SmartCare: Innovations in Caregiving Interventions
Conditions
Primary Malignant Brain Tumors
Conditions: official terms
Brain Neoplasms
Conditions: Keywords
Neuro-oncology, Caregivers, Intervention Research, Representational Approach, Cognitive Behavioral Therapy, Family, Internet
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: CAU+ (Enhanced Care as Usual) Type: Behavioral
Name: Beating the Blues Type: Behavioral
Name: SmartCare Type: Behavioral
Overall Status
Recruiting
Summary
This is a study to evaluate the effectiveness of using an established intervention for depressive symptom management in conjunction with a needs-based caregiver intervention for improving the psychological and physical health of family caregivers of persons recently diagnosed with a Primary Malignant Brain Tumor.
Detailed Description
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 21 Years
Gender: Both
Criteria: 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
Location
University of Pittsburgh, School of Nursing
Pittsburgh, Pennsylvania, United States
Status: Recruiting
Contact: Jason M Weimer, MA - 412-624-1316 - jmw154@pitt.edu
Start Date
February 2014
Completion Date
June 2017
Sponsors
University of Pittsburgh
Source
University of Pittsburgh
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page