SmartCare: Innovations in Caregiving Interventions

University of Pittsburgh

Status: Completed

Conditions: Primary Malignant Brain Tumors

Treatments: Behavioral: SmartCare; Behavioral: Beating the Blues; Behavioral: CAU+ (Enhanced Care as Usual)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02058745

PRO11060487

R01NR013170 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 3 patient groups

CAU+ (Enhanced Care as Usual)

Active Comparator group

Description:

CAU+ (Enhanced Care as Usual) is defined as the care received from the care recipient's oncologist supplemented by unlimited access to three components of the study website: caregiver guides, links to web-based resources, and a basic friends and family page for the 10 month duration of the study.

Treatment:

Behavioral: CAU+ (Enhanced Care as Usual)

CAU+ and SmartCare

Experimental group

Description:

CAU+ (Enhanced Care as Usual) for eight weeks, followed by eight weeks of SmartCare. SmartCare is a web-based, nurse guided intervention for caregivers based on the Representational Approach of symptom management.

Treatment:

Behavioral: CAU+ (Enhanced Care as Usual)

Behavioral: SmartCare

CAU+ and Beating the Blues and SmartCare

Experimental group

Description:

CAU+ (Enhanced Care as Usual) and Beating the Blues concurrently for eight weeks, followed by SmartCare for eight weeks. Beating the Blues is an established, web-based, self-directed, cognitive behavioral therapy for managing depressive symptoms.

Treatment:

Behavioral: Beating the Blues

Behavioral: CAU+ (Enhanced Care as Usual)

Behavioral: SmartCare