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Carlson, L.E., Speca, M., Patel, K.D., & Goodey, E. (2003). Mindfulness-based stress reduction in relation to quality of life, mood, symptoms of stress, and immune parameters in breast and prostate cancer outpatients. Psychosomatic Medicine, 65, 571–581.

Intervention Characteristics/Basic Study Process

Didactic, inductive, and experiential modes of learning were used to implement the intervention and convey information to patients. The intervention was provided over the course of eight weekly 90-minute group sessions (maximum of 15 participants per group) as well as a three-hour silent retreat on Saturday between weeks 6 and 7.

Patients received a booklet containing information about each week’s instructions as well as an audiotape with sensate-focused body scan meditation on one side and a guided sitting meditation on the other.

The program was composed of three primary components.

  1. Theoretical materials related to mindfulness, relaxation, meditation, and the mind-body connection
  2. Experiential practice of meditation and yoga during group meetings and home-based practice
  3. Group process focused on problem-solving concerning obstacles to effective practice, daily applications of mindfulness, and supportive interaction between group members

Sample Characteristics

  • N = 59
  • MEAN AGE = 54.5 years
  • KEY DISEASE CHARACTERISTICS: 49 women with breast cancer and 10 men with prostate cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: Most patients (N = 42) were married or cohabiting, with a mean of 14.7 years of formal education. Patients had a median cancer diagnosis of 1.1 years prior to study enrollment (range = three months to 20 years). Two-thirds had stage II cancer (62.7%).
  • EXCLUSION CRITERIA: Treatment with chemotherapy, radiation therapy, or hormone therapy currently or within the past three months; psychiatric illness; a concurrent autoimmune disorder; and past participation in a mindfulness-based stress reduction (MBSR) group
  • RECRUITMENT: Patients primarily were recruited with pamphlets and posters around the center, in each of the breast and prostate clinic areas, and were able to self-refer.

Setting

  • LOCATION: Tom Baker Cancer Center

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active treatment

Study Design

  • Pre-post intervention study

Measurement Instruments/Methods

  • European Organization for Research and Treatment in Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30)
  • Profile of Mood States (POMS)

Results

The MBSR intervention did not result in a significant difference for fatigue outcomes between pre- and post-intervention time points. Only 42 patients had complete data for both time points. When comparing the 17 patients with incomplete data to the rest of the sample, participants with complete data were more likely to be married or cohabitating. Non-completers had higher scores than completers on several of the baseline measures for POMS subscale, including depression, anger, and confusion.

Limitations

  • Lack of a neutral comparison group
  • Lack of correction for multiple comparisons during statistical analysis
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Carl, H.M., Walia, G., Bello, R., Clarke-Pearson, E., Hassanein, A.H., Cho, B., . . . Sacks, J.M. (2017). Systematic review of the surgical treatment of extremity lymphedema. Journal of Reconstructive Microsurgery. Advance online publication. 

Purpose

STUDY PURPOSE: To examine the results of various surgical treatment for lymphema

TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: MEDLINE, EMBASE, Scopus, Web of Science, and Cochrane Collaboration from January 2000–May 2016
 
INCLUSION CRITERIA: Minimum sample of eight patients; study describing surgical treatment for extremity lymphedema
 
EXCLUSION CRITERIA: Not specified

Literature Evaluated

TOTAL REFERENCES RETRIEVED: Not reported
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: MINORS scoring system was used. Highly valid studies were based on scores of 12 of 16 points or 19 of 24 points.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 69 studies met inclusion criteria.
  • TOTAL PATIENTS INCLUDED IN REVIEW = Not provided
  • SAMPLE RANGE ACROSS STUDIES: Not provided

