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Kavalieratos, D., Corbelli, J., Zhang, D., Dionne-Odom, J.N., Ernecoff, N.C., Hanmer, J., . . . Schenker, Y. (2016). Association between palliative care and patient and caregiver outcomes: A systematic review and meta-analysis. JAMA, 316, 2104–2114. 

Purpose

STUDY PURPOSE: To complete a systematic review of palliative care interventions in randomized, controlled trials (RCTs) involving adults with life-limiting illness and meta-analysis to identify the relationship of those intervention with quality of life, symptom burden, and survival of those adults and their caregivers

TYPE OF STUDY: Systematic review of palliative care RCTs

Search Strategy

DATABASES USED: MEDLINE, EMBASE, CINAHL, and CENTRAL (inception to 2016)
 
ARTICLE TOPIC INCLUSION CRITERIA: Adults aged 18 years or older with a life-threatening illness diagnosis; patient report of a minimum of one of nine patient-level outcomes: mood, advance care planning, place of death, survival, use of resources, healthcare expenditures, care satisfaction, symptom burden, or quality of life (QOL). Interventions included at least two of eight possible domains of palliative care defined by the National Consensus Project for Quality Palliative Care. The systematic review included RCTs that featured usual care, waitlist, or attention control comparisons.
 
ARTICLE TOPIC EXCLUSION CRITERIA: Pediatrics, non–English-language, single symptom interventions (e.g., opioids for dyspnea), focus on only one palliative care domain (e.g., advance care planning only), non-focus on patients with life-threatening illness, caregiver-only intervention
 
Most of meta-analysis trials (72%) occurred in the United States and in ambulatory (32.5%) or home settings (41.8%). Forty-two trials reported subjective outcomes (those reported by patients), but over half were deemed high risk for bias or unclear bias (total of 81.4%). Of the 43 trials, 32 reported objective (survival) outcomes, but over 67% were deemed as high risk or unclear risk of bias. Trial interventions focused on a median of five interventions related to eight palliative care dimensions. Forty-two trials delineated physical dimensions of care, whereas 39 focused on psychological care, although no trial explicitly addressed cultural influences on interventions. Of 15 trial interventions evaluating caregiver outcomes, only five collected caregiver data only without an explicit intervention for caregivers. A variety of research designs existed in studies used for the meta-analysis. 
 
 
 

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 6,158
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Conduct of the systematic review and meta-analysis occurred in concordance with the Cochrane Handbook for Systematic Reviews of Interventions. Articles met inclusion criteria from four database searches (inception to 2016). To evaluate the quality of studies in the systematic review, two reviewers independently evaluated each study for meeting inclusion criteria. If two reviewers’ evaluations varied, two different authors collaborated with the initial two reviewers to reach consensus. In addition, two of the four authors reviewed each trial according to a systematic and customized form to elicit information from study primary and secondary reports. Two investigators independently rated study risk of bias using the Cochrane Collaboration tool. A narrative synthesis included all trials (N = 43, 30 of patients with cancer) and considered quality of life, survival outcomes, and symptom burden premeta-analysis. Various statistical techniques controlled for trial heterogeneity, variation in study endpoint times, influence of study risk, intervention strength, study setting, and patient disease that may have influenced meta-analysis results and outcome measurement of patient symptom burden, survival, and quality of life, and their influence on caregivers.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 56 (30 with cancer)
  • TOTAL PATIENTS INCLUDED IN REVIEW = 12,731 patients, 2,479 caregivers 
  • SAMPLE RANGE ACROSS STUDIES: The mean patient age was 67 years; no caregiver age data were available. Sample sizes ranged from 27–434 participants.
  • KEY SAMPLE CHARACTERISTICS: All patients had life-limiting illnesses. Patients were in hospital, home, and ambulatory settings. Subjective outcomes: Half of reviewed trials had a high level of bias (55.8%), and 16% had a low level of bias; the rest was unknown. Objective outcomes: 44% had a high level of bias, and 6.9% had a low level of bias; the rest was unknown or not measured. Study interventions included physical and psychological aspects of care, with cultural sensitivity underused and underrepresented. Interventions addressed a median of five of eight palliative care components.

