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Ljungman, P., Engelhard, D., de la Cámara, R., Einsele, H., Locasciulli, A., Martino, R., . . . Infectious Diseases Working Party of the European Group for Blood and Marrow Transplantation. (2005). Vaccination of stem cell transplant recipients: recommendations of the Infectious Diseases Working Party of the EBMT. Bone Marrow Transplantation, 35, 737–746.

Purpose & Patient Population

To update previous recommendations (released in 1995 and last updated in 1999) for vaccinations in pediatric and adult hematopoietic stem cell transplantation (HSCT) recipients.

Type of Resource/Evidence-Based Process

This resource was classified as a guideline.  

Recommendations for 18 vaccinations were drawn from published data, most of which were specific to stem cell transplantation recipients. The strength of each recommendation and the quality of evidence supporting it are noted in a summary table, using grading standards endorsed by the Centers for Disease Control and Prevention (CDC).

Phase of Care and Clinical Applications

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

Guidelines & Recommendations

Patients undergoing HSCT are advised to be vaccinated against bacterial and viral infections beginning six to 12 months after transplantation, with the exception of meningococcal vaccine. Because polysaccharide pneumococcal vaccines are ineffective in patients with chronic graft-versus-host disease (GVHD), antibiotic prophylaxis should be given to patients with GVHD in addition to the pneumococcal vaccine. Three doses of Haemophilus influenzae type B (Hib) conjugate vaccine, tetanus toxoid vaccine, and diphtheria toxoid vaccine should be given beginning six months posttransplantation and spaced one to three months apart. Routine vaccination against pertussis was not recommended. Bacillus Calmette-Guerin vaccine was specifically contraindicated in this population.

Inactivated influenza vaccine was recommended for all patients undergoing HSCT, beginning no earlier than four to six months posttransplantation.  For patients undergoing allogeneic HSCT, influenza vaccination should be given annually (prior to influenza season) and continue at least as long as the patient remains immunocompromised. For patients undergoing autologous HSCT, the duration of yearly influenza vaccination should be assessed individually. Patients undergoing HSCT and those in close contact with them (e.g., family members and hospital staff who care for these patients) should be vaccinated against polio using the inactivated poliovirus vaccine only.

Patients undergoing HSCT should receive three doses of the inactivated vaccine, beginning six to 12 months following transplantation, with subsequent doses one to three months apart. Hepatitis B vaccination (HBV) is recommended for patients undergoing HSCT living in countries where HBV is recommended for the general public and should be given six to 12 months following HSCT. Vaccination with two doses of hepatitis A may be considered for patients who live or plan to travel to areas where the disease is endemic. The measles, mumps, and rubella (MMR) vaccine is generally recommended to begin no sooner that 24 months after HSCT but may be considered earlier if there is a high risk of measles. MMR is contraindicated in patients with chronic GVHD or ongoing immunosuppression. To prevent varicella, seronegative family members should be immunized with the varicella-zoster virus (VZV) vaccine. Seronegative patients undergoing HSCT may be considered for the VZV vaccine two years following transplantation, provided they are free of GVHD or ongoing immunosuppression. Vaccination of seropositive patients undergoing HSCT is not recommended.

Vaccination against yellow fever should only be considered in patients undergoing HSCT who must travel to areas of the world where yellow fever is endemic. Guidelines for serological testing of immune status are also included, again following the CDC grading standards. Immunity testing before vaccination is not necessary for tetanus toxoid, diphtheria toxoid, polio, influenza, pneumococcal, and Hib but is recommended for HBV, measles, mumps, and rubella (MMR), and varicella-zoster virus (VZV). Postvaccination testing to assess immune response is not recommended for tetanus toxoid, diphtheria toxoid, polio, Hib, or influenza. It is recommended for hepatitis B, MMR, and VZV and also may be considered for pneumococcal vaccine for patients at increased risk of poor response.

Nursing Implications

This article provided a concise summary for providers to use when considering the vaccination needs of HSCT recipients. It rated the strength of each recommendation using CDC guidelines. The article was extensively referenced to aid readers who wish to delve more deeply into the studies supporting each recommendation.

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Li, J.R., Yang, C.R., Cheng, C.L., Ho, H.C., Chiu, K.Y., Su, C.K., . . . Ou, Y.C. (2013). Efficacy of a protocol including heparin ointment for treatment of multikinase inhibitor-induced hand-foot skin reactions. Supportive Care in Cancer, 21, 907–911. 

