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Namkoong, K., DuBenske, L.L., Shaw, B.R., Gustafson, D.H., Hawkins, R.P., Shah, D.V., . . . Cleary, J.F. (2012). Creating a bond between caregivers online: Effect on caregivers' coping strategies. Journal of Health Communication, 17, 125–140.

Study Purpose

To evaluate the effects of bonding experience among caregivers of patients with advanced lung cancer while participating in a structured, Internet-based education, communication, and coping skill-building program on caregiver coping strategies. (The main study results on caregiver quality of life and mood associated with this program were presented in 2010 by DuBenske et al. at the International Psyco-Oncology Society in Quebec.)

Intervention Characteristics/Basic Study Process

Patient and caregiver pairs were randomized to participate in the Comprehensive Health Enhancement Support System (CHESS), an Internet-based program incorporating an asynchronous support group, education, communication, and coping skill instruction (“Coping With Lung Cancer: A Network of Support” module), or a control group able to access the Internet freely and provided with several reputable websites on lung cancer.

Sample Characteristics

  • The sample was comprised of 285 patient–caregiver dyads (104 completed).    
  • Caregiver mean age was 55.56 years, with a range of 18–84 years.
  • The sample was 31.7% male and 68.3% female.  
  • Patients were diagnosed with stage IIIA/B or IV lung cancer, with clinician-estimated prognosis of four+ months to live.
  • Patients were recruited between January 2005 and April 2007.

Setting

  • Multisite
  • Home setting
  • Four cancer centers located in the northeastern, midwestern, and southwestern United States

Phase of Care and Clinical Applications

Mutliple phases of care

Study Design

A randomized controlled trial design was used, with attentional control of provision of Internet sites for the control group.

Measurement Instruments/Methods

  • Bonding  was measured using a five-item Likert-type scale developed and validated previously by the investigators.
  • Three domains were selected from Carver’s (1997) Brief COPE tool: (a) active coping, (b) positive reframing, and (c) instrumental support.

Results

This paper focused on the effect of bonding among the caregiver participants in the CHESS group on coping. A mediating effect was noted using structural equation modeling, with the caregiver-perceived bonding with other group members positively associated with the three coping domains (active coping: β = 0.26, p < 0.05; positive reframing: β = 0.20, p < 0.05; instrumental support: β = 0.32, p < 0.01). Other variables such as age, gender, education level, caregiver comfort with the Internet at study entry, and baseline bonding and coping scores were not significant in the model. The report does not provide data on differences in outcomes between groups; it only cites a prior presentation of these findings that are apparently not yet published.

Conclusions

Caregivers of patients with lung cancer that participated in the CHESS program perceived increased levels of human bonding within their group, and this effect was related to coping.

Limitations

  • The study had a risk of bias (sample characteristics).*
  • Selective outcomes reporting occurred.*
  • Subject withdrawal was ≥ 10%.
  • * Study eligibility relied on subjective clinician prognostication of survival; whether bias might have been introduced during the selection period is unknown. This paper did not report the full study intervention description and overall findings, potentially limiting interpretation of the overall context. Of 325 dyads enrolled, 40 withdrew prior to pretest and 39 withdrew prior to intervention start (4 due to patient deaths). Only 104 caregivers completed the six-month instruments from which the main study and this paper’s conclusions were based.

Nursing Implications

This study illustrated that caregiver and patient participation in an Internet-based, self-paced support, educational, and coping program with a consistent group of peers facilitated human bonding with those in a similar situation, which apparently enhanced quality of life (per a reference to the results of the main study) and positive coping. It is valuable for nurses to encourage caregivers to engage in such a program where they can seek support, receive and share information, and be coached through communication skill-building from home at a time of their choosing. Because of the high attrition rate noted, it appears that more work to understand how to keep participants engaged over time for maximum benefit is needed.

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Nalamachu, S., Hassman, D., Wallace, M.S., Dumble, S., Derrick, R., & Howell, J. (2011). Long-term effectiveness and tolerability of sublingual fentanyl orally disintegrating tablet for the treatment of breakthrough cancer pain. Current Medical Research and Opinion, 27(3), 519–530.

