Lydiatt, W.M., Bessette, D., Schmid, K.K., Sayles, H., & Burke, W.J. (2013). Prevention of depression with escitalopram in patients undergoing treatment for head and neck cancer: Randomized, double-blind, placebo-controlled clinical trial. JAMA Otolaryngology—Head & Neck Surgery, 139, 678-686.
To determine whether prophylactic use of the antidepressant escitalopram oxalate would decrease the incidence of depression in patients receiving primary therapy for head and neck cancer
Patients were randomized and stratified by sex, site, stage (early vs. advanced), and the primary means of treatment (radiation or surgery). During the study, patients received either escitalopram or placebo. This was dosed at one tablet (10 mg if escitalopram) and increased by one tablet during the second week. This was the study dose until week 16. At this point, all patients were “weaned” by 10 mg per week, then “medication” was discontinued. Patients were reassessed at 20, 24, and 28 weeks.
PHASE OF CARE: Active antitumor treatment
APPLICATIONS: Elder care, palliative care
Randomized, double-blind, placebo-controlled
Prophylactic escitalopram reduced the rate of depression in patients with head and neck cancer undergoing treatment. Rate of depression was 10% with escitalopram and 24.6% among those on placebo (p = .04). The rate of depression was significantly higher in patients receiving radiation as their primary therapy as compared to surgery. Those patients who received drug reported better overall and health-related quality of life throughout the trial and during three consecutive months following drug cessation. Due to unacceptable side effects of medication, 12.8% withdrew from the study.
Escitalopram used in the setting of head and neck cancer immediately following diagnosis can have a positive effect on depression, possibly preventing depression from occurring. It also positively affects quality of life and ability to cope with cancer treatments, possibly enabling patients to continue with treatments.
Subject withdrawals ≥ 10%
Nurses do not have influence as to what the practitioner prescribes for patients (i.e., escitalopram). However, they can suggest it to practitioners. Some oncology practitioners are reluctant to prescribe anti-depressants, as they feel that this is outside their scope of practice. However, consideration is also generally recommended in professional guidelines. Depression may be underdiagnosed in patients with cancer; nurses can advocate for patients by raising attention to the problem in clinical practice. Initial and ongoing assessments for this patient population is imperative based on the high risk for depression. Results should be reported to the provider so patients who are exhibiting signs of depression can be addressed.
Lutz, S., Berk, L., Chang, E., Chow, E., Hahn, C., Hoskin, P., . . . Hartsell, W. (2011). Palliative radiotherapy for bone metastases: An ASTRO evidence-based guideline. International Journal of Radiation Oncology *Biology* Physics, 79, 965–976.
The literature search yielded 4,287 articles. Of these, the review of evidence included of the sample 25 randomized clinical trials, 20 prospective single-arm studies, and four meta-analyses/systematic reviews. No method of evaluation of study quality was described.
This systematic review provides information for nurses about evidence regarding use of radiation therapy for the palliation of pain from bone metastases. It points out that use of bone-modifying agents does not preclude use of radiation therapy. It also points out that for patients with multiple sites of disease-related pain, the use of radiopharmaceuticals may be more useful.
Lutgendorf, S.K., Mullen-Houser, E., Russell, D., Degeest, K., Jacobson, G., Hart, L., . . . Lubaroff, D.M. (2010). Preservation of immune function in cervical cancer patients during chemoradiation using a novel integrative approach. Brain, Behavior, and Immunity, 24, 1231–1240.
To examine the effects of healing touch on natural killer (NK) cell activity, mood, and specific clinical and quality-of-life outcomes among women receiving chemoradiation for locally advanced cervical cancer
After consent, patients randomized to one of three treatment arms: healing touch, relaxation, and control (usual care). The healing touch and relaxation interventions were administered individually four days per week throughout chemoradiation, on nonchemotherapy days, immediately following radiation. Healing touch participants received on average 15.25 (±6.97) sessions versus 11.75 (±5.20) sessions for relaxation (p = 0.08). Psychosocial surveys were completed for a total of four assessments (including baseline) over six weeks of chemoradiation. Each healing touch or relaxation session lasted 20–30 minutes and was delivered by experienced practitioners.
Active treatment
Prospective, randomized clinical trial with repeated measures
Results indicate that, in patients with cervical cancer who are undergoing chemoradiation, healing touch may be effective in preventing some aspects of decreased immunity and reducing depressed mood.
Complementary interventions may be an important adjunct for patients during active treatment, in both improving depressed mood as well as maintaining immunocompetence. However, the intervention must be feasible and acceptable to patients. This very well-reported study took five years to accrue a final sample of 51 patients (fewer than one patient per month), which illustrates the complexity of performing such research.
Luo, Y., Feng, M., Fan, Z., Zhu, X., Jin, F., Li, R., . . . Lang, J. (2016). Effect of Kangfuxin solution on chemo/radiotherapy-induced mucositis in nasopharyngeal carcinoma patients: A multicenter, prospective randomized phase III clinical study. Evidence-Based Complementary and Alternative Medicine, 2016, 8692343.
