Heller, L., Kowalski, A.M., Wei, C., & Butler, C.E. (2008). Prospective, randomized, double-blind trial of local anesthetic infusion and intravenous narcotic patient-controlled anesthesia pump for pain management after free TRAM flap breast reconstruction. Plastic and Reconstructive Surgery, 122(4), 1010–1018.
To assess the efficacy of continuous infusion pump delivery of bupivacaine at TRAM flap donor site; to assess the safety of continuous infusion pump delivery of bupivacaine at TRAM flap donor site
Patients received 0.375% bupivacaine or isotonic saline through a continuous infusion pump in the suprapubic area and caudal to the donor site incision. All patients received narcotic via PCA programmed for demand-only mode, with no basal rate. Patients could receive oral narcotics. Pain at rest was evaluated four times per day while patients were awake. Overall satisfaction was assessed every four hours for the first three days.
Prospective randomized, double-blinded trial
Continuously infused bupivacaine reduced patients' need for PCA opioids early in the postoperative period.
Postoperative mastectomy-TRAM patients may benefit from continuous infusion of anesthetic to an operative site. Ongoing research to determine the most effective dosage and the most effective anesthetics is warranted.
Hejna, M., Kostler, W.J., Raderer, M., Steger, G.G., Brodowicz, T., Scheithauer, W., … Zielinski, C.C. (2001). Decrease of duration and symptoms in chemotherapy-induced oral mucositis by topical GM-CSF: Results of a prospective randomized trial. European Journal of Cancer, 37, 1971–1975.
Patients were randomized to one of two arms.
Both groups were instructed to continue using the respective mouthwashes until complete response (CR). A third, independent investigator randomized patients without knowing individual mucositis ratings.
The study was conducted between March 1998 and June 1999.
This was a prospective, randomized, controlled study.
Every three days, objective and subjective evaluations were conducted.
Heinrichs, N., Zimmermann, T., Huber, B., Herschbach, P., Russell, D.W., & Baucom, D.H. (2012). Cancer distress reduction with a couple-based skills training: A randomized controlled trial. Annals of Behavioral Medicine, 43, 239–252.
To investigate the short- and long-term effects of a psychosocial side-by-side couple's intervention on disease distress, post-traumatic growth, communication, and dyadic coping among women with breast and gynecologic cancers and their partners
The side-by-side intervention consisted of four meeting sessions between a participating couple and a therapist on a biweekly, face-to-face basis at the couple’s home. Each meeting session lasted two hours. Each of the four sessions focused on a certain theme and had specific objectives.
The Couples Control Program was the control group. Control group couples received only one two-hour session where they were given written educational materials about breast and gynecological cancers. The therapist used a structured protocol when interacting with participants.
Active antitumor treatment phase
A two-site, controlled, parallel-group study with random assignment (balanced randomization [1:1]) was used.
Psychosocial distress:
Benefit finding:
Relationship satisfaction:
Communication:
Dyadic coping:
Sample description and differences:
The following changes were observed in the outcome variables:
Side-by-side intervention showed clear benefit compared to the control group in fear of disease progression and avoidant behavior. This benefit was short-term and did not carry through to long-term assessments. There was also clear benefit in dyadic coping and communication, but both were also short-term.
Side-by-side intervention has shown potential benefit in faster post-traumatic growth compared to control group.
The findings indirectly indicate that the interdisciplinary team caring for women with cancer should involve the services of psychologists, family therapists, or advanced practice nurses with specialized training in mental and relationship wellness for patients and their partners.
Nursing care should include an assessment of a couple's distress level and communication patterns over the trajectory of a breast or gynecologic cancer illness.
Attrition and recruitment in long-term studies involving caregivers remain serious threats, and future research designs and methodologies should include clear plans to manage these challenging aspects.
Heiney, S.P., Reavis, K., Tavakoli, A.S., Adams, S.A., Hayne, P.D., & Weinrich, S.P. (2015). The impact of STORY on depression and fatigue in African-American women with breast cancer. Journal of National Black Nurses' Association, 26, 1–7.
To test the hypothesis that depression and fatigue would be decreased more in the Sisters Tell Others and Revive Yourself (STORY) intervention group than in controls
The STORY intervention was a therapeutic activity delivered to a group via teleconference, using information and storytelling to increase social connections among African American women with breast cancer. A series to teleconferences was facilitated by two social workers with groups of 10 patients. The series was done weekly for eight weeks, and every other week for two weeks. Participants received small stipends during the study. Patients were randomly assigned to the STORY intervention or usual care. This particular report used secondary analysis to determine the impact of this intervention on depression and fatigue.