Phase of Care and Clinical Applications

PHASE OF CARE: Not specified or not applicable

Results

  • Five studies involving excisional procedures, including 76 patients reporting limb volume reduction ranging from 16%–52%; four of the five studies reported multiple complications from the procedures.
  • Four studies, including 105 patients with lower or upper extremity lymphedema reporting the effects of liposuction procedures; the weighted average percent of volume reduction was 96.63%.
  • Lymphatic reconstruction procedures reported a weighted average for limb reduction of 5.8%. Lymphaticovenous anastomosis results were reported in 12 studies.
  • Ten studies reported results from 185 patients who had tissue transfer procedures. For these, the weighted average limb reduction based on circumference was 39.5%.
  • Eight studies, including 135 patients reporting the use of multiple surgical approaches; the combinations of techniques were varied.
  • Studies varied regarding continued use of compression garments and physiotherapy postoperatively.
  • Based on the results of this review, the authors provided an algorithm for decision making in the application of various surgical techniques.

Conclusions

The findings suggest that various surgical techniques can be effective to reduce limb volume; however, the research has several limitations. Relatively few studies examine each specific technique, and little evidence comparing these techniques to outcomes with other interventions known to be effective exists.

Limitations

  • High heterogeneity
  • Low sample sizes
  • Varied methods of measuring lymphedema

Nursing Implications

A variety of surgical techniques and microsurgical procedures are being evaluated for their effects on the development of lymphedema. Currently, limited evidence supports any particular procedure or technique. Nurses should be aware of any potential long-term side effects of such procedures as this information becomes available.

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Caress, A.L., Chalmers, K., & Luker, K. (2009). A narrative review of interventions to support family carers who provide physical care to family members with cancer. International Journal of Nursing Studies, 46, 1516–1527.

Purpose

To identify and critique studies of the development and/or evaluation of interventions to enable family carers to provide physical care to a family member with cancer

Search Strategy

  • PsycINFO, Cochrane Central Register of Controlled Trials, Embase Ovid, Embase, Ovid MEDLINE, CINAHL, DARE (Database of Abstracts of Reviews of Effectiveness), related systematic and other reviews, and reference lists from published articles were used for the search. Only English-language articles in the databases were reviewed.
  • Key words were cancer, intervention, program(me), evaluation, research, physical/practical care, needs, skills, home care, palliative care, end of life care, terminal care, cancer care, symptom management/control, skills, family (including spouse, husband, wife, partner), carers, caregivers, lay carers, and family support.
  • Inclusion criteria were studies with male or female adults (age 18 or older) who provided care to family member with cancer; literature using family, family member, or significant other; and the carer was expected to live in the home with the patient to provide care.
  • Literature on caregiver bereavement interventions was excluded.

Literature Evaluated

The number of studies initially reviewed was not reported.

After an initial search and crossing of search terms addressing physical (practical) care by carers of patients with cancer, the final tally of 19 studies met the following inclusion criteria: the study reported on an empirical study or program development; focused on carers of a family member with cancer; reported on the development and/or evaluation of an intervention to help carers provide physical care to a family member with cancer; and appeared in the literature between 1990 and June 2008. A critical consideration of article quality occurred by comparing articles to recommendations developed by three published authors, but formal quality scoring was not undertaken.

Initial search terms seemed to be too broad, overlapping, and perhaps unclear to initiate the study. The authors desired to distinguish between physical and psychosocial care of carers, but many studies blended the two types of care as interventions. Studies were not scored on quality of research design due to the authors’ desire to focus on the content of the interventions in a narrative review.

Sample Characteristics

  • The report included 19 interventional studies.
  • The total sample was 3,286 caregivers, with a sample range across studies of 34–750 caregivers.
  • The sample was comprised of older adult patients with cancer and patients with end-stage cancer and their partners (patient/caregiver dyads).

 

Results

The authors found four categories of intervention that allowed family carers to provide physical/practical care of a family member with cancer (one study): (a) interventions that included skills training for the caregiver (nine studies), (b) interventions to improve care through managing symptoms (five studies), (c) interventions with a problem-solving focus, and (d) interventions with a learning focus (four studies).

