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Owen, J., O'Carroll Bantum, E., Pagano, I., Stanton, A., Owen, J.E., & Pagano, I.S. (2017). Randomized trial of a social networking intervention for cancer-related distress. Annals of Behavioral Medicine, 51, 661–672.

Study Purpose

To evaluate the effects of a web-based social networking and coping skills training intervention on cancer-related patient based outcomes: distress, depression, anxiety, and psychological well-being. Secondary outcomes are vigor and fatigue.

Intervention Characteristics/Basic Study Process

Participants initially completed a baseline survey following which they were given access to the online health space intervention or waitlisted for the intervention (waitlist control group) randomly. Intervention included an evidence-based online distress management intervention for a period of 12 weeks, including modules, chats, discussion boards, and web mails.

Sample Characteristics

  • N = 347   
  • AGE: Treatment group, mean = 52.9 years; waitlist control group, mean = 53.1 years; all combined, mean = 53.1 years
  • MALES: 21%; n = 73
  • FEMALES: 79%; n = 274
  • CURRENT TREATMENT: Other
  • KEY DISEASE CHARACTERISTICS: Multiple tumors: Most common were breast cancer (n = 161, 46.4%) followed by prostate cancer (n = 43, 12.4%)
  • OTHER KEY SAMPLE CHARACTERISTICS: Participants with multiple cancers and participants with female reproductive cancers were at 6.1% each (n = 21)

Setting

  • SITE: Multi-site (tumor registry, outreach to websites, and cancer forums)
  • SETTING TYPE: Other (online)
  • LOCATION: Online

Phase of Care and Clinical Applications

PHASE OF CARE: Multiple phases of care

Study Design

Randomized controlled clinical trial

Measurement Instruments/Methods

  • Primary outcomes: distress measured by Distress Thermometer, psychological functioning by Outcomes questionnaire-45, depression by Center for Epidemiologic Studies Depression scale, and trauma-related anxiety by Impact of Event Scale-revised 
  • Secondary outcomes: Fatigue and vigor by the subscales from Profile of Mood States (POM-SF) 
  • Engagement on outcomes: Time spent online with the intervention  
  • Outcomes measured at baseline and 12 weeks.

Results

No baseline difference was noted between the intervention and control group in terms of demographic and clinical characteristics. All the five outcomes improved over time, but no significant difference between the treatment and control group for psychological functioning, depression, anxiety, and vigor. Interaction between time and treatment group fatigue (time fatigue declined in the treatment group compared to control group). No significant reduction in distress and depression between the groups, although it reduced within the groups over time, association between intervention and engagement.

Conclusions

Health space social networking did not improve the cancer-related distress outcomes.

Limitations

  • Unintended interventions or applicable interventions not described that would influence results
  • Questionable protocol fidelity
  • Subject withdrawals ≥ 10%  
  • Other limitations/explanation: Attrition

Nursing Implications

Online interventions could be suggested to patients as it is associated with strong engagement.

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Mertz, B.G., Dunn-Henriksen, A.K., Kroman, N., Johansen, C., Andersen, K.G., Andersson, M., . . . Envold Bidstrup, P. (2017). The effects of individually tailored nurse navigation for patients with newly diagnosed breast cancer: A randomized pilot study. Acta Oncologica, 56, 1682–1689.

Study Purpose

To determine the feasibility and effectiveness of an individual, nurse-navigator intervention for relieving distress, anxiety, depression, and health-related quality of life in women newly diagnosed with breast cancer.

Intervention Characteristics/Basic Study Process

Symptom screening and counseling by nurse navigator; specific intervention described in detail in prior paper.