Study Purpose

To evaluate the long-term effectiveness of sublingual fentanyl orally disintegrating tablets (ODTs) for the treatment of breakthrough cancer pain in opioid-tolerant patients

Intervention Characteristics/Basic Study Process

The study comprised a two-week titration phase to establish an effective dose of sublingual fentanyl ODT. If an effective dose was achieved, the patient entered a maintenance phase that lasted up to 12 months. During the maintenance phase, patients self-administered sublingual fentanyl ODTs at the dose identified in the titration phase. Effectiveness of pain regimen was assessed at screening and at each monthly visit.

Sample Characteristics

  • The sample was composed of 139 patients.
  • Mean patient age was 57 years (SD = 11.6 years). The age range was 28–85 years.
  • Of all patients, 54.7% were female and 45.3% were male.
  • All patients were experiencing cancer-related background pain, with 1–4 episodes of breakthrough cancer pain daily. All patients were on a fixed-schedule oral opioid regimen equivalent to 60–1000 mg oral morphine per day or transdermal fentanyl therapy equivalent to 50–300 mcg/hour.
  • All patients were Eastern Cooperative Oncology Group performance status 0–2.
  • Of all patients, 116 (83.5%) were white.

Setting

Multisite (44 sites in the United States)

Study Design

Nonrandomized, open-label, phase III study

Measurement Instruments/Methods

  • Patient Global Evaluation of Medication scale, a one-question assessment that asks the patient \"How satisfied are you overall with your current medication for pain?\"
  • Brief Pain Inventory (BPI), to measure pain and physical functioning
  • Depression, Anxiety, and Positive Outlook Scale (DAPOS)

Results

  • Sixty-two patients received sublingual fentanyl ODTs for at least 3 months; 19 were treated for 12 months. Mean duration of the maintenance phase was 149 days.
  • Of 92 patients, 77% (71 patients) were very satisfied or satisfied with their pain medication at the end of the study.
  • Scores obtained at screening and at the six-month visit showed a significant (p = 0.001) increase in reported satisfaction.
  • The BPI scores of 85 patients showed that current pain was significantly (p ≤ 0.01) lower at  six months than at screening. Compared to pain relief at screening, pain relief had improved significantly at the six-month and end-of- study visits (p < 0.05).
  • Depression scores showed a statistically significant (p = 0.011) improvement at six months.
  • The median stable dose of sublingual fentanyl ODT identified during the titration phase was 400 mcg (range, 100–800 mcg; mean, 475.0 mcg).
  • The most common adverse effects related to sublingual fentanyl ODTs were nausea (8.6%, or 12 of 139 patients), constipation (5.8%, or 8 of 139 patients), and somnolence (5.8%, or 8 of 139 patients).

Conclusions

Sublingual fentanyl ODT may provide effective analgesia while maintaining quality of life during long-term treatment of breakthrough cancer pain.

Limitations

  • The study had a small sample size, with fewer than 30 patients.
  • The single-arm design of this study was a limitation as was the large number of withdrawals. Of 139 patients, 120 withdrew: 37 for adverse events, 32 as the result of sponsor or investigator decisions, 18 following withdrawal of consent, 13 as the result of protocol violations, 10 for lack of efficacy, and 10 for other reasons unspecified. Forty-three withdrew during the required titration phase, decreasing sample size from 139 to 96.
  • Analysis was done on the 139 patients who entered the titration phase and the 96 who completed the titration phase, not the 19 who completed the maintenance phase. This may have had an impact on the outcomes at patient-assessed endpoints and on the generalizability of the study.
  • The study did not follow patients through the most advanced stages of their illness.

Nursing Implications

Study of a larger and more racially diverse patient population, over a longer period of time, is required. Additional research in a palliative care setting may be warranted.

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Nalamachu, S.R., Pergolizzi, J., Taylor, R., Slatkin, N.E., Barrett, A.C., Yu, J., . . . Forbes, W.P. (2015). Efficacy and tolerability of subcutaneous methylnaltrexone in patients with advanced illness and opioid-induced constipation: A responder analysis of 2 randomized, placebo-controlled trials. Pain Practice, 15, 564–571.

