SmartCare: Innovations in Caregiving Interventions

We have designed a needs-based intervention to improve neuro-oncology caregivers' health. Our
novel approach treats depressive symptoms prior to implementing a needs-based intervention in
a sample of PMBT family caregivers who score above threshold on depressive symptoms. Study
outcomes are psychological responses (unmet needs, depressive symptoms, anxiety, and burden)
and physical responses (levels of stimulated and circulating IL-6 and IL-1β, C-reactive
protein, peripheral blood mono-nuclear cells, physical symptoms, and new diagnoses or
exacerbations of co-morbid conditions). The proposed study addresses research priorities set
by both NCI and NINR to improve the quality of life of patients and their families and NINR's
emphasis on integrating bio-behavioral science and adopting, adapting and generating new
technologies.

Primary aims:

1. Compare the efficacy of a) an intervention for depressive symptoms (Beating the Blues)
delivered prior to a needs-based caregiver intervention (SmartCare©) versus b)
SmartCare© alone versus c) enhanced care as usual (CAU+) in improving caregivers'
psychological and physical responses.

H1: At 4- and 6-months, caregivers who receive Beating the Blues prior to SmartCare©
will display improved psychological and physical responses compared to caregivers who
receive CAU+.

H2: At 4- and 6-months, caregivers who receive SmartCare© alone will display improved
psychological and physical responses compared to caregivers who receive CAU+.

H3: At 4- and 6-months, caregivers who receive Beating the Blues prior to SmartCare©
will display improved psychological and physical responses compared to those who receive
SmartCare© alone.

2. Compare the efficacy of Beating the Blues versus CAU+ in improving subjects' short-term
psychological and physical responses.

H1: At 2-months following baseline, caregivers who receive Beating the Blues will display
improved psychological and physical responses compared to CAU+.

Exploratory aims:

1. Determine whether any changes in psychological and physical health resulting from
receiving Beating the Blues prior to SmartCare© or SmartCare© alone are maintained at
10-months after baseline.

2. Evaluate whether the effect of Beating the Blues + SmartCare© (vs. SmartCare© alone) on
4- and 6-month psychological and physical responses is mediated by 0- to 2-month changes
in depressive symptoms.

Inclusion Criteria:

Care recipient:

- Over 21 years of age.

- Newly (within 1 month) diagnosed with a PMBT (tumor verified via pathology report to
be a glioblastoma multiforme, anaplastic astrocytoma, anaplastic oligodendroglioma,
anaplastic oligoastrocytoma, medulloblastoma, or anaplastic ependymoma).

Caregiver:

- Primary nonprofessional, non-paid caregiver, as identified by the care recipient.

- Over 21 years of age with telephone access.

- Reads-speaks English

- Obtains a score of >6 on the shortened CES-D.

- Caregivers may or may not be receiving pharmacotherapy for depressive symptoms

Exclusion Criteria:

Caregiver:

- Currently considers self to be a primary caregiver for anyone else other than children

- Currently receiving any type of formal counselling for depressive symptoms