Sample Characteristics

  • N = 50   
  • AGE: Mean age = 55 in control group and mean age = 50 in intervention group
  • FEMALES: 100%
  • CURRENT TREATMENT: Not applicable
  • KEY DISEASE CHARACTERISTICS: Breast cancer

Setting

  • SITE: Single site   
  • SETTING TYPE: Outpatient    
  • LOCATION: Copenhagen, Denmark

Phase of Care and Clinical Applications

PHASE OF CARE: Multiple phases of care

Study Design

Randomized, interventional pilot study with outcomes assessed at baseline, 6 months, and 12 months

Measurement Instruments/Methods

Distress Thermometer; Hospital Anxiety and Depression Scale; European Organisation for Research and Treatment of Cancer QLQ-C30

Results

Women in the intervention group reported significantly greater satisfaction with treatment and rehabilitation and lower levels of distress, anxiety, and depression after 12 months. No significant effects on health-related quality of life were noted.

Conclusions

Individually tailored nurse navigation intervention resulted in statistically significant lower levels of distress, anxiety, and depression.

Limitations

Small sample (< 100)

 

Nursing Implications

Oncology nurses are in a key position to screen for distress in women with breast cancer. Patients with high levels of distress may benefit from individually tailored counseling to decrease distress, anxiety, and depression.

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Tuinmann, G., Preissler, P., Böhmer, H., Suling, A., & Bokemeyer, C. (2017). The effects of music therapy in patients with high-dose chemotherapy and stem cell support: A randomized pilot study. Psycho-Oncology, 26, 377–384.

Study Purpose

Evaluate the effects of music therapy in addition to standard treatment in patients undergoing high-dose chemotherapy (HDC) plus autologous stem cell transplantation (ASCT) on quality of life, anxiety, and depression.

Intervention Characteristics/Basic Study Process

For the intervention group, a trained music therapist administered therapy two times per week for at least 20 minutes, based on the individual needs of each patient established prior to therapy, and each session included a debrief or aftertalk. Quality of life was assessed prior to therapy, weekly during treatment, at discharge, and again three months later.

Sample Characteristics

  • N = 66   
  • AGE: Mean = 50 years (all older than 18 years)
  • MALES: 43 
  • FEMALES: 23 
  • CURRENT TREATMENT: Chemotherapy, other
  • KEY DISEASE CHARACTERISTICS: Malignancies treated with HDC plus ASCT with an expected inpatient stay of two weeks or longer
  • OTHER KEY SAMPLE CHARACTERISTICS: No evidence of participation in other clinical trials, immobilization, brain metastasis, experiencing a severe psychotic episode, or having major depression. Seventy percent of patients in the intervention group had multiple myeloma versus 40% in the control group

Setting

  • SITE: Single site   
  • SETTING TYPE: Inpatient    
  • LOCATION: Department of Oncology and Hematology of the University Medical center Hamburg-Eppendorf, Germany

Phase of Care and Clinical Applications

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

Study Design

Randomized controlled trial

Measurement Instruments/Methods

EORTC QLQ-C30, HADS-D, Karnofsky performance score

Results

Quality of life declined less in the intervention group (8.1 points) versus control (11.4 points), difference between groups was not significant (p = 0.394)

Conclusions

Because of multiple limitations of study, the authors declared their findings to be preliminary.

Limitations

  • Small sample (< 100)
  • Baseline sample/group differences of import
  • Selective outcomes reporting
  • Measurement validity/reliability questionable
  • Subject withdrawals ≥ 10%  
  • Other limitations/explanation: 29 of the 66 patients involved in the study were assessed in follow up (high dropout rate); extracted data from the large number of patients with multiple myeloma to report positive effects of music therapy, but when this data was considered, results were no longer significant.

Nursing Implications

Opportunity for further research

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Ergin, E., Midilli, T.S., & Baysal, E. (2018). The effect of music on dyspnea severity, anxiety, and hemodynamic parameters in patients with dyspnea. Journal of Hospice and Palliative Nursing, 20, 81–87.

Study Purpose

To examine the effects of music therapy in patients with dyspnea on the severity of dyspnea, state anxiety, and hemodynamic parameters such as heart rate, diastolic, systolic blood pressure, respiratory rate, and oxygen saturation.