Study Purpose

To examine the influence of demographic and baseline characteristics on the efficacy and tolerability of methylnaltrexone (MNTX) in patients with advanced illness and opioid-induced constipation

Intervention Characteristics/Basic Study Process

Data were pooled from two multicenter, randomized, double-blinded, placebo-controlled, phase 3 clinical studies of subcutaneous MNTX (0.15 and 0.03 mg/kg). The primary outcome analyzed was the percentage of patients with rescue medication-free bowel movement (RFBM) within four hours of the first dose.

Sample Characteristics

  • N = 287  
  • AGE = Younger than 65 years (38.2%-49.6%) and 65 years and older (50.4%-61.8%)
  • MALES: 47.3%-56.4%, FEMALES: 43.6%-52.7%
  • KEY DISEASE CHARACTERISTICS: Advanced illness
  • OTHER KEY SAMPLE CHARACTERISTICS: Age, gender, primary diagnosis, baseline constipation-related distress score, baseline oral morphine equivalent dose

Setting

  • SITE: Multi-site

Phase of Care and Clinical Applications

  • PHASE OF CARE: Mutliple phases of care
  • APPLICATIONS: Palliative care

Study Design

  • Randomized and double-blinded study with placebo controlled arm

Measurement Instruments/Methods

  • Chi-squared test to explore the effects of MNTX versus placebo treatment

Results

More than 50% of 165 patients treated with MNTX dose experienced a rescue-free bowel movement (RFBM) within four hours versus 14.6% of the placebo-treated patients. The largest difference was observed in patients taking the MNTX 0.3 mg/kg without cancer versus the placebo group.

Conclusions

Subcutaneous MNTX provides a rapid and robust and consistent RFBM response in patients with advance illness and OIC. MNTX 0.3 mg/kg may have a more favorable response in selected patient populations.

Limitations

  • Baseline sample/group differences of import
  • Unintended interventions or applicable interventions not described that would influence results 

Nursing Implications

MNTX continues to show efficacy for opioid-induced constipation for various types of patients. Additional work is warranted to determine most effective doses.

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Nakayama, Y., Ito, Y., Tanabe, M., & Takahashi, S. (2016). Omission of dexamethasone from antiemetic treatment for highly emetogenic chemotherapy in breast cancer patients with hepatitis B infection or diabetes mellitus. The Journal of Community and Supportive Oncology, 14, 210–214. 

Study Purpose

To examine the effects of a dexamethasone-sparing antiemetic regimen for women receiving highly emetogenic chemotherapy (HEC)

Intervention Characteristics/Basic Study Process

Data were obtained from medical records for women treated with anthracycline and cyclophosphamide regimens who were given antiemetic regimens not containing dexamethasone. Complete control (CC) and complete response (CR) rates were calculated and compared to reported rates. Varied medications were used for rescue, including aprepitant.

Sample Characteristics

  • N = 97   
  • MEAN AGE = 57.6 years
  • FEMALES: 100%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: All had breast cancer and were receiving HEC regimens.
  • OTHER KEY SAMPLE CHARACTERISTICS: Dexamethasone was not used because of a Hepatitis B or diabetes mellitus diagnosis. Most were chemotherapy naive.

Setting

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

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Retrospective

Measurement Instruments/Methods

  • Patients completed questionnaires of when seen in the clinic for time and chemotherapy-induced nausea and vomiting (CINV) events during treatment.
  • CR was defined as no vomiting and no use of rescue medication.
  • CC was defined as no vomiting, no use of rescue, and no more than mild nausea.

Results

Patients received one of three regimens: granisetron only, aprepitant and granisetron, or aprepitant and palonosetron. In the acute phase, the CR rates ranged from 44.8%–76.9% with the highest CR rates in aprepitant-containing regimens. The CC rates ranged from 31%–46.2%. In the delayed phase, the CR rates ranged from 44.8%–74.4%, again, with the highest rates in aprepitant-containing regimens. The CC rates in the delayed phase ranged from 27.6%–51.7%. Comparisons showed that the CR and CC rates were about 20% higher with the dexamethasone-containing regimens.