To evaluate the efficacy and safety of Kangfuxin solution, a pure Chinese herbal medicine, on mucositis induced by chemo/radiotherapy in patients with nasopharyngeal carcinoma
The treatment patients gargled three times a day after each meal. Patients were monitored from the first day of chemotherapy or radiotherapy until the emergence of grade 3 oral mucositis or when the patients finished the entire course of radiotherapy using the Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Oral mucositis and pain were measured according to guidelines.
Randomized, parallel-group clinical trial
Kangfuxin solution reduced the incidence of all levels of mucositis, especially high-grade mucositis, to improve patients' tolerance to radiation, ensuring the continuity of radiotherapy. So, it demonstrated its superiority to compound borax gargle on mucositis induced by chemo/radiotherapy.
Kangfuxin solution effectively prevented chemo/radiotherapy-induced oral mucositis, reduced the incidence of upper gastrointestinal inflammation, and decreased the severity of oral pain compared with compound borax gargle. It improves the quality of life in patients. Additional research to confirm the effects is warranted.
Lundorff, L.E., Jonsson, B.H., & Sjøgren, P. (2009). Modafinil for attentional and psychomotor dysfunction in advanced cancer: A double-blind randomised, cross-over trial. Palliative Medicine, 23, 731–738.
The study's primary aim was to assess the effectiveness of single-dose modafinil on cognitive function in patients with advanced cancer treated in palliative care settings. Its secondary aim was to assess the effectiveness of modafinil on other symptoms.
On day 1, patients were randomly assigned to receive either 200 mg of modafinil or an oral placebo. On day 4, each patient group was given the alternative treatment that was not dispensed on day 1.
The study took place in the palliative care department of Herning Hospital in Denmark.
The study was a double-blind, randomized, cross-over, single-dose trial.
Patients on the modafinil treatment group saw statistically significant improvements in psychomotor speed with the dominant hand (as measured by the FTT) and speed of processing (as measured by the TMT-B), as compared with the placebo group (p = 0.006). The modafinil treatment group also showed statistically significant improvements in depression and drowsiness as compared with the placebo group (p = 0.042).
The frequency and intensity of side effects were similar on both treatments, and no statistically significant differences were reported. However, four patients experienced disrupted sleep and vivid dreams after modafinil treatment.
Modafinil improved attention and psychomotor speed and diminished depression and drowsiness.
Lundin, E.S., Johansson, T., Zachrisson, H., Leandersson, U., Backman, F., Falknas, L., & Kjolhede, P. (2014). Single-dose tranexamic acid in advanced ovarian cancer surgery reduces blood loss and transfusions: Double-blind placebo-controlled randomized multicenter study. Acta Obstetricia Et Gynecologica Scandinavica, 93(4), 335–344.
To compare a single-dose infusion of tranexamic acid with a placebo given IV before the surgery of advanced ovarian cancer to compare blood loss and need for packed red blood cell (PRBC) transfusions
The patients were randomized via computer to receive either tranexamic acid or normal saline (0.9% NaCl) prepared by the local pharmacy. The amount of tranexamic acid of 15 mg/kg in 100 ml of normal saline or the same volume of placebo was administered. The infusion of the medication/placebo was administered via IV 15–20 minutes prior to surgery immediately after general anesthesia was established. A single dose of prophylactic antibiotic was given prior to surgery to all patients as well as 28 days of low-molecular heparin for 28 days postoperation. Hospital staff and patients were blinded to the treatment received. Perioperative bleeding was managed by established clinical protocol and blood transfusions were given during surgery or postoperatively if hemoglobin was below 90 g/L. A single dose of TA 1,000 mg or desmopressin (0.3 µg/kg body weight) was administered if deemed necessary by the surgeon. Drainage was allowed. Postoperative blood and plasma transfusions were given based on the patient’s clinical presentation and hemoglobin level. Hemoglobin levels were assessed five days after surgery or on the day of discharge if it was earlier. Patients were interviewed by a nurse five weeks after surgery.
Multi-center, randomized, double-blind, placebo-controlled trial
Outcomes measured were blood loss amount and total of red blood cell transfusions. Blood loss was assessed with drains, sponges, and drapes. Total blood loss was based on the hemoglobin balance method.
The overall results of the study showed that the total blood loss volume and the transfusion rate were lower in the tranexamic group using a single dose of tranexamic acid. Total blood loss p = 0.03 and transfusions given p = 0.02.
The evidence does suggest that using tranexamic acid immediately before surgery reduces blood loss and the need for transfusions as a prophylactic measure. However, one needs to take into consideration that the strength of this study may need to be further analyzed due to the lack of homogeneity in the participants and the validity of the measuring tools.
Given the fact that this medication is reasonably inexpensive and has no serious adverse side effects, nurses need to be aware that this intervention may decrease blood loss and subsequently the need for transfusions.
Luker, K., Cooke, M., Dunn, L., Lloyd-Williams, M., Pilling, M., & Todd, C. (2015). Development and evaluation of an intervention to support family caregivers of people with cancer to provide home-based care at the end of life: A feasibility study. European Journal of Oncology Nursing, 19, 154–161.