Intervention Characteristics/Basic Study Process

Random assignment occurred by having patients who were hospitalized for dyspnea draw groups (A or B) from a bag for intervention or control groups. Intervention group patients were to rest supine in their hospital rooms for five minutes; patients were given earphones for music listening to 30 minutes of prepared music with instructions to listen with eyes closed and to concentrate on the music. Volume was adjusted by the researcher according to facial expressions of the participant. 

Control group patients were to rest in bed for 30 minutes with eyes closed and headphones connected to a CD player but with no music playing, creating a quiet environment. 

Testing via face-to-face interviews took place before and after the 30 minute period took place in both groups to measure dyspnea severity, respiratory rate, state anxiety, and hemodynamic parameters such as heart rate and diastolic and systolic blood pressure.

Sample Characteristics

  • N = 60 (30 in each group) with 81% power; effect size = 0.519, 0.05 one-side significant level   
  • AGE: Range - 60-62.43 years; mean age = 61.21 years
  • MALES: 50% in control group; 70% in intervention group  
  • FEMALES: 50% in control group; 30% in intervention group
  • CURRENT TREATMENT: Not applicable
  • KEY DISEASE CHARACTERISTICS: Severe dyspnea
  • OTHER KEY SAMPLE CHARACTERISTICS: Control group: 50% had unnamed chronic illness(es); intervention group: 33.3% had unnamed chronic illness(es). Overall, 41.7% had a chronic illness; most frequent was hypertension (48%).

Setting

  • SITE: Single site   
  • SETTING TYPE: Inpatient    
  • LOCATION: Chest Diseases Service of Manisa Public Hospitals Association Government Hospital (western Turkey)

Phase of Care and Clinical Applications

PHASE OF CARE: Seems not applicable in the current study

Study Design

Randomized controlled study with pre-/post-test intervention and control group

Measurement Instruments/Methods

  • Patient identification form: Six items for sociodemographic data: age, sex, education level, diagnosis, chronic illness, chest tube presence.
  • Effect of music on hemodynamic data: Respiratory rate, heart rate, systolic and diastolic blood pressure, oxygen saturation.
  • Dyspnea visual analog scale: 100 mm vertical line where self-report of 0 mm means no dyspnea and 100 mm means the most severe dyspnea.
  • State-Trait Anxiety Inventory (Turkish adaptation): State and trait items were read aloud to the patients; patients indicated answers by holding up 1 to 4 fingers or by pointing to corresponding answers on signs. State and trait scored separately and then combined for total score of 20-80. Scores of 20-39 indicate slight; 40-59 indicate medium; 60 and greater indicate severe dyspnea, profess help needed.
  • Patient satisfaction: Single question to rate the music

Results

Effect size: 0.519; significant at p = 0.05. The demographic and clinical characteristics of the intervention and control group were similar. There were no differences between groups before or after on hemodynamic measures. However, a simple paired t test of post-test scores revealed a significant between-groups difference in the decrease in diastolic blood pressure (p = 0.05) and state anxiety (p = 0.01) scores on post test, but no significant diff in systolic blood pressure, heart rate, respiratory rate, or oxygen saturation.

Conclusions

Music therapy has no significant effect on severity of dyspnea or on hemodynamic measures named, but showed an effective or significant change in state anxiety (p = 0.01) and a significance for decrease in diastolic blood pressure (p = 0.05) only for post-test between-groups scores.

Limitations

  • Small sample (< 100)
  • Selective outcomes reporting
  • Findings not generalizable
  • Other limitations/explanation: Selective outcomes: the change in diastolic blood pressure measurements from pre- to post-test seemed to be reported inconsistently in the table and in the text. Findings are not generalizable beyond small test group use of classical Turkish music.

Nursing Implications

Increased awareness that music of a patient’s choice may decrease anxiety: data needs to be collected before and after to determine effectiveness of music categories or genres. Patient choice may vary (according to cultural and spiritual and regional circumstances).

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Bilgiç, Ş., & Acaroğlu, R. (2017). Effects of listening to music on the comfort of chemotherapy patients. Western Journal of Nursing Research, 39, 745–762.

