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Kravitz, R.L., Tancredi, D.J., Grennan, T., Kalauokalani, D., Street, R.L., Jr., Slee, C.K., . . . Franks, P. (2011). Cancer Health Empowerment for Living without Pain (Ca-HELP): Effects of a tailored education and coaching intervention on pain and impairment. Pain, 152, 1572–1582.

Study Purpose

To determine the effectiveness of a lay-administered tailored education and coaching intervention on cancer pain severity, pain-related impairment, and quality of life  

Intervention Characteristics/Basic Study Process

Patients with baseline “worst pain” of more than 4 on a 0–10 scale or at least moderate functional impairment were randomized to tailored education coaching (TEC) or enhanced usual care (EUC). TEC was delivered by a health educator in a private room one hour prior to the patients' visit with their healthcare provider. The intervention was a brief, patient-centered, tailored education and coaching intervention designed to enhance skills and self-efficacy for communicating with the oncologist while also correcting common misconceptions. The EUC intervention included review of selected aspects of a National Cancer Institute (NCI) booklet on pain control by a health educator. The TEC patients also received the NCI booklet. Patients completed questionnaires before and after the visit and were interviewed by telephone at 2, 5, and 12 weeks. Oncologists and follow-up assessors were blinded to patient group assignments.

Sample Characteristics

  • The study reported on 258 patients (126 in the intervention group and 132 in the usual care group).
  • Mean patient age was 58 years.
  • The intervention group was 77.8% female and 22.2% male. The usual care group was 79.5% female and 20.5% male. 
  • Patients had breast and lung cancers and were predominantly white (71%).

Setting

  • Mutlisite
  • Outpatient setting
  • Three healthcare systems and one private practice located in the metropolitan Sacramento, CA, area
  • Forty-five medical oncologists and three radiation oncologists participated in the study.

Phase of Care and Clinical Applications

Patients were undergoing multiple phases of care.

Study Design

The study was a randomized controlled trial.

Measurement Instruments/Methods

  • Pain severity: two component numeric scales     
  • Pain impairment: five of thesix items from the Medical Outcomes Study
  • Functional status and well-being: physical and mental health components of the SF-12
  • Pain misconceptions: 11 five-point Likert scale items based on the Short Barriers Questionnaire
  • Self-efficacy for communicating about pain with the cancer doctor: five items in the Perceived Efficacy in Patient-Physician Interactions Scale
  • Pain-control self-efficacy: 2 items from the pain management subscale of the Chronic Pain Self-Efficacy Scale
     

Results

The TEC patients had an improvement in pain-related impairment at two weeks (–0.025 points on a five-point scale, 95% confidence interval –0.43 to –0.06, p = 0.01), but it was not sustained at 6 and 12 weeks (p > 0.20). Pain severity was not improved at two weeks (–0.21 points on an 11-point scale, –0.60 to 0.17, p = 0.27). Pain misconceptions in both the intervention and control group decreased significantly between baseline and the two-week follow-up interview (p < 0.001), but there was no significant effect of the intervention on misconceptions at the two-week follow-up (p = 0.8). Communication self-efficacy increased more among the TEC patients than in the control group (p < 0.001).

Conclusions

TEC provides a temporary improvement in pain impairment but not in pain severity.

Limitations

The TEC intervention was designed to be brief and easy to deliver, but the health educator needed 30–40 hours of training and regular reinforcement (several hours every three to six months) in order to deliver the intervention appropriately. Physicians were not randomized to the study, so they may have learned from the TEC patients and applied it to the EUC patients. Generalizability of findings is limited due to the fact that the study was conducted in a metropolitan area in California, with no blinding.

Nursing Implications

Because the TEC provided only temporary relief of pain impairment and no improvement of pain severity, it is not recommended for use in cancer-related pain management.

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Kravitz, R.L., Tancredi, D.J., Jerant, A., Saito, N., Street, R.L., Grennan, T., & Franks, P. (2012). Influence of patient coaching on analgesic treatment adjustment: Secondary analysis of a randomized controlled trial. Journal of Pain and Symptom Management, 43, 874–884.