Conclusions

Dexamethasone-sparing regimens were less effective than standard triple drug antiemetics for CINV prophylaxis in patients receiving HEC. The best antiemetic control in dexamethasone-sparing regimens in this study was seen with the use of aprepitant.

Limitations

  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Measurement/methods not well described
  • Specific timing and questionnaire information for CINV measure not well described

Nursing Implications

Some patients may require dexamethasone-sparing antiemetic regimens while on chemotherapy because of other chronic health conditions. The findings suggest that steroid-sparing regimens are less effective for CINV control in patients receiving HEC. Further research is needed to determine the most effective alternatives to triple drug antiemetics in these cases.

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Nakau, M., Imanishi, J., Imanishi, J., Watanabe, S., Imanishi, A., Baba, T., . . . Morimoto, Y. (2013). Spiritual care of cancer patients by integrated medicine in urban green space: A pilot study. Explore, 9, 87–90. 

Study Purpose

To examine the effects of an integrated medicine therapy involving forest therapy, horticultural therapy, yoga meditation, and group supportive therapy on spirituality and related symptoms

Intervention Characteristics/Basic Study Process

Participants walked in a forest in a park for about 40 minutes while conversing. Sixty-minute horticultural sessions were focused on vegetables that were easy to grow. Yoga sessions using postures, deep breathing, relaxation, and meditation were done for 90 minutes, and patients were encouraged to perform simple yoga exercises at home daily. Group support sessions were held for 60 minutes five times during the study.

Sample Characteristics

  • N = 22    
  • MEAN AGE = 55.5
  • MALES: 9.5%;  FEMALES: 90.5%
  • KEY DISEASE CHARACTERISTICS: All participants had completed initial treatment at least one month prior to participation. All were in essentially good physical condition.
  • OTHER KEY SAMPLE CHARACTERISTICS: All were city dwellers with no access to green environments in daily life.

Setting

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

Phase of Care and Clinical Applications

  • PHASE OF CARE: Transition phase after active treatment
  • APPLICATIONS: Palliative care 

Study Design

  • Quasiexperimental

Measurement Instruments/Methods

  • SF-36®
  • Profile of Mood States (POMS)
  • State-Trait Anxiety Inventory (STAI)
  • Cancer fatigue scale 
  • Natural killer (NK) cell activity

Results

There were improvements in functional and spiritual well being (p < .05). There were significant improvements in fatigue, with an average decline of 6.4 points (scale possible total score = 60; baseline average = 21) (p = .004).  Changes in fatigue were seen in physical and affective, but not cognitive components. Only the confusion subscale of POMS showed improvement (p = .002).  STAI scores declined (p = .001).  NK cell activity declined (p < .001)

Conclusions

Therapies involving green space, relaxation, yoga, and group supportive interventions may improve well-being, fatigue, and anxiety in patients with cancer.

Limitations

  • Small sample (< 30)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Other limitations/explanation: It is not clear if baseline levels of symptoms were clinically significant. Authors compare results to a reference list of patients with cancer, but there is no comparison to other measures with known clinical significance levels.

Nursing Implications

Integrative therapies incorporating green space as well as other relaxation and supportive interventions may improve fatigue and anxiety and promote a sense of well-being in patients with cancer. This intervention included other components of relaxation, yoga, and group support, so it is not possible to tell how much the exposure to green space contributed to changes. Further research in this area would be useful. Exposure to the natural environment would be a relatively simple activity for patients to do on their own, and it may be helpful

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Nakatsumi, H., Komatsu, Y., Yuki, S., Sogabe, S., Tateyama, M., Muto, S., ... Asaka, M. (2012). Optimal dose period for indisetron tablets for preventing chemotherapy-induced nausea and vomiting with modified FOLFOX6: A randomized pilot study. Chemotherapy, 58(6), 439–444. 

