Hernandez-Reif, M., Ironson, G., Field, T., Hurley, J., Katz, G., Diego, M., . . . Burman, I. (2004). Breast cancer patients have improved immune and neuroendocrine functions following massage therapy. Journal of Psychosomatic Research, 57, 45–52.
Immediate effects: Analysis of variance on STAI revealed a significant (p < 0.001) group effect on the first day’s change scores, and subsequent Bonferroni t-tests revealed reduced anxiety scores for the massage and PMR groups when compared to the control group. The longer-term effects (SCL-90R subscale) did not differ significantly among the three groups.
Hernández Muñoz, G., & Pluchino, S. (2003). Cimicifuga racemosa for the treatment of hot flushes in women surviving breast cancer. Maturitas, 44(Suppl. 1), S59–S65.
The purpose of this study was to examine the effect of Cimicifuga racemosa (CR BNO 1055) on hot flashes caused by tamoxifen adjuvant therapy in young premenopausal breast cancer survivors. This treatment presents an off-label use of CR BNO 1055 (also known as black cohosh).
Participants took one tablet twice daily with meals for 60 days. Duration of treatment was five years for tamoxifen, and 12 months for CR BNO 1055. Participants were instructed not to initiate new therapies for hot flashes while participating in the study. Forty-six participants were randomly assigned (1-2) to receive tamoxifen 20 mg per day orally (usual-care group;mean age = 47 years); 90 participants received tamoxifen plus CR BNO 1055 corresponding to 20 mg of herbal drug (intervention group; mean age = 46 years.).
This was a two-arm, randomized and open-label trial. The primary endpoint was to assess the effect of CR BNO 1055 on the frequency and intensity of hot flushes.
Control visits occurred every two months, when the supply of CR BNO 1055 was replaced and clinical assessments made. Hot flashes were considered severe when five or more heat episodes occurred during the day and were accompanied by sweating, sleep disturbances, feeling of irritation, and anxiety. A few episodes of heat with discrete sweating were classified as moderate hot flushes. Participants completed hot flash diaries at baseline, at every control visit, and at the end of the study at 12 months.
The hot flash patterns were significantly different between the two groups using Fisher’s exact test (p < 0.01). Among the 46 study participants included into the usual-care group, 73.9% experienced severe hot flushes and 26.1% moderate symptoms. Among the 90 study participants in the intervention group, at the end of the study, 46.7% were free of hot flashes, and 24.4% reported severe symptoms.
In the intervention group, the administration of CR BNO 1055 in combination with tamoxifen for a 12-month period significantly reduced the vasomotor episodes induced by tamoxifen in breast cancer survivors.
Methodologic problems included an open label trial and unbalanced arms (twice as many participants in the Black Cohosh group as in the usual care group).
Hernandez-Reif, M., Ironson, G., Field, T., Hurley, J., Katz, G., Diego, M., . . . Burman, I. (2004). Breast cancer patients have improved immune and neuroendocrine functions following massage therapy. Journal of Psychosomatic Research, 57, 45–52.
The intervention consisted of 30-minute progressive muscle relaxation (PMR) sessions three times per week for five weeks versus massage therapy for five weeks versus a control group. Participants completed the State-Trait Anxiety Inventory (STAI) before and after the first and last sessions. Longer-term anxiety effect was examined by comparing pre first day and pre last day measures on the STAI and by the Symptom Checklist (SCL)-90R (revised) anxiety subscale administered on the first and last days of intervention. Blood samples were drawn to evaluate immune response for natural killer (NK) cell production, cytotoxicity, and hormone levels.
The study reported on three groups: PMR (n = 20), massage therapy (n = 22), and control (n = 16).
A three-group experimental study design was used.
ANOVA on STAI revealed a significant (p < 0.001) group effect on the first day’s change scores; subsequent Bonferroni t tests revealed reduced anxiety scores for the massage and PMR groups when compared to the control group. The longer-term effects (SCL-90R subscale) did not differ significantly among the three groups. Massage therapy demonstrated an increase in dopamine, serotonin, NK cells, and lymphocytes.
This study supports the use of massage treatment and relaxation therapy to reduce anxiety, pain, and depression in women with breast cancer.
Hernandez-Reif, M., Field, T., Ironson, G., Beutler, J., Vera, Y., Hurley, J., . . . Fraser, M. (2005). Natural killer cells and lymphocytes increase in women with breast cancer following massage therapy. International Journal of Neuroscience, 115, 495–510.