Phase of Care and Clinical Applications

PHASE OF CARE: Active cancer care
 
APPLICATIONS: Palliative care

Results

The reviewers looked at nine domains: patient quality of life, physical symptoms, survival, patient mood, advanced care planning, site of death, resource utilization and expenditures, satisfaction with care, and caregiver outcomes resulting from patient symptom burden, survival, and quality of life. Patient quality of life was assessed in 24 studies (4,576 patients). Twelve of those studies had high risk of bias and seven were low risk of bias (five were unknown). Of the seven low-risk-of-bias studies, five reported improved quality of life. In fifteen trials, quality of care was associated with a statistically significant improvement in quality of life. High bias and heterogeneity were significant issues in the analysis. Physical symptoms were reviewed in 29 trials (10,105 people). Seventeen of 29 trials looked at physical symptoms. Of the seven that were low risk bias, after sensitivity analyses, palliative care was not associated with change in symptom burden in four trials at the 1- to 3-month follow-up because of heterogeneity. The reviewers went on to describe that, because of high risk of bias and heterogeneity, no association existed between palliative care and improved survival, patient mood, advanced care planning, site of death, and resource use.

Conclusions

In this review, the evidence suggests that palliative care intervention improves symptom burden and patient quality of life in those who have been diagnosed with an advanced cancer or with a serious illness. The review was not able to establish if palliative care improved caregiver quality of life. Significant issues existed with assessing the association of palliative care with quality of life, symptom burden, and adult survival because of the problematic quality and rigor of RCTs used in the systematic review and meta-analysis.

Limitations

  • Mostly low quality/high risk of bias studies
  • High heterogeneity
  • The authors reported multiple limitations of this review, including the wide spectrum and diversity in palliative care interventions. This diversity contributed to heterogeneity to the meta-analysis. Missing data, the exclusion of quasiexperimental studies, and trial statistical analysis may have contributed to underpowered studies in the meta-analysis. Across trials, clinical trial data were not uniformly reported, and information about points in time when patient and caregiver may have received palliative care was lacking. The risk of study bias (a subjective interpretation) and use of the Cochrane Risk of Bias tool may not have defined specifics of behavioral interventions found in many of the trial studies used in the meta-analysis and systematic review.
  • No specific information provided on evaluation rating forms
  • No caregiver-only studies included in meta-analysis to measure caregiver outcomes
  • No trial focused on influence of culture on intervention assessment or effect.

Nursing Implications

Multiple RCTs have established that palliative care improves patient experience and quality of care. Insufficient evidence exists to assess whether that is true for patient and caregiver dyads or for caregivers assessed separately from patients. More studies reflecting methodological rigor, cultural sensitivity, and quality to identify aspects of effective palliative care for both patients and caregivers remain a priority.

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Kautio, A.L., Haanpaa, M., Leminen, A., Kalso, E., Kautiainen, H., & Saarto, T. (2009). Amitriptyline in the prevention of chemotherapy-induced neuropathic symptoms. Anticancer Research, 29, 2601–2606.

Study Purpose

The purpose of the study was to determine if amitriptyline would be effective in treating chemotherapy-induced peripheral neuropathy (CIPN) compared to placebo.

Intervention Characteristics/Basic Study Process

Patients were allocated to amitriptyline or placebo groups. Treatment was started at 25 mg per day, and doses were elevated 25 mg per week up to a maximum dose of 100 mg per day if tolerated. Treatment was continued until the end of the neurotoxic chemotherapy. Follow-up visits were performed every two months and patients were asked to maintain a diary in which they graded neutopathic symptoms by a visual analog scale twice a week. The primary end point was the appearance or progression of neuropathic symptoms based on diary data.

Sample Characteristics

  • A total of 99 participants were recruited for this study, with women outnumbering men 72% to 28%, respectively.
  • The mean age of study participants was 56 years with a range of 25–75 years.
  • The most common diagnoses amongst the participants were ovarian cancer, lymphoma, and colorectal cancers.
  • Other key characteristics include receiving vinca alkaloids, platinum-based taxanes, or a combination of these agents.
  • Forty-seven percent of the participants were in first-line chemotherapy; 44% were receiving adjuvant chemotherapy.

Setting

The study was conducted in an outpatient, single-site setting in Helsinki, Finland.

Study Design

The study was designed as a double blind, randomized, placebo-controlled parallel group.

