Boele, F.W., Hoeben, W., Hilverda, K., Lenting, J., Calis, A.L., Sizoo, E.M., . . . Klein, M. (2013). Enhancing quality of life and mastery of informal caregivers of high-grade glioma patients: A randomized controlled trial. Journal of Neuro-Oncology, 111, 303–311.

To determine factors that impact health-related quality of life (HRQOL) and mastery of caregivers of patients with high-grade glioma, and to investigate if a structured intervention consisting of psycho-education and cognitive behavioral therapy (CBT) leads to an improvement in the mental component of HRQOL and mastery of caregivers

Caregiver dyads randomly were assigned to the intervention group or care as usual group. The intervention group consisted of six one-hour sessions with a psychologist for CBT and psycho-education regarding disease-specific symptoms. Participants completed questionnaires concerning their perception of the patients' HRQOL, neurologic functioning, cognitive functioning, their own HRQOL perceptions, and feelings of caregiver mastery at baseline (prior to randomization) and every two months thereafter until eight months later, five times total.

• N = 56 caregiver dyads  
• MEAN AGE = 50 years
• MALES: Intervention group = 26%, control group = 48%; FEMALES: Intervention group = 74%, control group = 52%
• KEY DISEASE CHARACTERISTICS: High-grade glioma stage III/IV
• OTHER KEY SAMPLE CHARACTERISTICS: Participants were informal caregivers (defined as a spouse or significant other providing at least 21 hours of care per week); aged 18 years or older; 57% were receiving active treatment during the study 

• SITE: Multi-site    
• SETTING TYPE: Outpatient  
•  LOCATION: VU University Medical Center (Amsterdam)/Academic Medical Center (Amsterdam), and Medical Center Haaglanden (Netherlands)

• PHASE OF CARE: Multiple phases of care
• APPLICATIONS: Palliative care

• Randomized, controlled trial

• MOS 36-item short form survey (SF-36)
• Caregiver mastery scale
• MOS Cognitive Functioning Scale
• Brain cancer module

Caregivers' HRQOL and caregiver mastery were associated with patient-related factors at baseline. A positive correlation was found between a positive mental functioning (MCS) of the patient and a positive MCS of the caregiver. Feelings of mastery in the intervention group increased over time, while feelings of mastery in the control group showed the opposite pattern. Those who received the intervention maintained a more stable level of mental functioning and showed modest improvement in feelings of mastery in comparison to the control group. Patients' HRQOL and neurologic functioning were found to be related to HRQOL and feelings of mastery of the informal caregiver at baseline. The intervention helped caregivers in maintaining a stable level of HRQOL and improved feelings of mastery over an eight-month period.

The findings from this RCT suggest that informal caregivers can benefit from a psychological CBT intervention because it is a helpful tool in maintaining a stable level of mental functioning and caregiver mastery.

• Small sample (less than 100)
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Findings not generalizable as a result of high attrition
• Intervention expensive, impractical, or training needs—significant time/burden for the caregiver (burdensome)
• Subject withdrawals 10% or greater
• Other limitations/explanation: Approximately 24% died prior to study conclusion

Future nursing practice should focus on offering supportive interventions to patients with high-grade glioma and their informal caregivers. Further research should continue to look at the effects of a psychological intervention on HRQOL and feelings of mastery of informal caregivers of the high-grade glioma patient population. Findings suggest that CBT interventions can be of benefit to caregivers.