Hendrix, C.C., Landerman, R., & Abernethy, A.P. (2013). Effects of an individualized caregiver training intervention on self-efficacy of cancer caregivers. Western Journal of Nursing Research, 35, 590–610.
To (a) investigate the effects of an individualized caregiver training intervention on a caregiver’s self-efficacy in home care and symptom management, and (b) identify whether caregiver training would affect a caregiver’s psychological well-being (depression, anxiety, and quality of life)
After signing informed consent, dyads completed baseline questionnaires and were randomly assigned to either a treatment group or a control group. Interactive nurse–caregiver training for one to two sessions was offered when discharge was imminent. Immediately after caregiver training, caregivers completed questionnaires on self-efficacy. Follow-up questionnaires for caregivers and patients were completed at one week, two weeks, and four weeks after hospital discharge of patients.
The caregiver training intervention provided caregiver training for managing patients’ cancer symptoms with four major components: (a) prevention of infection, (b) pain control, (c) maintenance of nutrition, and (d) adequate elimination. The program was manualized, including a book for caregivers with “how to” pictures. Additional time and content were allocated to address specific homecare issues identified by caregivers. The training followed a consistent outline, but information shared was specific to needs of the patient and caregiver.
The control intervention consisted of an interactive nurse–caregiver standardized, manualized one-two session intervention focused on information about community resources for caregiving. This included but was not limited to home health agencies, respite care, and caregiver support services.
A randomized controlled trial design was used.
There was increased self-efficacy immediately following the caregiver training intervention and higher self-efficacy and symptom management at four weeks after the intervention when compared to the control group. A significant group-by-time interaction (p = 0.008) was present in the training intervention caregiver group that showed decreased depression scores from baseline to time 3 (one week). However, significant differences between treatment and control groups were not found after time 3. A similar result occurred when analyzing the effect of the intervention on caregiver anxiety. In terms of the effect of the caregiver intervention on patient’s physical symptoms, the overall intervention over time did not significantly improve symptoms. There was also no significant effect of the intervention on caregiver quality-of-life scores in both the control and caregiver training groups.
Caregivers have a major role in the outcome of a successful transition from hospital to home. This study provides information about caregiver training that improved their self-efficacy when addressing symptom management of a family member with cancer. More research is needed to determine the most effective caregiver training to manage patients’ symptoms at home.
Caregiver training for the patient’s home care and symptom management is critical in bridging the transition for patients from hospital to outpatient care. Nurses play a key role in this caregiver training tailored to specific caregiver and patient needs. Evidence-based information about the most effective training, including decisions about frequency, dosing, timing, formatting of information, and preparation of the nurse, is needed to improve caregiver quality of life and psychological well-being.
Hendriks, L.E., Hermans, B.C., van den Beuken-van Everdingen, M.H., Hochstenbag, M.M., & Dingemans, A.M. (2016). Effect of bisphosphonates, denosumab, and radioisotopes on bone pain and quality of life in patients with non-small cell lung cancer and bone metastases: A systematic review. Journal of Thoracic, 11, 155–173.
STUDY PURPOSE: To assess the evidence of effectiveness of these agents on bone pain and quality of life (QOL)
TYPE OF STUDY: Systematic review
PHASE OF CARE: Late effects and survivorship
APPLICATIONS: Palliative care
Thirteen studies examined use of bisphosphonates and/or denosumab. Twelve studies used various radioisotopes. No randomized studies using bone-modifying agents were found. One randomized study compared zoledronic acid versus ibandronate. Most of these studies were examining effects to prevent skeletal events. Overall for those with NSCLC, a mean of 67% of patients had a decrease in pain score (3 studies, 225 patients). Of patients given samarium, 60%-95% experienced a decrease in pain. Overall radioisotopes appeared to reduce pain with rapid onset, lasting one to three months. Data were limited for individuals specifically with NSCLC. Most studies did not include QOL measurement; in the five studies that did, only two showed improvement.
Limited evidence exists that bisphosphonates or denosumab reduce or prevent pain from bone metastases or impact QOL in patients with NSCLC . Radioisotopes appear to have a palliative effect on pain, but no high-level evidence for this was found.
Although some evidence exists that bone-modifying agents prescribed to prevent skeletal events may reduce associated pain, the evidence is limited, particularly for patients with NCSLC. Radioisotopes appear to reduce pain for a limited amount of time, and repeated use can have significant adverse effects on bone marrow. Authors of this report suggest that efficacy for pain relief may be tumor dependent, and that, due to potential bone marrow suppression, radioisotopes should be reserved for patients who are not receiving active anticancer therapy and pain that is not appropriate for palliative radiotherapy.
Hemati, S., Asnaashari, O., Sarvizadeh, M., Motlagh, B. N., Akbari, M., Tajvidi, M., & Gookizadeh, A. (2012). Topical silver sulfadiazine for the prevention of acute dermatitis during irradiation for breast cancer. Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer, 20(8), 1613–1618.
To evaluate the effectiveness of topical silver sulfadiazine to prevent radiation dermatitis in women receiving radiotherapy for breast cancer
Patients were randomized to intervention and control groups and were matched by the investigator in terms of the flatness of the chest wall. Patients in the intervention group were instructed to apply 1% silver sulfadiazine cream to the irradiated field every eight hours for three consecutive days. No application was done on the days they received radiation therapy. Use of the cream was continued for one week after completion of radiotherapy. Both groups were educated in general skin care. No other creams were to be applied to the radiation field. Skin in the field was examined weekly by a random radiation oncologist who was not informed of patient group assignment.
The study took place in an outpatient setting in Iran.
Patients were undergoing active antitumor treatment.
The study used a single blind randomized controlled trial design.
The Radiation Therapy Oncology Group scoring of skin toxicity was used.
From the second week onward, patients who received the silver sulfadiazine cream showed lower grades of skin injury (p < 0.002).
Silver sulfadiazine was more effective than no treatment in reducing the severity of radiation-induced dermatitis.
Silver sulfadiazine was more effective than no skin treatment to reduce severity of radiation-induced dermatitis. It would be more helpful to determine the difference between this approach and other topical treatments, which have been shown to have some efficacy.
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.