The intervention was five weeks of massage therapy sessions for 30 minutes per session. Massages were given three times per week, for a total of 15 massages (control group).
A longitudinal randomized controlled trial design was used.
Anxiety was reduced in the massage group on STAI (p < 0.05) after the first and last sessions (decreased by 25%).
Herbst, C., Naumann, F., Kruse, E.B., Monsef, I., Bohlius, J., Schulz, H., & Engert, A. (2009). Prophylactic antibiotics or G-CSF for the prevention of infections and improvement of survival in cancer patients undergoing chemotherapy. Cochrane Database of Systematic Reviews, 1, CD007107.
The purpose of the study was to compare the effectiveness of prophylactic G-CSF or GM-CSF with prophylactic antibiotics for the prevention of febrile neutropenia, severe infection, infection-related mortality, and overall mortality in patients of all ages with any type of malignancy receiving myeloablative chemotherapy.
The Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and EMBASE databases were searched from January 1985 to January 2008, as were proceedings from the American Society of Clinical Oncology and the American Society of Hematology (2000–2007). In addition, references from identified trials, relevant reviews, guidelines, and ongoing clinical trials were searched.
Key words included granulocyte–colony-stimulate factors (G-CSF), granulocyte macrophage–colony-stimulating factors(GM-CSF), antibiotics, cancer
Studies were included if they were randomized, controlled trials conducted from January 1980 to January 2008 comparing G-CSF or GM-CSF prophylaxis with antibiotic prophylaxis in patients with cancer receiving myeloablative chemotherapy.
Studies were excluded if they were non-randomixed and were quasi-randomized with information on perioperative infection prophylaxis, stem cell mobilization, and priming of malignant cells with G-CSF or GM-CSF.
10,924 abstracts and 473 full-text articles were reviewed.
Forty-four were considered for the review.
Two articles were included in the final review.
Subgroup analyses conducted for types of underlying malignancies, baseline risk factors for febrile neutropenia for infection, inpatient versus outpatient setting, type of treatment (chemotherapy, hematopoietic stem cell transplantation), types of growth factors administered, age, and antimycotic prophylactic administration.
It was not possible to conduct a meta-analysis as planned due to differences in outcomes among the two studies included in this review.
Studies that were excluded were made up of 36 trials that compared antibiotics and G-CSF prophylaxis to antibiotic prophylaxis alone, four trials that compared prophylactic antibiotics and growth factors to growth factors prophylaxis alone, one due to different chemotherapeutic agents used in each of the study arms, and one non-randomized study comparison. Therefore, only two studies fit the exact inclusion criteria.
In the two trials evaluated, both showed efficacy for use of prophylactic colony-stimulating factors (G-CSF or GM-CSF) or antibiotics for decreased risk of infection; however neither colony-stimulating factors or antibiotics proved better than the other in adults with solid tumors who received myeloablative chemotherapy. No differences were found for infection-related mortality, treatment-related or early mortality, febrile neutropenia, the incidence of severe infections, or infectious episodes.
The use of prophylactic treatment with G-CSF, GM-CSF, or antibiotics for the reduction of risk of infections among adults receiving myeloablative chemotherapy for the treatment of small cell lung cancer or breast cancer is effective; however, use of a colony-stimulating factor versus an antibiotic is inconclusive in terms of better efficacy. More trials are warranted to evaluate prophylactic antibiotic versus colony-stimulating factor use for reduced risk of neutropenia, febrile neutropenia, infections, hospitalizations, and survival.
Implications for nursing practice include knowledge of the known literature and lack of information available. Use of a prophylactic treatment (colony-stimulating factor or antibiotic) for infection prevention is warranted.
Heras, P., Hatzopoulos, A., Heras, V., Kritikos, N., Karagiannis, S., & Kritikos, K. (2011). A comparative study of intravenous ibandronate and pamidronate in patients with bone metastases from breast or lung cancer: Effect on metastatic bone pain. American Journal of Therapeutics, 18(5), 340–342.
To compare the effects of ibandronate with those of pamidronate in patients with bone metastases from breast or lung cancer
All patients were diagnosed with either breast or lung cancer and had scan-confirmed bone metastases. Patients were in one of two treatment groups, each receiving IV medication every four weeks for six months. Group A received 6 mg ibandronate. Group B received 90 mg pamidronate.
The authors are practitioners at three facilities in Greece: General Hospital of Nafplio, General Hospital of Kos, and the Hellenic Medical Society for the Study of Psychosomatic Problems, Athens. The report does not specify that these were locations used in the study, however.