Measurement Instruments/Methods

Measurements include the National Cancer Institute's Common Terminology Criteria for Adverse Events, the European Organisation for the Research and Treatment of Cancer C30 quality-of-life measure, and a visual analog scale for symptom grading.

Results

The median follow-up was at 19–21 weeks. Seventy-four percent of patients were on the highest dose of amtriptyline, which was well tolerated. Tiredness was the most frequent reason for dose reduction. In addition, no differences were noted in intensity of neuropathy between groups. In the majority of cases, the intensity of neuropathy was mild at grade 1. Neuropathy was seen in 76% of patients after nine cycles of treatment. Because of a lack of effect, the study was discontinued earlier than planned.

Conclusions

The study did not demonstrate any effect by amitriptyline on the prevention or treatment of CIPN.

Limitations

  • Small sample size (less than 100 participants).
  • The study was underpowered.
  • The study ended early because of a lack of effectiveness in the study design.

Nursing Implications

The findings from this study do not support the use of amitriptyline for the prevention and management of CIPN.

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Kaushal, J., Gupta, M.C., Kaushal, V., Bhutani, G., Dhankar, R., Atri, R., & Verma, S. (2010). Clinical evaluation of two antiemetic combinations palonosetron dexamethasone versus ondansetron dexamethasone in chemotherapy of head and neck cancer. Singapore Medical Journal, 51(11), 871–875.

Study Purpose

To compare the antiemetic effectiveness of palonosetron plus dexamethasone (PD) versus ondansetron plus dexamethasone (OD) for patients with head and neck cancer receiving moderately emetogenic chemotherapy (MEC)

Intervention Characteristics/Basic Study Process

Patients with head and neck cancer who were receiving a standardized MEC regimen (60 mg/m² IV docetaxel, 300 mg/m² IV carboplatin, and 600 mg/m² IV 5-flurouracil) were randomly assigned to one of two groups. During the first cycle of chemotherapy, group one received palonosetron plus dexamethasone (PD) as antiemetic prophylaxis therapy and group two received ondansetron plus dexamethasone (OD) as antiemetic prophylaxis therapy. For the second cycle, the groups crossed over and group one received OD as antiemetic prophylaxis therapy and group two received PD as antiemetic prophylaxis therapy. The efficacy of the antiemetic prophylaxis medication combinations was evaluated at each of the two cycles of chemotherapy by recording the intensity of nausea and the frequency of vomiting. These outcome variables were evaluated during three phases of treatment: the acute phase beginning at chemotherapy administration and ending 24 hours after, the delayed phase beginning 24 hours after chemotherapy administration and ending five days after, and overall for the five days following chemotherapy administration.

Sample Characteristics

  • The sample consisted of 30 patients who had been diagnosed with head and neck cancer receiving MEC (60 mg/m2 IV docetaxel, 300 mg/m2 IV carboplatin, and 600 mg/m2 IV 5-FU).
  • Patients' ages ranged from 25–60 years.
  • Mean age and gender of patients was not reported.

Setting

The study was conducted at a single outpatient site at a large medical center in India.
 

Phase of Care and Clinical Applications

All patients were in active treatment.

Study Design

The study used a randomized, crossover design.

Measurement Instruments/Methods

Patients recorded each instance of emesis over the five-day, post-chemotherapy period and the intensity of their nausea using a four-point, descriptive ordinal scale ranging from no nausea to severe nausea.

Results

No significant differences were found between groups for any of the study outcomes (emesis frequency and nausea intensity) in any of the treatment phases (acute phase, delayed phase, and overall).

Conclusions

No difference was found in antiemetogenic efficacy between the PD and OD groups.

Limitations

The study sample was small with fewer than 100 patients.

Nursing Implications

As a second-generation 5-HT3 antagonist, palonosetron, may be more effective in preventing and reducing chemotherapy-induced nausea. Some studies have demonstrated that palonosetron is more effective at reducing chemotherapy-induced nausea and vomiting (CINV), while other studies, such as this one, have not. More research must be done before any formulary changes can be proposed.

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Kaushal, P., Atri, R., Soni, A., & Kaushal, V. (2015). Comparative evaluation of triplet antiemetic schedule versus doublet antiemetic schedule in chemotherapy-induced emesis in head and neck cancer patients. ecancermedicalscience, 9, 567. 

