Goldberg, R.M., Loprinzi, C.L., O’Fallon, J.R., Veeder, M.H., Miser, A.W., Mailliard, J.A., … Burnham, N.L. (1994). Transdermal clonidine for ameliorating tamoxifen-induced hot flashes. Journal of Clinical Oncology, 12, 155–158.
The study evaluated transdermal clonidine for alleviating tamoxifen-induced hot flashes in women with a history of breast cancer.
Four weeks of transdermal clonidine (equivalent to a daily oral dose of 0.1mg) was followed by four weeks of placebo patches or vice versa. Patches were changed weekly.
The study enrolled 116 women with a mean age of 54 years who were receiving tamoxifen for breast cancer experiencing hot flashes and requesting intervention; experiencing hot flashes for longer than one month and at least seven per week. One hundred ten (110) of the 116 completed the study. Participants were stratified by age, duration of hot flash symptoms, and the average frequency and severity of hot flashes.
This was a randomized, double-blind, crossover prospective study.
The study employed the following measures:
The study showed a statistically significant decrease in hot flashes (frequency and severity) (p < .0001), and clinically moderate decreases in frequency (20%) and severity (10%). Toxicities included dry mouth (p < .001) and constipation (p < .02).
Small study size limited the value of the outcomes.
Goldberg, G.R., & Morrison, R.S. (2007). Pain management in hospitalized cancer patients: A systematic review. Journal of Clinical Oncology, 25, 1792–1801.
To provide a systematic review of institutional interventions designed to improve management of pain in hospitalized patients with cancer
Databases searched were MEDLINE, Cochrane Library, and authors’ personal libraries.
Search keywords were pain, pain measurement, outcomes assessment, or quality assurance.
Inclusion criteria was not specifically stated, other than that studies involved patients with cancer.
Exclusion criteria was not specifically stated.
Total number of studies retrieved or initially evaluated is not provided.
Articles were reviewed and independently summarized by the authors, and any disagreements were discussed until consensus was achieved.
Studies were not exclusively for patients with cancer, but all did involve some cancer care cases.
Nursing educational interventions improve knowledge and correct misconceptions but have not shown improved pain or patient satisfaction.
Studies suggest that patient education and tailored counseling sessions directed at patients can improve pain scores and negative beliefs and misconceptions.
Routine pain assessment has been shown to improve staff and patient satisfaction; however, interventions have not been shown to improve overall pain scores or pain severity.
Provision of audit and feedback of patient pain scores to nursing staff improved pain assessment rates but had no effect on pain severity.
The study involving CDSS showed some improvement in prescribing practices, predominantly reducing use of meperidine, but did not demonstrate improved pain scores.
Meta-analysis of eight studies in the effect of a hospital-based palliative care team suggests that referral to such programs results in small but positive effects on pain, other symptoms, satisfaction, and reduction in length of stay compared to conventional care.
The major types of institution-wide interventions aimed at improving pain management include education, inclusion of pain assessment as a vital sign, auditing and staff feedback of pain scores, use of CDSS, and referral to palliative care specialists. Improved knowledge, assessment, and process of care measures have been demonstrated; however, no substantial effects on actual pain scores and severity have been demonstrated as a result of these interventions. From this review, the most promising interventions related to actual pain outcomes appear to be patient education and counseling and referral to palliative care specialists. The authors conclude that no generalizable interventions were identified.
Findings point to the difficulty of being able to demonstrate the effects of institutional interventions on patients’ measurable pain outcomes other than satisfaction with pain management. Most of these efforts are not necessarily appropriate in a randomized controlled trial type of design, leading to questions of methodological rigor in findings, and suggest that the patient’s experience of pain is complex and not readily determined by standardized processes.
Findings suggest that individual patient interventions including counseling and education are worth further investigation in order to have an effect on pain outcomes.
Involvement of palliative care specialists appears to be somewhat effective to improve pain outcomes; however, it is not clear that universal referrals to such groups for all pain management are practical. This raises the question of how such specialized knowledge, focus, and expertise might be shared and utilized in new ways to impact all patients. It is not clear that educational interventions for staff that have been studied are sufficient to improve knowledge of providers to the extent required to impact pain-related results.