Study Purpose

To determine the optimal dosing period for indisetron during modified FOLFOX6 in patients with advanced colorectal cancer

Intervention Characteristics/Basic Study Process

Eligible patients were randomly assigned to receive either a three-day or one-day endisetron dosing regimen arm. On day 1, indisetron 8 mg was administered orally and dexamethasone 8 mg was administered intravenously 30 to 120 minutes prior to the administration of oxaliplatin. In the three-day regimen arm, indisetron 8 mg was administered orally in the morning of days 2 and 3. In the one-day regimen, no prophylactic medications were given on days 2 and 3. Rescue medication was permitted, including dexamethasone and/or metoclopramide for the treatment of breakthrough emesis on an as-needed basis. The follow-up period was five days from the start of chemotherapy. The primary endpoint was complete protection from vomiting, defined as no vomiting for five days after initiation of chemotherapy.

Sample Characteristics

  • N = 42 
  • MEDIAN AGE: 60 years (three-day group); 67 years (one-day group); range = 37–80 years
  • MALES: 57 %, FEMALES: 43%
  • KEY DISEASE CHARACTERISTICS: Chemotherapy-naive patients with advanced colorectal cancer receiving modified FOLFOX6 without administration of molecular-targeted agents.
  • OTHER KEY SAMPLE CHARACTERISTICS: Other eligibility criteria include age between 20 and 80 years; a score of 0–2 on the Eastern Cooperative Oncology Group performance status; and adequate hematologic, hepatic, and renal function.

Setting

  • SITE: Multi-site  
  • SETTING TYPE: Not specified  
  • LOCATION: Patients were all treated at eight hospitals belonging to the Hokkaido Gastrointestinal Cancer Study Group in Japan.

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Multi-center, randomized, comparative, open-label pilot study

Measurement Instruments/Methods

  • Common Terminology Criteria for Adverse Events version 3.0

Results

The proportion of patients with complete protection from vomiting was 85.7 % (95% CI 63.7–97.0) in the three-day regimen arm and 81% (95% CI 58.1–94.6) in the one-day regimen arm. In the acute phase, the proportion of patients with no nausea was 100% in the three-day arm and 95.2% in the one-day arm. The proportion of patients with complete response in the delayed phase was 66.7% in the three-day regimen arm and 57.1% in the one-day regimen arm. No-rescue therapy rates were 66.7% (95% CI 43.0–85.4) in the three-day regimen and 57.1% (95%CI 34.0–78.2%) in the one-day regimen. Severity of nausea and vomiting based on the worst grade was similar between both regimens.

Conclusions

The study demonstrated that three-day dosing of indisetron is equivalent in efficacy to a one-day dosing schedule for patients receiving mFOLFOX6. The combination of indisetron and dexamethasone is effective in preventing emesis in about 80% of patients receiving mFOLFOX6. However, neither regimen (three-day or one-day) was particularly effective for preventing delayed chemotherapy-induced nausea and vomiting (CINV).

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Measurement/methods not well described
  • Measurement validity/reliability questionable
  • Findings not generalizable

Nursing Implications

This study demonstrated equivalent efficacy for indisetron plus dexamethasone with past 5-HT3 receptor antagonists to prevent acute CINV with mFOLFOX6. However, multiday dosing was not effective in preventing delayed CINV in many patients. This article does not provide evidence to support a practice change.

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Nakamura, Y., Lipschitz, D. L., Kuhn, R., Kinney, A. Y., & Donaldson, G. W. (2013). Investigating efficacy of two brief mind-body intervention programs for managing sleep disturbance in cancer survivors: a pilot randomized controlled trial. Journal of Cancer Survivorship, 7, 165–182.

Study Purpose

To determine the effects of mindfulness meditation (MM) and mind-body bridging (MBB) on self-reported sleep disturbance and quality of life (QOL) in cancer survivors.

Intervention Characteristics/Basic Study Process

All interventions lasted for three consecutive weeks, with weekly two-hour sessions. The sleep hygiene education (SHE) group served as an active control group. No usual care group was included.