There was no significant difference in fatigue or depression between study groups.
The psychoeducational intervention delivered via teleconference as tested here did not demonstrate an effect on fatigue or depression.
The psychoeducational and supportive intervention tested did not show an effect on depression or fatigue. This report does provide information regarding using a teleconference approach to provision of a group intervention, which might be applicable in a number of situations to facilitate patient involvement in this type of activity. Further research regarding the most effective methods of delivery of educational and supportive interventions is needed.
Heim, M.E., v d Malsburg, M.L., & Niklas, A. (2007). Randomized controlled trial of a structured training program in breast cancer patients with tumor-related chronic fatigue. Onkologie, 30, 429–434.
Intervention consisted of physiotherapy, group exercises, and psycho-oncologic interventions. Patients received a brochure with instructions for nine muscle strength and nine stretching exercises for large muscle groups. Outcomes were assessed at baseline, start of intervention (T1), end of intervention (T2), and at a three-month follow-up (T3).
Trial outcome index for fatigue in the FACT-F questionnaire showed improvement in fatigue from T1–T3. The interaction of time and group were statistically significant (p = 0.003). For MFI measures, interaction between group and time effects was significant for physical fatigue between T2–T3 (p = 0.028). The mean MFI total score was higher for both the control and intervention group in comparison to the mean MFI total score for healthy women in the age group of 40–50 years at the three-month follow-up.
Future research should incorporate better measures for the intensity of the exercise.
Hegg, R., Mattar, A., Matos-Neto, J.N., Pedrini, J.L., Aleixo, S.B., Rocha, R.O., . . . van-Eyll-Rocha, S. (2016). A phase III, randomized, non-inferiority study comparing the efficacy and safety of biosimilar filgrastim versus originator filgrastim for chemotherapy-induced neutropenia in breast cancer patients. Clinics, 71, 586–592.
To compare the efficacy and safety of two filgrastim formulations for controlling chemotherapy-induced neutropenia and to evaluate the noninferiority of the test drug against the original
Patients with grade 4 neutropenia were randomized 1:1 to Eurofarma filgrastim or Roche filgrastim. Doses were administered subcutaneously daily 5 mg/kg until absolute neutrophil count was 10,000/mm3 or greater or until the 15th day of the chemotherapy cycle (V14). Only a single event of febrile neutropenia was considered during the study period per patient. Neutrophil counts were drawn every two days.
Phase III, open-label, noninferiority, randomized, two-group trial
To assess the noninferiority of the test drug to the original the 90% confidence interval for the difference in the rates of grade 4 neutropenia between the two groups were initially calculated.
No significant difference (p = 0.9971) in the rate of grade 4 neutropenia existed in the total number of patients in each group during the first chemotherapy cycle.
Risk of bias (no blinding)
The increased surveillance of patients’ neutrophils may have produced better outcomes. The difference between the two drugs was negligible. Strong patient teaching is warranted, regardless of the process of events during the chemotherapy cycle.
Heggie, S., Bryant, G. P., Tripcony, L., Keller, J., Rose, P., Glendenning, M., & Heath, J. (2002). A phase III study on the efficacy of topical aloe vera gel on irradiated breast tissue. Cancer Nursing, 25, 442–451.
To see if topical aloe vera gel would be beneficial in reducing the skin side effects of radiation therapy (RT).
Participants were stratified according to bra cup size, history of lymphocele drainage, and smoking. Participants were randomized to use of aloe vera or an aqueous cream for control.
Mater Centre, Australia, and the Royal Brisbane Hospital Centre, Australia
The study was a randomized, controlled, double-blind trial.
Aqueous cream was significantly better than aloe vera gel in reducing the incidence of dry desquamation and moderate or higher pain (p < 0.001). Participants with cup size D or more in either treatment arm experienced a significantly greater incidence of moderate or higher erythema compared with smaller-breasted women (p < 0.02). For non-chemotherapy participants, the aloe vera arm experienced a significantly reduced incidence of moderate or higher erythema (p = 0.02). The control group arm experienced a significantly reduced incidence of moderate or higher pain (p = 0.03). The most important predictors of development of skin reaction were radiation dose, breast size, patient smoking, and damage to the lymphatic system manifested by one or more lymphocele drainage. Cumulative dose was greater than 2,700 cGy, and there was a delay to onset of erythema (p = 0.013).
Aqueous cream is superior to aloe vera in reducing the acute RT skin reactions of dry desquamation and pain.
Hegarty, F., & Wong, M. (2014). Polymeric membrane dressing for radiotherapy-induced skin reactions. British Journal of Nursing, 23, S38–S46.