Goldberg, D.R., Wardell, D.W., Kilgarriff, N., Williams, B., Eichler, D., & Thomlinson, P. (2016). An initial study using healing touch for women undergoing a breast biopsy. Journal of Holistic Nursing, 34, 123–134.
To determine if healing touch can benefit women undergoing diagnostic procedures for breast cancer
Patients were randomized to receive healing touch or to a control group receiving usual care by the day of the week after completing baseline surveys. Those in the experimental group were placed in a treatment room and placed on a massage table. Healing touch was provided by a trained practitioner for 15 minutes. Surveys were again completed after the breast biopsy procedure in both study groups. Participants were given a third set of surveys to return via mail the following day.
PHASE OF CARE: Diagnostic
Randomized, controlled trial
State anxiety levels declined significantly immediately after the biopsy in both groups. On the next day, anxiety remained lower in the therapeutic touch group, but the difference between groups was only marginally significant (p = 0.06). Physiologic measures showed that the intervention groups respiratory rate and heart rate decreased, but differences between groups were not significant.
The findings suggest that healing touch may be helpful to reduce anxiety associated with undergoing a breast biopsy. Further study is needed to demonstrate efficacy.
Therapeutic touch is a noninvasive intervention that may be helpful for some individuals undergoing periods of stress and anxiety related to diagnostic procedures. Further research is needed to determine the effectiveness of this intervention compared to usual care. Future studies should incorporate comparison to a sham intervention.
Goldberg, R.M., Loprinzi, C.L., Mailliard, J.A., O'Fallon, J.R., Krook, J.E., Ghosh, C., . . . Shanahan, T.G. (1995). Pentoxifylline for treatment of cancer anorexia and cachexia? A randomized, double-blind, placebo-controlled trial. Journal of Clinical Oncology, 13, 2856–2859.
Patients were randomized, in double-blind fashion, to pentoxifylline 400 mg by mouth three times daily or placebo three times daily. If patients lost 5% of their on-study weight, the bind was broken and patients could cross over to the pentoxifylline arm.
Patients were randomized in a double-blind fashion.
No significant difference was seen between cohorts in weight gain (P = .43). According to the questionnaires, there was no evidence that pentoxifylline is more effective than placebo in enhancing appetite. Toxicity data were similar for both groups for nausea and vomiting, fluid retention, and abdominal pain. The study was closed after the planned interim analysis, and it was concluded that pentoxifylline is not an effective treatment for cancer anorexia and cachexia.
The 95% confidence interval for the difference in the percentage of weight gain for pentoxifylline minus placebo ranged from a loss of 3.3% to a gain of 1.9%; this confidence interval suggests that the percentage of weight gain for pentoxifylline-treated patients is about the same for patients receiving placebo.
Gokal, K., Wallis, D., Ahmed, S., Boiangiu, I., Kancherla, K., & Munir, F. (2016). Effects of a self-managed home-based walking intervention on psychosocial health outcomes for breast cancer patients receiving chemotherapy: A randomised controlled trial. Supportive Care in Cancer, 24, 1139–1166.
To evaluate the effectiveness of a self-managed, home-based walking program of moderate intensity
Prior to randomization, patients completed baseline questionnaires before beginning chemotherapy and after completing two of six cycles of chemotherapy. Patients were then randomized to usual care control or usual care plus exercise groups. Patients in the exercise group were given an intervention booklet with recommendations to ensure adherence, tips, guidance, and a diary to keep a log of walking duration and intensity. Self-management strategies used for guidance were based on the theory of planned behavior, including setting weekly goals, reflecting by writing achievements and shortfalls, and modifying goals. Pedometers were provided to the walking group. The intervention lasted 12 weeks.
PHASE OF CARE: Active antitumor treatment
Randomized, controlled trial
Eighty percent adhered to the intervention based on walking diaries. Group by time analysis showed that the intervention had a positive effect on fatigue (p = 0.02). No effects on anxiety or depression as measured by HADS were reported.
The self-managed, home-based walking program had a positive effect on fatigue.
This study adds to the body of evidence showing that exercise has a positive effect on fatigue. A self-managed, home-based walking program is a practical approach to incorporating activity during active treatment.
Gotzsche, P.C., & Johansen, H.K. (2002). Routine versus selective antifungal administration for control of fungal infections in patients with cancer. Cochrane Database of Systematic Reviews, 2, CD000026.
