SmartCare: Innovations in Caregiving Interventions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-01

Study Completion Date

2017-06-14

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Primary Malignant Brain Tumors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CAU+ (Enhanced Care as Usual)

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.

Group Type ACTIVE_COMPARATOR

CAU+ (Enhanced Care as Usual)

Intervention Type BEHAVIORAL

CAU+ 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. These resources are routinely available on the Internet. We provide these as a "one-stop shopping" resource in order to standardize care as usual for caregivers. All caregivers will be sent personalized e-mails from the project director every week during the intervention period.

CAU+ and SmartCare

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.

Group Type EXPERIMENTAL

CAU+ (Enhanced Care as Usual)

Intervention Type BEHAVIORAL

CAU+ 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. These resources are routinely available on the Internet. We provide these as a "one-stop shopping" resource in order to standardize care as usual for caregivers. All caregivers will be sent personalized e-mails from the project director every week during the intervention period.

SmartCare

Intervention Type BEHAVIORAL

SmartCare is a web-based, nurse guided intervention for caregivers based on the Representational Approach of symptom management. The RA builds on traditional cognitive-behavioral interventions by promoting in depth reflection of previous and current experiences, beliefs, and knowledge (referred to as representations) prior to providing new information or engaging in problem-solving.

CAU+ and Beating the Blues and SmartCare

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.

Group Type EXPERIMENTAL

CAU+ (Enhanced Care as Usual)

Intervention Type BEHAVIORAL

CAU+ 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. These resources are routinely available on the Internet. We provide these as a "one-stop shopping" resource in order to standardize care as usual for caregivers. All caregivers will be sent personalized e-mails from the project director every week during the intervention period.

Beating the Blues

Intervention Type BEHAVIORAL

Beating the Blues is an established, self-directed, web-based cognitive behavioral therapy program for managing depressive symptoms. Caregivers are asked to complete 8 weekly sessions, each lasting approximately 50 minutes. Participants are also given simple "homework" after each lesson.

SmartCare

Intervention Type BEHAVIORAL

SmartCare is a web-based, nurse guided intervention for caregivers based on the Representational Approach of symptom management. The RA builds on traditional cognitive-behavioral interventions by promoting in depth reflection of previous and current experiences, beliefs, and knowledge (referred to as representations) prior to providing new information or engaging in problem-solving.

Interventions

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CAU+ (Enhanced Care as Usual)

CAU+ 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. These resources are routinely available on the Internet. We provide these as a "one-stop shopping" resource in order to standardize care as usual for caregivers. All caregivers will be sent personalized e-mails from the project director every week during the intervention period.

Intervention Type BEHAVIORAL

Beating the Blues

Beating the Blues is an established, self-directed, web-based cognitive behavioral therapy program for managing depressive symptoms. Caregivers are asked to complete 8 weekly sessions, each lasting approximately 50 minutes. Participants are also given simple "homework" after each lesson.

Intervention Type BEHAVIORAL

SmartCare

SmartCare is a web-based, nurse guided intervention for caregivers based on the Representational Approach of symptom management. The RA builds on traditional cognitive-behavioral interventions by promoting in depth reflection of previous and current experiences, beliefs, and knowledge (referred to as representations) prior to providing new information or engaging in problem-solving.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No