Comparative study
Patient demographics were similar in both groups. At baseline, linear analog scale scores were similar in both groups. Compared to the pamidronate group, the ibandronate group had lower pain scores, higher mobility and QoL scores, and lower serum calcium levels. Patients who were taking ibandronate needed fewer analgesics (p = 0.001). In regard to bone pain, patients taking ibandronate reported scores in the range 0–1 and patients taking pamidronate reported scores in the range 3–4.
Ibandronate may be superior to pamidronate in alleviating pain, improving mobility and QoL, and reducing bone resorption in patients with bone metastases from breast or lung cancer.
Evidence from this study strongly supported the effectiveness of bone-modifying agents in reducing the pain of patients with bone metastases. This study attempted to compare the effectiveness of different bisphosphonates. The size and limitations of the trial did not permit researchers to draw firm conclusions regarding the usefulness of one agent over another. Further research is needed to determine the relative efficacy of bone-modifying agents in pain control.
Hensley, M.L., Hagerty, K.L., Kewalramani, T., Green, D.M., Meropol, N.J., Wasserman, T.H., . . . Schuchter, L.M. (2009). American Society of Clinical Oncology 2008 clinical practice guideline update: Use of chemotherapy and radiation therapy protectants. Journal of Clinical Oncology, 27(1), 127–145.
STUDY PURPOSE: To update the American Society of Clinical Oncology (ASCO) guidelines on the use of chemotherapy and radiation therapy protectants for patients with cancer
PHASE OF CARE: Active antitumor treatment
Using various chemotherapy/radiotherapy protectants is useful in certain malignancies for prevention of toxicity related to therapy. Future trials need to be blinded with placebo-controlled arms to provide key evidence to ensure safe guideline recommendations.
Most of the trials lacked a placebo arm in the studies with the quality of the literature reviewed being limited. The panel found that different instruments and/or assessment tools varied for assessing the same outcome in multiple trials.
Nurses caring for this patient population need to be aware and understand that there are medications that can be given to prevent certain chemotherapy/radiation toxicities.
Henke, M., Alfonsi, M., Foa, P., Giralt, J., Bardet, E., Cerezo, L., … Berger, D. (2011). Palifermin decreases severe oral mucositis of patients undergoing postoperative radiochemotherapy for head and neck cancer: a randomized, placebo-controlled trial. Journal of Clinical Oncology, 29, 2815–2820.
To determine if palifermin reduces severe oral mucositis (OM), defined as grade 3 or 4 on the World Health Organization (WHO) Oral Mucositis Grading Scale, in patients undergoing postoperative radiochemotherapy for locally advanced head and neck cancer
This was a multisite study conducted in Australia, Canada, France, Germany, Italy, Spain, and United Kingdom.
Patients were undergoing the active treatment phase of care.
This was a double-blind, randomized, placebo-controlled trial.
Palifermin administered prior to initiation of and weekly during concurrent chemotherapy-radiation therapy reduced OM incidence. The study also examined secondary endpoints (i.e., duration and onset, xerostomia, mouth and throat soreness (MTS) score) as well as radiation treatment breaks and chemotherapy delays. Patients receiving palifermin did not experience fewer breaks or lower average MTS even though these patients did receive fewer opiod analgesics.
This study was supported by Amgen, which manufactures paliferrmin.
Treatment-related OM is debilitating for patients with head and neck cancer undergoing concurrent chemotherapy-radiation therapy. This can significantly impact patient comfort, nutritional status, and response to therapy. Further research is needed to identify effective therapies to better protect the oral mucosa.
Hendrix, C.C., Abernethy, A., Sloane, R., Misuraca, J., & Moore, J. (2009). A pilot study on the influence of an individualized and experiential training on cancer caregiver's self-efficacy in home care and symptom management. Home Healthcare Nurse, 27, 271–278.
To formally evaluate whether a tailored and experiential training approach by an experienced nurse would enhance confidence (self-efficacy) of family cancer caregivers to provide home care and manage patients’ symptoms of illness
The study principal investigator (PI) provided a conceptually based, tailored, and patient-centered bedside intervention for family caregivers providing home care to patients with hematologic malignancies. Caregiver training included symptom management on prevention of infection, pain, poor nutrition, constipation/diarrhea, and management of medications for patient cancer symptoms. Interactive discussion on these topics occurred between interventionist (experienced nurse), caregiver, and patient. To encourage patient involvement in problem-solving symptoms, dyad participation was also incorporated into bedside training. Caregivers received an illustrated take-home manual on discussed topics. Discussion focused on nonpharmacologic interventions to improve patient comfort and meet other patient needs. Caregivers provided a return demonstration following nurse delivery of didactic teaching and skill performance (e.g., catheter care management) specific to patients’ home situation. Sufficient time was provided in the teaching encounter for patients and caregivers to ask questions and to allow satisfactory completion of the skills required for effective patient home care before patient discharge.
