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Blackhall, L., Petroni, G., Shu, J., Baum, L., & Farace, E. (2009). A pilot study evaluating the safety and efficacy of modafinal for cancer-related fatigue. Journal of Palliative Medicine, 12, 433–439.

Study Purpose

The primary aim was to evaluate the safety and efficacy of modafinil in improving cancer-related fatigue (CRF) in patients with cancer.

The secondary aim was to assess the effect of modafinil on depression, quality of life (QOL), functional status, and cognitive function.

Intervention Characteristics/Basic Study Process

After initial assessment for all outcome measures, patients were treated with self-administered modafinil at an initial dose of 100 mg per day during weeks one to two. During weeks three to four, the dose was increased to 200 mg per day. All study parameters were reassessed at week two and at week four (completion of the trial).

Sample Characteristics

  • Twenty-seven patients were enrolled, and 19 completed the study.
  • Average age was 60 years.
  • Of the participants, 37% were male and 63% were female.
  • Eastern Cooperative Oncology Group (ECOG) Performance: ECOG 1 was 37%; ECOG 2 was 44%; and ECOG 3 was 19%.

Study Design

This was an open-label pilot study.

Measurement Instruments/Methods

  • Primary Aim: Brief Fatigue Inventory (BFI)–Fatigue
  • Secondary Aim
    • Cognitive Measures
      • Hopkins Verbal Learning Test (HVLT)—assessed verbal learning and memory
      • Grooved Pegboard Test—fine motor ability and hand-eye coordination
      • Controlled Oral Word Association Test (COWAT)—verbal fluency
      • Trail Making Test (TMT) Parts A & B—visual attention, motor speed, and cognitive flexibility
    • Other Measures
      • Hospital Anxiety and Depression Scale (HADS)—depression
      • Functional Assessment of Cancer Therapy-Brain (FACT-BR)—QOL
      • Barthel Index—functional status
      • ECOG—performance status
      • National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0––scored severity of detected side effects

Results

BFI was improved at two weeks for 46% of participants, and at four weeks, 75% had a significantly improved score (p = 0.025). FACT-BR showed an improvement in all subsets of well-being except social/family at two and four weeks (p < 0.05). HADS score declined significantly at two and four weeks (p < 0.001). Cognitive function was not significantly changed, except TMT-B showed a trend for an overall improvement. Functional status (Barthel Index) did not change, but overall performance status (ECOG) improved, with 40% of patients improving at least one level. Most side effects were mild. Side effects seen were dizziness, nausea, diarrhea, and heartburn.

Conclusions

Modafinil use was associated with improvement in fatigue, depression, and QOL measures and was well tolerated.

Limitations

  • The study had a small sample size, with an almost 30% drop-out rate.
  • The study was an open-label design pilot study.
  • No control comparison was included.
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Björneklett, H. G., Lindemalm, C., Ojutkangas, M. L., Berglund, A., Letocha, H., Strang, P., & Bergkvist, L. (2012). A randomized controlled trial of a support group intervention on the quality of life and fatigue in women after primary treatment for early breast cancer. Supportive Care in Cancer, 20, 3325–3334.

Study Purpose

To evaluate the effects of a psychosocial support intervention on health-related quality of life (QOL) and fatigue.

Intervention Characteristics/Basic Study Process

Participants were randomized to an intervention or usual care control group. The intervention consisted of education sessions mixed with exercise, relaxation training, massage, qigong, visualization, and social activities, such as concerts and museum and restaurant visits. As reported in a previous pilot study, participants were residents at a spa-type facility during the intervention. The intervention was provided by an interdisciplinary group comprising physicians, psychologists, an art therapist, a massage therapist, a dietician, social workers, and a trained qigong provider for seven days. Follow-up was performed at two, six, and 12 months. Participants in the usual care control were only provided follow-up data collection.

Sample Characteristics

  • In total, 360 participants (100% female) were included.             
  • Mean age was 58 years (range 30–84).
  • All participants had breast cancer. Most had undergone breast-conserving surgery and had received or were receiving radiation therapy.
  • Of the participants, 53% were married.

Setting

  • Single site  
  • Inpatient   
  • Sweden

Phase of Care and Clinical Applications

  • Participants were undergoing the transition phase after active treatment.
  • The study has clinical applicability for elderly care.