Study Purpose

To examine the effect of listening to music on comfort from chemotherapy symptoms (pain, tiredness, nausea, depression, anxiety, drowsiness, lack of appetite, not feeling well, and shortness of breath) for patients undergoing chemotherapy.

Intervention Characteristics/Basic Study Process

Intervention group: Each member was given a portable mp3 player (with double earphones) containing music prepared by Turkish Psychological Association (TPA) containing 30 minutes of relaxation wave sounds with harp and violin. Participants were asked to listen to the music in the chemotherapy unit before treatment. Instructions were to listen to the music at least three times weekly in keeping with recommendations from TPA. 

Summary: Participants were given a pre-loaded mp3 player with instructions to listen for 20 to 30 minutes once a day for a minimum of three days per week and to record specific observations: dates and times of symptom experiences and music listening.

Sample Characteristics

  • N = 70; 35 in each group   
  • AGE: Mean = 54.51 years (SD = 10.35) 
  • MALES: 47.1%  
  • FEMALES: 52.9%
  • CURRENT TREATMENT: Chemotherapy, other
  • KEY DISEASE CHARACTERISTICS: Lung cancer, 31.4%; breast cancer, 32.9%; colon cancer, 12.8%; other cancer, 22.9%
  • OTHER KEY SAMPLE CHARACTERISTICS: Sequential selection: First 35 to control group, next 35 to intervention group to avoid inter-group influence by association or talking.

Setting

  • SITE: Single site   
  • SETTING TYPE: Multiple settings, such as listening in clinic and at home
  • LOCATION: Public hospital in Tekirdağ, Turkey

Phase of Care and Clinical Applications

PHASE OF CARE: Active anti-tumor treatment

Study Design

Quasi-experimental with two groups (intervention and control) using pre-/post-test measures

Measurement Instruments/Methods

  • Patient Information Form: Self-developed by researchers for demographics (age, sex, educational level, marital status, profession, and diagnosis). Delivered to each participant for completion at home. 
  • Patient Observation Form: For the control group, a chart for recording chemotherapy symptoms, dates, and communication with the researcher. For the intervention group, a form for recording days of treatment, duration of treatment, dates and times of symptoms, and music listening. 
  • Edmonton Symptom Assessment System (ESAS): Used to measure nine of the most commonly occurring chemotherapy symptoms (pain, tiredness, nausea, anxiety, drowsiness, lack of appetite, not feeling well, depression, and shortness of breath) using a number (scale not clear) to indicate severity. 
  • General Comfort Questionnaire (GCQ): 48-item Likert-type scale with three levels and four dimensions of comfort, ranging from 1 (low comfort) to 4 (high comfort). Includes reverse coding for negative items. Scale was adapted to Turkish language and context 2008.

Results

There was no significant between-group difference at baseline. The statistically significant differences in the intervention group related to music listening were for pain, exhaustion, nausea, anxiety, lethargy, lack of appetite, and not feeling well. However, no significant differences were found for depression or shortness of breath. 

There were statistically significant differences between groups for comfort measures: general comfort, physical comfort, psycho-spiritual comfort, and sociocultural comfort. All intra-group (within-group) differences were statistically significant for comfort measures.

Conclusions

Listening to specified music for specified time periods was positive for chemotherapy symptoms: pain, exhaustion (fatigue), nausea, anxiety, lethargy, lack of appetite, and not feeling well; and on measures of general comfort, physical comfort, psycho-spiritual comfort, and sociocultural comfort. 

There were no positive effects on depression or shortness of breath.

Limitations

  • Small sample (< 100)
  • Measurement/methods not well described; unclear how numbers scale was used to indicate symptom levels for common symptoms of chemotherapy treatment.
  • Findings not generalizable
  • Other limitations/explanation: Self-report of symptoms and listening adherence by patients. Small sample in one site of one country with one type of music–suggesting application to just one small group.

Nursing Implications

Music listening may diminish symptom severity in patients undergoing chemotherapy. Music therapy should be considered as an important element of holistic treatment for patients who have a cancer diagnosis and chemotherapy.

