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Hudson, P.L., Trauer, T., Lobb, E., Zordan, R., Williams, A., Quinn, K., . . . Thomas, K. (2012). Supporting family caregivers of hospitalised palliative care patients: A psychoeducational group intervention. BMJ Supportive and Palliative Care, 2, 115–120. 

Study Purpose

To examine the effectiveness of an inpatient group psychoeducational intervention for caregivers of patients receiving inpatient palliative care

Intervention Characteristics/Basic Study Process

Five education group sessions were delivered using a standardized method, the components and conduct of which were developed by authors in the pilot study that preceded the current study. Each was 90 minutes, and they focused on five topics: what palliative care is, the typical role of family caregivers (CGs), available support services to help CGs, preparing for the future, and self-care strategies for CGs. Caregivers were also given the opportunity to arrange individual meetings with designated multidisciplinary team members based on their needs. CGs were referred formally to family meetings if needed.

Sample Characteristics

  • N = 126 in T1, 107 in T2   
  • AGE = 57 years
  • MALES: 33.3%, FEMALES: 66.7%
  • CURRENT TREATMENT: Other
  • KEY DISEASE CHARACTERISTICS: Adults receiving palliative care, patients with various advanced cancers
  • OTHER KEY SAMPLE CHARACTERISTICS: Adults aged older than 18 years, CGs of adults with cancer receiving palliative care, English speakers, adults willing to be recognized as a patient's primary CG. Those with significant emotional distress were excluded.

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Inpatient    
  • LOCATION: Australia

Phase of Care and Clinical Applications

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

Study Design

Pre-/postdesign

Measurement Instruments/Methods

  • Family CGs’ needs measured with the Family Inventory of Needs (FIN)
  • Preparedness for CG role measured by the Preparedness for Caregiving Scale (PREP)
  • Competence for the CG role measured by the Caregiver Competence Scale (COMP)
  • General Health Questionnaire (GHQ) to determine if CGs were emotionally eligible to participate.
  • All measures had an alpha greater than 0.87.
  • Measurement occurred before the educational intervention and after three days.

Results

  • Significant (p = 0.028) but small effect (0.22) on FIN, indicating improvement in met needs
  • Significant (< 0.001), moderate effect (0.43) on preparedness
  • No significant change in general health or competence
  • A significant difference between those who declared a religious affiliation (improved GHQ scores) and those who had no religion

Conclusions

The educational intervention showed a small to moderate effect on reducing CGs' unmet needs and improved their sense of preparedness. The intervention did not affect CGs’ competence, although a trend of improvement was observed. The intervention did not improve CGs’ psychological well-being (secondary outcome—intervention was not geared to improve psychological well-being).

Limitations

  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Unintended interventions or applicable interventions not described that would influence results
  • Questionable protocol fidelity
  • Subject withdrawals ≥ 10%
  • Thirteen of the 52 educational sessions 1:1 rather than group

Nursing Implications

Educational interventions improved CGs' sense of preparedness and decreased their sense of unmet needs. They may help improve CGs’ competence.

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Hudson, P., Trauer, T., Kelly, B., O'Connor, M., Thomas, K., Zordan, R., & Summers, M. (2014). Reducing the psychological distress of family caregivers of home based palliative care patients: Longer term effects from a randomised controlled trial. Psycho-Oncology, 24, 19–24. 

Study Purpose

To evaluate changes in family caregiver distress between the referral of a patient with advanced cancer to palliative care and eight weeks after patient death based on caregiver involvement in a theoretically- and home-based one-on-one psychoeducational intervention

Intervention Characteristics/Basic Study Process

Family caregivers of patients with advanced cancer enrolled in home-based palliative care services in Australia were randomized to usual care (control) or one of two experimental groups that received usual care and one of two versions of a psychoeducational intervention. One intervention included one home visit and three phone calls, and the other included two home visits and two phone calls to meet rural access issues with some caregivers. Caregivers received written information in a piloted tested guidebook to prepare for the caregiver role, and trained family caregiver support nurses (FCSNs) used intervention manuals to provide consistency in developing and implementing plans to meet family role and caregiver psychological well-being and educational needs. Caregiver distress was measured within a two-week period of patient referral to palliative care (baseline, time 1), one week after the four-week intervention (time 2), and eight-weeks after patient death (time 3).