Study Design

The study was a randomized, controlled trial.

Measurement Instruments/Methods

  • Swedish version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), including the 23-item breast cancer module
  • Fatigue Questionnaire, Swedish version

Results

Fatigue scores were similar in both groups and declined over time up to 12 months in both groups. There were no differences in fatigue levels over time between the groups. There were no significant effects of the intervention on QOL measures.

Conclusions

The multimodal intervention demonstrated no significant effect on QOL or fatigue.

Limitations

  • The study had risks of bias due to no blinding, no appropriate attentional control condition, and the sample characteristics.
  • The findings were not generalizable.
  • The intervention was expensive, impractical, and required training.
  • Participants tended to self-select for involvement. 
  • This type of week-long stay and set of interventions can be expected to be expensive.

Nursing Implications

The specific approach providing a multifaceted, psychoeducational type of intervention was not shown to affect fatigue or QOL in women with breast cancer. The most effective content, duration, and frequency of psychosocial and multimodal support interventions were not clear.

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Björneklett, H.G., Rosenblad, A., Lindemalm, C., Ojutkangas, M.L., Letocha, H., Strang, P., & Bergkvist, L. (2013). Long-term follow-up of a randomized study of support group intervention in women with primary breast cancer. Journal of Psychosomatic Research, 74(4), 346–353.

Study Purpose

Long-term follow-up to evaluate quality of life after support group intervention in a randomized group of women with primary breast cancer presenting for postoperative radiotherapy.

Intervention Characteristics/Basic Study Process

The current study is a long-term follow-up 5–9 years after randomization into groups. The intervention and control groups were stratified by chemotherapy or nonchemotherapy treatment. The intervention was a one-week support group with four days of follow-up two months postintervention during residential care at the Foundation of Lustgården Mälardalen. The intervention involved lectures and group discussions about the etiology of cancer, risk factors, treatment, physical and psychological effects, and coping strategies. Patients engaged in physical exercise, relaxation, Qigong, and nonverbal communication exercises, as well as art and dance therapy. All participants completed questionnaires at baseline and follow-up questionnaires at 2, 6, and 12 months postintervention. The control group participated only in routine follow-up at the Department of Oncology or the Department of Surgery.

Sample Characteristics

  • N = 382 (final sample); 191 in intervention group and 191 in control group
  • AGE RANGE: 30–83
  • MALES: 0 %, FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Patients were newly diagnosed with primary breast cancer at the beginning of the parent study.

Setting

  • SITE: Single site    
  • SETTING TYPE: Outpatient   
  • LOCATION: Department of Oncology at the Central Hospital in Västeräs, Sweden

Phase of Care and Clinical Applications

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

Study Design

  • Prospective randomized trial
    • Long-term follow-up comparison of test scores at baseline, 12 months, and at end

Measurement Instruments/Methods

  • Hospital Anxiety and Depression Scale (HADS)
  • European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
  • European Organisation for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire (QLQ-BR23)
  • Fatigue Questionnaire (FQ)

Results

Fatigue symptoms improved over time, which was a significant finding in the intervention and control groups. Being upset about hair loss improved over time in the intervention group. High anxiety scores improved over time and were not significantly different between the two groups in long-term follow-up. Depression scores were high at follow-up for seven women in each group, and no significant difference was found at baseline and postintervention, adjusting for covariates. Neither group showed improvement between the 12-month follow-up and long-term follow-up. 

Conclusions

Effects of support group intervention may provide a sense of security that can fade over time, reversing improvements in anxiety and depression. Treatment-related fatigue may improve over time. Significant improvement was found in cognitive function, body image, and future perspective, but no significant effect was found on levels of anxiety and depression.

Limitations

  • An average of 6.5 years elapsed between the parent study and the follow-up study.
  • Participants were lost to follow-up between the parent study and the follow-up study.
  • No initial need for an intervention was conducted.

Nursing Implications

Women who have received chemotherapy have greater symptom severity and may benefit more on global health and cognitive function fatigue, when compared to women who have not received chemotherapy. Additional research is needed to evaluate the influence of exercise and psychosocial support interventions, according to patient needs for content, duration, and an assessment of spiritual well-being using the Functional Assessment of Chronic Illness Therapy (FACIT).

