Cameron, J.I., Shin, J.L., Williams, D., & Stewart, D.E. (2004). A brief problem-solving intervention for family caregivers to individuals with advanced cancer. Journal of Psychosomatic Research, 57, 137–143.
To evaluate an intervention that was designed to improve the problem-solving abilities of family caregivers* of patients with advanced cancer**. Authors tested whether the intervention (a) enhanced positive problem-solving skills and decreased negative problem solving, (b) enhanced confidence in caregivers’ ability to perform caregiving activities, and (c) decreased caregivers’ emotional distress.
* Caregivers were defined as those unpaid family members assuming responsibility for homecare needs of an individual with advanced cancer.
** Advanced cancer was defined as patients with estimated survival prognosis of three to six months.
A one-hour intervention used explanations and a slide presentation or flip charts of problem solving. The intervention was given to caregivers only once, at the time of recruitment. The intervention involved:
A one-sample pretest/post-test design was used. There was no control group. Survey data were collected at baseline (recruitment) and then by phone four weeks after the intervention was done.
The authors provided a good description of how the original sample went from 112 to 34 caregivers, and the basis for attrition or exclusion were reviewed clearly, giving good insight into factors to consider when researching this group of caregivers of patients with advanced cancer. Reasons that led to shrinking of the sample included (a) some patients who were identified with advanced cancer did not need assistance at home, thus they did not have caregivers (n = 7), (b) some caregivers declined participation (n = 34), (c) some participating caregivers did not complete baseline survey because they changed their mind, their patient died, they were not coming back to the hospital in time to complete the intervention, or they had English language difficulty (n = 13), (d) some caregivers who completed the baseline data did not come back later to receive the intervention (n = 11), (e) some caregivers completing the baseline data and the intervention did not complete the follow-up survey (n = 6), and (f) some caregivers were wrongly identified (patients had advanced cancer but responded to curative treatments, or patients were outliers in terms of the length of time they had been diagnosed with advanced cancer) (n = 7).
Other significant findings include the following.
Overall, the findings clearly show potential evidence that the intervention affected caregivers positively. Given that improvements were noted even though participants already showed that they have good levels of confidence in their abilities and problem-solving skills at baseline, the findings strongly suggest that the intervention might have even greater potential among those with lower levels of confidence in their caregiving and problem-solving abilities. The intervention influenced one aspect of emotional well-being (tension subscale) and one aspect of problem-solving (positive problem-solving subscale), suggesting that a modified or more comprehensive or frequent intervention may improve other aspects of emotional well-being or problem-solving. Researchers of caregivers of patients with advanced cancer should consider and address the serious challenges that they may encounter in recruiting this group of caregivers.
Nursing care of patients with advanced cancer should be extended to include care of their caregivers, as they are key in providing care at home. This brief problem-solving intervention significantly improved the emotional tension in caregiver participants, suggesting the value of its use in palliative care settings. The fact that a significant difference existed between participants and nonparticipants in relation to the length of time their patients were diagnosed with cancer suggests that the longer caregivers provide care, the less likely they would be to participate in interventions. This suggests that they (a) may have figured out on their own how to manage the caregiving burden, or that they are too exhausted to participate, or (b) need different types of interventions that meet them where they are, either at home or in their locale, rather than require them to drive to where interventions would be conducted. This findings suggest that researchers may need to focus on caregivers of patients with new onset of disease or those who have had the disease for a short period. Any interventions with these caregivers should be set up in a way that decreases the demand on their time and meet them where they are. Thus, there is a need not only to develop short and effective interventions but also to find ways in which such interventions can be delivered/conducted with caregivers at home.
Cameron, L.D., Booth, R.J., Schlatter, M., Ziginskas, D., & Harman, J.E. (2007). Changes in emotion regulation and psychological adjustment following use of a group psychosocial support program for women recently diagnosed with breast cancer. Psycho-Oncology, 16, 171–180.
A 12-week structured psychosocial support group of weekly two-hour sessions was led by two facilitators using an adapted form of Cunningham’s “Healing Journey” program. The intervention included training in relaxation, guided imagery, meditation, emotional expression, and exercises promoting control beliefs and benefit-finding. The prospective design included 10 phases to recruit, and 8–11 women were recruited for each group. Data were collected at baseline and at 4 months (corresponding to the end of the intervention), 6 months, and 12 months.
New Zealand
A quasi-experimental study design was used.
Repeated measures ANOVAs revealed group differences in state anxiety over the first four months. Scores decreased for intervention participants, but not the standard care or decliner participants. Anxiety decreased overall from baseline to 6 months and from baseline to 12 months. Longitudinal follow-up occurred over 12 months.
