Heckler, C.E., Garland, S.N., Peoples, A.R., Perlis, M.L., Shayne, M., Morrow, G.R., . . . Roscoe, J.A. (2016). Cognitive behavioral therapy for insomnia, but not armodafinil, improves fatigue in cancer survivors with insomnia: A randomized placebo-controlled trial. Supportive Care in Cancer, 24, 2059–2066.
To assess the combined and comparative effect of cognitive behavioral therapy (CBT) and armodafinil to improve sleep and daytime functioning in survivors of cancer.
Participants were randomized to (a) CBT-I and placebo, (b) CBT-I and armodafinil 50 mg b.i.d., (c) placebo BID, or (d) armodafinil 50 mg BID. All received written sleep hygiene guidelines. Participants had CBT-I in 30–60-minute individual, in-person sessions during weeks 1, 2, and 4; and had 15–30-minute phone sessions during weeks 3, 5, and 7. Study medicine was taken for 47 days from 7 am to 9 am and 12 pm to 2 pm.
Improvement in fatigue was noted with CBT for insomnia (p = 0.002 on BFI; p < 0.001 on FACIT-F). No improvement in fatigue was noted with placebo, on armodafinil alone, or on armodafinil with CBT-I.
CBT for insomnia appears to improve fatigue in patients with insomnia, and armodafinil was not shown to improve fatigue in patients with insomnia and fatigue.
This study shows that CBT for insomnia may be beneficial to patients with fatigue and that armodafinil does not improve fatigue.
Hecht, J.R., Pillai, M., Gollard, R., Heim, W., Swan, F., Patel, R., . . . Malik, I. (2010). A randomized, placebo-controlled phase ii study evaluating the reduction of neutropenia and febrile neutropenia in patients with colorectal cancer receiving pegfilgrastim with every-2-week chemotherapy. Clinical Colorectal Cancer, 9, 95–101.
The purpose of this study is to evaluate whether prophylactic pegfilgrastim administered with first- or second-line chemotherapy was feasible and reduced the incidence of grade 3/4 neutropenia and neutropenia-related complications in patients receiving 14-day oxaliplatin- or irinotecan-containing 5-FU–based chemotherapy regimens for advanced or metastatic colorectal cancer (CRC).
One of three chemotherapy regimens (FOLFOX 4, FOLFIRI, or FOIL) was selected by physician discretion. Patients were randomized to receive either pegfilgrastim 6 mg or placebo on day 4 of each 14-day regimen. During the study period (the first four cycles of chemotherapy), the incidence of grade 3/4 neutropenia and febrile neutropenia were compared between the pegfilgrastim and placebo groups.
Active treatment
Randomized, controlled trial, double-blinded. The control group received placebo.
Patients treated with pegfilgrastim were significantly less likely (13%) to develop grade 3/4 neutropenia than those who received a placebo (43%) (p < 0.05). The pegfilgrastim group also experienced significantly fewer dose delays or dose reductions (33.4% versus 45%) (p < 0.05).
The study compares pegfilgrastim versus placebo, but does not consider pegfilgrastim versus filgrastim, which may have similar efficacy at reduced expense. Additional study is warranted, including a cost-benefit analysis.
Patients with CRC receiving every-two-week chemotherapy regimens may benefit from supportive medications to stimulate neutrophil production.
Hebert, R.S., Schulz, R., Copeland, V.C., & Arnold, R.M. (2009). Pilot testing of a question prompt sheet to encourage family caregivers of cancer patients and physicians to discuss end-of-life issues. American Journal of Hospice and Palliative Medicine, 26, 24–32.
To develop a question prompt sheet (QPS) for use by physicians and family members of seriously ill patients
QPS development: HCPs from various disciplines including medicine, nursing, psychology, social work, clergy, and ethics who had at least two years of experience in end-of-life care helped define the QPS. Family caregivers used a large community-based hospice consult service for care of a seriously ill family member who had a life expectancy of less than six months. Bereaved caregivers included those who had lost a family member within the past year. Bereaved caregivers were either African American (n = 15; 45%) or Caucasian (n = 18; 55%). Primary patient illnesses (n = 23) were cancer (n = 10; 82%) and cardiovascular disease (n = 6; 26%).
QPS pilot testing: Caregivers were Caucasian (95%), African American (2%), or other (2%). The relationship to the patient was spouse (55%) or nonspouse (45%). The mean number of months providing care to the patient was 28 months. The mean hours per week providing care was 132 hours. Patients mainly had a diagnosis of cancer.
Prospective tool development and a feasibility pilot study were used.
