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Fu, M.R., Axelrod, D., & Haber, J. (2008). Breast-cancer-related lymphedema: Information, symptoms, and risk-reduction behaviors. Journal of Nursing Scholarship: An Official Publication of Sigma Theta Tau International Honor Society of Nursing/Sigma Theta Tau, 40(4), 341–348.

Study Purpose

To explore the effect of providing lymphedema information on breast cancer survivors’ symptoms and practice of risk-reduction behaviors

Intervention Characteristics/Basic Study Process

All data collection was completed in person. The first author was available to answer questions and assist participants with physical disabilities (i.e., to provide help with reading, marking, or writing). Data were collected from August 22, 2006–May 1, 2007 in New York City, NY.

Sample Characteristics

  • The study sample (N = 136) was comprised of female patients with breast cancer.
  • Mean age of patients was 54 years.
  • Seventy-four percent of patients were White, 59% were married, and 44% held a graduate degree.

Setting

The study took place at New York University Cancer Center.

Study Design

The study used a cross-sectional, descriptive design.

Measurement Instruments/Methods

The study used the Lymphedema and Breast Cancer Questionnaire to assess lymphedema-related symptoms and the Lymphedema Risk-Reduction Behavior Checklist.

Results

Fifty-seven percent of patients reported that they received lymphedema information. On average, participants had three lymphedema-related symptoms. Only 18% of participants were free of symptoms. Participants who received information reported significantly fewer symptoms (t = 3.03, p < 0.00) and practicing more risk-reduction behaviors (t = 2.42, p = 0.01).

Conclusions

Providing lymphedema information has an effect on symptom reduction and more risk-reduction behaviors being practiced among survivors of breast cancer.

Limitations

  • The study used a cross-sectional design.
  • The majority of the sample were highly educated and White.

Nursing Implications

In the study, nurses were ranked as the second-most important source of lymphedema information or education after pamphlets. In clinical practice, nurses and other healthcare professionals could consider taking the initiative to provide adequate and accurate information and engage survivors of breast cancer in supportive dialogues concerning lymphedema risk reduction

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Furukawa, N., Kanayama, S., Tanase, Y., & Ito, F. (2015). Palonosetron in combination with 1-day versus 3-day dexamethasone to prevent nausea and vomiting in patients receiving paclitaxel and carboplatin. Supportive Care in Cancer, 23, 3317–3322. 

Study Purpose

To evaluate the efficacy and toxicity of palonosetron (PAL) and dexamethasone (DEX) on day 1 versus 3 of Decadron in patients with gynecologic cancer receiving carboplatin and paclitaxel (TC); to evaluate the efficacy of a one-day versus three-day Decadron regimen (primary endpoint was complete response in the delayed phase)

Intervention Characteristics/Basic Study Process

All patients received an intravenous prophylactic of Decadron at 20 mg within 15 minutes of a PAL dose of 0.75 mg 30 minutes before chemotherapy. Patients in the DEX1 arn received no further Decadron. Patients in the DEX3 arm received Decadron on days 2 and 3 at 8 mg.

Sample Characteristics

  • N = 88  
  • AVERAGE AGE = 59 years (DEX1), 62 years (DEX3)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Ovarian, cervical, and endometrial cancers
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients were receiving paclitaxel and carboplatin. All participants were chemotherapy-naïve.

Setting

  • SITE: Single site    
  • SETTING TYPE: Outpatient    
  • LOCATION: Japan

Phase of Care and Clinical Applications

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

Study Design

Single-institution, prospective, randomized, open-label study

Measurement Instruments/Methods

  • Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT) for data collection in the first cycle
  • The primary endpoint was complete response (CR) defined as no emetic episodes and no rescue medication in the delayed phase of the first cycle.
  • The secondary endpoint was CR in the acute and in all phases of chemotherapy-induced nausea and vomiting (CINV). Complete control (CC) defined as no emetic episodes, no use of rescue medications, and no significant nausea defined as a MAT score less than 3.