Sample Characteristics

  • N = 298  
  • MEAN AGE = Females; 59 years, males; 61.7 years (range = 22–88 years)
  • MALES: 30%, FEMALES: 70%
  • KEY DISEASE CHARACTERISTICS: English-speaking adult primary family caregivers of patients with advanced cancer enrolled in home-based palliative care
  • OTHER KEY SAMPLE CHARACTERISTICS: Exclusion criteria included caregivers of patients with nonmalignant diagnoses or a defined poor functional status

Setting

  • SITE: Multi-site    
  • SETTING TYPE: Home    
  • LOCATION: Three states in Australia

Phase of Care and Clinical Applications

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

Study Design

Randomized, controlled trial with two arms (two versions of intervention)

Measurement Instruments/Methods

  • General Health Questionnaire (GHQ): 12 items with a history of established reliability and validity

Results

The study sample included 86% urban caregivers. Diverse patient and caregiver factors caused a 42% caregiver attrition rate between time 1 and time 3 that affected the measurement of caregiver psychological well-being at eight-weeks after patient death. Almost 80% of caregivers provided care to a spouse or parent and lived with the patient an average of six years. There was a significant effect for age (p < 0.001) and gender (p < 0.04), and a close significance of time (p < 0.06), but no significant interaction of time with intervention. Younger and female caregivers had worse (higher) GHQ scores, and an overall analysis indicated that the intervention ameliorated a usual rise in caregiver distress after patient death but did not fully prevent an insult to caregivers' psychological well-being.

Conclusions

Psychological distress decreased by eight weeks after patient death among the caregivers of patients with advanced cancer enrolled in palliative care services if caregivers received a psychoeducational intervention involving one home visit and three phone calls.

Limitations

  • Unintended interventions or applicable interventions not described that would influence results: Authors acknowledged the inconsistency of caregiver support services as part of palliative care services, which would have affected FCSN effect with identified intervention
  • Subject withdrawals ≥ 10%

Nursing Implications

Trained FCSNs exert a powerful role in assisting the caregivers of patients with advanced cancer during the dying process, preventing the complications of prolonged grief. The implementation and evaluation of theoretically-based interventions, tailored to caregiver needs and sociocultural context, can support the efficient multidisciplinary team delivery of care to promote caregiver well-being.

Print

Hudson, P., Trauer, T., Kelly, B., O'Connor, M., Thomas, K., Summers, M., . . . White, V. (2013). Reducing the psychological distress of family caregivers of home-based palliative care patients: Short-term effects from a randomised controlled trial. Psycho-Oncology. [Epub ahead of print]

Study Purpose

To examine the effects of a four-step, nurse-led, in-person and phone-based psychoeducational intervention on psychological distress, perceived unmet needs, preparedness, competence, and positive emotions among family caregivers of patients with advanced cancer

Intervention Characteristics/Basic Study Process

Family caregivers of patients with advanced cancer enrolled in home-based palliative care services in Australia were randomized to usual care (control) or to a four-step intervention. Caregivers received a written instruction manual on preparation for the caregiving role and a home visit from a family caregiver support nurse (FCSN), who later developed a personalized care plan for the family’s needs in conjunction with the local palliative care team and educated the caregiver on indicated topics. The FCSN followed up by phone to assess needs and to evaluate the continued appropriateness of the care plan, and reinforced relevant educational and psychosocial coping topics, including attempts to assist the caregiver to identify positive aspects of the caregiving experience. Discussion to prepare for the patient’s death and bereavement was conducted during a second home visit, and a written summary of key strategies and resources for caregiving and coping was provided at the intervention’s conclusion.

Sample Characteristics

  • The sample was comprised of 161 family caregivers (70% female, 30% male).
  • Mean age of family caregivers was 59 years (range = 22–88 years).
  • Family caregivers cared for patients with advanced cancer who were enrolled in a home-based palliative care service.
  • Family caregivers were excluded if they were younger than age 18, unable to understand English, or if the patient for whom they cared had a nonmalignant diagnosis or poor functional status. (indicative of impending death).

Setting

  • Multisite 
  • Home setting
  • Three palliative care services in Australia

Phase of Care and Clinical Applications

  • End-of-life care phase
  • Palliative care

Study Design

 A randomized, controlled, two-arm trial design was used.

Measurement Instruments/Methods

  • General Health Questionnaire (GHQ) (12 items) – to measure psychological distress
  • Caregiver Competence Scale (4 items)
  • Preparedness for Caregiving Scale (8 items)
  • Family Inventory of Need–part/scale B (20 items)
  • Rewards for Caregiving Scale (10 items)

Results

No significant improvements were noted in the primary outcome, psychological distress, as measured by GHQ. Caregivers (especially older ones) who received both home visits scored higher for preparedness for caregiving (p = 0.035) compared to the control group, although the effect size was small (0.29 for the two-visit group). Caregiver competence scores were also significantly improved in the two-visit group compared to the controls (p = 0.04), but not for decrease in unmet needs or perceived positive aspects of caregiving postintervention.

Conclusions

The primary outcome of the study, decrease in psychological distress, was not met.