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Ho, R.T., Fong, T.C., Lo, P.H., Ho, S.M., Lee, P.W., Leung, P.P., . . . Chan, C.L. (2016). Randomized controlled trial of supportive-expressive group therapy and body-mind-spirit intervention for Chinese non-metastatic breast cancer patients. Supportive Care in Cancer, 24, 4929–4937.

Study Purpose

To examine the effect of two interventions on emotion suppression and psychological distress in patients with non-metastatic breast cancer

Intervention Characteristics/Basic Study Process

Each group met for eight weeks for two hours each week. There were three groups: 

  1. Supportive expressive intervention model: Adapted 52-week version down to brief protocol focused on social support and interpersonal relationships, emotional expression, life priorities, fear of death, and coping skills
  2. Body-mind-spirit: Sessions focused on holistic health lifestyle, including physical activities and discussions; developing resilience, normalizing traumatic experiences, looking for mutual support, promoting self-acceptance, and peace of mind; mental well-being and forgiveness 
  3. Control: Social support self-help without structured programming. Self-led group discussed healthy living (diet, food, exercise) and self-care; shared worries; showed mutual support

Sample Characteristics

  • N = 157 (BMS, n = 51; SEG, n = 49; control, n = 57)   
  • AGE: Range = 18-65 years; mean = 47.7 years
  • FEMALES: 100%
  • CURRENT TREATMENT: Not applicable; completion of active treatment  
  • KEY DISEASE CHARACTERISTICS: Non-metastatic breast cancer

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Multiple settings    
  • LOCATION: Hong Kong, China

Phase of Care and Clinical Applications

PHASE OF CARE: Transition phase after active treatment

Study Design

Three-arm RCT with measurement at baseline (T0), 4 months (T1), 8 months (T2), and 12 months (T3)

Measurement Instruments/Methods

  • Emotional suppression–Chinese Courtauld Emotional Control Scale (how often suppress anger, anxiety, and depression)
  • Perceived stress–Chinese Perceived Stress Scale (how often felt stressful in past month)
  • Anxiety and Depression–Chinese Hospital Anxiety and Depression Scale 
  • Baseline psychological functioning–Chinese General Health Questionnaire (higher scores indicate worse health)

Results

No difference in groups except for cancer duration, which was longer in SEG group and shorter in the BMS group (p = 0.01). There were no significant improvements in anxiety or depression. Emotion suppression: significantly decreased in the first four months for SEG and BMS with no change in control group. Perceived stress: No change in control or SEG but significant decreases in first four months in BMS group.
SEG resulted in moderate decrease in emotional suppression at 4 and 8 months, with participant perceived benefits; method is applicable for increased expression of emotions. SEG minimal effect on anxiety, depression and perceived stress. 
BMS showed no effect on anxiety and depression (d = 0.38–0.46) and little (small to medium  d = 0.07–0.2) effect on emotional suppression and perceived stress.

Conclusions

No significant effectiveness of the named therapies: SEG or BMS

Limitations

  • Small sample per group
  • Risk of bias (no random assignment)
  • Measurement/methods not well described
  • Findings not generalizable
  • Subject withdrawals ≥ 10%
  • Other limitations/explanation: Drop-out rate. 11.5% overall; 10.2% in SEG group and 17.5% in control group.
  • Low statistical power and low-moderate effect sizes. Unclear which aspects of the abbreviated 52-week protocol were applied. Self-selection bias may be at play. Treatment adherence was not measured; participants completed seven sessions on average.

Nursing Implications

Conduct large-scale research with sufficient power to examine effectiveness of these therapies. Learn and apply these therapeutic approaches. Use full-scale 52-week protocol for expression support therapy.

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Emerson, K., Murphy, M., Quinlin, L., O'Malley, P., & Hayes, K. (2017). Evaluation of a low-light intervention—starlight therapy—for agitation, anxiety, restlessness, sleep disturbances, dyspnea, and pain at end of life. Journal of Hospice and Palliative Nursing, 19, 214–220.

Study Purpose

To evaluate the effectiveness of low light therapy (starlight therapy) on symptoms at end of life, including anxiety, agitation, dyspnea, restlessness, insomnia, and pain.