Results

The authors noted that there was no significant difference between groups in complete response, complete control, or total CINV in the acute and delayed phases. There was no significant difference between groups in the rate of severe nausea. The CR rates in the delayed phase were not statistically different in the three-day group (76.9%) versus the one-day group (69.8%). The use of palonosetron and Decadron appears to be equally effective in treatment of delayed CINV for patients receiving paclitaxel and carboplatin.

Conclusions

The use of Decadron was effective with one-day use compared to three-day use. The side effect profile of steroids is very robust, meaning that fewer days of their usage with good control could improve patients' quality of life.

Limitations

  • Small sample (< 100)
  • Baseline sample/group differences of import
  • Risk of bias (no control group)
  • Risk of bias (no blinding) 
  • Risk of bias(sample characteristics)
  • Findings not generalizable
  • Other limitations/explanation: The homogenous population in Japan would affect drug metabolism.

Nursing Implications

Based on the results of this study, dexamethasone is effective after only one day of use compared to three days of use. The side effect profile of steroids is robust, so fewer days of their use with adequate CINV control could improve patients' quality of life.

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Furmaniak, A.C., Menig, M., & Markes, M.H. (2016). Exercise for women receiving adjuvant therapy for breast cancer. Cochrane Database of Systematic Reviews, 9, CD005001. 

Purpose

STUDY PURPOSE: To assess the effects of aerobic and resistance exercise on treatment-related side effects during adjuvant treatment for breast cancer

TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy

DATABASES USED: CENTRAL, MEDLINE, EMBASE, World Health Organization Clinical Trials Registry, ClinicaTrials.gov
 
INCLUSION CRITERIA: Program duration of at least six weeks, any form of repeatedly performed aerobic and/or resistance exercise, during adjuvant treatment, comparison of exercise versus no exercise or versus other interventions
 
EXCLUSION CRITERIA: Studies in which exercise was part of a complex intervention, trials with interventions only for local muscle endurance

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 3,297
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Cochrane risk of bias assessment and GRADES categorization

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 32 in review, 26 in meta-analysis
  • TOTAL PATIENTS INCLUDED IN REVIEW = 2,626
  • SAMPLE RANGE ACROSS STUDIES: 20–242 patients
  • KEY SAMPLE CHARACTERISTICS: All were receiving adjuvant treatment for breast cancer

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Results

  • Fatigue: SMD for in favor of exercise was –0.28 (95% confidence interval [CI] [–0.41, –0.16]) with moderate quality evidence (19 studies including 1,698 women).
  • Depression: The difference with exercise was not significant, and evidence quality was moderate (5 studies including 674 women).
  • Cognitive function assessed with Trail Making Test: MD –11.55 (95% CI [–22.06, –1.05]) with low quality evidence (2 studies including 213 women)
  • Anxiety: Three studies assessed anxiety. A meta-analysis of two studies found no significant difference with exercise.
  • A variety of other outcomes were assessed and reported, such as physical fitness, quality of life, and mood.

Conclusions

The findings show a moderate effect of exercise on fatigue among women receiving adjuvant treatment for breast cancer. No significant effects were seen for depression or anxiety. A statistically significant effect for cognitive function was found; however, the evidence was deemed to be of low quality.

Limitations

  • High heterogeneity
  • The authors reported lack of sufficient information in reports to make clear judgments about potential bias.

Nursing Implications

Exercise probably reduces fatigue and improves physical fitness among women during treatment for breast cancer. Adherence to exercise can be a challenge, and implementation of exercise recommendations or programs will need to address factors to foster exercise participation to be successful.

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Fukuoka, S., Shitara, K., Noguchi, M., Kawazoe, A., Kuboki, Y., Bando, H., . . . Yoshino, T. (2016). Prophylactic use of oral dexamethasone to alleviate fatigue during regorafenib treatment for patients with metastatic colorectal cancer. Clinical Colorectal Cancer. Advance online publication. 