Limitations

  • The intervention may be expensive, impractical, or require training needs*.
  • Subject withdrawals were 10% or greater.
  • Though improvements in caregiver preparedness and competence were noted in the subjects in the intervention group that remained in the study long enough to receive both scheduled home visits, the attrition rate over the four-week period was high, limiting the potential recipients. Whether scores were significant in the two-visit recipients because of the intervention effect alone or due to characteristics of the patients/caregivers who were able to/chose to remain throughout is unknown.
  • Other limitations/*explanation: The authors noted a suboptimal accrual rate (40% of those eligible) with many refusals, indicating a potential selection bias by the caregivers. Attrition was 42% between time 1 and time 2, without a clear etiology, although a trend for those caregivers related to a patient with declining functional status to withdraw was noted.

Nursing Implications

This intervention, although previously piloted, theoretical, and evidence-based, was relatively labor intensive, involving personalized care planning with several reassessments by a study nurse outside of the established palliative care service. The authors noted that, on occasion, recommendations made by the FCSN to address unmet needs were unable to be acted upon by local staff due to inadequate resources, and this may have impacted the lack of significant change in scores. Additionally, a high attrition rate was noted, especially among the subgroup possibly most in need of extra support: caregivers with rapidly declining patients. Future work to support this group is needed.

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Hudson, P.L., Aranda, S., & Hayman-White, K. (2005). A psycho-educational intervention for family caregivers of patients receiving palliative care: A randomized controlled trial. Journal of Pain and Symptom Management, 30, 329–341.

Study Purpose

To examine the effects of a psycho-educational intervention on the reported levels of preparedness, mastery, self-efficacy, competence, rewards, and anxiety among caregivers of patients receiving home-based palliative care for advanced cancer in comparison to caregivers receiving standard care

Intervention Characteristics/Basic Study Process

The intervention was psycho-educational in nature and was delivered by intervention nurses through two intervention home visits and one intervention follow-up phone call. In addition to the interaction with the nurse, caregivers were given a caregiving guidebook and an audiotape. The guidebook provided easy-to-access information about caring for a dying person, and the audiotape contained a structured relaxation exercise and featured reflections from other carers who also reviewed self-care strategies. The control group received the usual care (24-hour access to phone advice, emergency visits, and prescheduled home visits from nurses, physicians, and other health professionals).

Sample Characteristics

  • The sample (N = 106) included 54 intervention group participants and 52 control group participants.
  • Mean age of participants was 60.78 years (SD = 13.98), with a range of 21–84 years.
  • The sample was 34.9% male and 65.1% female (as calculated by the reviewer).
  • All patients were receiving palliative care.
  • Eligibility criteria for the caregivers included a minimum age of 18 years and be living with a patient with cancer receiving palliative care, be English speaking, and be free of psychiatric illness that could impede ability to complete the study requirements.

Caregiver profile: The majority of caregivers (74.8%) were Australian-born, and 74.3% self-identified as Christians. Thirty-one (31.7%) of participants had professional or university education, and 34.6% did not complete high school education. The caregivers were giving care to their patient for a mean length of time of 16.3 weeks (SD = 5). The majority (87.6%) of participants expressed that they were involved in the care because they wanted to, not because they had to, and 43.4% had at least three friends or family members assisting them in providing care. About half of participants had to stop or reduce their work in order to be able to provide care for their patient. Caregivers of patients who were identified as Eastern Cooperative Oncology Group level 4 (completely disabled and confined to bed at all times) were excluded from participating when identified at screening.                                                                                                                                                                    

Patient profile: Patients cared for by caregivers had advanced cancer and were admitted to home-based palliative services within a week before recruitment. The mean age of patients was 69.14 years (SD = 13.46), with a range of 31–92 years. About half (48.1%) were confined to bed almost 50% of the time, and 11.3% were completely disabled and confined to bed all the time. The majority of patients (66.7%) were spouses or partners of caregivers; the rest were either parents of caregivers (16%) or their offspring (7.6%).   

Setting

  • Multisite
  • Home setting through palliative care centers
  • Two community (home-based) palliative care services in Melbourne, Australia

Phase of Care and Clinical Applications

  • End-of-life care phase
  • Pediatrics; elder care 

 

Study Design

The study design was a controlled trial with random assignment of participants to intervention versus control group. Data were collected at multiple times using self-reported questionnaires.

