Howell, D., Oliver, T.K., Keller-Olaman, S., Davidson, J., Garland, S., Samuels, C., . . . Taylor, C. (2013). A Pan-Canadian practice guideline: Prevention, screening, assessment, and treatment of sleep disturbances in adults with cancer. Supportive Care in Cancer, 10, 2695–2706.
The AGREE II and Cochrane Risk of Bias tool were used for evaluation of articles. Three practice guidelines and 12 RCTs were evaluated, and 27 supplemental supportive documents were reviewed (e.g., reviews, information summaries, consensus statements, best practice advice), which were not always cancer-focused. Results are summarized briefly with modest overall quality found in the practice guidelines and RCTs. Considerations were made for small samples, short follow-up in effectiveness trials, and lack of details on methods. Formal assessments were not conducted on supplemental articles to fill in missing gaps of knowledge.
The guideline recommends, at minimum, a brief and focused assessment for sleep disturbances in patients with cancer and cancer survivors and provides options for screening tools and self-report assessments. Strategies, algorithms for screening, assessment, and management are provided based on literature, but they also are consensus-driven. The screening should include a short two-step process using standardized tools. The focused assessment then should identify chronicity and severity of the sleep problems (parameters of symptoms of poor sleep included). This includes key questions and a sleep diary for full evaluation. Referrals for noninsomnia-related disorders (e.g., apnea, restless legs syndrome) are prompted within the algorithm. Based on the initial evaluation, nonpharmacologic and pharmacologic interventions are recommended in a step process with care pathways that match the severity of the sleep disturbance (i.e., mild, transient, insomnia syndrome) with three corresponding care pathways. Preventative and supportive educational information is provided for all patients with cancer and cancer survivors that focuses on sleep hygiene and other sleep-promoting strategies. Rationale is provided for each strategy of treatment within this algorithm.
A basic and focused screening for sleep problems in patients with cancer is needed, with corresponding treatment and education as pertained to the scope of practice.
Howell, D., Keller-Olaman, S., Oliver, T.K., Hack, T.F., Broadfield, L., Biggs, K., . . . Olson, K. (2013). A pan-Canadian practice guideline and algorithm: Screening, assessment, and supportive care of adults with cancer-related fatigue. Current Oncology, 20, e233–e246.
Guidelines and algorithm developed
Guidelines developed for clinical practice.
Hovey, E., de Souza, P., Marx, G., Parente, P., Rapke, T., Hill, A., . . . Lloyd, A. (2014). Phase III, randomized, double-blind, placebo-controlled study of modafinil for fatigue in patients treated with docetaxel-based chemotherapy. Supportive Care in Cancer, 22, 1233-1242.
To determine whether modafinil could reduce fatigue related to docetaxel chemotherapy
Patients with metastatic breast or prostate cancer receiving docetaxel chemotherapy and experiencing significant fatigue were randomized to receive modafinil or placebo for 15 days beginning with their third cycle of treatment and repeated for 2–4 subsequent chemotherapy cycles.
The goal was a 10% or greater relative difference between the two treatment groups.
The primary endpoint of reduced fatigue during docetaxel chemotherapy was not statistically different between the two treatment arms.
Features a trend in docetaxel-related fatigue. Effectiveness was not established for the broader cancer-related fatigue treatment.
Hou, C., Wu, X., & Jin, X. (2008). Autologous bone marrow stromal cells transplantation for the treatment of secondary arm lymphedema: A prospective controlled study in patients with breast cancer related lymphedema. Japanese Journal of Clinical Oncology, 38(10), 670–674.
To determine the short- and long-term effects of bone marrow stromal cells (BMSC) transplantation for breast cancer-related lymphedema and to compare and contrast BMSC transplantation with complex decongestive physiotherapy
Patients in the complex decongestive physiotherapy group underwent manual lymphatic drainage, compression therapy, remedial exercises for arm and shoulder, and deep breathing to promote venous and lymphatic flow. Patients in the BMSC transplant group underwent bone marrow aspiration from the iliac crest, were admitted, and underwent brachial plexus or general anesthesia with range of transplantation being around the axilla, chest wall, and upper arm of the affected extremity. After the intensive phase, all patients were measured for and wore custom garment during waking hours. Patients were interviewed via telephone at 3 months and 12 months after treatment.