Study Purpose

To investigate the effect of dexamethasone (DEX) on fatigue and other toxicities in patients treated with regorafenib

Intervention Characteristics/Basic Study Process

Data were obtained from medical records for analysis. DEX was given to some patients prophylactically at the physician’s discretion at 2 mg/day throughout regorafenib treatment. Data from those given DEX versus those not given DEX were analyzed. Patients received 120–160 mg regorafenib on weeks 1–3 of each four-week cycle.

Sample Characteristics

  • N = 105, 31 received prophylactic DEX
  • MEDIAN AGE = 63–63
  • AGE RANGE = 38–80 years
  • MALES: 52.4%, FEMALES: 47.6%
  • CURRENT TREATMENT: Other
  • KEY DISEASE CHARACTERISTICS: 
  • OTHER KEY SAMPLE CHARACTERISTICS: The median follow-up period was 15.7 months, and the mean treatment duration was three months.

Setting

  • SITE: Single site   
  • SETTING TYPE: Outpatient    
  • LOCATION: Japan

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

Retrospective cohort

Measurement Instruments/Methods

Common Terminology Criteria for Adverse Events (CTCAE)

Results

The most frequent adverse event leading to dose modification in both groups was hand-foot syndrome (55.6%). No patients in the DEX group had dose modification because of fatigue compared to 8% in the non-DEX group. Median time to dose modification was longer in the DEX group (p = 0.009). The incidence of fatigue was lower in the DEX group (25.8% versus 50%, p = 0.022). The incidence of at least grade 3 hand-foot syndrome was lower in the DEX group (3% versus 25.7%, p = 0.002). The incidence of oral candidiasis was greater in the DEX group (16.2% versus 0%, p < 0.001).

Conclusions

Systemic corticosteroids were associated with a lower incidence of more severe hand-foot syndrome but also associated with a higher incidence of oral candidiasis in this group of patients.

Limitations

  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)

 

Nursing Implications

Prophylactic oral DEX was associated with reduced fatigue and incidence of hand-foot syndrome in patients receiving regorafenib. Systemic DEX may reduce some treatment side effects but was also associated with the development of oral candidiasis. Effectiveness of prophylactic DEX and associated adverse effects warrant further investigation. Nurses need to be aware of the potential infectious complications of patients receiving systemic corticosteroids, and the effects of long-term use needs to be investigated.

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Fukui, S., Ogawa, K., Ohtsuka, M., & Fukui, N. (2008). A randomized study assessing the efficacy of communication skill training on patients' psychologic distress and coping: Nurses' communication with patients just after being diagnosed with cancer. Cancer, 113, 1462–1470.

Study Purpose

To investigate whether a communication skill training program for nurses would reduce psychological distress and improve coping among patients newly diagnosed with cancer

Intervention Characteristics/Basic Study Process

The communication skill training (CST) program involved two workshops, one at the start of the study and the other after three months. Workshops lasted six hours and were structured in a six-step approach (SPIKES) involving (1) setting up the interview, (2) assessing the patient’s perception of his or her illness, (3) obtaining a patient invitation to disclose information, (4) giving information and knowledge to the patient, (5) addressing the patient's emotion with empathic responses, and (6) strategy and summary. The program involved a large group meeting on theoretic content followed by small facilitated group work in which nurses worked through various scenarios using the SPIKES steps. Study patients were randomly assigned to be interviewed three times by nurses who attended the CST program (experimental group) or interviewed the same three times by nurses in the control group. Interviews were scheduled on the day of diagnosis, and one week and one month after diagnosis. Study measurements were done at one week after diagnosis (T1), one month after diagnosis (T2), and three months after (T3). Nurses were randomly assigned to either CST or usual care provision.