Study Purpose

To compare the efficacy of triplet versus doublet antiemetic therapy in patients receiving mitoxantrone, etoposide, and cytarabine (MEC) chemotherapy

Intervention Characteristics/Basic Study Process

Patients were randomized to receive either palonosetron, dexamethasone, and aprepitant, or ondansetron and dexamethasone for chemotherapy-induced nausea and vomiting (CINV) control.

Sample Characteristics

  • N = 60
  • MEAN AGE = 51 years
  • AGE RANGE = 34–70 years
  • MALES: 86.6%, FEMALES: 13.4%
  • KEY DISEASE CHARACTERISTICS: All patients had head and neck cancer.

Setting

  • SITE: Single site  
  • SETTING TYPE: Not specified  
  • LOCATION: India

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Open-label, randomized, prospective trial

Measurement Instruments/Methods

  • Count of emesis episodes
  • Nausea measured on 100 mm visual analog scale (VAS)

Results

Complete response (CR), defined as no vomiting and no rescue medications, was seen in 86.7% of those on triplet therapy and 60% of those on doublet therapy in the acute phase (p < 0.05). In the delayed phase, the CR was 83.3% and 53.3% of those on triplet and doublet therapy respectively (p < 0.05). The authors cited the WHO cost effective and strategic planning guidelines to note that because triplet therapy was more effective, it was cost-effective.

Conclusions

The findings showed that triplet therapy was associated with higher CR rates for CINV prevention than doublet therapy (without an NK1) for patients receiving MEC.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)

 

Nursing Implications

A growing volume of research exists to compare antiemetic regimens with and without NK1s, likely because of the cost of NK1 medication. This study showed that triplet therapy containing NK1 was effective for the control of CINV in a greater proportion of patients than doublet therapy. CINV is a debilitation side effect of chemotherapy. Nurses can advocate for the use of the interventions that are most effective for symptom control among patients receiving MEC and HEC.

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Kaufman, M., Singh, G., Das, S., Concha-Parra, R., Erber, J., Micames, C., & Gress, F. (2010). Efficacy of endoscopic ultrasound-guided celiac plexus block and celiac plexus neurolysis for managing abdominal pain associated with chronic pancreatitis and pancreatic cancer. Journal of Clinical Gastroenterology, 44(2), 127–134.

Purpose

To evaluate the efficacy of endoscopic ultrasound-guided (EUS) celiac plexus block (CPB) and celiac plexus neurolysis (CPN) in alleviating chronic abdominal pain due to chronic pancreatitis (CP) or pancreatic cancer

Search Strategy

  • Databases searched were MEDLINE, PubMed, and EMBASE. Date range searched was January 1966–December 2007.
  • Search keywords were endoscopic ultrasound, EUS, celiac plexus block, celiac plexus neurolysis, chronic pancreatitis, pancreatic cancer, and CP.
  • Studies were included if
    • The reports were published in English.
    • Patients were at least 18 years old and had unremitting chronic abdominal pain due to CP or unresectable pancreatic cancer.
    • Patients needed narcotic analgesics for pain control.
    • The studies had enrolled at least 10 patients who had undergone EUS CPB or CPN.
  • Authors did not cite exclusion criteria.

 

Literature Evaluated

The initial search retrieved 588 articles. Authors selected nine studies for analysis (six of CP pain, three of pain due to pancreatic cancer). The report provides no data regarding quality rating. Of the six studies of CP, three were full articles and three were abstracts. Of the three studies of pancreatic cancer, one was an abstract. Across most studies, methods and procedures were similar. Because current expert consensus precludes the use of absolute alcohol in CPN of patients with CP, due to the potential for inducing fibrosis and limiting future surgical options, authors excluded from the meta-analysis partial data from one study. In this study investigators had used bupivacaine and alcohol in 5 of 19 patients.

Sample Characteristics

  • The sample was composed of 340 patients.
  • Authors did not report sample range.
  • Of all patients, 221 patients had CP and 119 had pancreatic cancer.

Results

EUS CPB for CP was associated with a reduction of abdominal pain in 51% of patients but not with consistent elimination of the need for narcotic analgesics. However, in one study 47% of patients withdrew from narcotics. EUS CPB in CP patients offered temporary relief, up to 48 weeks, in some studies, but short-term pain relief may not indicate long-term effect. EUS CPN for pancreatic cancer pain was associated with a 73% reduction in pain. However, two of three studies reported that narcotic use did not change significantly post-CPN. Analysis of the patients with pancreatic cancer pain showed that the location of the tumor and the timing of EUS CPN were significant factors in the efficacy of the treatment and in pain and narcotics use.

