Bevans, M., Castro, K., Prince, P., Shelburne, N., Prachenko, O., Loscalzo, M., . . . Zabora, J. (2010). An individualized dyadic problem-solving education intervention for patients and family caregivers during allogeneic hematopoietic stem cell transplantation: A feasibility study. Cancer Nursing, 33(2), e24–e32.
To evaluate the feasibility of providing an individualized problem-solving education intervention to patient-caregiver dyads during stem cell transplantation
The intervention was based on the COPE model involving creativity, optimism, planning, and expert information. Sessions used an active problem identified by each dyad to apply the COPE problem solving model. The clinician interventionist guided the dyad in problem identification, review of related expert information, and development of a plan to address the problem. Scripting, peer supervision, and session audiotapes were used to ensure integrity of the intervention. Data were collected with a log and subject interviews. Audiotaped interviews were transcribed for analysis, and a second transcriber did quality monitoring on 100% of the tapes to ensure accuracy and completeness. Four sessions were provided—prior to transplantation, at the time of hospital discharge, two weeks after discharge, and four weeks after discharge. Dyads also attended usual admission and discharge education classes provided as part of usual care. Data collection occurred at baseline, each of these time points, and six weeks after initial hospital discharge.
A single group repeated measures mixed method design was used.
Ninety-four percent of scheduled sessions were completed. Session length was a median of 45 minutes, ranging from 15–60 minutes. Clinicians reported session scheduling as the greatest challenge.
Themes that emerged from qualitative analysis were “opportunity to talk,” “expert information,” and “creative thinking.” Effect sizes for each measure for patients and caregivers over time were reported. Subjects’ SPSI-R scores were within normative group range, suggesting effective problem solving ability prior to the intervention. Patient baseline distress was significantly related to a change in SPSI-R scores over the course of the study (r = 0.8, p = 0.031). It was noted that the caregiving experience was not limited to a spouse, and the study experience pointed to the need to expand the network to all those involved. Effect sizes of change in measures were provided, but there were no differences in outcomes over time.
Provision of this type of intervention appears to be feasible, and although scheduling sessions was shown to be challenging to clinicians, a high proportion of sessions were completed. The study provides some initial effect size data in the outcome variables measured. Authors identified the need to include a broader network of caregivers and further explore alternative timing and scheduling approaches for this type of intervention.
Findings suggest that provision of individualized counseling and problem solving sessions using the COPE model is feasible with patients who have undergone stem cell transplant. In provision of caregiver support, nurses need to consider involving a number of caregivers because the network of individuals who are involved is often beyond a dyad. A broader involvement may also be helpful in dealing with session scheduling difficulties because of competing spouse priorities. Further research is warranted to evaluate effect sizes, different dosage, and timing of such interventions and involving various cultural groups. Further research including control groups is warranted as other similar studies have shown improvement in various patient and caregiver measures as a function of time alone.
Beuth, J., Schneider, B., & Schierholz, J. M. (2008). Impact of complementary treatment of breast cancer patients with standardized mistletoe extract during aftercare: a controlled multicenter comparative epidemiological cohort study. Anticancer Research, 28, 523–527.
Data were acquired by the investigators from the patients’ medical records at each of the study centers and were transferred to a standardized case report form (CRF). Data collected included patient demographics, characteristics of cancer disease and treatment, disease-related symptoms and adverse effects experienced by the patients, and the course of the disease. Outcomes were assessed at yearly intervals until the end of the observation or treatment period.
A total of 681 women with primary breast cancer were included.
Study Group
Control Group
Patients were excluded if they received other mistletoe products except the study medication, if they suffered from a relapse or metastatic disease at the beginning of the postoperative treatment, or if a secondary malignancy was detected.
The study was conducted in 53 randomly selected hospitals or practices representatively distributed in Germany, including oncologists, gynecologists, and general practitioners.
Unclear
This was a controlled, multicenter, comparative, epidemiological, cohort study.
Data were collected on CRFs in which, prior to data collection, the data elements required for the study were identified and defined.
The complementary standardized mistletoe extract study group reported a statistically significant lower number of fatigue or tiredness symptoms compared to the control group during an aftercare period of about five years, with 0.6% versus 1.0% reporting fatigue symptoms for the study and control groups, respectively.