Study Purpose

To evaluate the efficacy of a protocol including topical heparin therapy for hand-foot skin reactions (HFSR) during multikinase (MKI) treatment

Intervention Characteristics/Basic Study Process

Heparin Z ointment contains 500 IU unfractionated heparin sodium in each 1 g. Heparin, a member of the glycosaminoglycan family, has anti-inflammatory properties and is effective in the treatment of ulcerative wounds. All patients experiencing HFSR received mutifaceted care, including thick socks, shock-absorbing shoes, and topical treatment with heparin Z ointment (Zeria Pharmaceutical Co., Ltd., Japan), twice daily, integrated with urea-containing cream twice daily. Treatment with heparin Z ointment continued daily until grade of toxicity was downgraded to 0. All patients were seen monthly, and those with HFSR were seen weekly. Patients whose grade was downgraded to 0 were considered cured of HFSR. Treatment responders were recorded as the sum of cured and improved patients.

Sample Characteristics

  • N = 73 patients, 56 with metastatic renal cell carcinoma (MRCC) and 17 with castration-resistant prostate cancer (CRPC)  
  • AGE = 26–86 years
  • MALES: 80% of MRCC, 100% CRPC, FEMALES: 20% MRCC, 0% CRPC
  • KEY DISEASE CHARACTERISTICS: CRPC and MRCC in patients eligible for MKI therapies
  • OTHER KEY SAMPLE CHARACTERISTICS: Twenty-six patients developed HFSR, 16 developed MRCC, and 10 developed CRPC.

Setting

  • SITE: Single site  
  • SETTING TYPE: Not specified    
  • LOCATION: Unclear, likely outpatient

Phase of Care and Clinical Applications

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

Study Design

  • Intent-to-treat study design of patients on MKI therapy

Measurement Instruments/Methods

  • Percentages reported of four groups of patients experiencing HFSR
  • Analysis statistics not clearly defined

Results

Of patients whose grading was downgraded to 0, the highest percentage was in the axitinib group (50%), while 31.8% of the sunitinib group were downgraded to 0, which equated to the cure of HFSR. Patients with CRPC had a higher response rate on sunitinib therapy (80% to MRCC of 66.7%). A higher rate of HFSR was seen in patients with CRPC treated with sunitinib than those with MRCC treated with sunitinib. Only four patients required MKI dose reduction, and none of the 26 patients who experienced HFSR dropped out.

Conclusions

This study provides a new protocol for the treatment of HFSR in patients on MKI therapies who experience HFSR. It would appear beneficial for keeping patients on treatment with minimal need to decrease the dose.

Limitations

  • Small sample (< 100)
  • Baseline sample/group differences of import
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment) 
  • Risk of bias (no appropriate attentional control condition)
  • Unintended interventions or applicable interventions not described that would influence results
  • Key sample group differences that could influence results
  • Measurement/methods not well described
  • Findings not generalizable
  • The use of heparin Z ointment as an added intervention appears to improve outcomes, but no control existed to separate the intervention.
  • The sample is too small for an intergroup analysis.
  • No data on skin pathology or exclusion prior to initiated therapies exist.
 

 

Nursing Implications

Nurses are aware of the need for supportive care to decrease the incidence and severity of skin toxicities with MKI therapies. The use of heparin Z ointment as an additive intervention seems appropriate, particularly in light of heparin use in burned skin and wound healing. However, this study does not allow for inclusion as a new guideline intervention. More investigation with better designed trials is needed.

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Li, A.M., Miao, J.H., Liu, H., Ma, Y.Z., & Sun, Z.C. (2015). Drug-induced skin toxicity and clinical nursing of VitK cream on colorectal cancer patients. Pakistan Journal of Pharmaceutical Sciences, 28(Suppl. 4), 1499–1503. Retrieved from http://connection.ebscohost.com/c/articles/109346621/drug-induced-skin-…

Study Purpose

To discuss the affect of 0.1% VitK1 cream on cetuximab-induced skin toxicity in patients with colorectal cancer

Intervention Characteristics/Basic Study Process

Routine nursing was implemented for all patients. The experimental group also received VitK1 cream smeared on the face, neck, chest, back, and nail edges three times on the day of cetuximab infusion at 9 am, 3 pm, and 9 pm.

Sample Characteristics

  • N = 60 (30 experimental, 30 control)  
  • AGE = 20 years or older
  • MALES: 86.7% (experimental), 66.7% (control); FEMALES: 13.3% (experimental), 33.3% (control)
  • KEY DISEASE CHARACTERISTICS: Patients with colorectal cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients who were hospitalized and receiving cetuximab-containing therapy for the first time. No one with prior skin disease or diabetes was included.

