McDonald, J., Swami, N., Hannon, B., Lo, C., Pope, A., Oza, A., . . . Zimmermann, C. (2016). Impact of early palliative care on caregivers of patients with advanced cancer: Cluster randomised trial. Annals of Oncology, 28, 163–168. 

DOI Link

Study Purpose

To report the effect of an early palliative care intervention on quality of life (QOL) and satisfaction with care of caregivers of patients with advanced cancer

Intervention Characteristics/Basic Study Process

A cluster randomization process involving patients and their caregivers in 24 Canadian medical oncology clinics supported two randomized arms: an intervention with early palliative care team referral or usual oncology care with palliative care only as needed. Further stratification of clinics by tumor site supported the two study arms. Both arms included caregivers of patients with advanced cancer, defined as having a clinical prognosis of 6–24 months and an ECOG score of 0–2, who completed previously validated instruments on care satisfaction (FAMCARE-19) and QOL (SF-36v2 Health Survey, Caregiver Quality of Life Index-Cancer [CQOL-C]). A mixed effect model evaluated intervention group improvement over the control group at baseline assessment and monthly for as many as four months.

Sample Characteristics

  • N = 182, 94 in intervention and 88 in control
  • MEDIAN AGE = 58 years (intervention), 57 years (control) 
  • MALES: 35% (not specifically stated, extrapolated from female percentage), FEMALES: 65% 
  • CURRENT TREATMENT: Not specified
  • KEY DISEASE CHARACTERISTICS: Stage III with poor prognosis or stage IV disease (hormone refractory disease of breast and prostate cancer); cancer diagnoses included lung, gastrointestinal, genitourinary, breast, and gynecologic.
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients with an ECOG status of 0–2 and who passed a cognitive screening (Short Orientation-Memory-Concentration Test, greater than 20 or less than 10 errors)

Setting

  • SITE: Palliative care clinic
  • SETTING TYPE: Outpatient oncology clinics
  • LOCATION: Princess Margaret Cancer Centre, Toronto, Canada

Phase of Care and Clinical Applications

  • PHASE OF CARE: Advanced cancer diagnosis (prognosis of 6–24 months)
  • APPLICATIONS: Palliative care

Study Design

Cluster randomized trial design

Measurement Instruments/Methods

  • Satisfaction in care: 19-item FAMCARE Scale (FAMCARE-19) 
  • QOL measurements: SF-36v2 Health Survey, CQOL-C

Results

Analysis of FAMCARE-19 (satisfaction with care) data showed significant improvement in the intervention group over the control group during the trial period (three months: p = 0.007, four months: p = 0.02). FAMCARE-19 scores were not significantly associated with the number of caregiver palliative clinic visits (three months: p = 0.21, four months: p = 0.39). The intervention and control groups did not differ significantly during the study time on SF-36 physical component scores, the SF-36 mental component scores, and CQOL-C scores. Despite improvements in early palliative care team referral group satisfaction with care, the authors were unable to conclude whether such care improved that caregiver group’s QOL. An exploratory analysis of FAMCARE-19 domains showed that the group’s greatest improvement over that of the usual care group was in four areas: depth of doctor’s patient symptom assessment (p = 0.004), family knowledge of patient tests (p = 0.02), specialist referral (p = 0.02), and family access to nursing services (p = 0.01).

Conclusions

Canadian caregivers of patients with advanced cancer that receive early palliative care team intervention experience increased satisfaction with care compared to those who receive standard oncology care. Additional work to explore the impact of an early palliative care team intervention on caregiver QOL with an attention on factors like sample size and contextual factors of care will contribute to the science in this area.

Limitations

  • Risk of bias (no blinding) (no full blinding due to cluster design
  • Risk of bias (sample characteristics)
  • Measurement/methods not well described
  • Subject withdrawals ≥ 10%  (17% attrition after baseline assessment)
  • Recruitment from a single cancer center
  • The intervention was complex, and no measurement of dosage of ancillary interventions, which included qualitative interviews, was included.

Nursing Implications

Few clinical trials assess the effect of early palliative care interventions on caregivers of patients with advanced cancer. Current standards of care for patients with advanced cancer include integrating palliative care to improve patient care satisfaction and QOL. This study shows evidence that including those patient caregivers in such an approach improves their satisfaction with care, although it is unclear whether it improves their overall QOL.