Beutel, M.E., Weissflog, G., Leuteritz, K., Wiltink, J., Haselbacher, A., Ruckes, C., . . . Brahler, E. (2014). Efficacy of short-term psychodynamic psychotherapy (STPP) with depressed breast cancer patients: Results of a randomized controlled multicenter trial. Annals of Oncology, 25(2), 378-384.
To determine the efficacy of short-term psychodynamic psychotherapy among women with breast cancer diagnosed with depression
Patients were randomized to study intervention or usual care groups. The usual care group received information about local counseling centers, and psychological diagnostic information was provided to their general practitioners. Physicians could refer for further treatment. Those in the experimental group received up to 5 pretreatment and 20 additional weekly psychotherapy sessions provided by psychotherapists who were trained in specific techniques for the study and a treatment manual. To ensure treatment fidelity, psychotherapists presented each patient in group supervision three times during the study. Study assessments were done at baseline, 6 months, and 12 months.
Randomized clinical trial
Remission at follow-up determined by SCID–I interview and HADS
By intention-to-treat (ITT) analysis (p = .007) and per protocol analysis (p = .02), remission rate was higher in the STPP group by HADs analysis. There was no difference in rates of remission by SCID criterion. Variables that were predictive of remission were study group, higher depression level at baseline, and time until post-treatment measure. STPP patients received an average of 18 sessions compared to an average of 2.4 sessions among controls. There was a trend for more use of antidepressant medication in the STPP group (p = .09).
Individual psychotherapy was shown to improve depression among depressed patients with breast cancer.
Individual psychotherapy can be beneficial for patients with cancer experiencing clinical depression. Screening for depression can identify those patients who may benefit from interventions.
Bertoglio, S., Fabiani, F., Negri, P.D., Corcione, A., Merlo, D.F., Cafiero, F., . . . Zappi, L. (2012). The postoperative analgesic efficacy of preperitoneal continuous wound infusion compared to epidural continuous infusion with local anesthetics after colorectal cancer surgery: A randomized controlled multicenter study. Anesthesia and Analgesia, 115, 1442–1450.
To evaluate the effectiveness of preperitoneal continuous wound infusion (CWI) with ropivacaine, compared to continuous epidural infusion (CEI) with ropivacaine, on pain control after open colorectal surgery and on the quality of patient recovery
The intervention group had preperitoneal CWI analgesia. The control group had preperitoneal CEI analgesia. Participants were randomly assigned and received either CWI or CEI during first 48 hours postop. Infusion consisted of 0.2% ropivacaine at 10 ml/hour. All patients received morphine patient-controlled analgesia during the first 72 hours postop. All received standardized postoperative care not adhering to fast-track surgery programs. Investigators used the 100 mm visual analog scale (VAS) to measure pain.
A 4.5-point difference in VAS pain score showed that preperitoneal CWI was not inferior to CEI analgesia.
Multicenter randomized controlled trial (noninferiority design)
The primary outcome measure was a VAS whose scale ranged from 0 (no pain) to 100 (worst pain imaginable).
Other outcome measures included
CWI provides an acceptable alternative to CEI for the management of patients' pain after colorectal surgery for the treatment of cancer.
The study had a risk of bias due to no blinding.
This study shows that oncology nurses, as advocates for patients, can support CWI as an alternative to CEI as a means of postoperative pain management. Because CWI was associated with significant benefits regarding postoperative sleep disturbance, bowel function, and nausea and vomiting—as well as pain management—nurses can advocate for the use of CWI to address several symptoms of concern to oncology patients and direct-care nurses.
Bertoglio, J.C., Calderon, S., Lesina, B., Pilleux, L., Morazzoni, P., Riva, A., . . . Petrangolini, G. (2013). Effect of SAMITAL® in the treatment of chemotherapy-induced mucositis in adult oncohematological patients. Future Oncology, 9, 1727–1732.
To evaluate the efficacy and safety of SAMITAL in reducing mucositis in patients undergoing treatment for hematologic malignancies
Patients used SAMITAL mouth rinse three to four times daily and held it in the mouth for one minute.