Measurement Instruments/Methods

  • Preparedness for Caregiving Scale (8 items): This scale has good reliability (0.86–0.92). The reliability coefficient in the current study was checked and was above 0.70 according to the authors. The tool was used to assess the perceived level of readiness for the caregiving role among participants.
  • Caregiver Competence Scale (4 items): This scale has good reliability (0.74). The reliability coefficient in the current study was checked and was above 0.70 according to the authors. The tool was used to assess the perceived level of adequacy to give care among participants.
  • Rewards of Caregiving Scale: The authors selected 10 of the 15 original items. This scale has good reliability (0.77–0.94). The reliability coefficient in the current study was checked and was above 0.70 according to the authors. The tool was used to assess the perceived benefits of giving care among participants.
  • Hospital Anxiety and Depression Scale (14 items): Cronbach’s alpha value was above 0.70 but was not specifically stated; however, it was mentioned that this tool has been widely used to screen for depression and anxiety among the terminally ill and that it was used previously with caregivers of patients with cancer. The authors chose 11 as the cutoff score to make determination about participants’ anxiety and depression.
  • Mastery” scale: This scale has 6 items from the original Caregiver Appraisal Scale (Lawton et al., 1989), which has 12 items. The 6-item scale has a poor reliability (0.59–0.61); the reliability coefficient in the current study was not reported, but because it was low, the authors mentioned that this scale was excluded.
  • Self-efficacy instrument: This tool has two subscales: (a) caregiver self-care efficacy (Cronbach’s alpha 0.76) and (b) problem-solving self-care efficacy (Cronbach’s alpha 0.83). The tool has good reliability for the two subscales, but the reliability coefficients in the current study were above 0.70. The authors reported that they made changes in two  items to make them appropriate for the study.

Results

The intervention and control group were compared to identify any significant differences between them, but none were detected.

Only 12 participants in the intervention group and 15 in the control group filled out the data questionnaires at all three time points. However, the number of participants who completed the data at times 1 and 2 was 75 (35 in the control and 40 in the intervention group), and at times 1 and 3 was 45 (25 in the control and 20 in the intervention group).

Findings of time 1 to time 2 (n = 75):

  • No main effect for group was noticed for preparedness, and no effect for interaction between group and time was noticed either. There was a trend (not significant) for main effect within subjects over time F(1,73) = 3.36, p = 0.071 (ƞ2 = 0.044), indicating that preparedness increased over time.
  • No main effect for group was noticed for rewards. There was a significant interaction between group and time, F (1,73) = 8.44, p = 0.005 (ƞ2 = 0.10); this indicated that while the control group showed a decreased sense of rewards between time 1 and time 2, the intervention group showed an increased sense of perceived rewards between the two assessment times. There was a trend (not significant) for main effect within subjects over time, F (1, 73) =  2.84, p = 0.096 (ƞ2 = 0.37).
  • No significant effects or trends were noticed for self-efficacy, competence, and anxiety.

Findings of time 1 to time 3 (n = 45):

  • No significant main effects between groups were noticed for preparedness, rewards, anxiety, or competence between time 1 and time 3.
  • There was a significant main effect within-subjects over time, F (1, 42) = 4.94, p = 0.032 (ƞ2 = 0.11) for competence. This means that participants, irrespective of group, had increased overall sense of competence at time 3 compared to time 1.
  • There was a main effect trend (not significant) within-subjects for time noted for anxiety F (1, 43) = 2.77, p = 0.10 (ƞ2 = 0.06), indicating that there was decreased anxiety among participants, irrespective of group, between time 1 and time 3.
  • The interaction between group and time was significant in rewards F (1, 43) = 4.68, p = 0.036 (ƞ2 = 0.098). Comparing the means showed that there was decreased average rewards scores among control group participants between time 1 and time 3 and an overall increase of these scores among members of the intervention group. Furthermore, there was a main effect trend (not significant) for “time” within-subjects for rewards F (1, 43) = 3.22, p = 0.08 (ƞ2 = 0.07); this indicates that there was increased sense of reward among participants, irrespective of group, between time 1 and time 3.

Conclusions

Although the study showed that the intervention did not show much effect on most of the assessed caregiver outcomes, it did reveal an unexpected finding. That is, participants in the intervention group showed increased perceived sense of reward over time compared to participants in the control group. The findings suggest that the increased sense of perceived reward may play a role as a coping resource and could potentially have a buffering effect from caregiving burden.
 

Limitations

  • The sample was small (< 30 participants).
  • Risk of bias existed (sample characteristics).*
  • Findings were not generalizable.* 
  • The intervention was expensive, impractical, or required training.*
  • Subject withdrawals were ≥ 10%.
  • Other limitations/*explanation: The study was done in Australia, which runs a different health system than the United States, and this could have implications. It remains unclear whether the lack of evidence for intervention effectiveness is due to the small numbers of participants or due to lack of variability among participants to start with. It is possible that those enrolled in the intervention and control groups were highly functional and independent individuals who did not need help; the fact that they chose to participate could indicate that they were people who were resourceful and willing to learn more about the caregiving experience. It is possible that those who declined participation are the ones who most needed an intervention.

Nursing Implications

Attrition of participants in caregiving studies seems to be a significant factor to consider and one that is hard to control.

The sense of reward or maintaining positive emotions by caregivers of patients in palliative care could be used as a resource to help caregivers cope with caregiving burden.