Limitations

  • The number of studies analyzed was small. This could have had some effect on heterogeneity and publication bias.
  • Authors did not provide details regarding pain etiology applicable to studies of CPB in CP.
  • The studies did not track changes in quality of life.
  • Physiologic evaluation for narcotic addiction was not part of the exclusion criteria in any of the studies. Addiction could have contributed to the lack of response in the CPB subgroup.
  • Presentation of meta-analysis results is unclear.

Nursing Implications

Evidence suggests that EUS CPB is somewhat effective in managing the pain of appropriately selected patients. The evidence is not strong, however, and most effects appear to be temporary. EUS CPB is not an effective single method of pain control; EUS CPB may be useful only as a method of achieving temporary relief from acute flares.

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Katzer, K., Tietze, J., Klein, E., Heinemann, V., Ruzicka, T., & Wollenberg, A. (2010). Topical therapy with nadifloxacin cream and prednicarbate cream improves acneiform eruptions caused by the EGFR-inhibitor cetuximab–A report of 29 patients. European Journal of Dermatology, 20, 82–84.

Study Purpose

To evaluate the clinical efficacy of nadifloxacin and prednicarbate cream for treatment of cetuximab-induced acneiform eruptions

Intervention Characteristics/Basic Study Process

Patients who had acneiform eruptions of varying severity were treated with nadifloxacin 1% cream and prednicarbate 0.25% cream once daily for six weeks. Patients continued their usual use of sunscreens, cleansers, and antihistamines. The severity of eruptions was scored at baseline and after one, two, and six weeks of treatment.

Sample Characteristics

  • N = 29
  • MEAN AGE = 64.6 years (range = 38–89 years)
  • MALES: 76%, FEMALES: 24%
  • KEY DISEASE CHARACTERISTICS: All patients were receiving cetuximab

Setting

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

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Open-label trial

Measurement Instruments/Methods

Investigator developed skin score calculated from percentage body involvement, percentage facial involvement, and skin lesion scoring on a 3-point scale for erythema and other lesion characteristics.

Results

A significant reduction in skin score was seen at all time points (p < .05). Subjective symptoms such as pruritus, pain, and tenderness were reported to be improved. The treatment was well tolerated. Two patients reported mild burning and erythema following application of the nadifloxacin cream.

Conclusions

The combination of topical quinolone and corticosteroid was effective in reducing acneiform eruptions in this group of patients.

Limitations

  • Small sample (< 30)
  • Risk of bias (no control group) 
  • Risk of bias (no blinding)  
  • Risk of bias (no random assignment)
  • Measurement validity/reliability questionable
  • Other limitations/explanation: The skin score used is well described, but validity and reliability is not clear.

Nursing Implications

The combination of topical quinolone and steroid may be helpful in treating EGFR-inhibitor associated acneiform rash. This study had several methodological limitations, so it does not provide strong support. Further research in this combination is warranted.

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Katz, E., Dugan, N.L., Cohn, J.C., Chu, C., Smith, R.G., & Schmitz, K.H. (2010). Weight lifting in patients with lower-extremity lymphedema secondary to cancer: A pilot and feasibility study. Archives of Physical Medicine and Rehabilitation, 91(7), 1070–1076.

Study Purpose

To assess the feasibility of recruiting and retaining cancer survivors with lower-extremity lymphedema in an exercise intervention study and to determine preliminary estimates of the safety and efficacy of the intervention
 

Intervention Characteristics/Basic Study Process

Patients participated in slow, progressive weight lifting two times weekly, supervised for two months, then unsupervised for three months. Participants were instructed in warm-up, stretching, breathing, weight training and additional stretching exercises by a certified fitness professional. Exercises were performed using variable resistance machines, free weights, and ankle weights.

Sample Characteristics

  • The study sample was comprised of three male and seven female patients; five patients completed the intervention.
  • The study had an upper-age limit of 90 years old.
  • Patients had lower-limb lymphedema, with at least 6% discrepancy in the affected limb and did not have an infection.

Phase of Care and Clinical Applications

The study has clinical applicability for late effects and survivorship.