The grade of mucositis was reduced from grade 2 to 0–1 in seven patients (25%). It is stated that pain, mucosal erosions, bleeding, and dysphagia were reduced; however, it is unclear how these were measured.
SAMITAL may have some benefit in the prevention and management of oral mucositis.
The authors suggested performing randomized, placebo-controlled clinical trials to confirm the suitability of SAMITAL for the treatment and prophylaxis of mucositis.
Bertheussen, G.F., Kaasa, S., Hokstad, A., Sandmæl, J.A., Helbostad, J.L., Salvesen, Ø., & Oldervoll, L.M. (2012). Feasibility and changes in symptoms and functioning following inpatient cancer rehabilitation. Acta Oncologica, 51, 1070–1080.
To assess feasibility and effects of an inpatient rehabilitation program on symptoms and physical function
Participants attended three weeks of inpatient rehabilitation and a follow-up five-day stay 8–12 weeks later. All attended group programs, which included physical training and education following cognitive behavioral approaches. Physical training was done twice a day for 60–120 minutes.
Multiple symptoms showed decline. These were statistically significant; however, the degree of change seen from the end of the initial three weeks to the final measure was less than that which the authors identified as clinically relevant. Fatigue scores increased from baseline to postintervention measures (8.9–9.3 for physical fatigue and 4.9 for mental fatigue at both time points). All symptoms declined from baseline over time.
Findings suggest that a multicomponent rehabilitation program can improve multiple symptoms for patients with cancer.
Findings showed improvement of multiple symptoms after a three-week inpatient rehabilitation program. This was resource intensive and had many dropouts, causing one to question the practicality and cost-effectiveness of this approach. This study is limited by its design, with lack of a control group.
Bertheuil, N., Sulpice, L., Levi Sandri, G.B., Lavoue, V., Watier, E., & Meunier, B. (2015). Inguinal lymphadenectomy for stage III melanoma: a comparative study of two surgical approaches at the onset of lymphoedema. European Journal of Surgical Oncology, 41, 215–219.
To compare the difference in occurrences of lymphedema and other postoperative complications following two different surgical approaches for stage 3 melanoma
Researchers divided patients into two groups, one that received vertical incisions, and another that received transverse incisions. Taking into account individual variables and any postoperative issues, patients were retrospectively studied for the presence of lymphedema.
Retrospective chart review
No statistically significant difference was noted between the two groups regarding any variable or characteristics, including the primary lymphedema status.
The difference in surgical approach didn't influence surgical outcomes, potential complications, or potential for chronic lymphedema.
This study did not have a direct effect on nursing practice other than to help inform nurses about the low potential for surgical approaches to have a negative effect on outcomes.
Bertelli, G., Venturini, M., Del Mastro, L., Bergaglio, M., Sismondi, P., Biglia, N., … Rosso, R. (2002). Intramuscular depot medroxyprogesterone versus oral megestrol for the control of postmenopausal hot flashes in breast cancer patients: A randomized study. Annals of Oncology, 13, 883–888.
The study was designed to compare injected medroxyprogesterone vs. oral megestrol to control hot flashes in women with breast cancer.
Participants were randomized to two groups. Group 1 received I.M. depot MPA (500 mg on days 1, 14, and 28) and Group 2 received oral megesterol acetate (40 mg po daily days 1-42).
Eligible patients were postmenopausal females with a history of breast cancer, without evidence of relapse, whom had been suffering from hot flashes for at least 1 month prior to study entry. Group 1 enrolled 3 , and Group 2 enrolled 34. Major Inclusion/Exclusion Criteria:
Not described
The primary endpoint was the proportion of responding patients after 6 weeks of treatment (7 weeks after randomization). A patient was classified as a responder if she achieved a greater than 50% reduction in frequency of hot flashes and hot flash score. Frequency and severity of hot flashes were monitored through self compiled diaries. The three main efficacy parameters were:
The mean number of hot flashes and hot flash scores did not differ significantly at baseline between the two groups. Differences between the two groups at week six were not statistically significant. Good control by both treatments was apparent. No significant difference in the proportion of responders between the two arms was observed (p=0.567) Overal,l 50 of 71 patients (70.4%, 95% CI 58-81%) achieved a response as previously defined.Maintenance of response in the group of 50 initial responders was assessed at 2-monthly follow up visits for 6 months after randomization. By patient report, a difference in the duration of response was observed: out of 28 responding patients in the MPA group, 25 (89.3%) were still responding at 6 months. In the megestrol group, only 10 of the initial 22 responders (45.4%) were still in response after 6 months.