Setting

  • SITE: Single site    
  • SETTING TYPE: Inpatient    
  • LOCATION: The First Affiliated Hospital of Zhengzhou University (January 2013–October 2014)

Phase of Care and Clinical Applications

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

Study Design

  • Randomized, controlled clinical trial

Measurement Instruments/Methods

  • Common Terminology Criteria for Adverse Events (CTCAE), version 3.0

Results

Dry skin, itchy skin, acne-like rash, skin dehiscence, and paronychia were evaluated in both groups after four cycles of cetuximab therapy (56 days) using the Common Toxicity Criteria, version 3.0, assessment scale. No grade 4 results were observed in either group. No significant differences existed in acne-like rash, paronychia, or dehiscence in either group. A significant difference existed in skin dryness and itch, favoring the experimental group. All patients had skin toxicities. No reports of discomfort were received from the experimental group, receiving VitK1 cream.

Conclusions

The VitK1 cream appeared to reduce skin dryness and itching.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Findings not generalizable
  • Convenience sampling
  • Results consistent with studies from outside of China where VitK1 cream was available
  • Need further discussion

Nursing Implications

Reducing or improving the existence of skin toxicities from cetuximab therapies allows patients to stay on therapies without an extreme decrease in quality of life. VitK1 cream had not been available in China; therefore, this study used the compounding of this cream with specific directions. Safeguarding the production of emollients and creams from compounding pharmacies has met recent scrutiny. Nurses need to ensure consistency with medical interventions when able. Providing for symptom management options, such as VitK1 cream, should promote patient adherence to therapy and improve outcomes. Few interventions have been shown effective for the prevention and management of skin toxicities. Further research is needed.

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Li, N.L., Yu, B.L., Tseng, S.C., Hsu, C.C., Lai, W.J., Hsieh, P.F., . . . Chen, C.M. (2011). The effect on improvement of recovery and pain scores of paravertebral block immediately before breast surgery. Acta Anaesthesiologica Taiwanica: Official Journal of the Taiwan Society of Anesthesiologists, 49(3), 91–95.

Study Purpose

To investigate whether paravertebral block (PVB) implemented immediately before breast cancer surgery can affect pain and emesis and improve the quality of life of patients after breast cancer surgery

Intervention Characteristics/Basic Study Process

Consecutive patients received general anesthesia or PVB plus anesthesia before breast cancer surgery. Researchers compared the pain scores of both groups of patients at one hour and at six hours postoperatively and at midmorning of postoperative day 1 (POD1). At one hour, patients were observed in the postanesthesia care unit for one hour, where they were provided with analgesics to achieve a pain score of less than 4 on the Numeric Rating Scale (NRS). Choices of analgesic for patients with moderate to severe pain included intravenous morphine, 3–6 mg, and intravenous ketorolac, 30 mg. Patients with mild to moderate pain (a score of 4–7) received acetaminophen, 500–1000 mg, at the patient’s request. At six hours after surgery and on POD1, pain scores were recorded with patients at rest and during movement. Movement consisted of moving the arm until the arm and body were at a 90-degree angle. The amount of postoperative narcotics and the time to first request for pain medication was recorded.

Sample Characteristics

  • The sample was composed of 40 patients; presurgery, 25 received general anesthesia only and 15 received general anesthesia and a PVB.
  • In the general anesthesia group, mean patient age was 50.4 years. In the group that received general anesthesia and PVB, mean patient age was 54.2.
  • All patients were female.
  • All patients had breast cancer. In the group that received general anesthesia only, four patients underwent modified radical mastectomy and 21 underwent a breast-conserving procedure. Of patients that received PVBs, one underwent modified radical mastectomy and 14 underwent a breast-conserving procedure.

Setting

  • Single site
  • Inpatient
  • Taiwan
     

Phase of Care and Clinical Applications

  • Phase of care: active treatment
  • Clinical applications: end of life and palliative care

Study Design

Intervention study

Measurement Instruments/Methods

  • Quality-of-recovery (QoR) tool, 0–18 scale
  • Numeric Rating Scale for pain, 0–10 scale
  • Apfel risk score for postoperative nausea and vomiting (PONV)
  • American Society of Anesthesiologists (ASA) physical status classification

