Dionne-Odom, J.N., Azuero, A., Lyons, K.D., Hull, J.G., Tosteson, T., Li, Z., . . . Bakitas, M.A. (2015). Benefits of early versus delayed palliative care to informal family caregivers of patients with advanced cancer: Outcomes from the ENABLE III randomized controlled trial. Journal of Clinical Oncology, 33, 1446–1452. 

To assess the impact of early versus delayed (three months after patient diagnosis) initiation of palliative care for patients with advanced cancer on rural informal caregivers’ quality of life, burden (objective, demand, and stress), and depression

Caregivers were assigned to a palliative care intervention immediately following random assignment to groups (early or delayed) or three months after assignment. The telephone-based intervention, informed by authors’ earlier work sensitive to rural access issues, involved conversations between trained advanced practice palliative care nurse coaches and caregivers. Each coach provided three evidence-based content sessions delivered weekly in a scripted format. Each patient received a different coach than the family caregiver to support the open sharing of feelings about the caregiving experience. Coaches contacted their assigned caregivers on the telephone at least monthly to respond to emerging issues until patient death. Coaches encouraged caregivers to participate in patient palliative care consultations if acceptable to patient and called a caregivers when their family members died. All nurse coaches met weekly with study's primary investigator to support study integrity. To identify group differences on desired outcome measures, all caregivers completed three questionnaires at baseline and every six weeks until week 24.

• N = 122  
• MEAN AGE = 60 years
• MALES: 21.3%, FEMALES: 78.7%
• KEY DISEASE CHARACTERISTICS: Patients' predominant diagnosis was advanced gastrointestinal or lung cancer  
• OTHER KEY SAMPLE CHARACTERISTICS: 93% white; 80% completed high school or college; more than half employed; 29% retired; 62% professed Catholic or Protestant religious beliefs; 75% were the spouse or partner of a patient with cancer 

• SITE: Multi-site  
• SETTING TYPE: Outpatient    
• LOCATION: New Hampshire and Vermont

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

Randomized, controlled trials with a wait-control design

• Caregiver Quality of Life Scale: Cancer (CQOL-C0)
• Center for Epidemiologic Studies Depression (CESD) Scale
• Montgomery Borgatta Caregiver Burden (MBCB) Scale
• High reliability and validity assessment indices provided by authors

More than 30% of participants did not complete all the follow-up assessments although the authors used appropriate statistics to confirm there was no significant relationship of attrition and measured characteristics of caregivers. The early intervention group showed a decline in depression scores from baseline compared to the delayed group (d –0.32, p = 0.02). There were no differences between the groups in quality of life or burden scores. Among the caregivers of patients who died, results for depression (p = 0.02) and stress burden (p = 0.01) were better in the early intervention group. All measures showed decline somewhat in both groups.

Study data support that well-educated, white, female caregivers experience improved quality of life, less depression, and less burden with early involvement in palliative care programs distinct from similar patient programs. More studies of minority populations, male caregivers, and low literacy populations receiving similar programs could increase the generalizability of the current study's findings.

• Findings not generalizable
• Subject withdrawals ≥ 10%
• Other limitations/explanation: No inclusion criteria for caregivers except those caring for patients who met certain criteria (potential selection bias); sample mainly white with high school or more education levels living in close geographical distance to affect generalizability of results; 32% of caregivers did not complete all assessments (authors do not note rationale, seems patients became more ill and needed caregiver assistance); caregiver exclusion criteria did not clarify if a caregiver was excluded if he or she had cancer, a diagnosis of depression, or health issues that affected quality of life or perceived burden

Nursing knowledge and the clinical competency of support provision for early palliative care programs to family caregivers and patients challenged by end-of-life issues is important. The American Nurses Association Code for Nurses supports the ethical responsibility of nurses to ensure that both groups receive evidence-based programs tailored to patients and caregiver groups to meet current healthcare goals for person-centered care.