Sample Characteristics

  • The study reported on a sample of 89 patients, plus 8 nurse participants.
  • Mean patient age in the experimental group was 61.4 ± 10.8 years; mean patient age in the control group was 60.9 ± 14.3 years.
  • The sample was 56%–61% female and 39%–40% male.
  • Patients had gastric, colorectal, and breast cancers.
  • More than 90% of study patients had surgery, 76%–81% were married, 39%–44% were unemployed, and more than 50% in both groups had stage I disease.
  • Nurse participants had a mean age of 40.8 ± 7.2 years, and mean years of experience as an oncology nurse of 17.2 ± 6.87.
  • Inclusion criteria included patients who were newly diagnosed and informed of cancer in physician consultation, were older than age 18, and had disease that was not advanced and at an operable stage.
  • Patients were excluded if they had a severe psychological problem as assessed by the physician.

Setting

  • Single site
  • Outpatient setting
  • Japan

Phase of Care and Clinical Applications

Patients were undergoing the diagnostic phase of care.

Study Design

A randomized controlled trial design was used.

Measurement Instruments/Methods

  • Hospital Anxiety and Depression Scale (HADS)
  • Mental Adjustment to Cancer Scale (MAC)

Results

There was a significant different in HADS depression and total scores over time associated with group (p = 0.03). These scores declined over time in both groups; however, the decline was greater for the experimental group. There was no group interaction or for anxiety. There were no significant changes in any other HADS data. MAC score changes over time showed mixed results. The only consistent directional change in the experimental group, as compared to the control group, was in the area of fatalism, with decline over time in the experimental group and increase over time in the control group (p = 0.04).

Conclusions

CST appears to have a positive effect on psychological distress and some areas of coping for patients newly diagnosed with cancer.

Limitations

  • The study sample was small, with less than 100 participants.
  • The study sample was purposefully homogeneous in terms of diagnoses, disease stage, and phase of care, and findings may not be applicable to other patient groups.
  • Nurses in the study had extensive years of experience in cancer care. The CST described here may not have similar effects with nurses who are less experienced in general or in oncology care.
  • The authors point out that results may have been influenced by the cultural attitude of Japanese patients and poor support systems that are seen to exist in Japan for newly diagnosed patients. These patients tend to not seek professional assistance, so the magnitude of differences in results may not be the same for other cultural groups in which professional support is more available or acceptable.
  • There was no credible evaluation of actual communications between nurses and patients or between physicians and patients that may have also influenced findings. In addition to study nurses, nurses in charge who had not been trained were always present at physician consultations and were involved in patient support afterward. There is no way to tell if charge nurse interactions were different between groups, changed over time, or were influenced by interaction with CST-trained nurses.

Nursing Implications

Study findings support the idea that providing information, support, and empathic responses to patients can positively influence patient coping and emotional distress, and suggest that nurse training in communication skills of this nature can be useful. Further research in this area needs to demonstrate actual differences in communications between nurses and patients as a result of such training. It would be useful to see if such training can be beneficial in various groups of nurses based on differences in nursing education level and experience.

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Fujii, H., Iihara, H., Ishihara, M., Takahashi, T., Yoshida, K., & Itoh, Y. (2013). Improvement of adherence to guidelines for antiemetic medication enhances emetic control in patients with colorectal cancer receiving chemotherapy of moderate emetic risk. Anticancer Research, 33, 5549–5556.

Study Purpose

To determine whether an intervention could improve antiemetic guideline adherence and the control of chemotherapy-induced nausea and vomiting (CINV)

Intervention Characteristics/Basic Study Process

Evidence-based antiemetic medication information was provided as notification to physicians in a view format. The description of the intervention was not clear, and it was presumed that the notification was provided in some manner through the electronic medical record system. CINV control after the intervention was compared to CINV control in a cohort of patients treated prior to the intervention.

Sample Characteristics

  • N = 125 (64 in intervention group)
  • MEAN AGE = 64.2 years
  • MALES: 71%, FEMALES: 29%
  • KEY DISEASE CHARACTERISTICS: All patients had colorectal cancer and were receiving moderately emetogenic chemotherapy.