The QPS, which encompasses medical, practical, psychological, and religious/spiritual informal caregiver concerns, had high content validity (> 0.80) and appeared in a satisfactory structure and layout based on caregiver feedback. Caregivers noted 17 of 25 questions as important for caregiver–physician discussion, including patient medication effects (46%), what to expect in the future (45%), patient depression (39%), who to call for help (32%), addiction (30%), hospice (25%), home-health services (23%), treatment risk (23%), whether the patient will have pain (21%), nutrition and anorexia (21%), suffering (21%), what to expect when the patient is dying (21%), recovery from illness and life expectancy (20%), and bereavement support (20%). Caregivers found the QPS easy to understand and felt comfortable completing the form in the clinic. Physicians involved in the study believed the QPS was valuable and nondistracting to clinical work. Family caregivers (70%–75%) reported that the QPS made it easier to ask questions in front of the family.
The QPS was evaluated by informal caregivers who found the tool acceptable and feasible for use in an outpatient palliative care setting. A QPS used in caregiver–physician clinical discussions can facilitate informal caregivers’ ability to ask important questions that increase their comfort during end-of-life care of a loved one.
The QPS or a similar tool outlines possible informal caregiver questions that nurses could address in care delivery. The main questions that caregivers chose to use in the study, such as those pertaining to medication side effects, what to expect in the future, or patient depression, highlight and provide guidance for discussion with family caregivers.
Inclusion of caregivers in conversations with the nurse may build rapport and trust that may facilitate initiation of discussion regarding end-of-life concerns and caregiver coping and health promotion issues. An interdisciplinary approach, including nursing involvement, allows meeting of complex patient–caregiver needs throughout the trajectory of care of a serious illness, including cancer.
Further refinement and testing of the QPS is important since it addresses the need to improve communication and stimulate discussions between informal caregivers and HCPs about an ill patient. Areas for further development include the unique perspective of the woman caregiver, literacy level of the QPS user, and testing in other populations.
The questions this study raises regarding good communication for future study are important. The QPS, although providing a structure for question asking, does not address the caregiver–physician relationship aspect that supports understandable and comfortable delivery of information between both parties. The QPS questions seem to focus on the patient’s needs and how the caregiver can respond to those needs. Few focus on caregiver needs as a result of caregiving to support continued care or recovery from bereavement. Continued work must address ways, including use of appropriate screening tools, to facilitate optimal caregiver and physician communication throughout the care cycle of a seriously ill family member to increase quality of life for carers.
He, X.R., Wang, Q., & Li, P.P. (2013). Acupuncture and moxibustion for cancer-related fatigue: A systematic review and meta-analysis. Asian Pacific Journal of Cancer Prevention, 14, 3067–3074.
STUDY PURPOSE: To evaluate the auxiliary effectiveness of acupuncture and moxibustion in the treatment of cancer-related fatigue (CRF)
TYPE OF STUDY: Systematic review and meta analysis
PHASE OF CARE: Active anti-tumor treatment
Fatigue declined over time for all groups: true acupuncture, sham acupuncture, and controls. However, no significant difference between groups was noted. Three studies looked at moxibustion lacking information on adverse effects and inadequate methodology.
The authors concluded that data is currently insufficient to recommend as an intervention for CRF other than when traditional interventions fail. No data exist to recommend this over conventional interventions, which are not described in this article.
Insufficient date to recommend.
Haywood, A., Good, P., Khan, S., Leupp, A., Jenkins-Marsh, S., Rickett, K., & Hardy, J.R. (2015). Corticosteroids for the management of cancer-related pain in adults. Cochrane Database of Systematic Reviews, 4, CD010756.
Studies included were of steroids used as a treatment with pain assessed as an outcome. Dexamethasone was used in eight studies. Nine of the studies were designed with pain as an outcome. Six were placebo-controlled studies, one was a crossover study with a placebo, five had active controls, one was an open-label study, and two were low- versus high-dose studies. There did not appear to be a statistic benefit to the use of corticosteroids for all patients with cancer-related pain. Studies compared corticosteroids to standard therapy. A meta-analysis was done of six studies, and the others were not included because of missing data. There was insufficient data to do a subgroup analysis. A data point of one week was used as a standardization point for the interventions of the six studies in the meta-analysis. The meta-analysis showed an overall mean difference of –0.84 (p = 0.002) in favor of corticosteroids. There was insufficient evidence to evaluate side effects.
Evidence appeared to be weak in regard to the efficacy of corticosteroids for pain relief in patients with cancer. Although the meta-analysis suggested some benefit, the confidence interval was wide, and the quality of the studies included was low.
There was limited evidence to support the use of corticosteroids for chronic pain. If used, their benefit should be evaluated frequently and discontinued if none is found. Corticosteroids have numerous side effects, and the benefits versus harms must be weighed before their use in patients with cancer-related pain.
Hayes, S.C., Speck, R.M., Reimet, E., Stark, A., & Schmitz, K.H. (2011). Does the effect of weight lifting on lymphedema following breast cancer differ by diagnostic method: Results from a randomized controlled trial. Breast Cancer Research and Treatment, 130(1), 227–234.