Results

  • Compared to pain scores in the general anesthesia (GA) group, pain scores were significantly lower in the GA + PVB group at one hour (p < 0.0001), six hours (p < 0.0001), and at midmorning on POD1 (p = 0.041). SImilarly, in the GA + PVB group, pain scores with movement were lower at all three time points: one hour and six hours, p < 0.0001; POD1, p = 0.0012.
  • The median QoR scores were higher in the GA + PVB group than in the GA group. At six hours, the median QoR score in the GA group was 12; in the GA + PVB group, 18, (p < 0.0001). At 10 a.m. on POD1 the mean QoR score in the GA group was 16; in the GA + PVB group, 18 (p = 0.0079).
  • In the GA group, median cumulative postoperative analgesic consumption was four doses; in the GA + PVG group, 1 dose (p < 0.0001).
  • In the GA group, median cumulative postoperative narcotic consumption was 1 dose; in the GA + PVB group, 0 dose (p = 0.001).
  • Median time from the end of the operation to the first request for analgesia differed significantly between the two groups. In the GA group, the median time was 30 minutes; in the GA + PVB group, 435 minutes (p = 0.0002).
  • Incidence of PONV was higher in the GA group (64%) than in the GA + PVB group (6.67%) (p < 0.001). 
  • Patients in the GA group had significantly greater (p < 0.00001) antiemetic use overall than did patients in the GA + PVB group.

Conclusions

After breast cancer surgery, PVB plus GA may provide better pain relief than does GA alone. The researchers observed higher QoR scores and less antiemetic use in the GA + PVB than in the GA group.

Limitations

  • The study had a small sample size, with fewer than 100 patients.
  • The study was conducted at a single site.
  • Only 15 patients received the intervention.
  • The study contained no randomization.
  • At baseline, patients in the GA group used more antiemetic than did patients in the other group, a fact that makes results difficult to interpret.
     

Nursing Implications

PVB may be a useful tool to decrease pain after breast cancer surgery and to reduce PONV, but more research is needed before researchers can draw definitive conclusions.

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Li, X.M., Yan, H., Zhou, K.N., Dang, S.N., Wang, D.L., & Zhang, Y.P. (2011). Effects of music therapy on pain among female breast cancer patients after radical mastectomy: Results from a randomized controlled trial. Breast Cancer Research and Treatment, 128(2), 411–419.

Study Purpose

To explore the effects of music on pain, in patients with breast cancer, after radical mastectomy  

Intervention Characteristics/Basic Study Process

The intervention group consisted of 60 patients who received MP3 players with headphones. The players were loaded with 202 selections of music; the music was of four types. Patients were instructed to listen to music, during the postoperative period and two chemotherapy periods (18.9 days, SD = 7.1 days), for 30 minutes twice a day, between 6 and 8 a.m. and between 9 and 11 p.m. While patients were in the hospital, a researcher encouraged adherence to the schedule. After the patients were discharged, a researcher used the telephone to encourage adherence. The control group consisted of 60 patients who were not blinded regarding the music intervention. All patients took four tests (one at baseline and three postrandomization). Pain levels were assessed before the surgery, on the first preoperative day; on the day before disharge; and upon admission for the first and second chemotherapy sessions. Cycle lengths for chemotherapy were 14, 21, or 28 days. The assesment one day prior to discharge was known as the first post-test. The assesments before the chemotherapy sessions were known as the second and third post-tests, respectively.

 

Sample Characteristics

  • The sample was composed of 120 breast cancer patients.
  • The age range of patients was 25–65 years.
  • All patients were female.
  • All patients had breast cancer and underwent radical, modified radical, or extensive radical mastectomy. All patients received patient-controlled analgesia following surgery.

Setting

  • Single site
  • Inpatient
  • Surgical department of oncology center, First Affiliated Hospital of Xi’an, Jiaotong University, Shanghai
     

Phase of Care and Clinical Applications

Clinical applications: late effects and survivorship

Study Design

Randomized controlled trial

Measurement Instruments/Methods

  • General questionnaire    
  • Chinese version of Short-Form McGill Pain Questionnaire (which included a visual analog scale, VAS, and a measure of present pain intensity, PPI)
  • Pain Rating Index

Results

Both groups reported improvement in all areas of assessment from baseline through the third post-test. At the first post-test (day prior to discharge), the difference between the two groups was –2.38% in favor of music (p < 0.05). By the third post-test, the differences had decreased to –1.87 (p < 0.05).

Conclusions

Findings show that listening to music was associated with reduction in pain severity.

Limitations

  • The report provided no information regarding the use or nonuse of any form of analgesia in the postoperative period and during chemotherapy. 
  • Limitations outlined by the authors include an assessment procedure that depended on self-reporting, which is affected by many factors; the use of quantitative research only; the lack of biomarkers or physiological measurements; the fact that the assessor was not blinded to patient assignment to intervention or control group; and risk of bias due to no attentional control condition.

Nursing Implications

This study should be refined to determine and differentiate types and quality of pain and to consider the fact that pain typically decreases during the postoperative period. The differences noted between groups may indicate that music could play a role in reducing the pain that patients experience in the period immediately following surgery.