Setting

  • SITE: Single site  
  • SETTING TYPE: Outpatient    
  • LOCATION: Japan

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Cohort comparison

Measurement Instruments/Methods

  • Complete protection in the acute and delayed periods was defined as no vomiting and protection from nausea.

Results

The dosage of oxaliplatin or irinotecan was higher in the intervention group (p < 0.01). In the observational group, adherence to guidelines was 100% in the acute phase and 6.6% in the delayed phase. Nonadherence was caused by the lack of a prescription of dexamethasone on days 2 and 3. After the intervention, adherence to the administration of dexamethasone was 89%. In the intervention group, the complete protection rate was 20% higher after the intervention (p < 0.05), but adherence during the acute phase dropped and was significantly lower in the intervention group (p < 0.01). The incidence of leukopenia was higher in the intervention group (42.2% versus 23%, p = 0.024). There were no other differences in toxicity.

Conclusions

The intervention used in this study had mixed results in terms of adherence to CINV antiemetic guidelines and control of CINV in acute and delayed phases.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Key sample group differences that could influence results
  • Measurement validity/reliability questionable
  • Other limitations/explanation: The intervention group was significantly older. The exact intervention was not well described. The definition and method of measurement of CINV outcomes were not well described.

Nursing Implications

In this study, an organizational intervention had mixed results in improving adherence to antiemetic guidelines and patient CINV outcomes. The findings were limited by the lack of detail regarding the specific intervention used, but it appears to have been a notification in the medical record with no other action. Organizational initiatives to improve practice are not all created equally, and such studies need to provide sufficient detail about the actual intervention to determine if approaches that are effective in creating practice changes and improvements in patient outcomes.

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Fuccio, L., Guido, A., Eusebi, L. H., Laterza, L., Grilli, D., Cennamo, V., … Bazzoli, F. (2009). Effects of probiotics for the prevention and treatment of radiation-induced diarrhea. Journal of Clinical Gastroenterology, 43(6), 506–513.

Purpose

To evaluate the effectiveness of probiotic supplementation for the prevention and treatment of radiation-induced diarrhea

Search Strategy

Databases searched were PubMed, EMBASE, Cochrane Library, Google Scholar, and online clinical trials registers (Cochrane Central Register of Conrolled Trials, metaRegister of Controlled Trials, National Institutes of Health) until January 2009. Other relevant trials were identified from the reference list of selected articles. Abstracts presented up to 2008 at the United European Gastroenterology Week meetings, American Society for Therapeutic Radiology and Oncology Annual Meetings, and American Gastroenterological Association Digestive Disease Week were searched manually.

Search keywords were diarrhea, probiotics, radiotherapy, radiation therapy, Lactobacilli, Bifidobacteria, Enterococci, VSL no. 3, pelvic tumors, and abdominal tumors.

Studies were included in the review if they were randomized, controlled trials with at least two parallel groups that evaluated the effectiveness of probiotic supplementation to prevent or treat radiation-induced diarrhea.

Studies were excluded if they were review articles, involved nonradiation-induced diarrhea, or covered radiation-induced gastrointestinal (GI) symptoms other than diarrhea.

Literature Evaluated

The abstracts of 58 articles were reviewed. Fifty evaluated the effects of probiotic supplementation for conditions other than radiation therapy and were eliminated. Of the remaining eight, three were duplicate reports and one studied radiation-induced chronic bowel discomfort rather than diarrhea.

The remaining four studies were selected for this review. Three were randomized controlled trials evaluating probiotic supplementation for the prevention of radiation-induced diarrhea, and one trial evaluated probiotic supplementation for the treatment of radiation-induced diarrhea.

Sample Characteristics

Three studies evaluated the use of probiotic supplementation to prevent radiation-induced diarrhea. A total of 632 individuals initially were randomized to the studies; the final sample sizes were 21, 85, and 482. The study using probiotic supplementation to treat radiation-induced diarrhea had a sample size of 205 patients, with 102 receiving the intervention and 103 receiving a placebo.

