Skip to main content

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.

Print

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.

Print

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.

Print
Subscribe to