  • Some studies of interventions for managing symptoms indicated some benefits to patients and/or caregivers.
  • Interventions using problem-solving processes showed promise of benefit.
  • To what degree educational interventions addressed physical or practical care, and how this influenced outcomes, was not clear.

 

Limitations

The authors noted significant variability among included studies of terms defining the cancer experience (stage of cancer, point in cancer trajectory, type of cancer), specificity of the intervention, and measurement of distinct outcomes. This variability influenced the authors’ ability to interpret beneficial physical (practical) interventions for caregivers and patients. Furthermore, this variability, as well as limited article text that clearly specified the intervention, diminishes the ability to replicate those studies for further clarity on valuable caregiver interventions. The authors also admit to the complexity of dividing carer physical and psychosocial care for a family member with cancer, but believe such a division is important because of the limited literature on the physical role of carers.

Nursing Implications

The reality is that most carers learn “on the job” about ways to effectively care for a loved one. One might question the possible overlap of the four categories of interventions developed by the authors: they seem to address the urgent need for carer teaching and learning to meet both patient and carer needs. Realities in the United States (e.g., limited patient time with managed care, early patient discharge from acute agencies, push for more home care) may provide barriers to such teaching and assessment of carer learning. However, data from this narrative review support a mandate for nursing assessment of carer learning needs and then nursing follow-through to teach carers at each patient clinical encounter for the present cancer experience. With disease progression and even a changed carer/patient relationship, continued nursing assessment and teaching intervention can improve the quality of life for that carer/patient dyad. This review identifies a need for development and evaluation of well-defined interventions of practical skills. Given the range of needs of patients with cancer and carers, much of this work will need to address specific problems at particular points in the disease trajectory.

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Cardona, A., Balouch, A., Mohammed, M.A., Sedghizadeh, P.P., & Enciso, R. (2017). Efficacy of chlorhexidine for the prevention and treatment of oral mucositis in cancer patients: A systematic review with meta-analyses. Journal of Oral Pathology and Medicine. Advance online publication. 

Purpose

STUDY PURPOSE: To examine the effects of chlorhexidine on the incidence and severity of oral mucositis
 
TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy

DATABASES USED: PubMed, Web of Science, Cochrane Collaboration through May 2015
 
INCLUSION CRITERIA: Randomized, controlled trial; the incidence or severity of mucositis was reported.
 
EXCLUSION CRITERIA: Gray literature

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 143
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: The Cochrane risk of bias assessment and the GRADE level of evidence criteria were used. Most studies were deemed to be at high risk of bias.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 12, 9 studies in meta-analysis
  • TOTAL PATIENTS INCLUDED IN REVIEW = 846
  • SAMPLE RANGE ACROSS STUDIES: 16–222
  • KEY SAMPLE CHARACTERISTICS: Most had head and neck cancer or a hematopoietic cell transplantation.

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Results

The incidence of mucositis was less with chlorhexidine. Across all studies, the relative risk (RR) ranged from 0.097–0.771 in favor of chlorhexidine (p = 0.05), with an overall RR of 0.899 (95% confidence interval [0.656, 1.232]). The findings for severity of mucositis were mixed.

Conclusions

Chlorhexidine was not associated with reduced severity of mucositis. There was a trend toward lower incidence of mucositis with chlorhexidine.

Limitations

  • Mostly low quality/high risk of bias studies
  • High heterogeneity
  • Grade of mucositis not considered in analysis

Nursing Implications

There are overall mixed findings about the effects of chlorhexidine oral rinses on chemotherapy- and radiation therapy–induced mucositis, with limited evidence in each of these subgroups. It appears that chlorhexidine is not useful for the treatment of mucositis but may have some role in prevention.

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Carayol, M., Bernard, P., Boiche, J., Riou, F., Mercier, B., Cousson-Gelie, F., . . . Ninot, G. (2013). Psychological effect of exercise in women with breast cancer receiving adjuvant therapy: What is the optimal dose needed? Annals of Oncology, 24, 291–300.