Although the study did not show much impact of the intervention, it supports the notion that giving information to caregivers is important, especially when given at selected times that are based on the caregivers’ needs during the caregiving experience. The “proper” timing for interventions, as well as the “proper” intervention with caregivers, are areas open for research. The need remains to identify the nature of interventions that are needed by caregivers. These needs seem to be variable depending on the healthcare system in which they are delivered, the specific characteristics of the caregivers, and the settings in which potential interventions are delivered.

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Huang, C.J., Hou, M.F., Kan, J.Y., Juan, C.H., Yuan, S.S., Luo, K. H., . . . Hu, S.C. (2015). Prophylactic treatment with adlay bran extract reduces the risk of severe acute radiation dermatitis: A prospective, randomized, double-blind study. Evidence-Based Complementary and Alternative Medicine, 2015, 312072.

Study Purpose

To evaluate the efficacy of oral treatment with adlay bran extract to prevent severe radiodermatitis

Intervention Characteristics/Basic Study Process

Adlay is an annual cereal crop that has been used in Chinese medicine. Patients were randomly assigned to receive either capsules containing adlay bran extract or placebo (olive oil) twice daily. The dosage was two capsules 500 mg each taken twice daily from the first day to the last day of radiotherapy. Skin assessment was conducted at baseline and at the end of treatment, at 5–6 weeks. Patients were asked not to take anti-inflammatory medications or apply topical agents during the study period. Compliance to study medication was assessed at every follow-up visit.

Sample Characteristics

  • N = 110
  • MEAN AGE = 51.6 years 
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: All had breast cancer. The radiation therapy dose was 50–50.4 Gy administered in 1.8–2 Gy fractions five days per week. Those who had received breast-conserving surgery (BCS) were given an additional boost dose.
  • OTHER KEY SAMPLE CHARACTERISTICS: Of the participants, 87% had received BCS. The mean body mass index was 22.6.

Setting

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

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

  • Placebo-controlled, double-blind, randomized, controlled trial

Measurement Instruments/Methods

  • Radiation Therapy Oncology Group (RTOG) criteria for skin grading

Results

In the adlay bran group, 5.5% had grade 0, 49.3% had grade 1, 34.2% had grade 2, and 11% had grade 3 radiodermatitis at the end of treatment. In the placebo group, 0% had grade 0, 24.3% had grade 1, 67.6% had grade 2, and 8.1% had grade 3 skin reaction. No patients developed grade 4 dermatitis. The overall lower severity of radiodermatitis in the adlay bran group was significant (p = 0.006). The majority did not have any adverse effects, and no serious adverse reactions were seen. Regression showed that higher body mass index and use of the adlay bran intervention were predictive of radiation dermatitis severity.

Conclusions

Patients receiving oral adlay bran extract had overall lower severity of skin reaction from radiation therapy.

Limitations

  • Unintended interventions or applicable interventions not described that would influence results
  • Results of compliance assessment were not reported.

Nursing Implications

The findings suggest that prophylactic oral adlay bran extract may have a protective effect to reduce the severity of radiation dermatitis. This substance has been used in traditional Chinese medicine for centuries and is believed to have anti-inflammatory and antioxidant properties. Adlay bran may have potential for the prevention of severe radiodermatitis. Further studies are needed to determine the optimal dosage and duration of administration.

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Huang, T.W., Tseng, S.H., Lin, C.C., Bai, C.H., Chen, C.S., Hung, C.S., … Tam, K.W. (2013). Effects of manual lymphatic drainage on breast cancer-related lymphedema: A systematic review and meta-analysis of randomized controlled trials. World Journal of Surgical Oncology, 11, 1–8.

Purpose

To examine the evidence on manual lymphatic drainage (MLD) in the prevention or management of limb edema in postsurgical women with breast cancer

Search Strategy

  • Databases searched were PubMed, EMBASE, CINAHL, SCOPUS, Cochrane Central Register, ClinicalTrials.gov, and PEDro.
  • Search keywords were MeSH terms for manual lymph drainage, breast cancer, and lymphedema.
  • Studies were included in the review if they were randomized controlled trials or quasi-experimental and evaluated the outcome of MLD for prevention or management of lymphedema. All studies involved patients with breast cancer.
  • Studies were excluded from the review if they included patients who did not have axillary lymph node excision or clinical outcomes were not clearly stated.

Literature Evaluated

The literature search retrieved 170 references. Authors independently evaluated methodological quality in terms of blinding, attrition, and use of intention-to-treat analysis. No specific tool for evaluation was described.

 

Sample Characteristics

  • Ten studies were included in the review.
  • The total sample size was 536 patients, with a range of 24–158.
  • Age ranged from 25–77 years.
  • All patients had undergone axillary lymph node excision for breast cancer.

Phase of Care and Clinical Applications

Patients were undergoing multiple phases of care.