The study took place in a single site in China.
The study used a controlled trial design.
Both groups of patients experienced a reduction in pain and lymphedema volume. Patients in the BMSC transplant group had better long-term results. At three months (p = 0.0151) and at 12 months (p = 0.0001) patients in the BMSC group had significantly greater reduction in edema in the affected limb.
Autologous BMSC to treat breast cancer-related upper-extremity lymphedema was effective in the study at one year.
The study adds evidence to the effectiveness of complex decongestive physiotherapy in this population, which requires compliance with therapy, education, and support for patients and families.
Hosseinjani, H., Hadjibabaie, M., Gholami, K., Javadi, M., Radfar, M., Jahangard-Rafsanjani, Z., . . . Ghavamzadeh, A. (2015). The efficacy of erythropoietin mouthwash in prevention of oral mucositis in patients undergoing autologous hematopoietic SCT: A double-blind, randomized, placebo-controlled trial. Hematological Oncology. Advance online publication.
To evaluate the use of erythropoietin (EPO) for the prevention and reduction of oral mucositis (OM) in patients undergoing autologous hematopoietic stem cell transplantation
The intervention group used EPO mouthwash (50 IU/ml, 15 ml) four times per day beginning on the day of conditioning initiation and for 14 days post transplant or until DC, whichever came first. The control group received mouthwash (15 ml) four times a day without EPO for the same period of time. The mouthwash looked, smelled, and tasted the same. All patients were evaluated daily until day 21 by the same blinded evaluator. The World Health Organization (WHO) Oral Toxicity Scale was used for assessment.
Overall, less OM occurred in the EPO group (p < 0.001), less grade 2–4 OM occurrend in the EPO group (p = 0.003), and no significant difference existed in severe OM (grades 3–4) between groups, but the trend was less in the EPO group. Less intensity and severity of OM occurred in the EPO group (p < 0.001), shorter duration of OM occurred in the EPO group (p < 0.001), and the duration of neutropenic fever was less in the EPO group (p = 0.016). No differences in hematologic recovery, duration of neutropenia, or length of stay existed across groups. In addition, no differences in parenteral opioid use and transfusion were present across groups.
EPO mouthwash reduced the overall incidence of OM, decreased the severity and intensity of OM, and decreased the duration of OM. The duration of neutropenic fever was also decreased. A trend toward less severe OM (grades 3–4) in patients who used the EPO mouthwash was present.
EPO mouthwashes hold promise for preventing OM in patients undergoing autologous stem cell transplantation and receiving high-dose chemotherapy. Additional study is indicated, and the investigation of EPO mouthwash dosing will be important. The cost of EPO mouthwash may be an issue and will need to be evaluated.
Hosseini, M., Tirgari, B., Forouzi, M. A., & Jahani, Y. (2016). Guided imagery effects on chemotherapy induced nausea and vomiting in Iranian breast cancer patients. Complementary Therapies in Clinical Practice, 25, 8–12.
To evaluate the effects of guided imagery on chemotherapy-induced nausea and vomiting (CINV) among patients with breast cancer
Women who experienced nausea and vomiting within 24 hours after the first course of chemotherapy were assessed before and after the second course of chemotherapy. For the third course of therapy, participants listened to two audio recorded guided imagery scripts. One had mixed nature sounds as background and the other track instructed listeners to imagine feeling better within a pleasant setting of their choice. Patients listened to the first track the night before the third course of treatment. Prior to chemotherapy, severity and frequency of nausea and vomiting were measured.
PHASE OF CARE: Active antitumor treatment
Quasiexperimental
Morrow Assessment of Nausea and Vomiting
Pre- and post nausea and vomiting scores were lower in the third treatment cycle compared to those in the second cycle of chemotherapy (p = 0.0001).
Guided imagery may be helpful for reducing CINV.