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Li, M., Kennedy, E.B., Byrne, N., Gerin-Lajoie, C., Katz, M.R., Keshavarz, H., . . . Green, E. (2016). Management of depression in patients with cancer: A clinical practice guideline. Journal of Oncology Practice, 12, 747–756. 

Purpose & Patient Population

PURPOSE: This is an update of a previously published guideline that provided recommendations for the management of depression in adult patients with cancer.
 
TYPES OF PATIENTS ADDRESSED: Patients with cancer at various stages of treatment with suspected or diagnosed major depressive disorder

Type of Resource/Evidence-Based Process

RESOURCE TYPE: Evidence-based guideline

PROCESS OF DEVELOPMENT: A working group that involved experts in nursing, health research methodology, psychiatry, and psychology conducted the review. The project methodologist extracted data, and the project research assistant verified the data. The draft recommendations were reviewed by a panel of internal reviewers and external reviewers. Targeted peer review and professional consultation were also obtained, and the results were incorporated into the final guideline.
 
SEARCH STRATEGY: Search terms related to depression and cancer were used.
 
DATABASES USED: Websites of guideline developers, relevant cancer agencies, MEDLINE, and EMBASE
 
INCLUSION CRITERIA: Systematic reviews of randomized, controlled trials (RCTs) or single RCTs in the English language
 
EXCLUSION CRITERIA: Not mentioned

Phase of Care and Clinical Applications

PHASE OF CARE: Multiple phases of care

Results Provided in the Reference

Several clinical practice guidelines and two meta-analyses of 21 RCTs and some integrative reviews were included. Guideline quality was assessed with the AGREE II instrument, and a systematic review quality was assessed with the Assessment of Multiple Systematic Reviews (AMSTAR) tool.

Guidelines & Recommendations

Evidence synthesis resulted in eight recommendations for the management of depression: 
  • Screening of patients with cancer for depression is very important to guide treatment.
  • Psychoeducation and providing information about the nature of depression and its impact in cancer outcomes are important. Optimizing cancer-related symptom management
  • Pharmacologic or psychosocial interventions either alone or in combination have beneficial effects.
  • A stepped care model that suggests low intensity interventions (i.e., physical activity programs, group-based peer support, and self-help programs) for mild -to-moderate depression and high-intensity interventions (i.e., group cognitive behavioral therapy, behavioral couples’ therapy, and individual or group supportive-expressive psychotherapies) for severe depression were recommended.
  • Collaborative care (active collaboration between the oncologist or primary care provider and a patient care manager nurse, social worker, or psychologist) should be considered.
  • Referral to psychosocial specialist when needed
  • Selection of psychological therapy should be based on patient factors and local resource availability. This recommendation is based in consensus. 
  • Antidepressants should be considered for severe depression, not for mild depression related to high risk–benefit ratio.

Limitations

Some recommendations were consensus-based.

Nursing Implications

A quick reference algorithm for the initial management of depression in patients with cancer and the stepped care model for delivering care interventions depending on the severity of depression are great tools nurses and other healthcare professionals can use in their clinical practice while managing depression.

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Li, L., Yuan, L., Chen, X., Wang, Q., Tian, J., Yang, K., & Zhou, E. (2016). Current treatments for breast cancer-related lymphoedema: A systematic review. Asian Pacific Journal of Cancer Prevention, 17, 4875–4883. 

Purpose

STUDY PURPOSE: To summarize the effects of different breast cancer–related lymphedema (BCRL) treatments

TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: Cochrane, PubMed, EMBASE, ISI Web of Knowledge
 
YEARS INCLUDED: Inception–December 31, 2015
 
INCLUSION CRITERIA: Systematic review or meta-analysis for BCRL
 
EXCLUSION CRITERIA: Duplications, non–meta-analyses, nontreatment, traditional reviews

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 1,740
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Two investigators independently reviewed the studies and used the GRADE approach, specifying four levels of quality. All evidence was deemed low or very low quality.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 14
  • TOTAL PATIENTS INCLUDED IN REVIEW: Unknown
  • SAMPLE RANGE ACROSS STUDIES: Complex decongestive therapy (CDT), manual lymphatic drainage (MLD), intermittent pneumatic compression, exercise, botanicals, low-level laser therapy (LLLT), surgery, weight reduction, stem cells, Kinesio Tex Tape (KTT), acupuncture

Phase of Care and Clinical Applications

PHASE OF CARE: Multiple phases of care
 
APPLICATIONS: Elder care

Results

  • CDT needs comparisons.
  • MLD was deemed safe (60%–80% of participants reported feeling better). 
  • Exercise appeared to have no effect on lymphedema.
  • Insufficient evidence for the use of botanicals
  • LLLT demonstrated greater reductions, but sample sizes were small (8–64), for a total of 289.
  • Modern surgery has a role in management.
  • KTT is no more effective than usual care.
  • Acupuncture appears to be safe but lacks evidence.

