patch and standard transdermal or oral opioid treatment. Findings suggest that the new type of patch is safe and, in terms of efficacy, similar to standard treatments.
Transdermal fentanyl, delivered by means of conventional patch or FIT patch, is an effective means of controlling cancer pain.
Kress, H.G., Oronska, A., Kaczmarek, Z., Kaasa, S., Colberg, T., & Nolte, T. (2009). Efficacy and tolerability of intranasal fentanyl spray 50 to 200 microg for breakthrough pain in patients with cancer: A phase III, multinational, randomized, double-blind, placebo-controlled, crossover trial with a 10-month, open-label extension treatment period. Clinical Therapeutics, 31(6), 1177–1191.
To assess the efficacy and long-term tolerability of infranasal fentanyl spray (INFS)
In an initial titration phase, the effective dose of INFS was determined for each patient. An effective dose was defined as one that was successful in treating three of four episodes of breakthrough pain. If pain relief was insufficient, an additional dose was administered in the alternate nostril. Titration was repeated if the patients’ background opioid dosage was adjusted during the trial. During the efficacy phase patients received, in randomized double-blind sequence, the titrated effective dose of INFS or placebo for administration at home. Patients were randomized to treatment sequences for eight episodes of breakthrough pain. Patients used a diary to record pain intensity at 0, 10, 20, 40, and 60 minutes after administration. Pain ratings were according to a numeric rating scale. Patients were monitored during the 10-month open-label extension phase. Patients received 30-day supplies of INFS, in appropriate doses, during monthly clinic visits. Weekly telephone contact provided data about adverse events, concurrent medications, and INFS efficacy.
Double-blind randomized, double-dummy two-way crossover study
INFS titrated to an effective dose demonstrated some effectiveness in relieving breakthrough pain in this group of patients. Long-term tolerability could not be clearly determined because of the small number of patients who completed the extension phase of the study. Most patients appeared to tolerate IFNS well.
Findings suggest that INFS may be a useful adjunctive approach to deal with the breakthrough pain of patients with cancer who have chronic opioid-managed pain. INFS may be more useful as a short-term, rather than a long-term approach; the matter of long-term efficacy and tolerability requires further study.
Kress, H.G., Koch, E.D., Kosturski, H., Steup, A., Karcher, K., Lange, B., . . . Eerdekens, M. (2014). Tapentadol prolonged release for managing moderate to severe, chronic malignant tumor-related pain. Pain Physician, 17, 329–343.
To determine whether tapentadol prolonged-release (PR) is effective and tolerable for managing moderate to severe tumor-related pain
Patients whose pain was rated 5 or above on an 11-point scale were randomized (2:1) and titrated to an optimal dose of tapentadol PR (100–250 mg BID) or morphine sulfate CR (40–100 mg BID) over two weeks. Immediate-release morphine sulfate was allowed as needed as a breakthrough medication. During the last three days of titration, patients who achieved an average pain intensity of less than 5 and took less than 20 mg per day of rescue pain medication entered a four-week maintenance period. Patients who received tapentadol were rerandomized (1:1) to either tapentadol BID or a placebo for the maintenance period. Response at the end of titration and response at the end of the maintenance were assessed. Tolerability and side effects were evaluated.
Randomized-withdrawal, parallel-group, active- and placebo-controlled, double-blinded study
During the study, pain levels were evaluated with an 11-point Numeric Rating Scale (NRS) twice daily. The proportion of patients classified as responders (patients who completed 28 or more days, had a mean pain intensity score < 5, and had a mean total daily dose of ≤ 20 mg rescue medication during the maintenance period) was evaluated as a primary endpoint during the titration and maintenance periods. Mean pain intensity at the start of the maintenance period was calculated as the mean daily pain intensity scores during the last three days of the titration period. Mean weekly pain intensity during the maintenance period was calculated from the mean daily pain intensity scores during each week of the maintenance period. Adverse events were coded using the Medical Dictionary for Regulatory Activities v15.0. The treatments for emergent adverse events in all groups were collected and compared as were specific gastrointestinal and nervous system effects and general disorders or administration site effects.
Patients receiving tapentadol were twice as likely to respond than the patients who received a placebo. Tapentadol PR was noninferior to morphine CR (p < 0.001). Mean pain intensity scores improved in both the tapentadol PR and morphine CR groups during titration. These reductions were sustained throughout the maintenance period. There were no statistically significant differences between the tapentadol and placebo groups in changes in pain intensity from the start of maintenance to weeks 1–4 (p ≥ 0.0152). A higher percentage of patients in the placebo group (72.1%) took ≥ 20 mg per day of rescue morphine immediate-release compared to the tapentadol (71.4%) or morphine CR (61.5%) groups. During titration, 50% of patients in the tapentadol group and 63.9% of patients in the morphine group reported one or more treatment-emergent adverse effects (TEAEs). A smaller percentage of patients receiving tapentadol PR had any TEAEs (p = 0.0039) than those receiving morphine CR.
Tapentadol PR 100–250 mg BID was effective in the treating tumor-related pain. The analgesic effect of tapentadol PR was not inferior to morphine CR and had better overall and gastrointestinal tolerability than morphine CR. However, more tapentadol users required rescue pain medication than those taking morphine CR.
Tapentadol, one of a new class of centrally acting analgesics, was effective in treating tumor pain and was generally better tolerated than morphine CR. Nurses should be familiar with the common side effects associated with this medication including nausea, vomiting, constipation, dizziness, sleepiness, and fatigue to safely care for patients receiving this drug.