Intervention Characteristics/Basic Study Process

Patients observed or reporting symptoms were enrolled in the study and low light therapy (starlight therapy) was applied for two hours with observations at baseline, 30 minutes, and at two hours.

Sample Characteristics

  • N: 40
  • AGE:  Average age = 82.25 years
  • MALES: 65%
  • FEMALES: 35%
  • CURRENT TREATMENT: Not applicable
  • KEY DISEASE CHARACTERISTICS: Various terminal illnesses (cancer, dementia, neurologic disease, lung disease, heart disease) with prognosis of six months or less enrolled in hospice

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Two inpatient hospice facilities, one community and one VA
  • LOCATION: Southwest Ohio

Phase of Care and Clinical Applications

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

Study Design

Prospective trial of use of low light therapy in patients observed or self-reporting symptoms

Measurement Instruments/Methods

Lux meter (measuring light levels), vital signs, adapted Assessing Distressing Symptoms STAR Symptom Scale and Questionnaire, outcome measurement tools (physiological symptoms)

Results

Respiratory rate significantly reduced from a rate of 23.91 at baseline to a mean rate of 18.63 (p < 0.01) at 30 minutes and a mean rate of 17.88 (p < 0.0001) at two hours. Heart rate also significantly reduced from a mean of 98.45 at baseline to a mean of 84.9 at 30 minutes (p < 0.01) and 84.55 at two hours (p < 0.0001). End-of-life symptoms as measured on the STAR symptom scale were noted and presence of moderate or severe symptoms were totaled with significantly fewer patients with presence of moderate or severe symptoms at both 30 minutes and two hours for agitation (p = 0.003 for 30 minutes, p < 0.0001 for two hours), anxiety (p < 0.0001 for 30 minutes, p < 0.0001 for two hours), restlessness (p < 0.001 for 30 minutes, p < 0.0001 for two hours), and sleep (p = 0.002 for 30 minutes, p < 0.0001 for two hours), with no significant reduction in numbers of patients with moderate or severe pain or dyspnea seen at any other time point.

Conclusions

Low light therapy shows some promise symptoms of agitation/anxiety/restless/sleep in patients with terminal illness in hospice, but further research needed given the small sample size, prospective design, limited patient population, and specific setting. 

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Risk of bias (sample characteristics)
  • Measurement/methods not well described
  • Findings not generalizable
  • Other limitations/explanation: There seems a risk of selection bias and it was not clearly outlined how patients were chosen and there is a possibility that patients who were most likely to show benefit were disproportionately included. Tools used for measurement of symptoms were not provided, so evaluation was difficult. The impact of other interventions was difficult to evaluate, and it is noted that 7 of 40 patients received scheduled pain or sedation medication during therapy, but the medications are unknown and those patients were not broken out and analyzed separately.

Nursing Implications

An oncology nurse should be aware that noninvasive interventions such as low light therapy show promise for reductions in certain symptoms at end of life, but more research is warranted for recommendation for wider populations/settings.

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Peng, Y., Zhang, W., Zhou, X., Ji, Y., Kass, I.S., & Han, R. (2016). Lidocaine did not reduce neuropsychological-cognitive decline in patients 6 months after supratentorial tumor surgery: A randomized, controlled trial. Journal of Neurosurgical Anesthesiology, 28, 6–13.

Study Purpose

To investigate the effect of intraoperative lidocaine infusion on postoperative cognitive function after craniotomy for supratentorial tumor resection

Intervention Characteristics/Basic Study Process

Patients in the experimental group received lidocaine (2%) as an IV bolus (1.5 mg/kg) after anesthesia induction followed by infusion at 2 mg/kg per hour throughout surgery (lidocaine group). Patients in the control group received normal saline at the same rate (normal saline group).

