O'Hara, R.E., Hull, J.G., Lyons, K.D., Bakitas, M., Hegel, M.T., Li, Z., & Ahles, T.A. (2010). Impact on caregiver burden of a patient-focused palliative care intervention for patients with advanced cancer. Palliative and Supportive Care, 8, 395–404. 

To assess whether a previously supported patient-directed palliative care intervention would decrease caregiver burden

Patients received a random assignment to either an intervention (palliative care) or usual care group. Intervention patients participated in four weekly telephone sessions focused on communicating with healthcare providers, learning problem-solving skills, managing disease symptoms, and planning for end-of-life care. Patient caregivers received invitations and volunteered to participate in the intervention. Following the intervention, nurses called patients at least once a month to lend support and present additional information. Patients in the usual care group received standard oncology care at the cancer care center. Caregivers and patients completed questionnaires at baseline, one month post-baseline, and every three months until the end of the study. Following patient death during the study period, caregivers were asked to complete the After-Death Bereaved Family Member Interview (ADI).

• N = 198   
• MEAN AGE = 59 years
• MALES: 23%, FEMALES: 77%
• CURRENT TREATMENT: Other
• KEY DISEASE CHARACTERISTICS: Patients with advanced cancer receiving outpatient palliative care 
• OTHER KEY SAMPLE CHARACTERISTICS: Intervention caregivers were significantly more educated than those in usual care group.

• SITE: Multi-site   
• SETTING TYPE: Outpatient    
• LOCATION: U.S. comprehensive cancer centers in northern New England

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

Randomized, controlled trial

• Caregiver burden: 14-item Montgomery Borgatta Caregiver Burden Scale to measure objective burden, stress burden, and demand burden
• Quality of care: 67-item After-Death Bereaved Family Member Interview (ADI) to measure caregiver perception of patient quality of care four to six months after patient death
• Patient quality of life: 46-item Functional Assessment of Chronic Illness Therapy-Palliative Care (FACIT-Pal) to measure patient overall end-of-life well-being
• Physical symptoms: 10-item Edmonton Symptom Assessment Scale (ESAS) to measure patient symptom severity
• Depressed mood: 20-item Center for Epidemiological Studies-Depression (CES-D) to measure patient and caregiver depression frequency

Patient FACIT-Pal scores correlated negatively and at high levels with ESAS scores and CES-D scores, and ESAS and CES-D scores correlated positively. Fewer and less consistent correlation of caregiver burden scores occurred: caregivers perceiving objective burden sources reported stress but not demand burden (unreasonable patient requests for care). Demand burden was positively correlated with stress burden in caregivers. Patients who identified lower patient quality of life (FACIT-Pal) had caregivers scoring higher on objective and stress burden. Caregivers scored higher on objective burden and stress burden if patients had higher ESAS and CES-D scores (latter evident one month postbaseline). Of 96 caregiver burden correlations, patient well-being, and quality of care, five achieved statistical significance. These included patient spiritual and emotional support concerns associated with patient well-being (p < 0.01) and decreased caregiver stress burden (p < 0.01) at baseline. One month postbaseline, unmet patient needs correlated with caregiver stress burden (p < 0.05), and concerns with patient respectful treatment correlated with increased caregiver demand burden (p < 0.05).

Despite evidence in a previous ENABLE II study supporting the success of a palliative care interventions to decrease patient symptom intensity, depression, and improve quality of life, this study did not support improvement in caregiver burden with a similar methodology.

• Risk of bias (sample characteristics)
• Unintended interventions or applicable interventions not described that would influence results
• Findings not generalizable (96% Caucasian , 77% female, and 84% married or living with partner)
• Subject withdrawals ≥ 10% 
• Caregiver participation in intervention inconsistent to affect study outcomes
• High caregiver attrition prevented measurements after four months.
• ADI reports focused on only patients' quality of care, not caregiver experience.

Multiple studies document that minimizing caregiver burden requires specialized interventions focusing on emotional, financial, spiritual, and physical strains but also caregiving benefits gained in a dyadic relationship (patient and caregiver). Well-designed long-term randomized, controlled trials sensitive to documented health interaction outcomes of caregiving dyads may provide clinical direction for improved patient well-being and lower caregiver burden during palliative cancer care.