Conclusions

Based on the study limitations, the most effective treatment for BCRL could not be identified, because of varying quality and small sample sizes with high risk of bias. Different treatments for BCRL might reduce volume, but effects and well designed randomized, controlled trials with reported placebo effects are needed.

Limitations

  • Mostly low quality/high risk of bias studies
  • Low sample sizes
  • This review lacked a large number of studies in all the interventions reviewed.

Nursing Implications

CDT remains the standard of care for the treatment of lymphedema. Complementary therapies may be safe, but more well designed randomized, controlled trials are needed.

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Livingston, P.M., Craike, M.J., Salmon, J., Courneya, K.S., Gaskin, C.J., Fraser, S.F., . . . ENGAGE Uro-Oncology Clinicians' Group. (2015). Effects of a clinician referral and exercise program for men who have completed active treatment for prostate cancer: A multicenter cluster randomized controlled trial (ENGAGE). Cancer, 121, 2646–2654. 

Study Purpose

To determine the effectiveness of referrals from nurses or medical providers to a 12-week exercise program compared to usual care for the outcome of self-reported physical activity among men after completion of active prostate cancer treatment.

Intervention Characteristics/Basic Study Process

Participants were randomly assigned to the intervention or to the control: The intervention was a 12-week exercise program that included two gym sessions and one home-based session per week beginning 3–12 months after active treatment for prostate cancer was completed. Intervention participants were given a referral slip stating that the clinician recommended participation in the exercise program. The 12-week exercise program was at a local community gym, supervised by exercise physiologists, and followed exercise guidelines for cancer survivor exercises by the American College of Sports Medicine and the Exercise and Sport Science Australia. The exercise intervention also used social cognitive theory. The control group had usual care, which included a recommendation to exercise.

Sample Characteristics

  • N = 131  
  • MEAN AGE: 65 years (range = 39-84)
  • MALES: 100%  
  • KEY DISEASE CHARACTERISTICS: 3-12 months after completion of treatment with curative intent for prostate cancer 
  • OTHER KEY SAMPLE CHARACTERISTICS: A majority of participants had stage I (15%) or stage II (16.5%) prostate cancer, and there were no significant between-group differences except for the disease stage (p < 0.01) and treatment (p < 0.05) between groups. English language ability to read and complete surveys

Setting

  • SITE: Single site     
  • SETTING TYPE: Outpatient        
  • LOCATION: Melbourne, Australia

Phase of Care and Clinical Applications

  • PHASE OF CARE: Late effects and survivorship

Study Design

  • Prospective, multicenter, cluster, randomized controlled trial with two arms

Measurement Instruments/Methods

  • Godin-Shepherd Leisure Time Exercise Questionnaire: A monthly self-report of number of minutes of moderate-to-vigorous physical activity in a typical week in the past month. Measures were zero minutes, light intensity, moderate intensity, vigorous intensity, and minutes greater than 150 per week, with definitions of each level.
  • ActiGraph for T1 (7 days at the baseline) and T2 (immediately after the 12-week exercise program) with the same time period of measures in the control group. Freedson adult cut points for light-intensity and average daily activity: used in the activity calculations but not reported. 
  • Quality of life: Measured by the European Organization for Research and Treatment of Cancer Quality-of-Life Core-30 questionnaire (QLQ-C30, which has a cognitive functioning subscale) and prostate tumor–specific module (QLQ-PR25). 
  • Prostate cancer–related anxiety: Memorial Anxiety Scale for Prostate Cancer (MAX-PC).
  • Depressive symptoms: 20-item Center for Epidemiological Studies-Depression Inventory, with mean and total scores calculated.
  • Satisfaction: Measured in the intervention group using a survey to assess the acceptability, convenience, and feasibility of the clinician referral and exercise program. 

Results

Intervention participants indicated positive reports about clinician referral influencing participation in the exercise program.  Prostate cancer-related anxiety declined more in the control group (d = 0.42, p = 0.02).  Effects on depression were not significant, but there was greater decline in the intervention group (d = -0.35, p = 0.06). There was no significant change in the cognitive subscale of the QOL measure. A higher percentage of those in the intervention group reported achievement of aerobic exercise guidelines.