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Björneklett, H.G., Lindemalm, C., Rosenblad, A., Ojutkangas, M.L., Letocha, H., Strang, P., & Bergkvist, L. (2012). A randomised controlled trial of support group intervention after breast cancer treatment: Results on anxiety and depression. Acta Oncologica, 51, 198–207.

Study Purpose

To evaluate the effect of a support program on anxiety and depression in patients with breast cancer

Intervention Characteristics/Basic Study Process

The intervention was a weeklong multidisciplinary residential program. The intervention took place within four months after the end of tumor treatment and ran for seven days, followed by four days of follow-up two months after the initial visit. The team consisted of oncologists, social workers, art therapists, massage therapists, a dietitian, and a mindfulness practitioner.

Sample Characteristics

  • The study reported on a sample of 382 female patients with breast cancer; 309 completed the 12-month follow-up.
  • Mean ages in the treatment group were 54 years (range = 30–69) and 61 years (range = 34–84).
  • Mean ages in the control group were 55 years (range = 38–70) and 62 years (range = 38–83).
  • Patients were subgrouped into whether they had chemotherapy or not. Patients had either breast-conserving surgery or mastectomy. Those with breast-conserving surgery or lymph node involvement also received radiation therapy.

Setting

  • Single site
  • Retreat center setting
  • Sweden

Phase of Care and Clinical Applications

  • Transition phase of care
  • Late effects and survivorship

Study Design

A randomized controlled trial design was used.

Measurement Instruments/Methods

Hospital Anxiety and Depression Scale (HADS)–Swedish version

Results

After 12 months, 10% in the intervention group versus 19% in the control group had a high anxiety score (p = 0.055).

Conclusions

Support group intervention including education about the disease and psychological reactions, mixed with art and dance therapy, qigong, and relaxation, was shown to positively influence anxiety levels among patients with breast cancer over time, whereas depression levels were unaffected by the intervention.

Limitations

  • A variety of interventions and providers were used, limiting the ability to transfer the findings to other venues.
  • Reproducibility is an issue.
  • The study had no appropriate attentional control.

Nursing Implications

Because of costs and time constraints, the ability of this program to be replicated is suspect. The particular components of the program that provided the most effectiveness were not analyzed and therefore cannot be reproduced or further studied.

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Bjordal, J.M., Bensadoun, R.J., Tuner, J., Frigo, L., Gjerde, K., & Lopes-Martins, R.A. (2011). A systematic review with meta-analysis of the effect of low-level laser therapy (LLLT) in cancer therapy-induced oral mucositis. Supportive Care in Cancer, 19, 1069–1077.

Purpose

Review the effects of low level laser therapy (LLLT) in prevention and treatment of oral mucositis induced by cancer therapy. Meta-analysis was done, and all results are provided.

Search Strategy

Databases searched were Medline, EMBASE, CINAHL, PedRo, and Cochrane Controlled Trial Register. Hand searching in physiotherapy and medical journals from several countries also were used.

Search keywords were low level laser therapy, low intensity laser therapy, low energy laser therapy, phototherapy, oral mucositis, cancer, chemotherapy, radiation therapy, and specific laser types.

Studies were included if they

  • Involved patients with cancer who had been diagnoses with oral mucositis after chemotherapy or radiation therapy.
  • Used treatment with laser therapy with wavelengths of 632–1064 nm.
  • Incorporated a randomized parallel group or crossover design, with blinding and placebo control with identical placebo laser.

Literature Evaluated

A total of 149 papers were initially retrieved. Literature was evaluated using the Jadad checklist and inclusion of study funding sources.

Sample Characteristics

A final sample of 11 trials published from 1997–2009 included 415 patients. Samples ranged from 21–70 subjects and included those receiving chemotherapy, radiation therapy, combined therapy, and transplant cases. One study was done in children.

Results

  • Six trials involved prevention of OM. The overall effect size was 2.31 in favor of laser (p = 0.02). In one trial, which used less than 1 joule, results did not favor laser use. Subgroup analysis showed positive results with laser whether done before cancer therapy, before and during therapy, or during therapy.
  • Five trials assessed duration of OM. Overall effect size was 8.35 in favor of laser therapy (p < 0.00001).
  • Seven trials assessed severity of OM. Overall effect size was 4.01 in favor of laser (p < 0.00001). Subgroup analysis showed there was no significant difference in these findings with different wavelengths of infrared LLLT.
  • Three trials studied the effect on pain. Effect size was 4.97 in favor of laser (p < 0.00001).
  • All analyses showed substantial heterogeneity. LLLT was well tolerated with no serious incidents or withdrawals because of the LLLT treatment.