The purpose of this systematic review was to evaluate studies conducted with various antifungal agents to determine whether or not commonly used antifungals decrease mortality in patients with cancer.
The search strategy used databases such as the Cochrane Central Register of Controlled Trials (CENTRAL) and PubMed, as well as the reference lists of articles attached to the publications identified. Also reviewed were the proceedings of the ICAAC (from 1990–2007), General Meeting of the ASM (from 1990–2007), and the European Congress of Clinical Microbiology and Infectious Diseases (1995–2007). The authors also contacted expert researchers in the field.
Key words included random, control, blind, nystatin, amphotericin, fluconazole, itraconazol, ketoconazole, miconazol, voriconazol, bone-marrow, cancer, fungemia, hematologic, fumalignan, neoplasm, neutropenia, granulocytopenia, leukemia, or lymphoma
Randomized trials of antifungal treatments that were experimental in nature for patients with cancer were included. Studies that applied to treatment or prevention of oral candidiasis were excluded, as well as any non-randomized trials or randomized trials with noncancer patients.
Forty-four articles were retrieved. The authors reviewed the identified studies for mortality, mortality associated with a fungal infection, invasive fungal infection, colonization, use of additional antifungal therapy, and harm to patients.
The final article sample size was 32, with total subjects numbering 4,287.
Active treatment
Amphotecerin B was the only antifungal studied that showed reduced mortality significantly and consistently, used either prophylactically or empirically. Ketaconozole, fluconazole, and amhotercerin B were shown to be significant in overall effect for prophylactic administration. Itraconozole, fluconazole, and amphotecerin B all showed effectiveness in treating invasive fungal infection.
Amphotecerin B is highly effective in reducing mortality associated with fungal infection in patients with cancer. More studies should be done with large sample sizes to effectively compare amphotecerin B to other anti-fungals.
Goerling, U., Foerg, A., Sander, S., Schramm, N., & Schlag, P.M. (2011). The impact of short-term psycho-oncological interventions on the psychological outcome of cancer patients of a surgical-oncology department—A randomised controlled study. European Journal of Cancer, 47, 2009–2014.
To examine the influence of psycho-oncologic intervention on the psychological condition of patients with cancer
Patients, who had self-assessed regarding anxiety and depression levels, were placed in high- or low-risk groups. Participants were then randomized to either a psycho-oncologic support group or a control group. Support involved talks with a certified psychologist, who addressed development of a therapeutic relationship, supported the patient’s personal autonomy and defense mechanisms, worked to increase hopefulness and confidence, and facilitated communication between patients and providers. Patients were randomized at the time of surgery. Study measures were obtained at hospital discharge and 12 months later. The number of support sessions varied according to the length of inpatient care. High-risk groups averaged four sessions lasting an average of 41 minutes each. Low-risk patients had two or three sessions lasting an average of 40 minutes each.
Active treatment
Randomized controlled trial
Hospital Anxiety and Depression Scale (HADS), German version
The study showed statistically significant reduction of anxiety and depression in high-risk patients who had undergone psycho-oncologic intervention at the end of inpatient care (p = 0.001). At 12 months, anxiety and depression scores increased in all patients. Depression scores increased in all low-risk patients at the time of discharge.
Patients with cancer who have anxiety may benefit from psycho-oncologic support.
Postsurgical patients with cancer who are anxious may benefit from psycho-oncologic support services. In the study, the effect of the intervention was significant in only those patients who had high anxiety scores at baseline. Study findings are similar to those produced by other research. This fact may suggest that interventions for anxiety are most beneficial for individuals who have meaningful levels of anxiety to begin with. Psycho-oncologic support did not appear to affect depression scores; however, these scores were not high at baseline.
Goerling, U., Jaeger, C., Walz, A., Stickel, A., Mangler, M., & van der Meer, E. (2014). The efficacy of short-term psycho-oncological interventions for women with gynaecological cancer: A randomized study. Oncology, 87, 114–124.
To study the effects of two different interventions on anxiety and depression postoperatively
The interventions that were studied included a single educational session and a single session of progressive muscle relaxation delivered between the third and sixth postoperative day to women who had surgery for gynecologic cancers. Women randomly were assigned to intervention groups. Study measures were obtained preoperatively prior to hospital discharge.
