El-Jawahri, A., Greer, J.A., Pirl, W.F., Park, E.R., Jackson, V.A., Back, A.L., . . . Temel, J.S. (2017). Effects of early integrated palliative care on caregivers of patients with lung and gastrointestinal cancer: A randomized clinical trial. The Oncologist, 22, 1528–1534.

To test the effects of early integrated palliative care ([PC] plus oncology care) versus oncology care on caregivers’ distress and quality of life (QOL).

Patients in the intervention group met within the first four weeks of diagnosis with a PC-certified MD or APN and at least once monthly until the patient died; PC providers had the ability to contact patients in the intervention group by phone if an in-person visit was not possible, they also added more visits as needed. The PC visits focused on interventions with patients that were discussed in a different study that was referred to. Caregivers were not required to attend the PC visits but were encouraged to. Seventy-one percent of PC visits were attended by caregivers.

• N = 275   
• AGE: Mean = 57 years (SD = 13.6)
• MALES: 31%  
• FEMALES: 69%
• CURRENT TREATMENT: Not applicable, other
• KEY DISEASE CHARACTERISTICS: Incurable lung cancers or noncolorectal gastrointerstinal cancers
• OTHER KEY SAMPLE CHARACTERISTICS: Caregivers were 18 years and older, mostly White, Catholic, married to the patient, with a college education. Able to respond in English with minimal use of translator (minimal use not defined)

• SITE: Single site   
• SETTING TYPE: Outpatient; if patient were admitted to Massachusetts General Hospital, the PC team followed them during hospitalization
• LOCATION: Massachusetts General Hospital

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

Randomized nonblinded clinical trial. Randomization using 1:1 stratified by cancer type. Researchers/clinicians learned of assignment after it was done by the Office of Data Quality staff.

Caregiver mood and anxiety were assessed using the Hospital Anxiety and Depression Scale (HADS); the QOL was assessed using SF-36. Measurement of outcomes occurred at week 12 and week 24 post-enrollment.

At 12 weeks, caregivers in the intervention group has significantly lower total psychological distress (anxiety and mood) assessed by HADS total scale score (adjusted mean difference = -1.45, 95 CI [-2.76, -0.15], p = 0.029; the difference seems to be driven by the lower depression scores on the subscale level (adjusted mean difference = -0.71, 95% CI [-1.38, -0.05], p = 0.036). At 24 months, no significant differences between the two groups for any of the outcomes (total psychological distress, depression, anxiety, and QOL). Using terminal decline model (which factors in missing data and deterioration in caregivers outcomes closer to death), caregivers in the interventions group has significantly lower HADs-total (and lower scores on the subscales, depression and anxiety) (95% CI [4.11, 9.58]). No differences in QOL still under this model between the two groups of caregivers.

Early Integrated PC to patients with incurable cancer decreases their caregivers' psychological distress (anxiety and depression) but not QOL.

• Risk of bias (no blinding)
• Unintended interventions or applicable interventions not described that would influence results
• Intervention expensive, impractical, or training needs
• Questionable protocol fidelity
• Other limitations/explanation: The nature of the PC visits and what they involved were not described in the article. Authors referred reader to a previous research report. The fact that the number of PC visits may have varied widely between patients in the intervention group, calls to question if the frequency, not only the visit, affected the outcomes.

This was a compelling study for early palliative care--educating patients and their caregivers about benefits of early PC and addressing that the benefits extend beyond patients.