Conclusions

Moderate to strong evidence was found for effectiveness of LLLT in the prevention of OM, reduced duration and severity of OM, and reduced pain with doses of 1–6 joules per point. Trials aimed at prevention started LLLT seven days before cancer treatment regimens, and effective dosing seen ranged from 1–6 joules. This meta-analysis supported the effectiveness of LLLT in the dosage ranges reported here for the prevention and management of oral mucositis.

Limitations

The quality of studies was determined to be high; however, substantial variation existed in the actual treatment procedures, number of treatments, timing of treatments, and heterogeneity in the overall findings.

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Biswal, B.M., Sulaiman, S.A., Ismail, H.C., Zakaria, H., & Musa, K.I. (2013). Effect of Withania somnifera (ashwagandha) on the development of chemotherapy-induced fatigue and quality of life in breast cancer patients. Integrative Cancer Therapies, 12, 312–322. 

Study Purpose

To examine the effects of Withania somnifera (WS) on fatigue and quality of life among patients with breast cancer receiving chemotherapy

Intervention Characteristics/Basic Study Process

WS was supplied as a powder in 500 mg capsules. Patients was asked to take four capsules three times daily for total daily dose of 6 g. Patients were followed for six cycles of chemotherapy. Study measures were conducted at baseline and periodically through treatment. Some measures were conducted on the first day of every cycle, and others were conducted on the first day of cycle 1, 3, and 6. Consecutive patients were alternately assigned to treatment or usual care groups.

Sample Characteristics

  • N = 100  
  • MEAN AGE = 50.75 years (range = 32–72)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: All had breast cancer. Chemotherapy was done as either adjuvant or palliative treatment. Most patients had stage II or III disease. Patients were either on regimens of cyclophosphamide, epirubicin, and 5FU, or taxotere, adriamycin, and 5FU.

Setting

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

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active anti-tumor treatment
  • APPLICATIONS: Palliative care 

Study Design

  • Non-random, open label, two-group comparison

Measurement Instruments/Methods

  • Piper Fatigue Scale
  • Schwartz Cancer Fatigue Scale
  • EORTC QOL-C30

Results

Several QOL measures were significantly better in the treatment group compared to controls: physical functioning (p < .001), role functioning (p < .001), insomnia (p < .001), loss of appetite (p = .011), emotional functioning (p < .001), and social functioning (p < .001). Fatigue scores were significantly better as shown by repeated measures ANOVA in the intervention group (p ≤ .003). Ninety-eight percent of intervention patients found the intervention acceptable.

Conclusions

Findings suggest that the herbal treatment of WS is beneficial for the management of fatigue in patients with breast cancer undergoing chemotherapy.

Limitations

  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Other limitations/explanation: No information on adherence to the WS regimen; therefore, it is unclear if patients took all of the substance as planned. At baseline, the control group had significantly lower QOL scores.

Nursing Implications

The herbal treatment of WS, which has been used in Ayurveda medicine, may be beneficial to reduce fatigue in patients with cancer. This particular study has several important limitations; however, results are promising. Additional well-designed research with this herbal remedy is warranted.

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Bischoff, K., Weinberg, V., & Rabow, M.W. (2013). Palliative and oncologic co-management: Symptom management for outpatients with cancer. Supportive Care in Cancer, 21, 3031–3037.

Study Purpose

To assess the association between palliative care management, symptoms, and quality of life

Intervention Characteristics/Basic Study Process

Clinical records of patients referred for outpatient palliative care who had follow-up visits within 120 days of initial referral were included. Retrospective analysis of clinical data was done.

Sample Characteristics

  • N = 266
  • MEAN AGE = 57.2 years (SD = 13.8 years)
  • MALES: 46%, FEMALES: 54%
  • KEY DISEASE CHARACTERISTICS: 59% had metastatic disease. Multiple cancer sites were included, and 68% were on active treatment. Median time since diagnosis was 17 months. Mean time of follow-up after initial visit was 41 days.

