Maintaining health-related quality of life of caregivers of glioblastoma patients: A randomized, two-group, controlled trial.

Glioblastoma multiforme (GBM) is the most frequently occurring and most
aggressive type of malignant primary brain tumor. Despite intensive treatment
with neurosurgery, radiotherapy, and chemotherapy, patients with this type of
brain tumor invariably experience tumor recurrence. Median patient survival is
approximately one year from initial diagnosis. Due to the awareness of the
inevitable approaching death of their beloved as well as the fact that GBM
patients often demonstrate behavioral, emotional, and cognitive dysfunction
early in the course of their disease, caregivers of these patients often bear
an incalculable emotional burden for their work. Exhaustion, financial strain,
disrupted daily activities, and continuous caregiving contribute to significant
mental health morbidity, including anxiety and depression, poor sleep, and even
increased cancer risk.

This study aims at 1) ascertaining GBM patients* caregiver mastery and burden
and 2) determining to what extent a structured psychosocial intervention that
teaches coping and problem-solving skills leads to clinically significant
improvements in health-related quality of life (HRQOL) of the caregivers of GBM
patients. Concerning the 2nd aim, three questions will be addressed1) does the
intervention decrease emotional distress and augment HRQOL? 2) does the
intervention improve problem-solving skills? and 3) does the effectiveness of
the intervention depend on patient*s HRQOL, tumor, and/or treatment
characteristics?

A randomized, two-group, controlled clinical trial will be undertaken to
compare the efficacy of a coping/problem-solving skills intervention (n=36)
with standard medical care (n=36) in maintaining overall health-related quality
of life and caregiver mastery of GBM patients' informal caregivers.

Starting at baseline, individual sessions with caregivers will be held every
other week for a maximum of 6 one-hour sessions. The intervention is designed
to empower caregivers by enhancing their problem-solving skills and, thereby,
increasing their ability to cope with the demands of managing and providing
care to the GBM patient.

For the informal caregivers, the burden associated with participation consists
of (1) completing questionnaires regarding health-related quality of life,
caregiver-burden and caregiver-mastery at different points in time during and
following the intervention period, (2) (only for the intervention group)
participation in the six sessions of the intervention program, either at home
or in the hospital. No medical risks are involved. The possible benefits of
participation for the intervention group are: (1) better coping skills, (2)
better emotion-regulation and, (3) mastery of caregiving.