Results

Some trials focused on prevention and others involved treatment of lymphedema. Nine studies were included in meta-analysis. Findings showed a risk ratio of 0.063 (95% CI 0.14, 2.83, p = 0.54). High heterogeneity existed. Standard mean difference (SMD) findings showed no benefit of MLD, with SMD = 75.12 (95% CI -9.34, 159.58). Findings showed that the addition of MLD to other individual components of complete rehabilitation such as compression bandaging does not show a significant benefit in reducing arm volume. Overall published reports of MLD show conflicting results. No significant differences were found in the incidence of lymphedema between patients treated with MLD or not.

Conclusions

MLD does not add significant benefit for prevention or management of lymphedema in patients with breast cancer.

Limitations

  • High heterogeneity existed between studies. 
  • Several trials were small.
  • Only half of the studies reported adequate randomization. 
  • In most studies, data collectors were not blinded.

Nursing Implications

Findings suggest that MLD as an adjunctive treatment is not effective in preventing or managing arm lymphedema in women with breast cancer who have had axillary lymph node excision.

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Huang, J., Wang, X.J., Yu, D., Jin, Y.N., Zhen, L.Z., Xu, N., ... He, J. (2013). The effect of palonosetron hydrochloride in the prevention of chemotherapy-induced moderate and severe nausea and vomiting. Experimental and Therapeutic Medicine, 5, 1418–1426. 

Study Purpose

To determine the effectiveness of palonosetron hydrochloride in preventing nausea and vomiting in patients receiving chemotherapy agents known to cause moderate to severe nausea and vomiting

Intervention Characteristics/Basic Study Process

The study involved administering 0.25 mg palonosetron and a placebo to the experimental group and 3 mg granisetron and a placebo to the control group 30 minutes prior to the administration of moderate to severe emetogenic chemotherapy.

Sample Characteristics

  • N = 240
  • MEAN AGE = 52.15 years (range = 31–73 years)
  • MALES: 26.7%, FEMALES: 73.3%
  • KEY DISEASE CHARACTERISTICS: Both the control group and the experimental group had similar percentages of diseases represented: 61% were patients with breast cancer; 21% were patients with non-small cell lung cancer; and the remaining 18% were patients with colorectal, gastric, esophageal, head and neck, and ovarian cancer.    
  • OTHER KEY SAMPLE CHARACTERISTICS: About 18% of patients in both groups received moderate emetogenic chemotherapy while about 82% received severely emetogenic chemotherapy. Karnofsky Performance Status scores were ≥ 60; life expectancy was > 3 months; bone marrow function was satisfactory; liver and renal function were normal; ECGs were normal; patients had no side effects from previous treatment except alopecia and nail changes at least three weeks before the last treatment of radiotherapy and chemotherapy; and informed consent was obtained.

Setting

  • SITE: Multi-site  
  • SETTING TYPE: Not specified 
  • LOCATION: Eight trial centers in China

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Randomized, multi-centered, double-blind, double-dummy, parallel-group, positive-controlled clinical trial

Measurement Instruments/Methods

There were observational intervals of acute (0–24 hours), delayed (24–120 hours), and full-course (0–120 hours) vomiting. Criteria used to evaluate the effect of palonosetron on vomiting were complete remission (CR) = 0 times/24 hour; partial remission (PR) = 1 time/24 hour; mild remission (MR) = 2–5 times/24 hour; and failure (F) = > 5 times/24 hours. Remission rates were calculated as CR rate = number of vomiting-free cases/total number of cases; PR rate = number of PR cases/total number of cases; and effective rate = number of CR+PR+MR cases/total number of cases.  
 
Criteria used to evaluate the effect of palonosetron on nausea were complete control (CC) = normal and nausea-free and partial control (PC) = poor appetite with no changes in food habits or decreased food intake, no marked weight loss, dehydration, or malnutrition and an infusion time of ≤ 24 hours (moderate nausea). Control rates were calculated as CC rate = number of CC cases/total number of cases and PC rate = number of CC + PC cases.

Results

The acute vomiting CR rates of both the experimental and control groups showed no significant difference—the experimental group was 49% while the control group was 42%.
 
The delayed vomiting CR rates were significantly different between both groups—the experimental group was 51.75% versus 31.03% (p = .002, 95% CL). There were no significant differences between the vomiting control times, treatment failure times, or acute vomiting.

Conclusions

Palonosetron hydrochloride demonstrated better control of delayed vomiting and has a positive preventative effect on delayed nausea and vomiting. There was no difference between granisetron and palonosetron in preventing acute vomiting CR rates, full-course vomiting CR rates, vomiting control time, treatment failure, acute nausea CR rate, or adverse effects.