Sample Characteristics

  • N = 80   
  • AGE: Mean = 44.5 years (SD = 9.5) (as calculated with the reported values from each group)
  • MALES: 49%  
  • FEMALES: 51%
  • CURRENT TREATMENT: Other
  • KEY DISEASE CHARACTERISTICS: Supratentorial brain tumor (e.g., glioma, meningioma) 
  • OTHER KEY SAMPLE CHARACTERISTICS: 35% college or higher level of education. American Society of Anesthesiologists physical status I or II; body mass index (BMI) < 30; no history of systemic malignant tumors, diabetes, psychiatric disorders, or alcohol or drug abuse; ability to complete neuropsychological tests. To reduce the influence of potential preoperative cognitive dysfunction, patients with a preoperative Mini-Mental State Examination (MMSE) score < 24 or intracerebral vascular surgery were excluded.

Setting

  • SITE: Single site   
  • SETTING TYPE: Inpatient    
  • LOCATION: Academic hospital in China

Phase of Care and Clinical Applications

PHASE OF CARE: Active anti-tumor treatment

Study Design

Double-blind randomized controlled trial of lidocaine versus placebo with repeated measures

Measurement Instruments/Methods

  • Mini-Mental State Examination (MMSE)
  • Information-Memory Concentration Test (IMCT)
  • Hamilton Rating Scale for Depression (HRSD)
  • Hamilton Rating Scale for Anxiety (HAMA)
  • Outcome data were collected at six time points: before surgery, and at 24 hours, 1 week, 1 month, 3 months, and 6 months after surgery.

Results

There were no significant demographic or clinical differences between the lidocaine group and normal saline group at baseline. Postoperative neuropsychological-cognitive decline was defined as a decline greater than or equal to the preoperative standard deviation on two or more of the four tests (MMSE, IMCT, HRSD, and HAMA). Using this criteria, there were a greater proportion of patients with postoperative decline in the saline group as compared to the lidocaine group at 1 week after surgery (40% versus 16%, p < 0.05), but this was not statistically significant after correcting for multiple comparisons. There were no significant differences between the groups in the incidence of postoperative cognitive decline at 1 day, 1 month, 3 months, or 6 months. Additional analyses using less stringent criteria for cognitive decline on MMSE and IMCT alone also did not reveal any differences.

Conclusions

Intraoperative lidocaine had no effect on cognitive functioning after supratentorial tumor resection.

Limitations

  • Small sample (< 100)
  • Measurement validity/reliability questionable
  • Intervention expensive, impractical, or training needs
  • Questionable protocol fidelity
  • Other limitations/explanation: Measures for anxiety (HAMA) and depressive symptoms (HAMD) were considered measures of neuropsychological functioning in this study; however, findings were unchanged in post-hoc analyses that excluded these measures. MMSE and IMCT are typically used as screening measures for dementia rather than as an outcome measure for subtle cognitive changes.

Nursing Implications

There is insufficient evidence to support the use of intraoperative lidocaine to reduce the incidence of cognitive decline after supratentorial tumor surgery.

Print

Pimenta, F.C., Alves, M.F., Pimenta, M.B., Melo, S.A., de Almeida, A.A., Leite, J.R., . . . de Almeida, R.N. (2016). Anxiolytic effect of Citrus aurantium L. on patients with chronic myeloid leukemia. Phytotherapy Research, 30, 613–617.

Study Purpose

To evaluate anxiety levels in patients with CML undergoing bone marrow biopsy who were exposed to the odor of C.aurantium essential oil versus those who were not

Intervention Characteristics/Basic Study Process

C. aurantium is an essential oil of the Citrus genus. In this study, participants were exposed to the essential oil odor via electronic diffuser. The study was divided into three groups. The first group received oral diazepam (10 mg), the second group was exposed to C. aurantium, and the third group was exposed to a placebo vaporized solution. In the second and third groups, exposure was 30 minutes long.

Sample Characteristics

  • N: 42   
  • AGE: Adult average age of 45 (not further defined in article) 
  • MALES (%): Not noted.   
  • FEMALES (%): Not noted. 
  • CURRENT TREATMENT: Other
  • KEY DISEASE CHARACTERISTICS: Adult patients with CML at any phase of the disease under regular treatment at research site.
  • OTHER KEY SAMPLE CHARACTERISTICS: Both male and female patients with no history of psychiatric illness and a low level of anxiety at baseline were included. No other demographic data defined.