Results

  • Probiotic supplementation was well-tolerated in the prevention and treatment trials.
  • The three trials addressing probiotic supplementation for the prevention of radiation-induced diarrhea did not collectively show significant differences between the intervention and control groups.
  • The study addressing treatment also did not show significant differences between the intervention and placebo groups.

Conclusions

The few available studies on the use of probiotics to prevent or treat radiation-induced diarrhea do not allow for firm conclusions to be drawn regarding the benefits of this intervention.

Limitations

The studies included in the systematic review and meta-analysis used different single strains and different doses of probiotics.

Nursing Implications

More studies using preparations containing several strains of probiotics and studies looking at comparisons between different probiotics are needed.

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Fuccio, L., Guido, A., Laterza, L., Eusebi, L.H., Busutti, L., Bunkheila, F., . . . Bazzoli, F. (2011). Randomised clinical trial: Preventive treatment with topical rectal beclomethasone dipropionate reduces post-radiation risk of bleeding in patients irradiated for prostate cancer. Alimentary Pharmacology & Therapeutics, 34(6), 628–637. 

Study Purpose

To determine the effectiveness of topical rectal beclomethasone dipropionate (BDP) in the prevention of rectal proctopathy, which can lead to rectal bleeding, in patients undergoing radiation therapy for prostate cancer

Intervention Characteristics/Basic Study Process

The treatment arm consisted of a 3 mg BDP enema each evening before radiotherapy treatments and two 3 mg BDP suppositories (one in the morning and one in the evening daily) over four weeks. The placebo arm consisted of an identical looking enema and suppository given at the same intervals without medication. Time points for clinical evaluation were before radiotherapy, one month after completion of the treatment, and every three months thereafter. Time points for endoscopic evaluation were before treatment, at three months, and at 12 months postradiotherapy. The patients self-administered the treatment, and they were asked to hold the medication in for as long as they could and return the unused materials at the end of the study to assess compliance.

Sample Characteristics

  • N = 110  
  • AGE = Not collected
  • MALES: 100%         
  • KEY DISEASE CHARACTERISTICS: Prostate cancer 
  • OTHER KEY SAMPLE CHARACTERISTICS: N/A

Setting

  • SITE: Single-site
  • SETTING TYPE: Not specified  
  • LOCATION: S.Orsola-Malpighi University Hospital in Italy

Phase of Care and Clinical Applications

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

Study Design

Double-blind, placebo-controlled, randomized trial

Measurement Instruments/Methods

  • The endoscopic evaluation consisted of a flexible sigmoidoscopy procedure. The findings were measured using World Organisation of Digestive Endoscopy language and were evaluated using the Vienna Rectoscopy Score (VRS).
  • Simple Clinical Colitis Activity Index (SCCAI)
  • Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer acute and late toxicity scales (RTOG/EORTC)
  • Inflammatory Bowel Disease Questionnaire quality of life Index (IBDQ)

Results

With respect to bleeding rate, the BDP group showed a statistically significant lower amount of blood in stools (OR = 0.38; 95% CI 0.17–0.86). The patients in the BDP arm showed a later onset of blood in stools overall (p = 0.032). The quality of life IBDQ score was significantly lower in patients randomized to BDP who reported rectal bleeding (p < 0.001). Severe hemorrhagic proctopathy, defined as anemia with a drop in hemoglobin of at least 1.5 g/dL, was found in 10 patients (four in the BDP group and six in the placebo group).

Conclusions

The BDP therapy arm of this study seemed to fair better with respect to bleeding risk postradiation and the prevention of some of the mucosal changes that lead to significant complications. It does not seem to affect other quality of life issues like continence and diarrhea. Changing the formulation of the BDP and/or its frequency of usage may improve outcomes for patients. Since the treatment did not cause harm to patients, it seems to be a good recommendation for patients to try.