To identify the baseline prevalence of lymphedema in the PAL cohort according to three standard diagnostic methods commonly used in clinical practice and/or research, and to compare the effect of the weight-lifting intervention on lymphedema outcomes using these same three diagnostic methods.
The study evaluated the women’s lymphedema status at baseline and 12 months using four independent standardized methods: volumetric, sum of arm circumferences, bioimpedance spectroscopy, and validated self-report survey. In the PAL trial women were randomized to progressive weight lifting or usual care.
The study took place across multiple settings in Pennsylvania.
The study has clinical applicability for late effects and survivorship.
The study used a secondary analysis of a randomized controlled trial design.
There were no clinical or statistical differences in personal and treatment characteristics between the weight-lifting and control group. The authors identified that irrespective of the lymphedema diagnostic criteria used, weight lifting did not initiate nor exacerbate lymphedema. The PAL Trial’s definition for lymphedema identified 48% of the 295 participants as having lymphedema. When specific diagnostic criteria were independently applied to the cohort, lymphedema was clinically evident between 22% (sum of circumferences) and 52% (Norman survey). When all four criteria were applied, only 19% were considered to have lymphedema.
It is important to consider that the variations in lymphedema cohort and intervention studies may be reflected by these different diagnostic methods. It is important to consider the strengths and limitations of each criteria in light of the cohort being assessed. The results of the study may change the previous recommendations of restricting repetitive exercise; this study highlights that women should be encouraged and not restricted to participate in programs. Results also suggest large differences in reported lymphedema incidence based on the definitions used.
Unintended interventions or applicable interventions were not described and would influence results.
Findings suggest that progressive weight lifting does not exacerbate lymphedema. Still, we should caution that women in the PAL Trial were supervised and closely monitored for changes in signs or symptoms of lymphedema. The study was not powered to evaluate whether weight lifting could prevent lymphedema.
Hayes, S.C., Reul-Hirche, H., & Turner, J. (2009). Exercise and secondary lymphedema: Safety, potential benefits, and research issues. Medicine and Science in Sports and Exercise, 41(3), 483-489.
To investigate the effect of participating in a supervised, mixed-type exercise program on lymphedema status among women with lymphedema after breast cancer
All measures were assessed before the intervention, immediately after the intervention, and at 12-week follow-up and were conducted by the same assessor who was blinded to participant group allocation. Participants were randomly allocated to the intervention group or the control group after being assessed before the intervention. The intervention involved a 12-week, mixed-type exercise program, including aerobic and resistance exercise.
The study took place in an outpatient setting in Queensland.
The study used a randomized controlled trial design.
There were no significant differences in lymphedema status at baseline or changes between testing phases observed between the intervention and control groups.
Women with lymphedema can safely participate in this type of education.
Nurses should be aware that, at minimum, exercise does not exacerbate secondary lymphedema. Women with secondary lymphedema should be encouraged to be physically active, optimizing their physical and psychosocial recovery.
Hayes, S. C., Rye, S., DiSipio, T., Yates, P., Bashford, J., Pyke, C., . . . Eakin, E. (2013). Exercise for health: a randomized, controlled trial evaluating the impact of a pragmatic, translational exercise intervention on the quality of life, function and treatment-related side effects following breast cancer. Breast Cancer Research and Treatment, 137, 175–186.
To evaluate two modes of delivery of an exercise intervention: provided either face-to-face or via the telephone.
Women were randomized to one of three groups: face-to-face exercise, telephone exercise intervention, or usual care. For those in the exercise interventions, the intervention involved 16 sessions, starting weekly and tapering to monthly contact after four months. The exercise prescription was provided in sessions to progress to exercising 45 minutes at least four days per week, incorporating both aerobic and strength-based exercise. Assessments were performed at baseline and six weeks, six months, and 12 months postsurgery.
Patients were undegoing the active antitumor treatment phase of care.
This was a single-blind, randomized, controlled, longitudinal study.
Upper body function and adverse effects, such as menopausal symptoms, pain, anxiety, and depression, improved over time for all patients, with no differences between groups. The adherence rate was 88% in the face-to-face exercise group and 81% in the telephonic intervention group. Patients in both exercise intervention groups showed greater improvement in fatigue symptoms over time (p = 0.032). At the end of the study, fatigue scores improved by 4.9 points in the face-to-face intervention and by 6.8 points in the telephonic group. In the usual care group, fatigue initially got worse; however, scores improved by 4.6 points by 12 months. Sixty-six percent of those in the usual care group also participated in at least 180 minutes of physical activity per week and had an increased level of activity from baseline. Quality of life improved significantly more in the intervention groups over time (p = 0.03)
Findings suggested that delivery of an exercise prescription and instruction via the telephone can be an effective method of delivering an exercise intervention for women with breast cancer. Results of this study support those of others demonstrating improvement in symptoms in all patients over time, but significantly greater improvement in fatigue with exercise interventions.