  • MBB:  MBB is used to learn awareness skills that can help individuals recognize and change dysfunctional mind-body states. Sessions included training on identifying aspects of a mind-body state that might be contributing to poor sleep and learning skills of MBB (stress reduction and increasing self-awareness). Participants were encouraged to practice skills learned on a daily basis.
  • MM:  The program content was adapted from a six-week format and included sessions on forms of MM (awareness, body scans, walking meditation, and forgiveness meditation). Concerns about sleep were discussed in the context of MM techniques. Participants were encouraged to practice MM daily and were given mindfulness-based stress reduction (MBSR) meditation CDs and other handouts on MM and stress reduction. No actual homework sheets or practice tracking was required. One expressive writing assignment was completed.
  • SHE:  Education was pasted on the Huntsman Online Patient Education (HOPE) Guide and provided information about how to change sleep habits to improve sleep quality. Regular adherence to the guidelines provided was encouraged.

Sample Characteristics

  • The sample was comprised of 57 patients (24.5% male, 75.5% female).
  • Mean age was 52.6 years.
  • Participants were survivors of any type of cancer.
  • Participants were included if they had completed therapy at least three months prior to participation and had a report of sleep disturbance indicated by a score of 35 or greater on the Medical Outcomes Study Sleep Scale Index II subscale (MOS-SS, SPI-II).
  • Participants with prior experience with MM, MBB, MBSR, or mindfulness-based cognitive therapy were excluded.

Setting

  • Single site 
  • Other
  • Cancer Wellness House (nonprofit organization)

Phase of Care and Clinical Applications

Participants were undergoing the late effects and survivorship phase of care.

Study Design

This was a three-arm, randomized, controlled pilot study.

Measurement Instruments/Methods

  • MOS-SS, SPI-II
  • Functional Assessment of Cancer Therapy–General (FACT-G)
  • Perceived Stress Scale (PSS)
  • Center for Epidemiologic Studies Depression Scale (CESD)
  • Impact of Event Scale (IES)
  • Five-Facet Mindfulness Questionnaire
  • Self-Compassion Scale (SCS)
  • World Health Organization (WHO) Well-Being Index
  • Positive and Negative Affect Schedule (PANAS)
  • Screening and demographic questionnaire

Results

Baseline measurements of sleep differed significantly across groups at baseline (p = 0.011); adjusted baseline scores were used in the analysis. All intervention groups showed significant improvements in sleep quality from baseline (p < 0.001), although no immediate improvement was seen at  weeks 2 or 3 of any intervention arm. MM and MBB were effective longer after the intervention than SHE. FACT-G scores improved significantly from baseline in all groups (MBB:  p = 0.002; MM:  p = 0.010), although no significant difference was revealed in improvement across groups. Mean PSS scores decreased in all groups from baseline but with no significant difference across groups. All three arms had decreased CESD scores (SHE:  p = 0.001; MMB:  p = 0.008; MM:  p = 0.064), with MBB being more effective than SHE in reducing self-reported symptoms of depression (p = 0.040). MBB, but not MM, was also more effective at increasing mindfulness over SHE. Although scores improved for other secondary outcomes, there were no significant differences between groups.

Conclusions

MBB, SHE, and MM may improve sleep quality in cancer survivors. In addition, MBB may improve depressive symptoms and other comorbidities in this population.

Limitations

  • The study had a small sample size, with less than 100 patients.
  • Baseline sample/group differences were of import.
  • The study had risks of bias due to no control group, no blinding, and the sample characteristics.
  • Key sample group differences could have influenced the results.
  • Measurement validity/reliability was questionable.
  • Effects of MM may not have been apparent after only three weeks (this is typically a six- to eight-week program).
  • The study relied on self-report measures.
  • Patients were not evaluated for specific sleep disorders.
  • No measurement of intervention fidelity was reported. 
  • All groups showed improvement; without comparison to a study group with no intervention, efficacy of any of these interventions cannot be readily determined.

Nursing Implications

Simple targeted interventions may be effective in improving sleep quality in cancer survivors. Nurses should be aware of and assess for sleep disturbances in cancer survivors. Further study of interventions for sleep disturbance are needed to improve QOL for this population. Findings from this study suggest that the interventions studied here are feasible; however, the effectiveness of these interventions cannot be determined.