Nursing Implications

It would be best for nurses to train patients on the usage of BDP during and following radiation therapy. A nursing study to evaluate methods of application and quality of life for patients would be the next step to further improve this research.

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Fu, M.R., Axelrod, D., Guth, A.A., Cartwright, F., Qiu, Z., Goldberg, J.D., . . . Haber, J. (2014). Proactive approach to lymphedema risk reduction: A prospective study. Annals of Surgical Oncology, 21, 3481–3489.

Study Purpose

To evaluate the safety, feasibility, and acceptability of the Optimal-Lymph-Flow™ program for patients with breast cancer and to evaluate its benefit when introduced presurgically

Intervention Characteristics/Basic Study Process

The Optimal-Lymph-Flow™ (OLF) program is a patient self-care program designed to reduce the development of lymphedema through specific exercises and behaviors to improve lymph flow and reduce or maintain body mass index (BMI). Participants were recruited preoperatively and followed prospectively for 12 months after surgery. Trained nurses provided each participant with the study intervention through a 30-minute face-to-face meeting. Participants were trained in various exercise techniques and then did a return demonstration (shoulder, breathing, and pumping exercises). They also were instructed in a nutrition-balanced and portion-appropriate diet to maintain preoperative BMI. Participants’ limb volume was measured with a Perometer, and BMI was measured with bioimpedance presurgery, two to four weeks after surgery, and at 6–12 months. Any patient with a limb volume measurement ≥ 10% was referred for complete decongestive therapy. If a 5% increase in limb volume occurred, patients were instructed to increase OLF activities, and limb volume was rechecked a few weeks later.

Sample Characteristics

  • N = 140
  • AVERAGE AGE = 56 years (SD = 11.8 years, range = 25–84 years)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: First-time diagnosis of breast cancer (stages 1–3)
  • OTHER KEY SAMPLE CHARACTERISTICS: Women aged greater than 21 years and scheduled for surgical treatment including lumpectomy, mastectomy, sentinel lymph node biopsy, or axillary lymph node dissection; excluded stage 4 breast cancer, preexisting lymphedema, patients with a history of breast cancer, and bilateral breast cancer

Setting

  • SITE: Single site    
  • SETTING TYPE: Other  
  • LOCATION: New York, United States

Phase of Care and Clinical Applications

  • PHASE OF CARE: Multiple phases of care

Study Design

Prospective, longitudinal, quasi-experimental design with repeated measures

Measurement Instruments/Methods

  • The safety of the OLF program was assessed by asking participants if the program created any discomfort or injury at each follow-up visit.
  • The feasibility of the program was evaluated in terms of intervention delivery time by the trained nurses.
  • The acceptability of the program was assessed by asking the participants if the program helped the them to (a) understand how to reduce the risk of lymphedema, (b) reduce the fear and anxiety of developing lymphedema, and (c) develop a plan to reduce the risk of lymphedema.
  • Lymph volume changes were measured by an infrared Perometer, and BMI was measured by a bioimpedance device.

Results

One-hundred and thirty-four participants completed the study. At each follow-up visit, no participants reported injury or discomfort associated with the OLF program, making it safe. It took about 30 minutes for the trained nurses to deliver the program, making it feasible. Greater than 90% of the patients reported that the OLF program helped them reduce their fear and anxiety of developing lymphedema, making it acceptable.

The majority (97%) of patients maintained or improved their preoperative limb volumes and BMIs at the study endpoint of 12 months following surgery.

All four women who experienced a 10% lymph volume increase two to four weeks post-surgery and at six months decreased their lymph volume to less 5% at the 12-month visit. BMI did not change significantly. No control group was used, so the benefits of this treatment could not be determined.

Conclusions

This educational and behavioral program may be effective to enhance lymphedema risk reduction. The study provided initial evidence for an emerging change in lymphedema care from treatment focus to proactive risk reduction.