To design and evaluate an intervention to address caregiver information and needs when providing end of life care, and to evaluate the intervention for acceptability among caregivers and healthcare professionals, assessing the feasibility of healthcare workers adopting this as daily practice, and assessing its impact on caregiver burden, satisfaction, competence, and preparedness
The study was divided into two interventions. Phase 1 was comprised of interviewing caregivers about the need for practical information, support skills, and their preference on the form in which information should be delivered (identified as a booklet). Phase 2 evaluated the booklet used through validated questionnaires.
This was a mixed-method feasibility study with a convenience sample. Quantitative surveys were collected at recruitment and four to six weeks after initial recruitment. Qualitative data using semistructured interviews and structured personal diaries, logs, and interviews were collected.
This study demonstrated benefits from the booklet intervention on caregivers’ appraisal of caregiving. In addition, the study highlighted practical issues regarding the timing of the intervention delivery. A randomized control trial would be more effective in furthering the initial positive results identified by this study.
Additional effort should be made to adopt an intervention like this into everyday practice to improve both patient and caregiver quality of life outcomes. Nurses can assist in identifying at-risk caregivers earlier in the disease trajectory so the intervention can be initiated earlier on in palliative care.
Luebbert, K., Dahme, B., & Hasenbring, M. (2001). The effectiveness of relaxation training in reducing treatment related symptoms and improving emotional adjustment in acute and non-surgical cancer treatment: A meta-analytical review. Psycho-Oncology, 10, 490–502.
Databases searched included MEDLINE, PsycINFO, PSYNDEX, and CANCERLIT.
Randomized controlled trials (RCTs) conducted 1980–1995
Authors analyzed 15 studies.
Authors reported a small but significant effect on treatment-related symptoms, a significant medium effect on depression, and a small effect on anxiety.
Consistency of positive results showed reductions in treatment-related side effects and improved emotional adjustment.
Luebbert, K., Dahme, B., & Hasenbring, M. (2001). The effectiveness of relaxation training in reducing treatment-related symptoms and improving emotional adjustment in acute non-surgical cancer treatment: A meta-analytical review. Psycho-Oncology, 10, 490-502.
Databases searched were MEDLINE, PsycINFO, PSYNDEX, and CANCERLIT (1980-Dec., 1995).
Search keywords were relaxation techniques, progressive muscle relaxation (PMR), autogenic training, hypnosis, imagination, and guided imagery in combination with neoplasms, cancer treatment, chemotherapy, radiotherapy, drug therapy, and bone marrow transplantation.
A total of 280 abstracts were found, 58 studies were relevant, and 15 met the inclusion criteria for meta-analysis. Moderator variables included intensity, schedule, and focus of intervention.
A total of 742 primarily female subjects with variable malignancies receiving highly emetogenic chemotherapy and trained in progressive muscle relaxation (PMR) were part of this review.
Consistent positive results in meta-analysis studies showed clinically significant reductions in nausea and other symptoms. Relaxation during the courses of treatment made the experience less stressful, reducing side effects. Studies supported the implementation of relaxation training into clinical routines as standard adjunctive treatment.
Ludwig, G., Krenz, S., Zdrojewski, C., Bot, M., Rousselle, I., Stagno, D., . . . Stiefel, F. (2014). Psychodynamic interventions in cancer care I: Psychometric results of a randomized controlled trial. Psycho-Oncology, 23, 65–74.
To evaluate the effects of a psychodynamic-oriented intervention in patients with cancer
Patients who consented were randomized to an immediate intervention group or a waitlist controlled group. Patients who did not want to participate were assigned to an observation group, and they agreed to complete study measurements. The intervention involved an immediate phase of four sessions during which the therapist aimed to link the patients’ biographical information with current responses to disease. The authors noted that this intervention was not considered psychotherapy, but it was designed as psychological support. After the initial sessions, subjects were able to participate in 12 additional sessions if they chose to. Study questionnaires were completed by patients in the home at baseline and at four, eight, and 12 months.
Randomized, controlled trial
Only four patients in the immediate intervention group demonstrated improvements in total HADS scores (defined as a 50% improvement in score). Only 31.5% of those initially entered in the study had data for follow-ups, and the number of drop-outs in the waitlist controlled group was higher. There were no significant differences in study outcome measures between groups, and at some time points, control group scores were better. Only 50% of participants were interested in additional sessions of the intervention.
This study did not show any effects for the tested intervention. Multiple study flaws could have contributed to these results.
This study did not show any effects of the supportive psychodynamic intervention examined. These results need to be viewed with caution because of the multiple flaws and limitations of the study. This report points to the difficulty of getting sustained patient participation in this type of therapy or research. It is not clear if drop-outs were caused by competing issues such as transportation for sessions, problems encountered during cancer treatment, a lack of patient interest, or sense of benefit. Supportive interventions for patients with cancer need to be practical in their implementation for both providers and patients.