Callow, C.R., Swindell, R., Randall, W., & Chopra, R. (2002). The frequency of bleeding complications in patients with haematological malignancy following the introduction of a stringent prophylactic platelet transfusion policy. British Journal of Haematology, 118, 677–682.
Prophylactic platelet transfusion policy
Comparison of platelet usage to nine months preceding intervention
Cai, Q., Huang, H., Sun, X., Xia, Z., Li, Y., Lin, X., & Guo, Y. (2008). Efficacy and safety of transdermal fentanyl for treatment of oral mucositis pain caused by chemotherapy. Expert Opinion on Pharmacotherapy, 9(18), 3137–3144.
To evaluate the efficacy and safety of transdermal fentanyl in the treatment of mucositis pain associated with chemotherapy
Transdermal fentanyl (TF) was administered at a rate of 25 mcg/hour for adult patients, including those who were opioid naive. In pediatric patients, TF was administered at 12.5 mcg/hour. Because of the delayed effect of TF, patients received IV or subcutaneous morphine to relieve pain during the 8–12 hours after application of the patch. The dose of TF was adjusted after the first 24 hours, according to pain score, until pain was controlled. (Control was defined as a score of 3 or less on the rating scale.) The dose of TF was increased in 25 mcg/hour increments or 12.5 mcg/hour increments, according to age group. Severe breakthrough pain was managed with IV or subcutaneous morphine. All subjects were routinely treated with oral hygiene and antiviral, antibacterial, or antifungal oral agents. The same clinician evaluated patients on the first day of chemotherapy and daily for approximately three weeks. The patient reported pain daily by citing a score on a numeric scale. Mucositis was evaluated, on a daily basis, in terms of National Cancer Institute (NCI) Common Toxicity Criteria (CTC). Study questionnaires were sent to all patients. Questionnaire data were recorded before treatment with TF and 2, 6, and 10 days later.
Open-label prospective trial
In this study, transdermal fentanyl was effective in reducing pain and improving quality-of-life parameters in the sample specified. Transdermal fentanyl was associated with a relatively low prevalence of adverse effects.
Authors noted the delay of onset with TF opioid use. This delay suggests that TF therapy begin before onset of significant levels of pain. Further well-designed studies of TF, in adults and children, are needed.
Cairo, M.S., Davenport, V., Bessmertny, O., Goldman, S.C., Berg, S.L., Kreissman, S.G., . . . Reaman, G.H. (2005). Phase I/II dose escalation study of recombinant human interleukin‐11 following ifosfamide, carboplatin and etoposide in children, adolescents and young adults with solid tumours or lymphoma: A clinical, haematological and biological study. British Journal of Haematology, 128, 49–58.
Three of 47 patients withdrew. Also, 24 of 44 discontinued before receiving two cycles (9 because of disease progression; 3 for adverse events [papilloedema]; 2 for therapy changes; 10 for other reasons; 1 died). Twenty patients completed two cycles of therapy. Median time to platelet recovery was reduced (24.5–20 days in similar historical cohort). One patient developed incidence of anti-IL-11 antibody formation. Number of platelet transfusions was three versus six in historical controls. IL-11 was well-tolerated at doses less than 50; the maximum tolerated dose is 50 mcg/kg/day. Doses above this increased side effects of papilloedema in 6 of 26 patients, periosteal bone changes in 4 of 26 patients, and cardiomegaly.
Madeddu, C., Dessi, M., Panzone, F., Serpe, R., Antoni, G., Cau, M.C., . . . Mantovani, G. (2011). Randomized phase III clinical trial of a combined treatment with carnitine + celecoxib +/- megestrol acetate for patients with cancer-related anorexia/cachexia syndrome. Clinical Nutrition, 31, 176–182.
To compare the efficacy and safety of a two-drug combination (including nutraceuticals) with carnitine and celecoxib (arm 1) versus megestrol acetate (arm 2) for the treatment of cancer anorexia and cachexia syndrome
No dietary restrictions were placed on participants. Polyphenols (2 tabs, 300 mg/day), lipoic acid (300 mg/day), carbocystine (400 mg/day), vitamin A (30,000 IU/day), and vitamin C (500 mg/day) were administered orally to all patients. Patients were then randomized to treatment arms: arm 1, L-carnitine (4 g/day) + celecoxib, or arm 2, l-carnitine (4 g/day) + celecoxib + megestrol acetate (MA) (320 mg/day). Treatment duration was four months. Measurements were obtained at 4, 8, and 16 weeks. Analysis focused on differences from baseline to 16 weeks. Data were collected from 2009 to 2010. No placebo arm was included for ethical reasons and based on previous research. Planned study duration was four months.