Study Purpose

To estimate the effect of patient-centered tailored education and coaching (TEC) on the likelihood of analgesic treatment adjustment during oncology visits; to estimate the influence of treatment adjustment on subsequent cancer pain control

Intervention Characteristics/Basic Study Process

Patients with at least a moderate baseline pain received TEC or control just prior to a scheduled oncology visit. Just after the visit, they reported on whether the physician recommended a new pain medication or a change in the dose of an existing medication. Pain severity and pain-related impairment were measured 2, 6, and 12 weeks later. TEC included assessing knowledge, attitude, and preferences; correcting misconceptions; teaching about pain control and communication with providers; planning communication; and rehearsing communication with physicians. Sessions occurred one hour before initial clinic visits and were conducted on an individual basis. Sessions were recorded on audiotape. Control patients received the Natiional Cancer Institute booklet on pain control. Patients completed questionnaires immediately after a clinic visit.

Sample Characteristics

  • The sample was composed of 258 patients.
  • Patients' age range was 18–80 years.
  • Of all participants, 21.4% were male and 78.6% were female.
  • Diagnoses in the sample included lung, breast, prostate, head and neck, esophageal, colorectal, bladder, and gynecologic cancer.
  • Patients reported a score of 4 or higher, on a 0–10 scale, when asked to cite worst pain during the past two weeks or pain during the same period that interfered at least moderately with functioning.
  • Potentially eligible patients were identified using computer-generated lists. Consenting patients received an enrollment packet by mail and were promised $80 compensation for completing the trial.

Setting

Settings included three health systems—academic medical center, health maintenance organization, and Veterans Affairs hospital—and one private practice, all in Sacramento, California.

 

Phase of Care and Clinical Applications

  • Phase of care: active treatment
  • Clinical applications: elder care, palliative care

Study Design

Randomized controlled trial

Measurement Instruments/Methods

  • Medical Outcomes Study Pain Impairment Scale
  • Postvisit questionnaire regarding pain medication changes

Results

  • Patients assigned to TEC were more likely than controls to report a change in the analgesic treatment regimen (60% vs. 36%, p < 0.01).
  • Significant effects persisted after adjustment for baseline pain, study site, and physician (adjusted odds ratio 2.61, 95% CI 1.55, 4.40, p < 0.01).
  • In a mixed-effects repeated-measures regression, analgesic change was associated with a sustained decrease in pain severity (p < 0.05).

Conclusions

TEC increases the likelihood of self-reported, physician-directed adjustments in analgesic prescribing. Treatment intensification is associated with improved cancer pain outcomes.

Limitations

  • The study had low accrual rates.
  • Invesigators obtained data about independent and dependent variables by means of patients' self-reports. The study shows poor concordance between patients' reports and medical record review.
  • Authors did not assess appropriateness of physicians' decisions.
  • Regression effects that may cause between-group comparisons may appear to be larger than they would be if analgesic change were randomly assigned.
  • Time points at which pain severity were measured are unclear.

Nursing Implications

A routine oncology visit is an opportunity to adjust a patient’s analgesic regimen. Available evidence suggests that clinicians often miss opportunities to intensify analgesic regimens appropriately. Oncologists are often unaware of patients’ pain. Patients may be reluctant to discuss pain because of misconceptions about pain management or fear of distracting the physician. The findings of this study suggest that interventions to counter this reluctance, and to improve pain management, include education, including role-playing, that helps patients plan communication with physicians.

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Kozelsky, T.F., Meyers, G.E., Sloan, J.A., Shanahan, T.G., Dick, S.J., Moore, R.L., … North Central Cancer Treatment Group. (2003). Phase III double-blind study of glutamine versus placebo for the prevention of acute diarrhea in patients receiving pelvic radiation therapy. Journal of Clinical Oncology, 21(9), 1669–1674.

Intervention Characteristics/Basic Study Process

The study design was based on a goal of 120 patients, so that the two-sided, 0.05-level Wilcoxon rank sum would have a power of 97.5% to detect an improvement in diarrhea severity. After stratification, patients were randomly assigned to the experimental group (4 grams of glutamine twice per day for 7 days per week during radiation and for 2 weeks thereafter) or an identically appearing placebo (glycine) for the same time period.