Randomized, noncontrolled trial
Anxiety scores declined significantly in both groups (p < .005), and depression declined significantly in those receiving the educational intervention (p < .001). There were no differences between groups in self-reported stress, and there were no significant changes in physiologic measures.
The findings of this study demonstrate that the interventions tested here may have some benefit; however, the strength of the results is low due to study limitations
This study does not provide strong evidence in support of educational and muscle relaxation interventions for the reduction of anxiety or depression.
Goedendorp, M. M., Peters, M. E., Gielissen, M. F., Witjes, J. A., Leer, J. W., Verhagen, C. A., & Bleijenberg, G. (2010). Is increasing physical activity necessary to diminish fatigue during cancer treatment? Comparing cognitive behavior therapy and a brief nursing intervention with usual care in a multicenter randomized controlled trial. The Oncologist, 15, 1122–1132.
The primary aim was to demonstrate the efficacy of a brief nursing intervention (BNI) and cognitive-behavioral therapy (CBT) compared to usual care (UC). The secondary aim was to determine the role of physical activity in reducing fatigue during cancer treatment.
In total, 220 patients were randomly assigned to one of three groups: BNI, CBT, or UC.
The study was a multicenter, randomized, controlled trial.
The CBT group was significantly less fatigued than the UC group. Between the BNI and the UC groups, no significant difference in fatigue was found. Physical activity was found not to mediate the effect of CBT on fatigue.
CBT during curative cancer treatment resulted in less fatigue compared to the BNI and UC groups. The mediation hypothesis was rejected.
Further study is warranted to determine the effects of specific nursing interventions on the experience of fatigue in patients with cancer.
Goedendorp, M. M., Gielissen, M. F., Verhagen, C. A., & Bleijenberg, G. (2009). Psychosocial interventions for reducing fatigue
during cancer treatment in adults. Cochrane Database of Systematic Reviews, 1, CD006953.
To evaluate if psychosocial interventions are effective in reducing fatigue and to consider which interventions are the most effective.
Databases searched were Cochrane Central Register, PUBMED, MEDLINE, EMBASE, CINAHL, and PsycINFO to September 2008. Hand searching of reference lists was also performed.
Extensive keywords and specific search terms per database were provided.
Studies were included in the review if
Patients were excluded if they were breast cancer survivors receiving only hormonal therapy and were not considered in active treatment.
In total, 85 references were retrieved. The Jadad scale criteria were applied for quality rating, as well as additional criteria identified by vanTulder (1997).
In most studies, it was unclear at what stage of cancer the intervention ended. In most studies, the interventions were given by nurses. Formats varied and included intervention in groups; combination of face-to-face and telephonic support; and provision of additional written, videotape, or audiotape information. The number and duration of sessions varied across studies. In four studies, participants received an intervention of the same number and duration for the attention control. The number, type, and timing of outcome assessments also varied. Most studies used one instrument to measure fatigue, with the Profile of Mood States (POMS) used most often. Only five studies used a measure specifically defined to measure fatigue. Only three studies scored at least a three on the Jadad quality scale, and only one study had a good evaluation of quality scoring related to internal validity. Most had a moderate quality. Seven studies reported a significant effect on fatigue, with effect sizes ranging from 0.17 to 1.07 (p ≤ 0.05). In two of these, there was an immediate effect, but the results were not maintained at follow-up. Twenty studies were regarded as not effective. Interventions specifically aimed at fatigue, rather than multiple additional symptoms, tended to be more effective for fatigue.
Findings showed that there was no solid evidence that interventions not specifically focused on fatigue were effective in reducing fatigue. Overall, there was limited support and conflicting results for psychosocial interventions on fatigue during cancer treatment. Studies that showed an effect included education about fatigue and teaching in self-care or coping strategies and taught activity management, balancing activity, and rest.
Psychoeducational interventions, including education about fatigue, helping patients in self-care and coping, and teaching patients to balance activity and rest, may be helpful in alleviating fatigue among patients receiving cancer treatment. The degree and timing of fatigue can vary according to treatment type and the cancer trajectory. The most effective interventions based on treatment and phase of care were not clear, and further research in this area is warranted.