Assessment of the influence of the intervention occurred before and after PI training and one week following hospital discharge of the patients. Caregivers completed postintervention assessment within 24 hours of the PI’s didactic and skill performance presentation to caregivers.
Active antitumor treatment phase
A quasi-experimental, time-series design was used.
Total caregiver CCSE scores were significantly higher immediately after caregiver training (z = 4.49, p < 0.001) and one week after hospital discharge of patients (z = 3.22, p < 0.001). These higher scores reflect higher and some sustained levels of caregiver confidence to provide needed home care to patients comprising the sample. Although unanticipated, four patients died within one week of hospital discharge (20% attrition for study), producing a total sample of 16 from the initial sample of 20 patient–caregiver dyads for the one-week assessment.
Timely assessment and nurse-led interventions relevant to assessment findings may increase caregiver confidence to assume home care for patients with hematologic malignancies. Based on Bandura’s (1986) conceptual self-efficacy framework, this pilot study suggests that nurse-led individualized teaching and modeling of homecare skills at the patient’s bedside prior to discharge can sustain caregiver confidence for up to one week postdischarge of the patient. Caregivers and patients believed the intervention to be highly beneficial based on a 1:1 relationship with the nurse-teacher.
As part of their education, nurses learn about the teaching-learning process to optimally prepare patients, families, and communities about ways to improve personal and societal health. With early discharge of patients and the need for family members to often assume complex caregiving roles, there is a heightened need for nurses to use their knowledge of teaching-learning to assess and implement effective teaching to families during the cancer trajectory. Individualized and bedside teaching approaches, such as those found in this study, benefit patients and family members in both inpatient and outpatient settings. Study findings must be evaluated with caution due to the small sample size, one setting for data collection, and lack of control group. More specifically relative to sample size, additional replication of the study must occur to more clearly identify the influence of the individualized and experiential training program on diverse population groups related to ethnicity, clinic care type, education level, and gender (external validity). This would capture deeper understanding of needed components of tailored care in the healthcare team approach to efficiently meet caregiver and patient needs.
Hendrix, C.C., Bailey, D.E. Jr., Steinhauser, K.E., Olsen, M.K., Stechuchak, K.M., Lowman, S.G., . . . Tulsky, J.A. (2015). Effects of enhanced caregiver training program on cancer caregiver's self-efficacy, preparedness, and psychological well-being. Supportive Care in Cancer, 24, 327–336.
To examine the effects of enhanced training on caregivers’ self-efficacy in managing patients' symptoms, stress, preparedness for caregiving, depression, and anxiety
Researchers structured and used enhanced caregiver training (CT) that taught caregivers how to manage patients’ symptoms and their own stress. This training added distress management to previously developed training that focused on managing patients' symptoms only. Training was done at the patients' bedside, one on one, with dyads (patients and their caregivers), and required one to two hours. Training on symptom management involved a manual process that started with a needs assessment to tailor the training to the patient’s situation, an interactive discussion that involved both the patient and the caregiver about how to manage symptoms, and concluded with a one-page hand out on each symptom. Training related to caregivers’ stress management involved a three-step behavioral rehearsal procedure. The nurse modeled how to implement the skill, and the caregiver practiced the skill and received constructive feedback. Finally, the caregiver practiced until she or he mastered the skill.
Randomized, controlled trial in which the intervention arm received enhanced CT and the control group received information about community resources
Significant difference was identified between the intervention and control groups in self-efficacy for managing patients' symptoms, caregiver stress, preparedness for caregiving immediately after the intervention. The intervention group scored higher on the previous outcomes. No differences in other outcomes were found, and the differences initially observed after the intervention were not sustained at two and four weeks after discharge.
Enhanced CT improved caregivers’ self-efficacy, stress management, and preparedness for caregiving immediately after the intervention. However, it did not lead to significant changes in anxiety, depression, or burden. No sustained effects of the intervention were observed for any outcomes.
Caregiver training given in a single dose may not be the best approach to improving caregiver outcomes. Training or interventions for caregivers should be tailored based on emerging needs after discharge, and they should not be exclusively based on the observed or anticipated needs prior to a patient's discharge from the hospital.