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.

DOI Link

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.