Purpose

To investigate the effects of an exercise prescription on fatigue, anxiety, depression, and quality of life in patients with breast cancer receiving adjuvant therapy and to explore the relationships between the volume of targeted exercise and the effects observed on these psychological outcomes.

TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy

DATABASES USED: MEDLINE, PsycINFO, Pascal, PSYarticles, and Cochrane

KEYWORDS: anxiety, breast cancer, depression, exercise, fatigue, and quality of life

INCLUSION CRITERIA: Participants were adult women diagnosed with breast cancer. Studies had a randomized, controlled experimental design. Intervention programs involving physical activity (yoga-based) were included, whereas relaxation-based interventions were not. An intervention program was scheduled during adjuvant cancer therapy (chemotherapy and/or radiotherapy). At least one psychological outcome among fatigue, anxiety, depression, and quality of life was observed. Pre- and post-intervention data were included to calculate standardized mean differences.

EXCLUSION CRITERIA: Not given

Literature Evaluated

TOTAL REFERENCES RETRIEVED: N = 1,011

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: A quality score based on 10 methodologic criteria specifically chosen for the evaluation of exercise intervention randomized controlled trials and mostly derived from the PEDro scale was calculated for each included study. Targeted exercise volume was estimated using metabolic equivalent for task (MET), where 1 MET accounts for 3.5 ml O2/kg/min. Corresponding MET values for a given exercise intervention were coded from the Compendium of Physical Activity. Five and 3.8 METs were, respectively, assigned to moderate- and low-intensity aerobic physical activity; strength-training physical activity was coded 3.5 METs; warm-up and cool-down were estimated 2.5 METs if no more detail related to their content was provided; yoga and stretching activities were coded 2.5 METs.                                                        

Sample Characteristics

  • N (studies) = 17
  • TOTAL PATIENTS INCLUDED IN REVIEW: 748 subjects, 632 controls
  • KEY SAMPLE CHARACTERISTICS: The median age of included patients was 50.5 years old. All patients with breast cancer had been diagnosed with nonmetastatic cancer and were undergoing adjuvant therapy (i.e., chemotherapy and/or radiotherapy during exercise intervention).                                                                                                                     

The methodologic quality of the studies had a median score of 7, ranging from 2–9.

Phase of Care and Clinical Applications

PHASE OF CARE: Active anti-tumor treatment

Results

Controlled comparisons of pre- and post-intervention indicated that exercise intervention significantly reduced fatigue, anxiety, and depression, but only borderline significance was reached for anxiety (P = 0.06). Moreover, exercise intervention significantly improved quality of life. Findings showed that higher dose and duration of exercise targets had greater effectiveness. Effect sizes were modest. When low-quality studies were eliminated, effects for fatigue no longer were significant.

Conclusions

Adapted physical activity programs can be expected to decrease fatigue and depressive symptoms and increase quality of life during chemotherapy and/or radiotherapy for patients with early-stage breast cancer. Reduction in anxiety symptoms also was observed, but the evidence still is limited.

Limitations

A limitation of the study was the estimation of exercise dose. Targeted aerobic exercise intensity frequently was described within a range such as 50%–80% of the maximal heart rate, which did not enable considering it precisely. Except when it was explicitly stated as light or vigorous, intensity was considered moderate for dose calculation. Only targeted exercise doses were estimated instead of achieved exercise doses.

Nursing Implications

Exercise intervention may improve fatigue, depression, and quality of life in patients with breast cancer receiving adjuvant therapy, with findings suggesting that a prescription of relatively low doses of exercise (less than 12 MET h/week) consisting of about 90–120 minutes of weekly moderate physical exercise seems more efficacious in improving fatigue and quality of life than higher doses.

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Carati, C.J., Anderson, S.N., Gannon, B.J., & Piller, N.B. (2003). Treatment of post-mastectomy lymphedema with low-level laser therapy. Cancer, 98(6), 1114–1122.

Study Purpose

To study postmastectomy lymphedema using low-level laser therapy (LLLT).

