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Steinhauser, K.E., Alexander, S., Olsen, M.K., Stechuchak, K.M., Zervakis, J., Ammarell, N., . . . Tulsky, J.A. (2017). Addressing patient emotional and existential needs during serious illness: Results of the Outlook randomized controlled trial. Journal of Pain and Symptom Management, 54, 898–908.

Study Purpose

To evaluate outlook, an intervention to assist patients address emotional and existential needs, in people living with advanced disease yet not in the final months of life. If improvements were demonstrated, it could improve understanding of intervention in early versus late palliative care contexts.

Intervention Characteristics/Basic Study Process

Three-arm randomized controlled trial testing the effect of Outlook, with an attention control (RM) and a true control (usual care UC). Baseline interview completed in person or on the phone, then randomized 1:1:1. Participants assigned to Outlook were interviewed in person three times during a one-month period after the baseline interview. Session 1 was life review; session 2 was issues of forgiveness, regret, things left unsaid, or undone; and session 3 was heritage and legacy. Interviews were a week apart and lasted 45 minutes. Participants assigned to RM met with the interventionist in person three times during a one-month period and listed to a relaxation CD for 40 minutes. UC participants were not contacted. Interventionists were clinical social workers trained in delivering standardized interventions following a manualized script. Sessions were audio recorded.

Sample Characteristics

  • N = 221   
  • AGE: Mean = 67.8 years
  • MALES: 96%  
  • FEMALES: 4%
  • CURRENT TREATMENT: Not applicable
  • KEY DISEASE CHARACTERISTICS: Advanced cancer, congestive heart failure, chronic obstructive pulmonary disease, end-stage renal disease, end-stage liver disease
  • OTHER KEY SAMPLE CHARACTERISTICS: Non-hospice eligible, veterans

Setting

  • SITE: Single site   
  • SETTING TYPE: Outpatient    
  • LOCATION: Durham, North Carolina

Phase of Care and Clinical Applications

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

Study Design

Three-arm randomized controlled trial testing the effect of Outlook compared with an attention control (relaxation meditation [RM]) and a true control (usual care [UC]) on patient QOL, functional status, and emotional well-being.

Measurement Instruments/Methods

Primary outcomes:

  • Preparation and completion: QUAL-E a 31-item validated measure of QOL at the end of life

Secondary outcomes:

  • Anxiety: Brief Profile of Mood States
  • Depression: Center for Epidemiological Studies-Depression scale
  • Quality of Life: FACT-General FACT
  • Spiritual Well Being: Functional Assessment of Chronic Illness Therapy-spiritual well-being.

Results

The study compared change in primary and secondary outcomes over time between outlook and both the RM and UC groups. Outlook participants had higher improvements in mean preparation (p = 0.02) and mean completion (p = 0.04) at five week follow-up compared with UC. The differences did not persist for the seven week follow-up. Compared to the RM group, Outlook participants did not have a significant difference in preparation and completion at either follow up. Outlook social well-being was improved over RM at the seven-week follow-up. Outlook did not show significant difference over time in QOL, anxiety, or depression. Qualitative interview participants (15%) described Outlook at helpful. Participants valued the opportunity to review life memories as a source of strength and to identify unresolved issues.

Conclusions

Outlook did not demonstrate sustained improvements in preparation, anxiety, or depression and overall QOL compared to RM in adults with advanced illness who were not hospice eligible. Outlook as an intervention was positive for patient quality of life in reviewing memories as a source of strength, and releasing unresolved emotions and concerns.

Limitations

  • Baseline sample/group differences of import
  • Risk of bias (no appropriate attentional control condition)  
  • Risk of bias (sample characteristics)
  • Key sample group differences that could influence results

 

Nursing Implications

The structured Outlook intervention which assists patients to review and resolve important life issues and concerns is valuable for patients with terminal illness, including patients with cancer. Nurses can assess patients for distress and ensure that opportunities and referrals with support resources are explored. This would be relevant to the hospice setting.

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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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