A phase III, randomized, two-group, non-inferiority trial design was used.
Primary endpoints: There was no significant difference (based on t test) between arms for LBM and physical activity. DEXA and CT of L3 significantly increased at 16 weeks from baseline in both arms. BIA did not change in either arm. There were no significant changes in physical activity in either arm. The six-minute walking test improved in both arms, and grip strength did not change significantly in either arm. REE, fatigue, Eastern Cooperative Oncology Group score, and prognostic score decreased significantly in both arms. Body weight did not change significantly in arm 1 but did increase in arm 2 (p = 0.052, which was not significant but on the border and trending). Appetite was reported as improved significantly in both arms (p < 0.05). Fatigue scores were improved significantly in arm 1 after treatment (p = 0.036). Survival measurements did not change and were not significantly different between groups. Two patients reported grade 3 diarrhea.
No significant differences were found in patients based on the intervention arm.
A multimodal approach may help to improve anorexia and cachexia in patients with cancer. More work focused on patient-reported outcomes, safety, and adherence is needed. Specific description of how appetite is assessed should be included in studies reporting this outcome measure.
Butow, P., Price, M.A., Shaw, J.M., Turner, J., Clayton, J.M., Grimison, P., . . . Kirsten, L. (2015). Clinical pathway for the screening, assessment and management of anxiety and depression in adult cancer patients: Australian guidelines. Psycho-Oncology, 24, 987–1001.
PHASE OF CARE: Multiple phases of care
No information is provided regarding literature retrieved, quality of evidence, or how the evidence was used to develop the guidelines provided.
Outlines relevant healthcare provider roles. Identified the following assessment tools for use: Edmonton Symptom Assessment Scale, the NCCN's Distress Thermometer, and the Hospital Anxiety and Depression Scale. Provides a stepped path of interventions based on ongoing monitoring of symptoms and effectiveness of previous interventions. Recommendations for initial intervention are patient education (in-person or online) and brief emotional support. Ongoing interventions for those with cancer-related anxiety and depression include coping skills training, relaxation skills, communication skills, mindfulness, and a variety or psychological therapies.
Despite an extensive review process for guidelines, as well as input from stakeholders, there is little information on the evidence base for the recommendations provided.
This guideline outlines recommended providers, and nurses are not specifically outlined as recommended providers in the written pathway other than as “other appropriately trained staff,” although nurses are identified as having roles in screening, assessment, and educational and counseling types of roles. This guideline provides no new information and does not directly provide the evidence base on which recommendations are based. The guideline suggests more limited roles for nurses than has been demonstrated in relevant research.
Butler, L.D., Koopman, C., Neri, E., Giese-Davis, J., Palesh, O., Thorne-Yocam, K.A., . . . Spiegel, D. (2009). Effects of supportive-expressive group therapy on pain in women with metastatic breast cancer. Health Psychology, 28, 579–587.
To examine the effect of supportive-expressive group therapy using hypnosis in patients with metastatic breast cancer experiencing pain and to explore the interaction between hypnotizability and pain experience in women trained to use hypnosis
Baseline pain, distress, coping, social support, physical activity, and immune and endocrine function were evaluated, and patients were randomized by the project director and a research nurse using an adaptive randomization biased coin-design method. Treatments were conducted at each of the three sites weekly for 90-minute sessions. Group size varied from 3–15 participants because of rolling recruitment and participants dying. Each supportive-expressive therapy session was co-led by two psychotherapists; among these were a psychiatrist, psychologists, and social workers. Themes emerging in these sessions were fears of dying and death, including dealing with the deaths of group members, reordering life priorities, improving support from and communication with family and friends, integrating a changed self and body image, and improving communication with physicians. A hypnosis exercise ended each session, and participants were instructed to practice this several times a day and any time the pain was noticeable or increased. The control group members were offered self-directed education and a year membership to a consumer health library in their community. Post-baseline assessments were every four months for the first year and then every six months after.