To clinically evaluate the use of a polymeric membrane for the management of radiodermatitis in terms of skin integrity, management of desquamation, relief of pain and inflammation, and healing time
Patients with Radiation Therapy Oncology Group (RTOG) scores of 1–3 and early signs of skin reactions were followed for four weeks during treatment. Study data and patient assessments were obtained weekly. The polymeric dressing provided a mild cleansing agent activated by exudate that supported natural debridement. The dressing also contained glycerine, which provided moisture, and surfactant, which has been reported to reduce tension between healthy and unhealthy tissue.
Observational
From baseline to week 3, RTOG scores improved. Diary pain scoring showed an overall reduction in pain from an average of 6.5 to 1.6. Fixation of the dressing was a challenge, particularly among patients with breast and gynecologic cancers. Themes from a qualitative analysis of patient diaries identified skin improvement, a cooling effect of the dressing, and pain reduction.
Polymeric dressing use may be helpful for the prevention and treatment of radiodermatitis.
Polymeric dressings may be helpful for the prevention and treatment of radiodermatitis. Additional, well designed, clearly reported studies are warranted. Keeping this specific dressing in place was found to be a challenge for some patients.
Kim, Y.H., Kim, H.J., Ahn, S.D., Seo, Y.J., & Kim, S.H. (2013). Effects of meditation on anxiety, depression, fatigue, and quality of life of women undergoing radiation therapy for breast cancer. Complementary Therapies in Medicine, 21(4), 379–387.
Investigate the effects of meditation on the symptoms of anxiety, depression, and fatigue in women who were receiving radiation therapy for breast cancer
The intervention group received a total of 12 meditation therapy sessions during its six-week radiation therapy period. The control group received only conventional radiation therapy. The meditation intervention was Brain Wave Vibration meditation, which is based on a Korean traditional exercise, simple movements, music, and positive messages (changing weekly). This focuses on the senses of the body, relaxing the body and mind and relieving negative thoughts through natural rhythmic movements.
Randomized, controlled trial
Patients who received meditation therapy saw mild improvements, with a reduction in anxiety and fatigue. Patients in the control group also showed significant reduction in fatigue and anxiety, and post-intervention scores actually were lower for both of these in the control group. No effect was seen for depression.
The study states that an “affirmation” can be made that meditation can be used as a non-invasive intervention for improving fatigue and anxiety. However, results showed significant reductions in these symptoms for patients in the control group as well. This provides minimal support for effectiveness of the approach used here.
Nurses likely would not have any options of referral to meditation resources. Something more generalizable, like relaxation or mindfulness, would have been a better option for a study. The study is Korean; typically educated Korean women may have had previous exposure to meditation, and the intervention would be more acceptable to them than to American women.
Heckman, K.D., Weiner, G.J., Davis, C.S., Strauss, R.G., Jones, M.P., & Burns, C.P. (1997). Randomized study of prophylactic platelet transfusion threshold during induction therapy for adult acute leukemia: 10,000/microL versus 20,000/microL. Journal of Clinical Oncology, 15, 1143–1149.
To compare two common prophylactic platelet transfusion thresholds for patients receiving induction chemotherapy for acute leukemia
Patients were divided into four groups: new diagnosis of leukemia in patients aged less than 60 years; new diagnosis in patients 60 years or greater; relapsed disease in patients aged less than 60 years; and relapsed disease in patients aged 60 years or greater. Patients were randomized by selecting cards from an envelope to receive platelets when their morning platelet counts were either 10,000 microliters or 20,000 microliters. All platelet apheresis product transfusions were given according to the same transfusion orders. Controls for failure to respond to platelet transfusion for all participants were included in the study as well as guidelines for removing patients if warranted. For serious and life threatening bleeding, and as otherwise directed by the treating physician, therapeutic platelets were administered to study participants.
Prospective, randomized trial
The study found that there was no statistical difference in the total number of bleeding episodes between the two groups of patients (p = .12). Of note, there was a significant increase in platelet reactions in the platelet group receiving ≤ 20,000 microliters (p = 0.005).
Administration of prophylactic platelets at a threshold of 10,000 microliters can cut back the utilization of platelets and reduce the incidence of viral exposure without a statistically significant effect on morbidity.
Nurses need to be familiar with professional guidelines and institutional policies regarding platelet transfusions. This would include the use of premedications, post-transfusion blood drawing, and reporting of platelet reactions. For those institutions that use platelet thresholds higher than 10,000 microliters, it may be time to revisit practice based on the findings of this study.