For an 80% power and two sided 5% significance, 90 subjects were planned. Only 71 were accrued. After randomization, five patients in each group refused to start the assignment and withdrew from the study. Two more patients, both in group one, were found ineligible (one for medical contraindication and one not postmenopausal) and withdrawn. Six patients did not provide complete diary recordings during treatment (five patients who dropped out before completion for side effects and one who was lost to follow-up). Treatment allocation was not double-blinded because this would have required administration of I.M. placebo in group 2 which was judged impractical.
Berry, S., Waldron, T., Winquist, E., & Lukka, H. (2006). The use of bisphosphonates in men with hormone-refractory prostate cancer: A systematic review of randomized trials. The Canadian Journal of Urology, 13(4), 3180–3188.
To review results of published randomized controlled trials (RCTs) and meta-analyses to determine the benefits that bisphosphonates provide to men with hormone-refractory prostate cancer
The final sample of 17 reports included three systematic reviews and 12 RCTs. The sample included 1,446 patients. The range of sample size was 13–643. Eight trials supplied pain outcomes, and these eight trials involved 756 patients.
Variability of pain measurement across studies prevented statistical pooling. Overall, trials did not detect significant differences in pain outcomes between patients taking the study drug and patients taking placebo. However, over a relatively long period and among individuals with at least moderate pain severity at baseline, authors noted trends toward better pain relief with bisphosphonates than with placebo. Most trials were identified as underpowered, a fact that may have prevented investigators from detecting significant differences. In general, patients tolerated bisphosphonates well. Nausea was the most frequently reported adverse event; across trials 9%–33% of patients experienced nausea.
Overall, trials reviewed did not show significant differences in pain outcomes between those who received bisphosphonates and those who received placebo. However, at specific time points subgroups of bisphosphonate-using patients who had at least moderate pain showed trends toward improvement.
Findings suggest that bisphosphonates may be helpful in providing pain relief to men with hormone-refractory prostate cancer who have at least moderate pain levels. Clinicians should watch for nausea in bisphosphonate-using patients and be ready to provide relief. Further research, to define the most effective timing of bisphosphonate administration and the best way to use a bisphosphonate alone or in combination with other therapies, is warranted.
Berrak, S.G., Ozdemir, N., Bakirci, N., Turkkan, E., Canpolat, C., Beker, B., & Yoruk, A. (2007). A double-blind, crossover, randomized dose-comparison trial of granisetron for the prevention of acute and delayed nausea and emesis in children receiving moderately emetogenic carboplatin-based chemotherapy. Supportive Care in Cancer, 15, 1163–1168.
To compare tolerance for and the efficacy of granisetron at 10 µg/kg versus 40 µg/kg for the prevention of acute and delayed nausea and vomiting in patients receiving moderately emetogenic chemotherapy
Each patient was randomly assigned to receive either 10 µg/kg or 40 µg/kg of granisetron during alternating cycles of chemotherapy. Medication was given intravenously 30 minutes prior to the start of chemotherapy, and patients received no other prophylactic antiemetic medication. The dose was blinded from treating doctors, nurses, and patients. Data were collected the first five days following chemotherapy.
Randomized, double-blinded crossover trial
Antiemetic efficacy scores were not different between the two doses (1.045 for the 40 µg/kg dose and 1.040 for the 10 µg/kg dose [p = 0.330]). Neither gender nor age affected antiemetic efficacy scores. No granisetron-related side effects were reported. No patients withdrew from the study.
Granisetron was an effective antiemetic medication for moderately emetogenic chemotherapy with the majority of patients experiencing a complete antiemetic response over five days postchemotherapy. Higher doses of granisetron were associated with no significant improvements in efficacy. Granisetron was safe with no adverse events associated with administration.
Granisetron was a safe and effective medication that prevented acute and delayed nausea and vomiting associated with moderately emetogenic chemotherapy.