Findings suggested that providing an exercise prescription might be an effective way to engage patients in exercise, which can reduce symptoms of fatigue. This study demonstrated that providing an exercise program intervention via telephone contact can be as effective as engaging patients in a face-to-face intervention. This suggests that telephonic contact to teach and motivate patients to exercise may be an effective and practical way to deliver an intervention.
Hayek, S.M., Deer, T.R., Pope, J.E., Panchal, S.J., & Patel, V. (2011). Intrathecal therapy for cancer and non-cancer pain. Pain Physician, 14, 219–248.
Databases searched were PubMed, EMBASE, and Cochrane Collaboration.
Search keywords were intrathecal pump for pain, intrathecal infusion, spinal infusion, intrathecal drug delivery system, spinal pump, and intrathecal therapy.
Studies were included in the review if they
Studies were excluded if they
The initial search yielded 812 references; 59 of these were reviewed. A final sample of 20 studies was included. Of these, one randomized trial and four observational studies involved cancer pain. Study quality was evaluated using Agency for Healthcare Research and Quality (AHRQ) criteria for observational studies and Cochrane criteria for randomized controlled trials (RCTs).
For cancer-related pain, the final sample of five studies involved 482 patients with refractory pain and end-stage disease. Samples ranged from 35–202. Five systematic reviews also were included in the review; however, none of these specifically addressed cancer-related pain.
Overall, moderate quality level evidence was found with cancer-related pain. Three out of five of the studies showed 30% or greater pain relief at three months, and four out of five studies showed 50% or greater pain relief at three months. All studies showed improvement in both nociceptive and neuropathic pain control. Studies showed reduced complications with opioids. Complications occurred related to devices, the surgical implant procedure, or other procedure-related aspects in three studies. In one study, miscalculation of pump refill dates resulted in severe pain among five patients.
Long-term efficacy and safety of the intrathecal approach in terminal cancer is justified, and data supports the use of chronic intrathecal morphine for treatment of intractable malignant pain. Problems and complications can occur. Device-related complications and the need for surgical revision appear to have occurred at higher rates in earlier studies compared to more recent studies, which reflects ongoing improvements in techniques and education. Initial assessments of cost effectiveness suggest that cost savings are achieved after two years in comparison to systemic therapy in noncancer pain.
Patient selection and experience with implanted devices are important considerations in decision making for use of intrathecal pain management. Patient and caregiver self-care education is key to the safety and efficacy of this approach.
Hayashi, H., Kobayashi, R., Suzuki, A., Yamada, Y., Ishida, M., Shakui, T., . . . Itoh, Y. (2016). Preparation and clinical evaluation of a novel lozenge containing polaprezinc, a zinc-L-carnosine, for prevention of oral mucositis in patients with hematological cancer who received high-dose chemotherapy. Medical Oncology, 33, 91-016-0795-z.
To evaluate the clinical effect of a newly developed lozenge containing polaprezinc for the prevention of oral mucositis in patients who received conditioning high-dose chemotherapy for hematopoietic stem cell transplantation (HSCT) compared to a polaprezinc (zinc-L-carnosine) suspension in a sodium alginate solution that has been shown to be effective in the prevention of oral mucositis in patients who received radiotherapy or high-dose chemotherapy
Patients were pretreated with either polaprezinc suspension during January 2013 and December 2014 or polaprezinc lozenge during January 2015 and December 2016 for the prevention of oral mucositis. The control group consisted of patients who received high-dose chemotherapy without any premedication during March 2006 and February 2011. The incidence and severity of oral mucositis and its associated symptoms, such as oral pain, were reviewed from medical records and compared among the three groups. The severity of adverse events was graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.
PHASE OF CARE: Active antitumor treatment
Retrospective cohort comparison
CTCAE, version 3.0
The results showed grade 2 and grade 3 oral mucositis in the no-premedication control group. The polaprezinc suspension group and the polaprezinc lozenge group showed less incidence of grade 2 mucositis, and the overall average grade of oral mucositis was 0.6 for the suspension group and lozenge group. No statistical difference existed in the average grade or incidence rate of oral mucositis between the suspension group and lozenge group.
The newly developed lozenge containing polaprezinc for the prevention of oral mucositis was shown to be highly effective in the prevention of moderate to severe oral mucositis in patients receiving high-dose chemotherapy for HSCT. There was some question about the efficacy of the lozenge preparation when compared to the suspension.
Gender was not clearly identified, and the method of evaluating the grade of mucositis was not clearly described. The lozenge is not a readily available product, developed and compounded for this study. The product has promise if the study is replicated as randomized, controlled trial.