Study Design

The study used a pre-post design with no control.

Measurement Instruments/Methods

  • A Perometer was used to calculate limb volume.
  • Multiple leg circumference measurements were taken.
  • Patients completed a lymphedema survey.
  • A visual analog scale assessed associated pain.
  • Patients completed the 36-Item Short Form Health Survey (SF-36).
  • Patients took six-minute walks.
     

Results

All but one person attended at least 81% of supervised sessions. Five patients did not complete the study because of cellulitis that occurred early in the study, progression of cancer, and inconvenience. There were no significant differences in lower-limb volume. Strength increased and the six-minute walk increased.

Conclusions

The study was too small to draw any conclusions, and the number of drop outs for various reasons makes the feasibility of this approach for patients with lower-limb lymphedema questionable.

Limitations

The sample size was small, with less than 30 participants.

Nursing Implications

 The study is one of few that begins to address lower-limb lymphedema. Further study on the safety and potential benefits of exercise and weight training for this condition are needed.

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Katz, M.R., Irish, J.C., & Devins, G.M. (2004). Development and pilot testing of a psychoeducational intervention for oral cancer patients. Psycho-Oncology, 13, 642–653.

Intervention Characteristics/Basic Study Process

The intervention involved a 95-page teaching booklet, What to Expect From Your Oral Cancer Surgery: A Guide for Patients and Families. The booklet included information about oral cancer, treatments, and effective coping strategies. Contents were divided into preparing for surgery, postoperative care, and returning home.

In the intervention group, the booklet was given to patients pre- and postoperatively by a nurse experienced in caring for patients with head and neck cancers. The preop session was 60–90 minutes of individual teaching before admission to the hospital for surgery. The predischarge session was 60–90 minutes of individual teaching several days prior to expected discharge from the hospital.

In the control group, patients received standard level of care, which included a preop meeting with the surgeon for consent to treatment as well as a brief description of the illness and treatment. Also included in the preadmission information was a tour of the ward and a team visit from the physician, dietitian, social worker, speech therapist, and enterostomal nurse. No information about coping or emotional difficulties was provided routinely. Measurements were taken at baseline, predischarge, and three months follow-up.

Sample Characteristics

  • The sample was comprised of 19 patients newly diagnosed with head and neck cancer who were scheduled for their first surgery.
  • The intervention group had 10 patients, and the control (standard care) group had 9 patients.

Setting

  • Hospital setting
  • Toronto, Ontario, Canada

Study Design

A randomized controlled trial design was used.

Measurement Instruments/Methods

  • Demographic/disease history tool
  • Observer-Rated Disfigurement Scale
  • Short Michigan Alcoholism Screening Test (SMAST-13): Used to measure history of alcoholism
  • Medical Outcomes Study (MOS) Social Support Survey
  • Recent stressful life events checklist for chronically ill populations
  • Knowledge questionnaire to measure oral cancer–related knowledge
  • Stanford Inventory for Cancer Patient Adjustment (SICPA): Used to measure self-efficacy
  • State-Trait Anxiety Inventory (STAI)
  • Center for Epidemiologic Studies–Depression scale
  • Affect Balance Scale: Used to measure quality of life (QOL)
  • Body Image Scale
  • Atkinson Life Happiness Rating Scale: Used to measure QOL in medically ill populations
  • Illness Intrusiveness Ratings Scale
  • EORTC QOL questionnaire: Five-item patient satisfaction survey
  • Analysis of stats: Simple ANOVA (group x time interaction)

Results

The authors reported significant improvement in anxiety scores within the intervention group from time 1 to time 3 (t = 2.88, df = 9, p = 0.018).

Limitations

  • The study had a small sample size.
  • The intervention was a booklet created by a psychiatrist, head and neck surgeon, health psychologist, head and neck dietitian, head and neck speech-language pathologist, nurse educator, and medical illustrator, with patient focus groups as reviewers. This would be costly to replicate.
  • An RN spent 60–90 minutes with each patient/family to teach, both preop and predischarge.
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Katranci, N., Ovayolu, N., Ovayolu, O., & Sevinc, A. (2012). Evaluation of the effect of cryotherapy in preventing oral mucositis associated with chemotherapy: A randomized controlled trial. European Journal of Oncology Nursing, 16, 339–344.