Limitations

  • Measurement/methods not well described

Nursing Implications

Palonosetron hydrochloride is an effective 5-HT3 antagonist in preventing delayed nausea and vomiting related to high to moderate emetogenic chemotherapy as compared to another 5-HT3 antagonist, granisetron.

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Hu, W., Fang, J., Nie, J., Dai, L., Chen, X., Zhang, J., . . . Han, J. (2014). Addition of aprepitant improves protection against cisplatin-induced emesis when a conventional anti-emetic regimen fails. Cancer Chemotherapy and Pharmacology, 73, 1129–1136. 

Study Purpose

To study the effectiveness of aprepitant as a secondary agent to prevent chemotherapy-induced nausea and vomiting (CINV) in patients with lung cancer for whom cisplatin-induced nausea and vomiting was poorly controlled by a conventional antiemetic regimen of granisetron and dexamethasone

Intervention Characteristics/Basic Study Process

Stage 1 of the study recruited patients receiving cisplatin-based chemotherapy being actively treated for lung cancer. Patients who experienced vomiting of grade 2 or higher and needed rescue antiemetics during their first cycle of chemotherapy (stage 1) were enrolled in stage 2 of the study. During stage 2, patients had oral aprepitant added on day 1 at 125 mg and on days 2 and 3 at 80 mg daily of subsequent chemotherapy cycles. Patients were asked to keep diaries during the first two chemotherapy cycles.

Sample Characteristics

  • N = 25 (stage 2)  
  • MEDIAN AGE = 61 years (range = 32–71 years)
  • MALES: 4, FEMALES: 21
  • KEY DISEASE CHARACTERISTICS: All patients were being actively treated for lung cancer.
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients were expected to receive at least two cycles of cisplatin-based chemotherapy.

Setting

  • SITE: Single site    
  • SETTING TYPE: Inpatient    
  • LOCATION: Beijing, China

Phase of Care and Clinical Applications

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

Study Design

Two-stage, prospective observation study

Measurement Instruments/Methods

  • Demographics and patient characteristics were collected. 
  • Patients recorded the number and times they experienced vomiting or retching, the frequency and timing of rescue antiemetic use, the severity of CINV, and adverse events or additional medications taken.
  • CINV was monitored for acute (0–24 hours) and delayed (25–120 hours) episodes using the Common Terminology Criteria for Adverse Events version 3 grading scale.
  • Outcomes were classified as complete response (CR, no emetic episodes or use of rescue therapy) or complete control (CC, no nausea, emetic episodes, or rescue therapy).

Results

Patients who advanced to stage 2 of the study and who had aprepitant added to subsequent chemotherapy regimens reported significantly less acute and delayed nausea and vomiting compared to their first chemotherapy cycle. During the first cycle of chemotherapy, 18.7% of the 132 patients initially recruited required rescue antiemetics, and 52% required intravenous hydration. Of the 25 patients continuing to stage 2 of the study, none required rescue antiemetics or required intravenous hydration. 64% met the criteria for CR, and 28% met the criteria for CC after round two of chemotherapy.

Conclusions

The findings of this study show that aprepitant was effective in preventing acute and delayed nausea after high-dose, cisplatin-based chemotherapy for patients with lung cancer at a high risk of emesis, anticipatory vomiting, and poor CINV control.

Limitations

  • Small sample (< 30)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Unintended interventions or applicable interventions not described that would influence results
  • Findings not generalizable
  • Other limitations/explanation: The study was not blinded, the role of anticipatory nausea and vomiting was not considered, and the effects of the addition of aprepitant was only studied in cycle 2. 

Nursing Implications

Nursing care would benefit from improved strategies to manage CINV for patients with lung cancer receiving chemotherapy. However, the authors of this study acknowledged that larger randomized, controlled studies are needed before recommendations can be made. The assessment of CINV risk during all cycles of chemotherapy is an important aspect of nursing care and patient advocacy. Outcomes for CINV improve when standardized antiemetic guidelines are followed.

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Hu, Z., Cheng, Y., Zhang, H., Zhou, C., Han, B., Zhang, Y., ... Zhang, L. (2014). Aprepitant triple therapy for the prevention of chemotherapy-induced nausea and vomiting following high-dose cisplatin in Chinese patients: A randomized, double-blind, placebo-controlled phase III trial. Supportive Care in Cancer, 22(4), 979–987. 

Study Purpose

To determine the efficacy of aprepitant on patients in Asian countries receiving highly emetogenic chemotherapy (HEC)

Intervention Characteristics/Basic Study Process

Patients receiving HEC were stratified by gender and randomized to receive either aprepitant or a standard therapy with a placebo. Placebo medications were matched to aprepitant capsules. Data were collected from the time of chemotherapy (0 hours) to six days (120 hours). Patients recorded vomiting episodes, daily nausea, and rescue medications.