Conclusions

Clinician referral from doctor or nurse care provider influences decision to participate in a tailored exercise program among men who have completed prostate cancer treatment. Exercise program supervision helps to ensure that exercise is tailored to each individual, risk of injury is reduced, and potential for adherence is improved.

Limitations

  • Risk of bias (no blinding)
  • Risk of bias (no appropriate attentional control condition)
  • Other limitations/explanation: Activity level may have been higher at baseline due to time after completion of treatment; activity measures may not have been as accurate as desired or may have been worn at different times than desired.

Nursing Implications

Nurse clinicians may influence participation in an exercise program for men who have completed radiation, chemotherapy, or surgery for prostate cancer, touting benefits of improved physical activity, cognition, QOL, and other health outcomes, including significant reduction of anxiety self-report and moderate reduction of depression symptoms. A specific referral or prescription for exercise may enhance exercise participation and activity that meets current national recommendations.

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Liu, Y., Zhang, J., Teng, Y., Zhang, L., Yu, P., Jin, B., … Li, Z. (2009). Thalidomide improves prevention of chemotherapy-induced gastrointestinal side effects following a modified FOLFOX7 regimen: Results of a prospective randomized crossover study. Tumori, 95, 691–696.

Study Purpose

To evaluate the safety and effectiveness of thalidomide plus ramosetron and dexamethasone in controlling delayed chemotherapy-induced GI side effects following a moderately emetogenic FOLFOX7 regimen 

Intervention Characteristics/Basic Study Process

Patients who were chemotherapy-naïve and scheduled to receive a moderately emetogenic FOLFOX7 regimen were randomized to two groups. Group A-B received ramosetron plus dexamethasone on day 1 in the first cycle. Group B received thalidomide twice a day on days 2-5 in cycle 1. Group B-A received the same drugs in reverse sequence.

All patients received ramosetron. All patients were permitted to receive a rescue dose of 10 mg dexamethasone IV if vomiting occurred more than two times within 24 hours.

Sample Characteristics

  • The study consisted of 52 patients.
  • Patient ages ranged from 18–70 years. The median age in group AB was 55.5 years, and the median age in group BA was 54 years.
  • The sample was 33% female and 67% male.
  • Cancer diagnoses were gastric (40%), colorectal (52%), and other (8%).
  • Just over half (52%) of patients had a European Cooperative Oncology Group (ECOG) performance status of 0, and the balance (48%) had an ECOG performance status of 1.

Setting

The study was conducted at a single site at the China Medical University in China.

Phase of Care and Clinical Applications

All patients were in active treatment.

Study Design

This was a prospective, randomized, crossover-controlled study.

Measurement Instruments/Methods

  • For five days, patients recorded any episodes of vomiting and the degree of nausea and anorexia as well as peripheral neuropathy, sedation, hot flushes, headache, dry mouth, and rash. The article did not address where these effects were documented.
  • Side effects were graded with the Common Toxicity Criteria of Adverse Events, version 2.0 (CTAE v.2.0).

Results

  • Complete response rates (CRR) and effective rates (ER) for acute nausea were not different on day 1. However, they were statistically significant for delayed nausea on days 2-4 for group B. The CRR and ER for both groups on day five were similar and showed no significance (CRR: p = 0.309, ER: p = 0.050).
  • Efficacy for acute vomiting showed no significant difference between the groups. Group B's delayed vomiting rates were higher and statistically significant on days 2–3.
  • No significant differences in adverse events was noted.

Conclusions

Neither palonosetron or aprepitant are commercially available in China. Thalidomide was associated with greater complete response of delayed nausea and delayed emesis. No significant adverse effects were noted with thalidomide.

Limitations

  • The sample size was small with fewer than 100 participants.
  • No mention was made of how patients recorded their symptoms.
  • Confirmation of clinical value is warranted with a larger study.
  • The control group did not receive any placebo medication so patients knew when they were in the treatment phase because they received more medication; this may have biased the results.

Nursing Implications

Thalidomide has some efficacy in controlling delayed chemotherapy-induced nausea and vomiting (CINV) in patients receiving FOLFOX7 therapy in combination with other antiemetic regimens.

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Liu, C., Hsiung, P., Chang, K., Liu, Y., Wang, K., Hsiao, F., . . . Chan, C. (2008). A study on the efficacy of body-mind-spirit group therapy for patients with breast cancer. Journal of Clinical Nursing, 17, 2539–2549.