Sample Characteristics

  • The study reported on 129 patients from 14 institutions.
  • Patients were stratified by
    • History of anterior resection of the rectum versus no prior rectal surgery
    • Total planned cumulative radiation dose
    • Use of fluorouracil (FU)
    • Primary tumor site (rectal versus prostate versus gynecological versus other).

Study Design

This was a two-arm, placebo-controlled, randomized clinical trial.

Measurement Instruments/Methods

The primary measure of treatment efficacy was diarrhea levels, which were evaluated using a bowel function questionnaire that was derived from previous studies on radiation therapy and bowel functioning. Participants completed the questionnaire weekly for 4 weeks, then at 12- and 24-month follow-up intervals. Toxicity was measured using National Cancer Institute (NCI) Common Terminology Toxicity Criteria for Adverse Events: Diarrhea.

Results

No significant differences were found in incidence of diarrhea (p = 0.99), stools per day, maximum stools per day, antidiarrheal agent used, or use of loperamide.

Limitations

  • This study was inconsistent with other studies which found a significant effect (improvement) in diarrhea with glutamine supplementation. Further research is needed to determine whether a lower dose of glutamine was used in this study.
  • The authors did not report on the validity or reliability of the bowel function questionnaire.
  • No dose-response data was provided to assess whether higher doses or longer pretreatment use of glutamine would have been more effective in treating or preventing diarrhea.
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Kozanoglu, E., Basaran, S., Paydas, S., & Sarpel, T. (2009). Efficacy of pneumatic compression and low-level laser therapy in the treatment of postmastectomy lymphoedema: A randomized controlled trial. Clinical Rehabilitation, 23(2), 117–124.

Study Purpose

To compare the long-term efficacy of pneumatic compression and low-level laser therapies in the management of postmastectomy lymphoedema

Intervention Characteristics/Basic Study Process

Sixty-four women who had undergone modified radical mastectomy with complete axillary dissection and radiotherapy were recruited for the study. All patients gave informed consent, and the hospital ethics committee had approved the study protocol. Patients who had a history of arm lymphedema of at least three months were recruited to the study. Fourteen patients were excluded from the study (three had current metastases, five had continuing radiotherapy, one had cellulitis, two had a history of receiving a physical therapy program in the previous six months, one was using diuretic agent for hypertension, and two refused the treatment and did not provide informed consent). Patients were randomized to the pneumatic compression therapy group (group I, n = 25) or the low-level laser therapy group (group II, n = 25) by consecutive alternate allocation according to the admittance to the study clinic. The physician who randomized the patients was blind to the treatment groups. Group I received two hours of therapy with an intermittent pneumatic compression therapy device. A pressure of 60 mmHg, which is generally recommended for the treatment of lymphedema, was used. Total treatment period was four weeks and consisted of 20 sessions. Group II received 20 minutes therapy (2800 Hz, 1.5 J/cm2) with a Ga-As 904 nm laser device three times a week. Total treatment period was four weeks and consisted of 12 sessions. Laser therapy was administered at three points on the antecubital fossa and at seven points on the axilla where the lymph nodes accumulated. All patients were advised to perform daily limb exercises (active range of motion, elevation and pumping exercises), hygiene, and skin care. In addition to pre- and post-treatment evaluation, follow-up measurements were performed at 3, 6 and 12 months by the same physician.

Sample Characteristics

  • The study sample (N = 50) was comprised of two groups receiving either pneumatic compression therapy (group I, n = 25) or low-level laser therapy (group II, n = 25). 
  • Mean age for group I was 51.2 years and group II was 45.4 years. 
  • All patients had breast cancer-related lymphedema. 
  • Patients were included in the study if they had a history of arm lymphedema of at least three months. 
  • Patients were excluded from the study if they
    • Had current metastases, continuing radiotherapy, cellulitis, venous thrombosis, chronic inflammatory diseases, a history of severe trauma, or photosensitivity
    • Were using any medications that affect body fluid and electrolyte balance
    • Had limitation of the upper-extremity joints
    • Had a history of physical therapy other than skin care and home exercises directed to lymphedema within the previous six months.

 

 

Setting

The study took place at the Department of Physical Medicine and Rehabilitation of Cukurova University in Turkey.