The findings suggest that guided imagery might be helpful to reduce CINV symptoms. This study and report do not provide strong evidence because of multiple limitations. Additional research is needed to determine efficacy. Guided imagery is a very low-risk intervention that might be helpful to some patients, but the appropriate timing of such an intervention related to timing of chemotherapy administration needs to be determined in future research.
Hoskin, P., Rojas, A., Fidarova, E., Jalali, R., Mena Merino, A., Poitevin, A., . . . Jeremic, B. (2015). IAEA randomised trial of optimal single dose radiotherapy in the treatment of painful bone metastases. Radiotherapy and Oncology, 116, 10–14.
To determine the optimal single-dose radiotherapy schedule for pain related to bone metastases
Patients were randomly assigned to receive a single dose of 8 Gy, a single dose of 4 Gy, or 12 Gy in four fractions given over two consecutive days. Additional treatment with 8 Gy was given if moderate or severe pain persisted. Analgesic use was documented at baseline and at each follow-up. Patients were assessed at baseline and at four, eight, 12, 24, and 52 weeks.
Randomized trial
Across all follow-up time points, the proportion of those with CR and PR was higher with radiotherapy at 8 Gy although the difference between the groups was only significant at eight weeks. More treatments were needed with 4 Gy radiotherapy (p = 0.01). The response rate with 8 Gy was 70%–80% at four weeks compared to 82% with 4 Gy.
A single dose of 8 Gy radiotherapy was associated with higher CR rates, and a dosage of 4 Gy was effective in a substantial number of patients.
Both single-dose 4 Gy and 8 Gy radiotherapy were effective in reducing pain in the majority of patients. An 8 Gy dosing was beneficial in a higher proportion of patients, and fewer patients at this dose required additional treatment. Individual patient variables need to be considered in determining dosages based on tolerance and concerns about toxicity.
Hoskin, P., Sundar, S., Reczko, K., Forsyth, S., Mithal, N., Sizer, B., . . . Hackshaw, A. (2015). A multicenter randomized trial of ibandronate compared with single-dose radiotherapy for localized metastatic bone pain in prostate cancer. Journal of the National Cancer Institute, 107, djv197.
To compare a single, intravenous infusion of ibandronate with single-dose radiotherapy for metastatic bone pain
Patients referred for pain management were randomized to receive 6 mg ibandronate or a single dose of 8 Gy radiotherapy. Patients whose pain failed to respond to the treatment at four weeks were allowed to cross over to the opposite treatment within four to eight weeks. Assessments were done at baseline and at four, eight, 12, 26, and 52 weeks.
Randomized noninferiority trial
Overall, 31% of participants who began with ibandronate were crossed over, and 24% who began with radiotherapy were crossed over. There was no difference in WHO worst pain response between the groups at any study assessment period. There were no differences between the groups in worst pain response. At four weeks, those receiving radiotherapy had better responses (p = 0.04), but there was no difference at 12 weeks. There were no differences in quality of life between groups. Twice as many patients in the radiotherapy group had diarrhea (p = 0.014), and more had nausea (p = 0.058).
Single-dose radiotherapy and a single infusion of ibandronate had similar results on pain caused by bone metastases in men with prostate cancer. Radiotherapy was associated with more short-term adverse effects.
This study showed similar results for pain reduction with single-dose radiotherapy and a single infusion of ibandronate. Ibandronate is a newer bone modifying agent, so it is not clear if all bone modifying agents would provide equivalent results in comparison to radiotherapy. Bone modifying agents may have fewer side effects, which can be of importance depending upon the site of radiotherapy.
Hoskin, P. J., Robinson, M., Slevin, N., Morgan, D., Harrington, K., & Gaffney, C. (2009). Effect of epoetin alfa on survival and cancer treatment-related anemia and fatigue in patients receiving radical radiotherapy with curative intent for head and neck cancer. Journal of Clinical Oncology, 27, 5751–5756.
To evaluate the effect of epoetin alfa on local disease-free survival (DFS) (primary endpoint), overall survival, and cancer treatment-related anemia and fatigue (secondary endpoint).