Intervention Characteristics/Basic Study Process

The control group received a placebo with one block of sham therapy followed by an eight-week period of rest and then one week of LLLT. The study group received two blocks of LLLT separated by an eight-week period of rest.

Sample Characteristics

  • The study sample (N = 61) was comprised of female patients who were randomized to the control group (n = 28) and the study group (n = 33). 
  • Patients were included in the study if they were aged 18 years or older, female, and had clinically manifested postmastectomy. 
  • Patients were excluded from the study if they had current metastases, a history of severe trauma to the arm, instability of condition, or cellulitis within past three months.
  • Lymphedema was defined as a greater than 200 ml difference between arms. 

Setting

The study took place in Australia.

Study Design

The study used a double-blind, randomized, placebo-controlled trial design, with 30 weeks of follow-up measurements.

Measurement Instruments/Methods

  • Objective measurements were taken at the beginning and end of every session.
  • Perometry measured limb circumference.
  • Bioimpedence provided an objective measure of fluid distribution.
  • Tonometry provided indication of the compliance of the skin.
  • Data were analyzed using analysis of variance and multiple regressions; p < 0.05 was determined using t-tests.

Results

There was no significant effect of placebo treatment or just one cycle of LLLT treatment on mean affected limb volume. There was no significant decrease in limb volume immediately after two treatments of LLLT. Limb volume at three months after two LLLT treatments were significantly less than after placebo treatment (p < 0.017). Limb extracellular fluid (ECF) was significantly decreased in placebo and with one treatment of LLLT; however, the mean ECF was most reduced after two LLLT cycles. Significant decreases in tonometry readings (indicating increased tissue hardness) were noted in patients treated with placebo or one LLLT. Participants receiving two LLLT cycles had an increased tonometry reading, which indicates softening of the tissues. There was no significant effect on range of motion.

Conclusions

Two cycles of LLLT improved the condition of the lymphedema-affected limbs.

Limitations

  • The study sample was small.
  • Special training is required.
  • Use of laser makes costs higher.
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Caraceni, A., Hanks, G., Kaasa, S., Bennett, M.I., Brunelli, C., Cherny, N., . . . European Association for Palliative Care (EAPC). (2012). Use of opioid analgesics in the treatment of cancer pain: Evidence-based recommendations from the EAPC. Lancet Oncology, 13, e58–e68.

Purpose & Patient Population

The guidelines, which relate to the use of opioids to treat cancer pain, are the result of revision of previous European Palliative Care Research Collaborative guidelines.

Type of Resource/Evidence-Based Process

  • In the development of the revised guidelines, collaborators assigned 22 topics to groups of reviewers, who completed the systematic review using a standardized method. The evidence profile of each relevant outcome was reviewed and became the basis of the final recommendations. The Scientific Advisory Board of the European Palliative Care Research Collaborative and the Board of Directors of the European Association for Palliative Care reviewed the recommendations. Upon revision, the recommendations were again distributed to the groups for comment and/or approval.
  • The data search completed in connection with the project was a systematic retrieval of randomized and nonrandomized trials and meta-analyses that
    • Involved adults with chronic cancer pain
    • Contained data on efficacy, side effects, and the treatments considered
    • Described outcomes.
  • Databases searched were MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials (CENTRAL).
  • Search keywords were terms relevant to each outcome. Outcomes related to the following: World Health Organization (WHO) step II opioids, WHO step III opioid of first choice, opioid titration, role of transdermal opioids, role of methadone, opioid switching, relative opioid analgesic potencies, alternative systemic routes of opioid administration, opioids for breakthrough pain, treatment of opioid-related emesis, treatment of opioid-related constipation, treatment of opioid-related central nervous system symptoms, use of opioids in patients with renal failure, role of paracetamol and nonsteroidal anti-inflammatory drugs (NSAIDs) in addition to step III opioids, role of adjuvant drugs for neuropathic pain (antidepressants and anticonvulsants), and spinal route of opioid administration.
  • Studies were excluded if they dealt with the role of opioids in liver failure and the use of opioid combinations. (Data were of insufficient quality to support a recommendation regarding these topics.) Reviewers excluded a literature review regarding the treatment of opioid-related constipation; its content completely overlapped that of a Cochrane review. The role of ketamine was not included because resources to complete the work were unavailable.
  • Authors made 16 recommendations based on evidence profiles.