Phase of Care and Clinical Applications

Patients were undergoing long-term follow-up care. The study has clinical applicability for late effects and survivorship. 

Study Design

The study used a randomized controlled trial design.

Measurement Instruments/Methods

  • The affected and unaffected upper limbs of the patients were measured by tape at seven anatomic sites, including the axilla, 10 cm proximal and distal to the antecubital fossa, elbow, 5 cm proximal to the wrist, wrist, and mid-palm. Lymphedema was defined as a difference of more than 2 cm at least three of the seven points. The sum of the circumferences of the affected and unaffected limbs was calculated and the difference between these two values was recorded as delta circumference.
  • Pain with motion was measured by a visual analog scale of 0–100 mm, ranging from no pain to very severe pain.
  • Range of motion of the upper-extremity joints was measured using a conventional goniometer when patients were lying in the supine position.
  • Grip strength was measured by portable hydraulic hand dynamometer. The measurements were performed when patients were seated in straight position, with the shoulder adducted, elbow flexed at 90°, and forearm in neutral rotation. A mean of three attempts was calculated, with a 15-second rest in between each of three contractions.

Results

Delta circumference decreased significantly at one, three, and six months within both groups, and the decrease was still significant at month 12 only in group II (p = 0.004). Improvement of group II was greater than that of group I post-treatment (p = 0.04) and at month 12 after 12 months (p = 0.02). Pain was significantly reduced in group I only at post-treatment evaluation, whereas in group II it was significant post-treatment and at follow-up visits. No significant difference was detected in pain scores between the two groups. Grip strength was improved in both groups, but the differences between groups were not significant.

Conclusions

Patients in both groups improved after the interventions. Group II had better long-term results than group I. Low-level laser might be a useful modality in the treatment of post-mastectomy lymphedema.

Limitations

  • The study sample was small, with less than 30 participants for each group and less than 100 participants in total. 
  • The study lacked a sham or control group because of ethical issues.
  • Patients were not blinded because of the different types of treatment. 

Nursing Implications

Prospective randomized controlled studies with a larger sample size are needed to better understand the efficacy of low-level laser therapy and pneumatic compression in the treatment of postmastectomy lymphedema. In addition to these suggested treatment modalities, patients are recommended to perform daily limb exercises and follow skin care instructions throughout their lives.

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Kovacs, G., Wachtel, A.E., Basharova, E.V., Spinelli, T., Nicolas, P., & Kabickova, E. (2016). Palonosetron versus ondansetron for prevention of chemotherapy-induced nausea and vomiting in paediatric patients with cancer receiving moderately or highly emetogenic chemotherapy: A randomised, phase 3, double-blind, double-dummy, non-inferiority study. Lancet Oncology, 17, 332–344.

Study Purpose

To assess the efficacy and safety of palonosetron versus ondansetron in the prevention of chemotherapy-induced nausea and vomiting (CINV) in pediatric patients receiving moderately (MEC) or highly emetogenic chemotherapy (HEC)

Intervention Characteristics/Basic Study Process

Four cycles of 10 mc/kg palonosetron was compared to three 150 mc/kg doses of ondansetron on day 1 of chemotherapy, and 20 mc/kg palonosetron was compared to three 150 mc/kg doses of ondansetron on day 1 of chemotherapy. The intervention assignment was stratified based on the age of the participant and the emetogenicity of the chemotherapy. The efficacy of antiemetic regimens was evaluated through the proportion of patients who achieved complete response (CR) (no vomiting, retching, or use of rescue drugs) during the acute phase (0–24 hours post chemotherapy) of chemotherapy on day 1. Safety was evaluated through the number of adverse events reported.

Sample Characteristics

  • N = 493   
  • AGE RANGE = 2.1 months–16.9 years
  • MEAN AGE = 8.21 years
  • MALES: 53.1%, FEMALES: 46.9%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: No specific type of cancer required for inclusion
  • OTHER KEY SAMPLE CHARACTERISTICS: MEC or HEC

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Not specified    
  • LOCATION: United States, South America, and Europe

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Pediatrics

Study Design

  • Double-blind, double-dummy, phase-III study

Measurement Instruments/Methods

  • Episodes of CINV, retching, and rescue medications used were documented in a daily diary kept by the patient/caregiver.  
  • Adverse events were measured through physical examination, vital signs, laboratory assessments, and 12-lead electrocardiograms. The severity of all adverse events was rated mild, moderate, or severe based on the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.