Study Purpose

To assess the effect of oral cryotherapy on development of oral mucositis associated with infusion of fluorouracil (5-FU) with leucovorin

Intervention Characteristics/Basic Study Process

Patients were randomized to cryotherapy or usual care. Prior to randomization, patients completed a study questionnaire, and 60 patients, who had similar characteristics, were selected for randomization. Ice chips were given to patients in the treatment group 5 minutes before and throughout treatment for a total of 30 minutes of continuous use. Mucositis assessment was done on days 7,14, and 21 after chemotherapy.

Sample Characteristics

  • The study reported on 60 patients. Ages were not stated.
  • The sample was 50% male and 50% female.
  • More than 70% in each group did not brush their teeth, and none had gone to a dentist. All were receiving bolus 5-FU treatment. Patients with oral problems at baseline or head and neck cancer were excluded. Gastric and colon cancers were most common in the sample.
  • Just more than half (53.3%) of patients were elementary school graduates. 

Setting

This was a single-site study conducted in an outpatient setting in Turkey.

Phase of Care and Clinical Applications

Patients were undergoing the active antitumor treatment phase of care.

Study Design

This was a randomized controlled trial (RCT).

Measurement Instruments/Methods

The World Health Organization (WHO) mucositis grading scale was used to assess mucositis severity.

Results

On days 7 and 14, more patients in the experimental group did not have mucositis (p < 0.05). On day 21, patients in the experimental group tended to have lower-grade or grade 0 mucositis, but the difference was not significant.

Conclusions

Findings demonstrated a short-term benefit of cryotherapy in patients receiving 5-FU.

Limitations

  • The sample size was small, with fewer than 100 patients.
  • A risk of bias exists because of the lack of blinding and no appropriate attentional control condition.
  • The findings are not generalizable as no information about usual care was provided. Investigators selected the group of patients for randomization, which could have biased results. This was a group of patients who did not have any normal oral care, such as routine toothbrushing or ongoing dental prophylaxis. Findings may not be applicable to other groups. No information on oral pain, use of pain medication, or use of other interventions for oral care were included.

Nursing Implications

Findings suggest that short-term cryotherapy may be beneficial for patients receiving bolus 5-FU; however, longer-term effectiveness may not be seen.

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Kastler, A., Alnassan, H., Pereira, P.L., Alemann, G., Barbe, D.A., Aubry, S., . . . Kastler, B. (2013). Analgesic effects of microwave ablation of bone and soft tissue tumors under local anesthesia. Pain Medicine, 14, 1873–1881.

Study Purpose

To evaluate the probability and usefulness of ablation on pain when performed via local anesthesia

Intervention Characteristics/Basic Study Process

Lesions targeted included spinal, sacral, and extraspinal. A visual analog scale was used to evaluate pain from 0–10 pre- and post-procedure, after one week, at 3 months, at 6 months, and at 12 months. Only three patients had data at 12 months.

Sample Characteristics

  • N = 15
  • AGE: Not defined
  • MALES, FEMALES: Not defined
  • KEY DISEASE CHARACTERISTICS: Lesions included spinal, sacral, and extraspinal locations.

Setting

  • SITE: Single site
  • SETTING TYPE: Not specified

Phase of Care and Clinical Applications

  • PHASE OF CARE: End-of-life care
  • APPLICATIONS: Palliative care

Study Design

  • Retrospective study

Measurement Instruments/Methods

  • Visual analog scale from 0–10

Results

The mean ablation time was 4.09 minutes, with an average of 4.2 cycles and mean ablation power of 60 W. Pre-procedure pain score was 7.2 (SD = 0.97). Post-procedure, mean visual analog scale scores were 1.64 on day 0, 1.82 on day 7, and 2.05 by the end of one month. At three months, the mean pain score was 2.13, and at six months, it was 2.36. One patient had no pain relief by one month, and follow-up was discontinued. One patient had a soft tissue abscess at the ablation site, which was drained. No other major or minor complications were found.

Conclusions

Microwave ablation of bone lesions may have some promise for relief of bone pain in patients with cancer.

Limitations

  • Small sample
  • No comparison group
  • No blinding

Nursing Implications

This study suggests that microwave ablation of painful bone lesions may be feasible and may substantially reduce bone pain. This was an extremely small sample. Further well-designed studies are warranted.

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