Phase of Care and Clinical Applications

  • Patients were undergoing multiple phases of care.
  • The study has clinical applicability for palliative care, late effects and survivorship, and elder care.

Results Provided in the Reference

Findings are submitted as a general framework to help clinicians make informed decisions regarding cancer pain management.

Guidelines & Recommendations

  • Data reveal no differences regarding the use of morphine, oxycodone, and hydromorphone; any can be used as step III treatment.
  • Guidelines include a weak recommendation regarding oral opioids:
    • Immediate- and slow-release oral opioids can be used for dose titration.
    • Transdermal fentanyl and buprenorphine are step III alternatives, and some patients may prefer them.
    • Methadone can be used as a step III opioid but only by experienced providers, given its complex pharmacokinetic profile.
  • Guidelines include a weak recommendation regarding patients who are not getting adequate analgesia: These patients may benefit from opioid switching.
  • Guidelines include strong recommendations regarding route of administration:
    • The subcutaneous route should be the first choice when alternate routes of administration are needed.
    •  Breakthrough pain can be managed with oral, immediate-release opioids or buccal or intranasal fentanyl.
  • Guidelines include a weak recommendation about additions to step III opioids: Add NSAIDs or paracetamol to step III opioids. However, guidelines note that efficacy is not well documented.
  • Guidelines include a strong recommendation regarding neuropathic pain: Consider using amitriptyline or gabapentin for patients with neuropathic pain that is only partially responsive to opioids. 
  • Guidelines include a weak recommendation regarding epidural and intrathecal opioids: Consider using an epidural or intrathecal opioid with a local anesthetic in cases of intractable pain or intolerable adverse effects.

Limitations

  • Pharmaceutical industry sponsorships were noted.
  • The guidelines do not evaluate treatment costs.
  • The process evidenced lack of consensus regarding methods of pain assessment.
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Capuron, L., Gumnick, J. F., Musselman, D. L., Lawson, D. H., Reemsnyder, A., Nemeroff, C. B., . . . Miller, A. H. (2002). Neurobehavioral effects of interferon-alpha in cancer patients: phenomenology and paroxetine responsiveness of symptom dimensions. Neuropsychopharmacology, 26, 643–652.

Intervention Characteristics/Basic Study Process

Patients were given oral paroxetine/placebo 10 mg for one week pre-interferon treatment, paroxetine/placebo 20 mg during the first week of interferon treatment, and then paroxetine/placebo 20 to 40 mg for all subsequent weeks of interferon therapy. Total length of treatment with paroxetine was 12 weeks. The study was based on the hypothesis that, as a selective serotonin reuptake inhibitor (SSRI), paroxetine may improve the neuropsychiatric and neurovegetative symptoms associated with interferon-alpha treatment.

Sample Characteristics

  • The study included 38 patients (paroxetine group, n = 18; placebo group, n = 20); there were equal numbers of men and women.
  • Mean age was 50 years (25–74).
  • Most patients were married, and approximately 50% were college educated.
  • Approximately 25% of the sample had a history of major depression.
  • All patients were receiving a course of interferon-alpha consisting of 20 million units/m2 five days per week for four weeks, followed by eight weeks of interferon-alpha at a dose of 10 million units/m2 three days per week.

Setting

  • Single site
  • Major academic cancer center

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

The study was a randomized, double-blind, placebo-controlled trial.

Measurement Instruments/Methods

Neurotoxicity Rating Scale (NRS) was used to measure various depressive symptoms, cognitive disturbances, and vegetative symptoms, including fatigue.