Results

Twenty mc/kg palonosetron resulted in a significantly higher proportion of patients who achieved CR (no vomiting, retching, or use of antiemetic rescue medication) on day 1 of chemotherapy compared to those who received ondansetron (p = 0.0022). No difference existed in the proportion of CR on day 1 of chemotherapy for those who received 10 mc/kg palonosetron compared to ondansetron. Adverse events were reported in 80% (n = 134) of patients who received 10 mc/kg palonosetron, 69% (n = 113) of those who received 20 mc/kg palonosetron, and 82% (n = 134) of those who received ondansetron. Adverse events attributed to palonosetron were headache (n = 4), infusion site pain (n = 1), and cardiac issues (n = 5).

Conclusions

Compared to ondansetron, 20 mc/kg palonosetron resulted in significantly greater control of CINV and minimal adverse events in pediatric patients receiving MEC or HEC.

Nursing Implications

Based on the results from this study, the United States Food and Drug Administration has approved the use of 20 mc/kg palonosetron for the prevention of CINV in pediatric patients receiving chemotherapy.
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Kovacic, T., Zagoricnik, M., & Kovacic, M. (2013). Impact of relaxation training according to the Yoga In Daily Life® system on anxiety after breast cancer surgery. Journal of Complementary and Integrative Medicine, 10, 1–12.

Study Purpose

To evaluate the immediate and short-term effects of relaxation training with the Yoga in Daily Life program on anxiety in patients with breast cancer

Intervention Characteristics/Basic Study Process

Patients were randomized to standard physiotherapy or standard physiotherapy plus the relaxation program after surgery for breast cancer. Physiotherapy was provided for one week. The experimental group also had one-hour group sessions daily in groups of three for one week. The program involved relaxation breathing exercises, visualization, and body scan, providing progressive muscle relaxation techniques. Those in the experimental group were given audiocassettes with instructions for home practice and were asked to do this daily for another three weeks.

Sample Characteristics

  • N = 32  
  • AGE: All patients were over 40; further information was not provided.
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Patients with breast cancer having just undergone initial surgery

Setting

  • SITE: Single site  
  • SETTING TYPE: Multiple settings    
  • LOCATION: Slovenia

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Single blind RCT

Measurement Instruments/Methods

  • State Trait Anxiety Scale
  • Patient diary of use of relaxation at home

Results

There was significant reduction in anxiety in the experimental group (p < .01), while mean anxiety level in the control group remained essentially the same. State anxiety levels were significantly lower after physiotherapy and relaxation training in the experimental group compared to controls one hour after physiotherapy (p = .038).

Conclusions

Visualization and progressive muscle relaxation as provided in this program may help reduce anxiety after surgery among patients with breast cancer.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Risk of bias (no appropriate attentional control condition)
  • Measurement/methods not well described
  • Other limitations/explanation: Single blind only. There is no information about how often patients did the program at home after hospital discharge.

Nursing Implications

Relaxation therapy including visualization and progressive muscle relaxation as accomplished in this program may be helpful for patients to reduce anxiety. This study has limitations and does not provide strong support for effectiveness; however, these are very low-risk types of interventions that may be helpful to some patients.

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Kouvaris, J.R., Kouloulias, V.E., Plataniotis, G.A., Balafouta, E.J., & Vlahos, L.J. (2001). Dermatitis during radiation for vulvar carcinoma: Prevention and treatment with granulocyte-macrophage colony-stimulating factor impregnated gauze. Wound Repair and Regeneration, 9, 187–193.