Limitations

  • Baseline sample/group differences of import
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment) 
  • Other limitations/explanation: Single-site study

Nursing Implications

Studies with more rigorous research designs (i.e., randomized, controlled trials) are needed to replicate the findings from this study, evaluate the effectiveness of the OLF program, and determine the dosage and contribution of individual components of the program.

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Frisk, J., Källström, A. C., Wall, N., Fredrikson, M., & Hammar, M. (2012). Acupuncture improves health-related quality-of-life (HRQoL) and sleep in women with breast cancer and hot flushes. Supportive Care in Cancer, 20, 715–724.

Study Purpose

To evaluate the effectiveness of electroacupuncture (EA) and hormone therapy (HT) on health-related quality of life (HRQoL) and sleep in breast cancer survivors with vasomotor symptoms.

Intervention Characteristics/Basic Study Process

Women who had completed treatment for breast cancer were randomized to receive EA for 12 weeks or HT for 24 months. They completed the Psychological and General Wellbeing Index (PGWI) and Women’s Health Questionnaire (WHQ) pretreatment for vasomotor symptoms; during treatment; and at 6, 9, 12, 18, and 24 months after the start of treatment.

Sample Characteristics

  • The sample was comprised of 18 female patients.  
  • Mean age was 54.1 years (range 47–69). 
  • Patients had completed treatment for breast cancer in situ for a T1 or T2 tumor with a maximum of four metastatic lymph nodes or T3 tumors without metastatic lymph nodes.
  • Patients also had:
    • Vasomotor symptoms 
    • Been seen by a breast surgeon or oncologist within the last three months and were not receiving active treatment for breast cancer  
    • No clinical or mammographic signs of recurrence.

Women were excluded if they were receiving ongoing breast cancer treatment other than tamoxifen; had other malignancies; or had a history of thromboembolic, cereverbrovascular, or liver disease; porphyria; or active cardiovascular disease.

Setting

  • Multisite   
  • Outpatient
  • Sweden

Phase of Care and Clinical Applications

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

Study Design

The study was a multicenter, randomized, prospective trial.

Measurement Instruments/Methods

  • WHQ
  • PGWI
  • Log books for hot flushes and for sleep data, specifically the number of hours slept and times woken

Results

Nineteen women completed 12 weeks of EA. Eleven women were excluded due to changes in treatment. About 40% of the patients had no other treatment. The HT group had 11 women complete the 24 months of treatment. In both groups, reduction of hot flushes was noted. The EA group had a decrease in the median number of flushes/24 hours of 55% (p < 0.001) after 12 weeks. The decrease was 29% (p = 0.026) after 24 months. In the HT group, the median number of hot flushes/24 hours decreased by 100% (p = 0.001) after 12 weeks of treatment with no further changes. Sleep parameters improved significantly in both groups from baseline, with a WHQ sleep score in the EA group at baseline of 0.50 and at 24 months 0.33; in the HT group, the baseline score of 0.33 to declined 0.00 at 24 months.

The study showed improvement in sleep scores of both groups up to 21 months. The numbers of hours slept per night did not increase, but the numbers of flushes and distress caused by them decreased, resulting in fewer times woken, with overall improvement in HRQoL. Both groups also showed a significant decrease in the number of HF experienced, which was maintained up to 21 months after treatment was stopped.

Conclusions

EA, compared to HT for management of hot flashes in breast cancer survivors, shows some potential benefit in reducing numbers of hot flashes/24 hours, improving overall WHQ scores.

Limitations

  • The study had a small sample size, with less than 30 patients.
  • There was a high number of drop-outs in EA group.

Nursing Implications

HT is not recommended as a safe treatment for vasomotor symptoms for breast cancer survivors. Thus, the value of using that group to compare with a group that received EA is of concern. EA needs further investigation in larger sample sizes. Further research is needed for efficacy of EA in hot flash management for breast cancer survivors and in women treated with aromatase inhibitors experiencing hot flash distress, as this study did not address that phenomenon. 

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