Results

When compared with the control group, pretreatment with paroxetine was effective in preventing interferon-induced mood and cognitive symptoms, as well improving pain. Paroxetine had less effect on the development of interferon-alpha–related neurovegetative symptoms, including fatigue, as measured by the NRS. Fatigue and somatic symptoms increased in both depressed and nondepressed patients.

Across the twelve weeks of the study, seven patients from the placebo group and one patient from the paroxetine group withdrew due to severe depression or neurotoxicity.

Limitations

  • The study had a small sample size.
  • The study used an instrument with a single item to measure fatigue.
  • The study used a wide, uncontrolled paroxetine dose range.
  • The study excluded patients with a diagnosis of schizophrenia or bipolar disorder; a Mini-Mental State Exam (MMSE) of 24 or less; and uncontrolled neurological, cardiovascular, endocrine, hematologic, hepatic, or renal disease.

Nursing Implications

No special training is required. There are costs related to drug acquisition.

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Cappelli, C., Ragni, G., De Pasquale, M.D., Gonfiantini, M., Russo, D., & Clerico, A. (2005). Tropisetron: Optimal dosage for children in prevention of chemotherapy-induced vomiting. Pediatric Blood and Cancer, 45, 48–53. 

Study Purpose

To evaluate the efficacy of tropisetron in treating acute vomiting among children with solid tumors receiving chemotherapy

Intervention Characteristics/Basic Study Process

Tropisetron (5 mg for patients < 20 kg and 10 mg for patients > 20 kg) was given intravenously daily over 15 minutes 30 minutes before chemotherapy administration. No other antiemetics were given except for steroids in three patients with Hodgkin lymphoma and two patients with non-Hodgkin lymphoma. Data were collected hourly in the first 24 hours following chemotherapy.

Sample Characteristics

  • N = 50   
  • MEDIAN AGE = 5.8 years (range = 6 months to 19 years)
  • MALES: 27 (54%), FEMALES: 23 (46%)
  • KEY DISEASE CHARACTERISTICS: Central nervous system tumor, retinoblastoma, neuroblastoma, and chondrosarcoma (n = 30); Wilms tumor (n = 7); rhabdomyosarcoma (n = 4); Hodgkin disease (n = 3); non-Hodgkin lymphoma (n = 2); Ewing sarcoma (n = 2); and hepatoblastoma (n = 2)
  • OTHER KEY SAMPLE CHARACTERISTICS: All patients received either moderately or highly emetogenic chemotherapy.

Setting

  • SITE: Not stated
  • SETTING TYPE: Not specified    
  • LOCATION: Not reported

Phase of Care and Clinical Applications

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

Study Design

Descriptive

Measurement Instruments/Methods

  • Antiemetic effects were monitored by nurses and patients.
  • Effects were classified as total control (TC, absence of acute vomiting), major control (MC, one to two acute vomiting episodes), or no control (NC, three or more acute vomiting episodes). 

Results

Overall frequency: TC was obtained in 154 out of 189 chemotherapy courses (85%), MC in 7.5% of courses, and NC in 7.5% of courses.

Dosage: Patients who received greater than 8 mg/m2 of tropisetron achieved TC significantly more often (92%) than patients receiving 6–8 mg/m2 of tropisetron (78%) or 6 mg/m2 (69%) (p = 0.0072).

Emetic potential: TC was achieved in 85% of patients receiving highly emetic chemotherapy, 81% of patients receiving moderately emetic chemotherapy, and 100% of patients receiving slightly emetic chemotherapy. NC was achieved in 6% of patients receiving highly emetic chemotherapy and 12% of patients receiving moderately emetic chemotherapy.  

Time of administration: TC was achieved in 91% of patients with initial chemotherapy while TC was achieved in 81% of patients who received an antiemetic medication for earlier chemotherapy (p > 0.05).