Study Purpose

To determine effectiveness of GM-CSF impregnated gauze in preventing and healing acute radiation-induced dermatitis

Intervention Characteristics/Basic Study Process

The study took place from November 1981 to March 1998. Group A (n = 37) was comprised of patients treated from 1981 to 1993 and received steroid creams (e.g., Betamethasone) as prophylaxis to radiation-induced dermatitis. Group B (n = 24) was comprised of patients treated from 1993 to 1998 and received steroid creams from the start of treatment and, following 20 Gy of radiation, also recieved GM-CSF impregnated gauze. Dressings were applied twice daily, 12 hours apart, for the rest of their treatment, while steroid cream was applied once a day, intermediately. The same doctors and technicians treated all patients during this time interval and were evaluated using a standard protocol. Findings from both groups were analyzed retrospectively.

Sample Characteristics

  • The study sample was comprised of 61 female patients.
  • Median age of the sample was 74 years, with a range of 38–84 years.
  • Patients had a diagnosis of invasive squamous cell carcinoma of the vulva.

Setting

The study took place at a university hospital in Greece.

Study Design

The study used a retrospective design.

Measurement Instruments/Methods

  • Patients were examined clinically twice a week to estimate the cutaneous reactions to the groin areas, vulva, perineum, and labiocrural folds.
  • Radiation dermatitis was classified in four grades using Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer (RTOG/EORTC) toxicity scoring.
  • Pain was classified into four grades according to the subjective scale of Subjective Objective Management Analytic grading system.

Results

Group B had overall lower subjective pain results (p = 0.0014). Those who had received the GM-CSF had overall less severe skin toxicity by RTOG/EORTC grading (p = 0.008).

Conclusions

GM-CSF impregnated gauze can be effective in preventing and healing radiation-induced dermatitis and in reducing the interruption intervals in radiation therapy for vulvar carcinomas.

Limitations

  • The sample size is small, with less than 50 patients.
  • The study used a nonrandomized, retrospective design. Small non-randomized study, retrospective study, Low accumulation of participants:12 years of study for group A (37 patients)
  • Group A had 12 years of study and Group B had 5 years of study.
  • The study did not specify the breakdown of stage and grade of cancers in each group, and a wide range of patient characteristics in body mass were included.
  • The study did not specify number of patients per group who had surgery before radiation, required a boost dose, required pelvic radiation, or had a treatment break.
  • No explanation/validation of the SOMA pain grading system was provided.
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Kourlaba, G., Dimopoulos, M.A., Pectasides, D., Skarlos, D.V., Gogas, H., Pentheroudakis, G., . . . Maniadakis, N. (2015). Comparison of filgrastim and pegfilgrastim to prevent neutropenia and maintain dose intensity of adjuvant chemotherapy in patients with breast cancer. Supportive Care in Cancer, 23, 2045–2051. 

Study Purpose

To compare effectiveness of pegfilgrastim given as a prophylactic single-fixed dose versus daily filgrastim for incidence of febrile neutropenia (FN), severe neutropenia, treatment delays, and dose reductions in high-risk breast cancer patients receiving adjuvant dose dense chemotherapy. The secondary aim was to evaluate the impact of both granulocyte–colony-stimulating factors (G-CSFs) on patients’ overall survival (OS).

Intervention Characteristics/Basic Study Process

All patients treated with E-T-CMF received G-CSF in each cycle of chemotherapy. Patients randomized to receive ET-CMF received G-CSF only during intensified phase of CMF treatment; patients randomized to receive E-CMF-DOC or E-CMF-PAC received G-CSF during the intensified phase of epirubicin and CMF treatment. G-CSF was arbitrarily chosen by physicians. Patients received either single fixed dose of pegfilgrastim 6 mg on the next day after chemotherapy completion or daily administration of filgrastim 5 mcg/kg per day on days 2-7 of each cycle (compliance for filgrastim was more than 90% of cycles).