Patients were randomized to one of the following three groups:
The study was a phase III, randomized, controlled trial.
Hgb increased from baseline with epoetin alfa. Median duration of local DFS (primary endpoint) was not statistically significant (hazard ratio = 1.04). The groups did not differ significantly in terms of DFS, overall survival, tumor outcomes, or cancer-related anemia or fatigue.
The addition of epoetin alfa did not affect survival, tumor outcomes, anemia, or fatigue positively or negatively in the head and neck cancer population.
Epoetin alfa cannot be recommended for the treatment of cancer-related fatigue in the head and neck cancer population.
Hopko, D.R., Robertson, S.M., & Carvalho, J.P. (2009). Sudden gains in depressed cancer patients treated with behavioral activation therapy. Behavior Therapy, 40(4), 346–356.
The overall purpose of the study was to examine sudden improvements in the symptoms of depressed patients with cancer who were receiving brief (nine-session) behavioral activation therapy (BAT). Specificially, the study examined the the frequency of sudden gains, the relation of sudden gains to the intervention components, the association of sudden gains to clinical and demographic variables, and the relation of sudden gains to treatment response and maintenance at three-month follow-up.
Authors recruited study participants by means of medical clinic screenings at the University of Tennessee Medical Center Cancer Institute. Participants provided informed consent and were included if they scored 9 or higher on the Harvard Department of Psychiatry National Depression Screening (HANDS) scale and met inclusion criteria following completion of a pretreatment diagnostic assessment battery (see instruments below). Inclusion criteria consisted of being diagnosed with cancer at age 18 or older, having a primary diagnosis of major depression with moderate to severe symptoms, and not being psychotic or cognitively impaired. After developing rapport with each particpant, the therapy provider assessed the function of depressed behavior and introduced the treatment rationale. Rationale included to reduce reinforcement of depressed behavior, increase healthy behavior, or increase exposure to reinforcement of healthy behavior. Provider and patient discussed a behavioral checklist form each week, in the one-hour psychoeducation session. The provider presented the treatment rationale and facilitated activity and goal selection and behavioral activation. Examples of activities and goals included engaging in weekly self-monitoring of daily activities, providing baseline measurement, and identifying potential activities to target during BAT. Patients prioritized activities and values, and they set goals from easy to difficult, with the aim of working upward in this hierarchy: family, peer, intimate relationships, education, employment, career, hobbies, recreation, volunteer work, charity, physical, health issues, and spirituality.
Pre/post-test time-series measurements
During the treatment 50% of participants experienced sudden gains as measured by an average of 11.8 BDI-II points. None experienced more than one sudden gain. Four participants exhibited reversals following sudden gains; all four returned to within 50% of their sudden gain in the post-treatment assessment. The initial scores of participants who experienced sudden gains had less-severe depression as measured by the pretreatment ADIS-IV. Those who made sudden gains in measures related to emotional problems, as measured by the SF-36 subscales, reported greater physical functioning, less bodily pain, and fewer problems with work and daily activities. Authors found no between-group differences regarding demographic and cancer-related variables. Compared to those without sudden gains, patients with sudden gains had significantly lower HRSD post-treatment scores. However, “as a follow-up to the finding that decreased depression severity was associated with sudden gains, the relationship of depression severity and sudden gains in treatment responders was evaluated. ... [D]epression severity did not differ as a function of sudden gain status at post-treatment but was marginally significant at 3-month follow-up . . . with those experiencing sudden gains exhibiting a trend for lower pre-treatment depression severity ratings relative” to responders who did not report sudden gains.
Authors noted that 50% of depressed patients with cancer who had received BAT experienced a sudden gain. Findings suggest that, in regard to depression treatment in patients with cancer, a streamlined and parsimonious behavioral activation approach is as adequate as a more comprehensive cognitive-behavioral approach.
Nurses treating depressed patients with cancer are advised to consider the role of increased pain and physical functioning in preventing sudden gains and other desirable treatment responses. Nurses who assimilate this knowledge into treatment plans may provide better care to depressed patients with cancer than do nurses who do not.