Sample Characteristics

  • N = 411
  • AGE = > 18 years
  • MALES: 66 %, FEMALES: 34% 
  • KEY DISEASE CHARACTERISTICS: Solid tumors, cisplatin-naïve, and Karnofsky Performance Status Scale score > 60
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients were excluded for current illicit drug use; evidence of alcohol abuse; symptomatic primary or metastatic CNS malignancy; administration of chemotherapy of moderate or high emetogenicity within the prior six days; scheduled administration of abdomen/pelvis radiation therapy within one week; scheduled administration of multiple-day chemotherapy with cisplatin in a single cycle or stem cell rescue therapy with cisplatin chemotherapy; active infection or other uncontrolled disease; or concurrent medical conditions precluding Decadron use.

Setting

  • SITE: Multi-site  
  • SETTING TYPE: Outpatient  
  • LOCATION: China, 16 independent centers

Phase of Care and Clinical Applications

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

Study Design

A phase III, randomized, double-blind, placebo-controlled, parallel-group trial

Measurement Instruments/Methods

Patients self-reported the times and dates of vomiting or retching episode(s), use of rescue therapy, and daily nausea assessments during the first chemotherapy cycle along with Visual Analog Scale (VAS) overall nausea ratings. Patients were contacted on the mornings of days 2–6 to ensure compliance. Functional Living Index-Emesis (FLIE) questionnaire scoring was self-administered early on day 6 directly following completion of final self-reports.

Results

Of the 421 randomized patients, 411 (98%) were assessable for efficacy; 69.6% (142/204) and 57.0% (118/207) of patients reported complete response (CR) during the OP in the aprepitant and standard therapy groups, respectively (p = 0.007). CR rates in the aprepitant group were higher during the DP (74.0% versus 59.4%, p = 0.001) but were similar during the AP (79.4% versus 79.3%, p = 0.942). Toxicity and adverse events were comparable in both groups.

Conclusions

The addition of aprepitant to standard antiemetic treatment regimens for Chinese patients undergoing HEC provided superior chemotherapy-induced nausea and vomiting prevention and was very well tolerated.

Limitations

The efficacy and tolerability of aprepitant were studied only for one or two cycles of chemotherapy; further study will be required for multi-cycle treatment. 56.4% of patients in the aprepitant arm used Chinese medicine versus 49% in the control arm.

Nursing Implications

Aprepitant is well-tolerated and effective in the treatment of CINV in Chinese patients receiving HEC. This is the first study in Chinese chemotherapy patients. Based on nursing knowledge of drug metabolism, this is an important study to assess that aprepitant provides efficacy in this group of chemotherapy patients.

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Hsiung, W.T., Chang, Y.C., Yeh, M.L., & Chang, Y.H. (2015). Acupressure improves the postoperative comfort of gastric cancer patients: A randomised controlled trial. Complementary Therapies in Medicine, 23, 339–346. 

Study Purpose

To determine if acupressure affects the postoperative comfort of patients following subtotal gastrectomy

Intervention Characteristics/Basic Study Process

Patients were randomized to acupressure care and control groups. Control patients received usual care. The acupressure group received the intervention for three days. Pressure to the P6 and ST36 acupoints on both sides was applied for 12 minutes using the thumb to apply pressure followed by release, kneading of the area, and release again for each site. The intervention was provided by a trained researcher. Data were obtained at baseline and after the intervention, which began the second day after surgery. Experimental and control patients were placed in different wards in the hospital.

Sample Characteristics

  • N = 54
  • MEAN AGE = 62.3 years (SD = 15.3 years)
  • MALES: 78%, FEMALES: 22%
  • KEY DISEASE CHARACTERISTICS: All received subtotal gastric resection for gastric cancer

Setting

  • SITE: Single site  
  • SETTING TYPE: Inpatient  
  • LOCATION: Taiwan

Phase of Care and Clinical Applications

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

Study Design

Randomized, controlled trial

Measurement Instruments/Methods

  • 11-point Numeric Rating Scale (NRS) for pain
  • Rhodes Index of Nausea Vomiting and Retching (RINVR)

Results

There were no significant differences in the trends for pain or postoperative nausea and vomiting between groups.

Conclusions

This study did not show a significant benefit from acupressure for the management of acute pain.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Risk of bias (no appropriate attentional control condition)
  • Key sample group differences that could influence results 
  • Measurement/methods not well described 
  • Subject withdrawals ≥ 10% 
  • Other limitations/explanation: The exact timing and method of obtaining data were not clearly explained, and although it was stated that all patients received the same analgesic regimen, the data showed that some patients received IV PCA, some received epidural analgesia, and some had “other.”

 

Nursing Implications

This study did not demonstrate evidence for the efficacy of acupressure for the management of postoperative pain. Additional research would be useful to determine beneficial adjunctive interventions for acute pain management.

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