Setting

  • SITE: Single site   
  • SETTING TYPE: Not specified    
  • LOCATION: Paraiba, Brazil

Phase of Care and Clinical Applications

PHASE OF CARE: Multiple phases of care

Study Design

Randomized controlled trial

Measurement Instruments/Methods

State-Trait Anxiety Inventory (STAI) was used for subjective measurements. This is a self-reported anxiety scale. Physiological measurements including systolic and diastolic blood pressures, heart rate, and respiratory rate were also assessed.

Results

The groups that received diazepam and exposure to C. aurantium both showed significant decrease in systolic blood pressure (p < 0.05). The group exposed to C. aurantium experienced significant decrease in heart rate (p < 0.001) as well as significant differences in anxiety levels as reported on the STAI-S before and after the treatment when analyzed by Wilcoxon test (p < 0.001).

Conclusions

Findings suggest that C. aurantium may potentiate anxiolytic effects in patients with CML undergoing bone marrow biopsy.

Limitations

  • Small sample (< 100)
  • Risk of bias (sample characteristics)
  • Key sample group differences that could influence results
  • Measurement/methods not well described
  • Findings not generalizable
  • Other limitations/explanation: Patient demographics not fully defined; limited to patients with CML; methods could be defined in much better detail.

Nursing Implications

C. aurantium and other anxiolytic essential oils may be considered as nonpharmacologic tools for the reduction of anxiety in patients with cancer, although much more research is needed in more diverse patient populations.

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Geerse, O.P., Hoekstra-Weebers, J., Stokroos, M.H., Burgerhof, J.G.M., Groen, H.J.M., Kerstjens, H.A.M., & Hiltermann, T.J.N. (2017). Structural distress screening and supportive care for patients with lung cancer on systemic therapy: A randomised controlled trial. European Journal of Cancer, 72, 37–45.

Study Purpose

To examine effects of routine distress screening and referral on patient’s mood, satisfaction, and quality of life

Intervention Characteristics/Basic Study Process

Patients were randomized to receive the routine screening or usual care. Study assessment were done at outpatient visits weeks 1, 7, 13, and 25 after study entry. Usual care involved medical care and psychosocial care by the physician; psychosocial care was not integrated and referrals for psychosocial care were based on physician judgment. There was no structural distress screening. In the screening group, patients completed the Distress Thermometer and Problem List at each clinic visit. For scores of 4 or greater, patients were offered referral to an appropriate provider.

Sample Characteristics

  • N = 195 entered, 111 at 25 weeks 
  • AGE: Mean = 61.6 years
  • MALES: 42.8%  
  • FEMALES: 48.2%
  • KEY DISEASE CHARACTERISTICS: Newly diagnosed with lung cancer, prior to treatment
  • OTHER KEY SAMPLE CHARACTERISTICS: The majority had stage IV disease. Baseline scores did not show clinically relevant anxiety or depression

Setting

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

Phase of Care and Clinical Applications

PHASE OF CARE: Active anti-tumor treatment

Study Design

RCT

Measurement Instruments/Methods

  • EORTC-QLQ-C30: Quality of life
  • EORTC-LC13: Symptoms specific to lung cancer
  • Hospital Anxiety and Depression Scale (HADS)
  • PSQIII: Depression
  • Charlston Comorbidity Index

Results

There were no differences between groups in study outcome results for quality of life, depression, or anxiety. There were no differences in hospitalizations or ED visits between groups.

Conclusions

Findings did not show that routine distress screening and provision of care based on screening had any effect.

Limitations

  • Risk of bias (no blinding)
  • Subject withdrawals ≥ 10%  
  • Other limitations/explanation: Use of referrals in both study groups is not discussed and results of distress screening are not provided.

Nursing Implications

This study did not show any significant differences in patient outcomes due to implementation of routine distress screening and associated supportive care referral.

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