Setting

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

Phase of Care and Clinical Applications

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

Study Design

  • Retrospective, descriptive

Measurement Instruments/Methods

  • Edmonton Symptom Assessment Scale

Results

At the time of initial visit, average symptom scores were 2.9–5.8 (10-point scale). At the first follow-up visit, there was an average 0.67-point improvement in pain (p < .001), a 0.67-point improvement in fatigue (p < .001), a 0.94-point improvement in depression (p < .001), and a 0.89-point improvement in anxiety (p < .001). At least 50% of patients reported a greater than one-point improvement in symptoms by the first follow-up visit, and 16%–25% reported a one-point or greater worsening of symptoms. Among 142 patients who had a second follow-up visit, there was continued significant improvement from baseline symptom scores. Patients on active treatment had less improvement in fatigue than others (p = .02).

Conclusions

Most patients who continued follow-up by palliative care demonstrated improvement in pain, fatigue, anxiety, and depression.

Limitations

  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Risk of bias (sample characteristics)
  • Other limitations/explanation: The study only included those patients referred who had follow-up visits in the palliative care clinic. It is possible that at least some of those who did not come back for another visit did not have symptom improvement, so results may be overestimated. The opposite also is possible. There was a lot of variability in the timing of follow-ups. A single symptom measure was used repeatedly; it is possible that the study had threats to validity because of testing effect and patient expectations. It is not known if oncologic providers made any changes in medications for symptom management, as palliative care follow-up visits were relatively infrequent.

Nursing Implications

Palliative care, with attention to symptom management, has been shown to be effective in reducing symptom severity for the majority of patients. It is not clear, however, if formal palliative care services result in better outcomes than attention to symptom management in general. It would be expected that, whether provided by oncology or palliative care providers, focused attention on symptom management would result in improvement of symptoms. The optimum frequency of follow-up and timing for optimal symptom control has not been determined.

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Birocco, N., Guillame, C., Storto, S., Ritorto, G., Catino, C., Gir, N., . . . Ciuffreda, L. (2012). The effects of Reiki therapy on pain and anxiety in patients attending a day oncology and infusion services unit. American Journal of Hospice and Palliative Care, 29, 290–294.

Study Purpose

To examine the effects of Reiki on pain, anxiety, and global wellness among patients with cancer who are receiving chemotherapy

Intervention Characteristics/Basic Study Process

Reiki sessions were offered to patients in a day oncology and infusion services unit that provided chemotherapy. Patients sat in a chair or lay on a bed during Reiki sessions. Each session lasted approximately 30 minutes. Each patient received a maximum of four Reiki sessions. Prior to each session, Reiki practitioners assessed levels of anxiety and pain according to a numeric scale. After each session, levels of pain and anxiety were recorded on a visual analog scale. The study was done over three years.

Sample Characteristics

  • The study reported on a sample of 118 patients, but only 22 completed all sessions.
  • Mean patient age was 55 years, with a range of 33–77 years.
  • The sample was 57% male and 43% female.
  • Patients had various types of cancer, and all were receiving chemotherapy.

Setting

  • Single site
  • Outpatient setting
  • Italy

Phase of Care and Clinical Applications

Patients were receiving active antitumor treatment.

Study Design

A prospective pre/post-test design was used.

Measurement Instruments/Methods

  • Numeric rating scale
  • Visual analog scale (VAS)

Results

Only 48% of patients had more than one Reiki session, and only 22 patients (17%) completed four sessions and were included in statistical analysis. From session 1 to session 4, mean anxiety scores post-Reiki session declined, but scores immediately after each time point were higher than those reported immediately prior to the session.

Conclusions

Findings of this study do not support the effectiveness of Reiki. The study included numerous limitations in study design and methods.

Limitations

  • The study had a small sample size, with fewer than 30 participants.
  • The study had risk of bias due to no control group, no blinding, and no random assignment.
  • Measurement validity/reliability was questionable.
  • The intervention was expensive, impractical, or presented training needs.
  • The study reported that pre-session measures, on a numeric scale, were collected by Reiki providers and that post-session measures, per a VAS, were collected by the practitioner. These are two different scales that cannot be directly compared. The study does not make clear what the actual data scale was or the size of the VAS, for interpretation of data.
  • Scoring was done by the Reiki practitioners, which could introduce bias. Reiki practitioners required two years of training, one year of additional workshops, and one year of in-hospital practice with tutors.