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Nakagaki, M., Barras, M., Curley, C., Butler, J.P., & Kennedy, G.A. (2017). A randomized trial of olanzapine versus palonosetron versus infused ondansetron for the treatment of breakthrough chemotherapy-induced nausea and vomiting in patients undergoing hematopoietic stem cell transplantation. Supportive Care in Cancer, 25, 607–613.

Study Purpose

To compare the effectiveness of infused ondansetron, olanzapine, and palonosetron for the treatment of breakthrough chemotherapy-induced nausea and vomiting (CINV) in recipients of hematopoietic stem cell transplantation (HSCT)

Intervention Characteristics/Basic Study Process

All patients received CINV prophylaxis of ondansetron 8 mg IV TID and aprepitant 165 mg PO (one dose). The aprepitant was given on the same day that the patients received high-dose cyclophosphamide or melphalan. All patients were able to take metoclopramide 10 mg PO or IV or lorazepam 1 mg sublingual for breakthrough CINV. Patients who required more than one dose of rescue antiemetics per day or had emesis or moderate/severe nausea (visual analog scale [VAS] ≥ 30 mm) were randomized into one of three treatment arms. 
  • Arm 1: Ondansetron 32 mg IV daily over 24 hours
  • Arm 2: Olanzapine 10 mg PO wafer daily plus ondansetron 8 mg IV TID
  • Arm 3: Palonosetron 0.25 mg IV (one dose) (did not receive ondansetron for three days)
Steroids could be administered for hypersensitivity to blood products or medications but could not be used as antiemetics. All other supportive medications were given per standard treatment protocol.

Sample Characteristics

  • N = 62   
  • AGE = 20–68
  • MALES: 62.9%, FEMALES: 37.1%
  • CURRENT TREATMENT: Chemotherapy, combination radiation and chemotherapy
  • KEY DISEASE CHARACTERISTICS: Recipients of allogeneic or autologous HSCT

Setting

  • SITE: Not stated/unknown   
  • SETTING TYPE: Not specified    
  • LOCATION: Australia

Phase of Care and Clinical Applications

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

Study Design

Randomized, open-label, prospective study

Measurement Instruments/Methods

  • Patients documented the number of emesis events and severity of nausea, which was measured with a 100 mm VAS ranging from 0 (no nausea) to 100 (worst possible nausea).
  • After patients were randomized into a treatment arm, data were collected at 24 hours and 48 hours postinitiation of treatment. Patients were asked to score the overall intensity and frequency of nausea for the previous 24 hours. 
  • Rescue antiemetic doses were obtained from the medication record.

Results

Primary end points were defined as no emesis, no use of rescue antiemetics, and reduction in nausea severity of 50% or more compared to nausea severity at the time of randomization. The secondary end point was defined as a nausea score reduction of 50% or more compared to nausea severity at the time of randomization. Six percent of patients receiving ondansetron, 45% of patients receiving olanzapine, and 18% of patients receiving palonosetron achieved the primary end point at 24 hours. Six percent of patients receiving ondansetron, 64% percent of patients receiving olanzapine, and 18% of patients receiving palonosetron achieved the primary end point at 48 hours. Olanzapine was significantly more effective than ondansetron at 24 and 48 hours (p = 0.01 and 0.0002). Olanzapine was significantly more effective than palonosetron at 48 hours (p = 0.005). For the secondary end point, olanzapine was significantly more effective than ondansetron at 24 and 48 hours (p = 0.0009 and p = 0.048) but was not significantly different than palonosetron at either time point. Palonosetron was significantly more effective than ondansetron at 24 hours (p =  0.008).

Conclusions

Olanzapine is an effective treatment for breakthrough CINV after an allogeneic or autologous hematopoietic stem cell transplantation when used with standard prophylaxis of ondansetron and aprepitant.

Limitations

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

 

Nursing Implications

For the treatment of breakthrough CINV in recipients of HSCT receiving prophylactic ondansetron and aprepitant, olanzapine is superior to palonosteron and ondansetron. This is an indication to include this as a part of patients' antiemetic regimens.

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Nainis, N., Paice, J.A., Ratner, J., Wirth, J.H., Lai, J., & Shott, S. (2005). Relieving symptoms in cancer: Innovative use of art therapy. Journal of Pain and Symptom Management, 31, 162–169.