Sample Characteristics

  • N = 1,058 (529 filgrastim; 529 pegfilgrastim)  
  • MEAN AGE = 52.3 years
  • AGE RANGE = 22–79 years
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Postoperative high-risk patients with breast cancer receiving sequential chemotherapy with epirubicin, pacitaxel, or docetaxel, and CMF supported by G-CSF.
  • OTHER KEY SAMPLE CHARACTERISTICS: No difference in menopausal status, higher % of patients had positive estrogen/progesterone status, no difference in tumor size, number of positive nodes, 92% completed treatment in filgrastim arm/95.3% in pegfilgrastim arm. Eligible patients came from sample of 2,123 participants in randomized trials: ACTR N12609001036202 (HE10/00) (reported in: Fountizilas, G et al. [2008]. Postoperative dose-dense sequential chemotherapy with epirubicin, paclitaxel and CMF in patients with high-risk breast cancer: Safety analysis of the Hellenic Cooperative Oncology Group randomized phase III trial HE 10/00. Annals of Oncology, 19(5):853–860). ACTRN12610000151033 (HE 10/05) and 989 participants in an observational study (protocol HE 10/08).
  • INCLUSION CRITERIA: Exposure to pegfilgrastim or nonexposure (i.e., filgrastim) during treatment with dose-dense sequential chemotherapy E-T-CMF and E-CMF-DOC or E-CMF-PAC
  • EXCLUSION CRITERIA: Patients treated with ET-CMF; patients whose supportive care switched from pegfilgrastim to filgrastim and vice versa throughout the period they received chemotherapy, as well as those who received pegfilgrastim on the same day as chemotherapy

Setting

  • SITE: Multisite
  • SETTING TYPE: Unknown
  • LOCATION: Greece

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Elder care

Study Design

  • Retrospective cohort study with matched sampling using data from prior prospective randomized phase III trials and an observational study

Measurement Instruments/Methods

Data endpoints were rates of FN, severe (grade 3 or 4) neutropenia, dose reduction, and treatment delay. FN was defined as body temperature > 38.2 °C and neutrophil count < 0.5 × 109/L. Severe (grade 3 or 4) neutropenia was assessed according to standard NCI criteria. Dose reduction was defined as any reduction greater than 10% of the dose planned based on the protocol assigned, and treatment delay was defined as chemotherapy administration with more than a two-day delay from the planned date.

Results

No difference in rates of febrile neutropenia comparing filgrastim and pegfilgrastim arms existed. A significant increase in rates of severe neutropenia, treatment delays, and dose reduction in patients receiving prophylaxis with filgrastim was reported. More than half of the total episodes of febrile neutropenia occurred during the first four cycles of chemotherapy. No difference in overall survival between the two groups existed.

Conclusions

This retrospective study with matched sampling using data taken from a former prospective study of high-risk patients with breast cancer receiving postoperative dose dense sequential epirubicin, paclitaxel, and CMF matched samples found that those patients receiving pegfilgrastim had reduced incidence and risk for FN, dose delay, and dose reduction compared to filgrastim. No difference was found in reducing rates of neutropenia.

Limitations

  • Risk of bias (no random assignment)
  • Unintended interventions or applicable interventions not described that would influence results
  • Measurement/methods not well described
  • Questionable protocol fidelity
  • This study was not designed for the purpose of evaluating neutropenia as a secondary analysis with post hoc matching. 
  • Unknown sampling technique and methods for patient selection were poorly described. 
  • Retrospective data were from two randomized trials evaluating breast cancer treatment regimens ACTR N12609001036202 (HE 10/00) - ACTRN12610000151033 (HE 10/05) and one observational study (protocol HE 10/08). 
  • Treatment dose of filgrastim two to seven days compared to pegfilgrastim could be considered unequal dosing/timing support for neutropenia prophylaxis. 
  • Selection bias with G-CSF chosen arbitrarily by physician
  • Several different chemotherapy regimens had no data for incidence of grades of neutropenia or FN specific to the type of regimen comparing filgrastim versus pegfilgrastim.
  • No data existed for sequelae of FN events or infectious events.

Nursing Implications

Pegfilgrastim 6 mg 24 hours after chemotherapy is more effective in reducing incidence/risk of FN, dose delay, and dose reduction compared to filgrastim 5 mcg/kg/d on days two through seven in high-risk patients with breast cancer receiving postoperative adjuvant sequential chemotherapy regimens with epirubicin, paclitaxel, or docetaxel and CMF. Prospective randomized, controlled trials are needed to validate these results and to determine specific treatment regimens/population where pegfilgrastim or filgrastim dose/timing may be more effective in preventing FN.