Nursing Implications

 This study does not support the effectiveness of Reiki. The study and methods were not well designed or reported.

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Birnie, K., Garland, S.N., & Carlson, L.E. (2010). Psychological benefits for cancer patients and their partners participating in mindfulness-based stress reduction (MBSR). Psycho-Oncology, 19, 1004–1009.

Study Purpose

To conduct a preliminary exploration of mindfulness-based stress reduction (MBSR) participation of couples affected by cancer, particularly as participation affects symptoms of stress, mood disturbance, and mindfulness for patients with cancer and their partners

Intervention Characteristics/Basic Study Process

A convenience sample of 41 couples already enrolled in an MBSR program at a cancer outpatient center agreed to participate by completing the three study measures before the program started and two weeks following program completion. Weekly 90-minute classes held over an eight-week period, plus one weekend retreat lasting three to six hours, comprised the intervention. Of the 41 couples, only 21 completed post-test measures and at least six of eight MBSR classes.

Sample Characteristics

  • The sample was comprised of 21 couples (95% married).
  • The sample was 52.4% female and 47.6% male.
  • Mean patient age was 62.9 years (SD = 7.37); mean partner age was 62.8 years (SD = 9.34).
  • The most common patient diagnoses were prostate cancer (28.6%), breast cancer (19%), and colorectal cancer (14.3%).
  • Mean time since primary diagnosis for all patients was 2.03 years.
  • Mean educational level for couples was 14.6 years.

Setting

  • Single site
  • Outpatient setting
  • Cancer center in Calgary, Alberta, Canada

Phase of Care and Clinical Applications

  • Multiple phases of care
  • Late effects and survivorship

Study Design

A pretest/post-test design was used.

Measurement Instruments/Methods

  • Profile of Mood States (POMS): Measures identified mood and change in mood or affective states using a Likert scale with well-established reliability (Kuder-Richardson of six POMS subscales ranged from 0.84 to 0.95.)    
  • Calgary Symptoms of Stress Inventory (C-SOSI): Uses a Likert scale to measure physical and psychologic responses to stress and consists of eight subscales (depression, anger, muscle tension, cardiopulmonary arousal, sympathetic arousal, neurologic/gastrointenstinal, cognitive disorganization, and upper respiratory symptoms). The tool has been validated in the oncology population with convergent and divergent validity (Cronbach's alpha = 0.95).
  • Mindfulness Attention Awareness Scale (MAAS): Uses a Likert scale to  assess individual differences in mindfulness over time and measures the presence or absence of attention and awareness to the present moment. The scale has been validated with patients with cancer (Cronbach's alpha = 0.87).

Results

Of the couples, 21 provided POMS data, 19 provided C-SOSI data, and 16 provided MAAS data for baseline and postintervention measures. Before MBSR intervention, patients reported significantly higher scores on the POMS fatigue subscale (p = 0.05), while partners reported significantly higher scores on the C-SOSI sympathetic arousal subscale (p < 0.05) than did patients according to t-test analysis. Patients with only baseline data reported significantly higher levels of total mood disturbance before MBSR classes than those who provided complete data (p < 0.05). After program completion, both patients and partners experienced significant reduction in mood disturbance (p < 0.05) and the C-SOSI subscales of muscle tension (p < 0.01), fatigue (p < 0.05), neurologic/GI (p < 0.05), and upper respiratory symptoms (p < 0.01). Both groups significantly increased their mindfulness (p < 0.05) as a result of the intervention. After the MBSR intervention, couples’ scores on the POMS and C-SOSI were more highly correlated with one another. Partners’ mood disturbance scores were positively correlated (p < 0.05) with patients’ symptoms of stress and negatively correlated with patients’ levels of mindfulness (p < 0.05).

Conclusions

As one of the first studies using a sample of patients with cancer and partners, the MBSR program benefited both patients and their partners by reducing mood disturbance and physical symptoms of stress, psychologically aligning patients and partners during the cancer journey, and increasing levels of mindfulness. Moderate effect sizes were found for both patients and partners on these variables.

Limitations

  • The sample was small and underpowered, with less than 30 participants.
  • The study had no comparison group.
  • The study had 51% attrition following collection of baseline data from 41 couples.