Intervention Characteristics/Basic Study Process

The intervention was a one-hour art therapy session administered by a registered art therapist/counselor.

Sample Characteristics

The study reported on a sample of 50 adult inpatients with cancer.

Study Design

A quasi-experimental design was used.

Measurement Instruments/Methods

  • State-Trait Anxiety Inventory (STAI-S): To measure state anxiety
  • Edmonton Symptom Assessment Scale (ESAS)

Results

Change in anxiety scores was reported on both the STAI-S and ESAS (no p values were reported).

Limitations

  • The study reported on a small sample that was not randomized or controlled.
  • The study did not include data on dose, repeated measures, or longitudinal evaluation.
  • The study did not include pharmacologic assessment.
  • The study required specialized training of a registered art therapist/counselor.
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Naing, C., Aung, K., Racloz, V., & Yeoh, P.N. (2013). Safety and efficacy of transdermal buprenorphine for the relief of cancer pain. Journal of Cancer Research and Clinical Oncology, 139, 1963–1970.

Purpose

STUDY PURPOSE: To determine the efficacy and safety of transdermal buprenorphine for treating cancer pain

TYPE OF STUDY: Meta-analysis a systematic review

Search Strategy

DATABASES USED: MEDLINE, EMBASE, CINAHL, and the Cochrane Library up to May 2013

KEYWORDS: Search terms for the cancer type, including gastrointestinal, bladder, breast, stomach, colon, prostate, and lung; search term for buprenorphine

INCLUSION CRITERIA: Patients with cancer; RCTs; comparison of transdermal buprenorphine to placebo or any comparator drug; changes in cancer pain intensity measured by verbal rating scales, visual analog scales, numerical rating scales, or questionnaires

EXCLUSION CRITERIA: Sample size of less than 10 patients; pain that was not directly linked to the development of cancer or its treatment (i.e., chemotherapy-induced neuropathic pain); pain related to surgical procedures

Literature Evaluated

TOTAL REFERENCES RETRIEVED = 212

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: The quality of the studies was assessed by two reviewers using the domain-based evaluation.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 8 studies
  • SAMPLE RANGE ACROSS STUDIES = 17–189
  • TOTAL PATIENTS INCLUDED IN REVIEW = 909 patients
  • KEY SAMPLE CHARACTERISTICS: Not reported

Phase of Care and Clinical Applications

  • PHASE OF CARE: Multiple phases of care     
  • APPLICATIONS: Palliative care

Results

Two studies of patients whose pain relief was at least satisfactory at all time points found a significant difference between transdermal buprenorphine and placebo in all three doses of transdermal buprenorphine, 35.5, 52.5, or 70 micrograms per hour (RR 1.74, 95% Cl 1.31–2.32; I2 0%). Pain-free sleep was improved in two studies comparing transdermal buprenorphine to placebo (RR 1.25, 95% Cl 0.84–1.88; I2 0%). Adverse effects such as nausea, vomiting, and constipation were less with transdermal buprenorphine compared to fentanyl, morphine, or placebo.

Conclusions

Transdermal buprenorphine appears to be an effective and safe treatment for cancer pain; however, further research is needed to confirm its effectiveness because of the low quality of published research. Information about the following research quality indicators was unclear for a majority of the studies.

  • Random sequence generation
  • Allocation concealment
  • Blinding of participants
  • Blinding of outcome assessment

Limitations

  • A major limitation of this meta-analysis is that few studies used the same outcome measurement, so pooling of outcome data was problematic.
  • Follow-up of treatment effect was short (i.e, 15 days or less).

Nursing Implications

Although transdermal buprenorphine has been shown to have advantages over other opioids (i.e., noninvasive route, reduced respiratory depression, less frequent adverse effects), further research is needed to confirm its level of effectiveness in relieving cancer pain. In addition, the long-term effects of transdermal buprenorphine need to be determined. If nurses are caring for patients who are prescribed transdermal buprenorphine, they should be aware of the potential adverse effects, which are similar to other opioids.

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