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Koul, R., Dufan, T., Russell, C., Guenther, W., Nugent, Z., Sun, X., & Cook, A.L. (2007). Efficacy of complete decongestive therapy and manual lymphatic drainage on treatment-related lymphedema in breast cancer. International Journal of Radiation Oncology, Biology, Physics, 67(3), 841–846.

Intervention Characteristics/Basic Study Process

Medical records for 250 patients referred for lymphedema treatment during the first two years of the program were analyzed. Data from the charts of 138 patients were included if their affected arms were larger than their unaffected arms at baseline and one-year and follow-up measurements were available. Pre- and post-volumetric measurements were compared, and the correlation with age; body mass index; and type of surgery, chemotherapy, and radiotherapy was determined. Treatment was stratified on the basis of the treatment modality used for breast cancer management. The therapy could include all four components of CDT or some components could be omitted at the discretion of the therapists. Fifty-five percent of patients received all four components; 32% received manual lymphatic drainage (MLD) alone; and 13% with mild lymphedema received instructions and counseling for the home program, which included self-administered lymph drainage and exercises. All patients received compression wraps during the intensive phase. Data from 250 patients was reviewed, and 138 were included in the final analysis.

Sample Characteristics

Mean age of the study sample was 54.3 years.

Setting

The study took place at an outpatient lymphedema clinic staffed by two certified Vodder therapists in Winnipeg, Canada.

Measurement Instruments/Methods

Circumference was measured from the wrist to the axilla every 4 cm.

Results

Complete decongestive therapy and MLD with exercises were associated with a significant reduction in lymphedema volume. The mean affected arm pretreatment volume was 2,929 ml, with a range of 1,474–5,879. The normal arm range volume was 1,320–4,299 with mean volume 2,531 ml. The mean difference at base line was 398 ml. The number of MLD or CDT sessions was related to mastectomy (versus lumpectomy) and chemotherapy. One year after treatment an absolute volume reduction of 188 ml to 2,741 ml was found.

Limitations

  • The study had a risk of bias because of no randomization or control group.
  • The study is retrospective.
  • The components could not be qualified.
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Koul, R., Dufan, T., Russell, C., Guenther, W., Nugent, Z., Sun, X., & Cooke, L. (2007). Efficacy of complete decongestive therapy and manual lymphatic drainage on treatment-related lymphedema in breast cancer. International Journal of Radiation Oncology, Biology, Physics, 67(3), 841–846.

Intervention Characteristics/Basic Study Process

Researchers analyzed the medical records for 250 patients referred for lymphedema treatment during the first two years of the program and included 138 in the final analysis. Patients were included if their affected arms were larger than their unaffected arms at baseline and one-year follow-up measurements were available. Pre- and postvolumetric measurements were compared. The correlation with age, body mass index, and type of surgery, chemotherapy, and radiotherapy was determined. Treatment was stratified on the basis of the treatment modality used for breast cancer management. The therapy could include all four components of complete decongestive therapy (CDT) or only some components were omitted at the discretion of the therapists. Fifty-five percent of patients received all four components and 32% manual lymph drainage (MLD) alone. Thirteen percent with mild lymphedema received instructions and counseling for the home program, which included self-administered lymph drainage and exercises. All patients received compression wraps during the intensive phase.

Sample Characteristics

The mean age of patients in the sample was 54.3 years.

Setting

The study was conducted at an outpatient lymphedema clinic staffed by two certified Vodder therapists in Winnipeg.

Measurement Instruments/Methods

Circumference was measured from the wrist to axilla.  

Results

CDT and MLD with exercises were associated with a significant reduction in lymphedema volume. The mean affected arm pretreatment volume was 2,929 ml (range 1,474–5,879). The normal arm volume range was (1,320–4,299) with a mean volume of 2,531 ml. The mean difference at baseline was 398 ml. The number of MLD or CDT sessions was related to mastectomy (versus lumpectomy) and chemotherapy. After one year, absolute volume was reduced by 188 ml to 2,741 ml.

Conclusions

The study examines CDT and its components for a variety of patient needs and supports modifications of components of CDT and individualization of care.

Limitations

  • The study was not randomized. 
  • No control group was provided for the study.
  • Research relied on retrospective studies. 
  • The components could not be qualified.

Nursing Implications

Evidence supports a need for expert therapists.

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