Analysis of covariance on change in intensity of current pain showed statistical significance (P = .001) in those in the treatment group versus the education only group. Those who received therapy and education showed a smaller increase in the intensity of current pain than the control (education alone) (P = .034). Those who had a greater intensity of current pain and suffering at baseline experience a great decrease in intensity (P = .001), whereas those for whom baseline pain was less experienced increases in intensity. No statistically significant relationships associated with hypnotizability were found across recruitment sites, and hypnotizability did not show an interaction with treatment. The treatment effect was not significant with the baseline level of pain but still predicted a greater decrease in pain (p = .008). Those who reported the most pain at baseline showed a decrease in frequency of pain, whereas those who reported least frequent pain at baseline showed an increase in frequency (p = .001). Constant pain at baseline showed the greatest reduction in constant pain, whereas those who did not report constant pain showed an increase in constant pain (p = .001). Treatment did not have an effect on constant pain. Highly hypnotizable women reported greater use of hypnosis exercises for controlling nausea and vomiting, for management of stress and anxiety, and for comfort versus low hypnotizable women.
Hypnosis and group sessions can be successful in reducing pain and suffering—more specifically for those with high hypnotizability—and potentially could be used to help control other symptoms in metastatic breast cancer or even other cancers. Patients without constant pain or with low current pain seemed to show an increase in constant pain and frequency. Low hypnotizability was also a less desirable trait in controlling symptoms; however, these individuals were found to have used hypnosis less frequently and may not have experienced maximum benefit. This method could be utilized as an adjunctive to treat symptoms other than pain; however, this study addressed pain only.
Nurses may want to become educated in hypnosis as an adjunctive therapy to educate patients to utilize this method in controlling pain. Additionally, nurses may want to refer those particularly having a difficult time with symptom management to a supportive-expressive therapy group rather than providing only educational material to patients with metastatic breast cancer. Nurses also must keep in mind that group intervention and hypnosis may not be successful or appealing to all patients and certain characteristics and hypnotizability impact the success of treatment.
Butler, J.M., Jr., Case, L.D., Atkins, J., Frizzell, B., Sanders, G., Griffin, P., … Shaw, E.G. (2007). A phase III, double-blind, placebo-controlled prospective randomized clinical trial of d-threo-methylphenidate HCl in brain tumor patients receiving radiation therapy. International Journal of Radiation Oncology, Biology, Physics, 69(5), 1496–1501.
This study was conducted to assess the effect of prophylactic d-methylphenidate HCl (d-MPH), a central nervous system stimulant, on quality of life and cognitive function in patients with brain tumors undergoing radiation therapy.
The treatment group received a starting dose of 5 mg twice daily of d-MPH; this was escalated to a maximum of 15 mg twice daily. Patients were stratified by tumor type (primary versus metastatic), treatment (radiation therapy alone versus radiation therapy plus chemotherapy), and Karnofsky Performance Status (< 90 versus 90), and were randomized within strata to one of the two treatment arms.
This was a randomized, double-blind, placebo-controlled study.
There was no difference in cognitive functioning at baseline, end of radiation therapy, or at 4, 8, and 12 weeks after brain radiation therapy. No difference in fatigue or quality of life was observed.
Prophylactic use of d-MPH in patients with brain tumors undergoing radiation therapy did not result in an improvement in cognitive functioning, quality of life, or fatigue.
Buss, T., de Walden-Gałuszko, K., Modlińska, A., Osowicka, M., Lichodziejewska-Niemierko, M., & Janiszewska, J. (2010). Kinesitherapy alleviates fatigue in terminal hospice cancer patients-an experimental, controlled study. Supportive Care in Cancer, 18, 743–749.
To evaluate the effect of physical exercise on terminally ill patients with cancer.
Patients in the exercise group exercised three times a week for 20 to 30 minutes for a three- to four-week period. The schedule of exercises was individually planned by a physiotherapist. Study outcome measures were obtained at baseline, weekly, and at the end of the study. No information was provided regarding the control group procedures.
Patients were undergoing end of life care/end of life and palliative care phase of care.
This was a two-group comparative trial – no information was provided on whether patients were randomly assigned.
There were no apparent effects on outcomes during the first two weeks. By week 3, mean VAS intensity of fatigue declined in the exercise group from 6.5 to 5.5. In the control group, fatigue increased from 6.5 to 7.5 (ANOVA; p < 0.001). Physical symptoms tended to decline slightly in the exercise group and increase slightly in the control group, with changes ranging from 0.1 to .05 (p < 0.05). There were no observable effects on quality of life scores from the symptom checklist data.
Results suggested that individualized exercise can be beneficial for fatigue in terminal patients with cancer.
The study did not provide strong evidence for the effectiveness of exercise due to multiple issues in this report and the small measured changes seen. Findings suggested that exercise may be beneficial in terminally ill patients and showed that there were no apparent adverse effects from the activity provided to these patients.