Age: The youngest age group (aged 0–5 years) achieved TC and MC 98% of the time while children aged 6–10 years achieved TC and MC 90.5% of the time and children aged greater than 10 years achieved TC and MC 84% of the time (p = 0.0235). Side effects of acute vomiting occurred immediately at the start of chemotherapy among one patient receiving tropisetron at 13.5 mg/m2

Conclusions

Tropisetron was an effective antiemetic medication for pediatric patients receiving highly emetic chemotherapy. It was mostly effective for patients receiving moderately emetic chemotherapy. The medication was more effective in younger children (aged 0–5 years). The dosage should range from 8–12 mg/m2 and be used with the initial chemotherapy course.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Measurement/methods not well described

 

Nursing Implications

Tropisetron was an effective antiemetic medication that should be administered prior to the initial chemotherapy course.

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Capozzi, L.C., McNeely, M.L., Lau, H.Y., Reimer, R.A., Giese-Davis, J., Fung, T.S., & Culos-Reed, S.N. (2016). Patient-reported outcomes, body composition, and nutrition status in patients with head and neck cancer: Results from an exploratory randomized controlled exercise trial. Cancer, 122, 1185–1200.

Study Purpose

To detect the optimal timing for the initiation of an exercise training intervention

Intervention Characteristics/Basic Study Process

This was a 12-week lifestyle intervention consisting of five components: physician referral and clinic support, health education, behavior change support, social support through group-based settings, and an individualized exercise program based on patient need. Patients were asked to attend exercise sessions twice a week with additional at-home implementation of the exercise regimen twice more per week. The individualized exercise programs consisted of progressive resistance-training programs with a short, moderate intensity warm-up followed by two sets of 8 repetitions for 10 exercises. Progression of the regimen occurred at weeks 4, 6, and 9, as appropriate. In addition to attending the exercise sessions, participants were required to attend six education sessions after their exercise sessions.

Sample Characteristics

  • N = 60   
  • AGE = 56.1 years (SD = 9.2 years)
  • MALES: 81.7%, FEMALES: 20.3%
  • CURRENT TREATMENT: Chemotherapy, radiation, combination radiation and chemotherapy
  • KEY DISEASE CHARACTERISTICS: Head and neck cancer

Setting

  • SITE: Single site   
  • SETTING TYPE: Outpatient    
  • LOCATION: University of Calgary

Phase of Care and Clinical Applications

PHASE OF CARE: Multiple phases of care

Study Design

The study design is a randomized, controlled exercise trial in which patients were randomly assigned to either the immediate lifestyle intervention (ILI) group or the delayed lifestyle intervention (DLI) group.

Measurement Instruments/Methods

  • Godin Leisure-Time Exercise Questionnaire
  • Functional Assessment of Cancer Therapy (FACT)
  • FACT-Anemia (FACT-An)
  • FACT Head/Neck Symptom Index-22 (FHNSI-22)
  • FACT-An Trial Outcome Index
  • Center for Epidemiological Study Depression Scale (CESD)
  • Patient-Generated Subjective Global Assessment (PG-SGA)
  • Intervention survey
  • Body composition, fitness, functional, flexibility tools

Results

No significant differences were reported for lean body mass or percentage body fat during the 24 weeks. A main effect of time for lean body mass, body mass index, and percentage body fat was detected (lean body mass: F[2,74.5] = 54.141, p < 0.001; BMI: F[2,74.5] = 67.955, p < 0.001; percent body fat: F[2,74.5] = 29.679, p < 0.001). No between group statistical difference was detected for fitness outcomes, the six-minute walk test (6MWT), or the sit-to-stand test (SST), which may be because of the small sample size. No statistical differences were observed between the two groups’ quality of life during the 24-week period. A significant effect was observed on depression, but no associated difference was observed between study groups.

Conclusions

The intervention did not demonstrate an effect on patient outcomes.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Findings not generalizable

Nursing Implications

This study did not show efficacy of an intervention involving exercise and supportive interventions. The findings are limited by study design aspects and sample size.

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