Nursing Implications

MBSR programs for patients with cancer and their partners may buffer physical and psychological challenges during their cancer journey. Nurses, as members of the healthcare team, may suggest these increasingly evidence-based programs as a complementary intervention for patients and partners who seek additional nonmedical ways to cope with the cancer illness. Validation of MBSR will enhance couples’ willingness to seek out MBSR that may respond to psychosocial gaps in care of patients with cancer and their partners who struggle with predominant high-technology approaches to oncology care. Further examination is also needed to identify cost-effective ways of meeting healthcare system goals for person-centered care in diverse populations of families facing cancer.

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Billio, A., Morello, E., & Clarke, M.J. (2010). Serotonin receptor antagonists for highly emetogenic chemotherapy in adults. Cochrane Database of Systematic Reviews (Online), CD006272.

Purpose

To compare the effectiveness of different 5-HT3 receptor antagonists (RAs) in the control of acute- and delayed-onset emesis associated with highly emetogenic chemotherapy

Search Strategy

Databases searched were Cochrane Register of Clinical Trials (CENTRAL), PubMed, Embase, and Latin American and Caribbean Health Sciences Literature (LILACS).

Search keywords were MeSH for granisetron; ondansetron, tropisetron, dolasetron, ramosetron, palonosetron, azasetron, in all possible comparison sets; chemotherapy, antineoplastic agents, and cisplatin. Internet databases of gray literature were searched, and hand searching was performed of potentially relevant journals and conference proceedings.

Studies were included in the review if they

  • Were randomized controlled trials (RCT) comparing different 5-HT3 RAs in adults with cancer.
  • Had at least 20 participants per treatment group.
  • Reported on patients older than 16 years.
  • Reported on patients receiving cytotoxic drugs for which emesis is expected in more than 90% of administrations according to American Society of Clinical Oncology (ASCO) emetic risk classification (2006).

Studies were excluded if they 

  • Had insufficient concealment of allocation in the study procedures.
  • Included patients with nausea and vomiting associated with moderately emetogenic chemotherapy, radiotherapy, surgery, or bone marrow transplant.

Literature Evaluated

Of the 25 studies found that met the eligibility criteria, 16 RCTs were included. These studied granisetron, ondansetron, tropisetron, ramosetron, palonosetron, and dolasetron. Four studies were excluded because of inadequate outcome assessment, two studies because of the unavailability of the protocol, one study because of very poor methodological quality, and one study because it included patients receiving only moderately emetogenic therapy.

Sample Characteristics

The final sample of 16 studies reported on 7,808 patients across all studies.

Results

Acute nausea

  • Pooled data from seven studies (involving 4,160 participants) that evaluated granisetron versus ondansetron were included.
  • Pooled results favored ondansetron (odds ratio [OR] = 0.97, confidence interval [CI] = 95%, 0.85–1.10).

Total control of acute nausea and vomiting

  • Data from six studies of granisetron versus ondansetron, involving 2,809 patients in total, were included.
  • No significant differences were found with respect to different 5‑HT3 RAs or any other factors.

Delayed nausea

  • Data were combined and analyzed from two studies with a total of 1,024 patients.
  • Palonosetron appeared to be superior to granisetron in controlling delayed nausea.
  • Both drugs were given in combination with dexamethasone (OR = 1.63, CI = 95%; 1.27–2.10).

Total control of delayed nausea and vomiting

  • Data were pooled and analyzed from two studies involving 1,045 patients.
  • Palonosetron was superior to granisetron.

Meta-analysis of granisetron and ondansetron

  • Both had similar effects on either acute or delayed nausea and vomiting.
  • Both had similar side effects.

Conclusions

  • Ondansetron and granisetron were essentially equivalent for prevention of acute and delayed nausea and vomiting with highly emetogenic chemotherapy.
  • No 5-HT3 RA appeared to be superior to any other for acute nausea.
  • Palonosetron plus dexamethasone may perform better than others for delayed nausea and vomiting; however, this was shown by a single study and more evidence should be obtained in this area before a firm recommendation can be made.
  • Findings suggested that 5-HT3 RAs are equally effective for management of nausea and vomiting with highly emetogenic chemotherapy.
  • Some suggested differences were found in terms of side effect profiles and effectiveness for delayed nausea.

Nursing Implications

Further RCTs comparing palonosetron and dexamethasone for delayed nausea are warranted.

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