Study Purpose

To examine the effects of body-mind-spirit group therapy on anxiety, depression, and holistic well-being among women with breast cancer

Intervention Characteristics/Basic Study Process

Patients in the control group received standard care. Patients in the experimental group received standard care plus 10 sessions of weekly group therapy, 180 minutes per session. Therapy integrated concepts and practices, such as qigong exercises of vital energy, massage, meditation, positive thinking, group mutual support, long-term survivors’ sharing, songs, home assignments, and exercises. These activities were based on traditional Chinese medicine, the Eastern philosophies of Taoism and Confucianism, and the practice of Buddhism. The goal of the activities were to manage physical, psychosocial, and spiritual distress. Sessions included qigong exercises provided for 20 minutes each week by a qigong master and body-mind-spirit group assignments that included sharing and singing. The qigong master facilitated the first 20 minutes of each session. Then the primary investigator and co-investigators, working as mental health nurses, managed the rest of each session. Co-investigators held a 90-minute focus group interview after the last group therapy session. They conducted the interview in Mandarin and transcribed it. A bilingual researcher translated the transcription.

A coinvestigator implemented the randomization so that the patients, physician, and primary investigator were blinded to the randomization process. The primary investigator conducted groups after randomization and completion of initial surveys. Participants completed a baseline questionnaire after informed consent. After two months of intervention, participants completed a postintervention questionnaire.

Sample Characteristics

  • The sample was composed of 28 participants: 12 in the experimental group and 16 in the control group. 
  • Mean patient age in the study was 40–60 years. In the experimental group, mean patient age was 52 years (SD = 8.3 years). In the control group, mean patient age was 46.1 years (SD = 7.8 years).
  • The sample was composed of female patients with breast cancer only. Those suffering ailments in addition to breast cancer or receiving other psychotherapy were excluded.
  • Patients had cancer in stages I–III. The distribution of stages in groups follows: stage I, three patients in the experimental group and three in the control group; stage II, six patients in the experimental group and eight in the control group; stage III, two patients in the experimental group and three in the control group.
  • The types of surgery that patients had undergone included modified radical mastectomy, conservative surgery, and radical mastectomy, with the distribution of types in groups as follows: modified radical mastectomy, seven patients in the experimental group and nine in the control group; conservative surgery, three patients in the experimental group and five in the control group; radical mastectomy, two patients in the experimental group and two in the control group.
  • One patient in the experimental group and two patients in the control group experienced relapse.

Setting

  • Single site
  • Outpatient setting 
  • Consultation room of a cancer foundation center

Phase of Care and Clinical Applications

  • Phase of care: active treatment
  • Clinical applications: late effects and survivorship

Study Design

Mixed-methods design incorporating a randomized controlled trial and focus-group interviews

Measurement Instruments/Methods

  • Beck Depression Inventory II (BDI-II)      
  • State-Trait Anxiety Inventory (STAI)
  • Body-Mind-Spirit Well-being Inventory (BMSWBI)

Results

  • Pre/post-test comparison of symptoms of depression in the intervention, or experimental, group and control group showed a difference in depression improvement and body-mind-spirit well-being; the difference was not significant.
  • Pre/post-test comparison of symptoms of anxiety in the intervention, or experimental, group and control group showed a significant difference (p < 0.03) in state anxiety.
  • Qualitative focus group interviews revealed eight domains with subthemes. The imparting information domain had seven themes: learning about appropriate diet, learning about treatment and care of breast cancer, learning how to monitor physical condition, learning to exercise, learning to practice relaxation, learning to reframe cognitive distress, and learning to practice forgiveness.
  • The interpersonal learning domain had two themes: having more interpersonal interactions and obtaining support from group members.
  • The catharsis domain had three themes: understanding the impact of suppressing emotions on holistic well-being, sharing suffering with group members, and learning to use projective methods to express emotions.
  • The universality domain had two themes: learning that I am not the only one who suffers from cancer and learning that personal characteristics are the common cause of cancer.
  • The domains of group cohesiveness and altruism each had one theme: having a sense of belonging and using one’s own successful experience to help others, respectively.
  • The existential factors domain had two themes: practicing self-love and learning to view misfortune positively.

Conclusions

Culturally sensitive body-mind-spirit group therapy reduced anxiety among outpatients with breast cancer.

Limitations

  • The study had a small sample, with fewer than 30 participants.
  • The researchers were not completely blinded to the randomization process because the coinvestigator implemented it.
  • Forty-nine participants were enrolled in the study, but only 28 completed the study. The drop-out rate reduces the power of the study.
  • Findings may have limited generalizability beyond women ages 40–60 with stage II breast cancer.
  • Longer-term follow-up to study maintenance of depression improvement are needed.

Nursing Implications

Mental health nurses who provide group therapy for patients with cancer could help to enhance quality of care in psycho-ontological nursing. Further research with older and younger women — as well as with patients in stages I, III, and relapse — are suggested.

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