SmartCare: Innovations in Caregiving Interventions

Study Overview
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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.

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: 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. 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: 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. 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.

Official Title
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SmartCare: Innovations in Caregiving Interventions

Conditions
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Primary Malignant Brain Tumors

Intervention / Treatment
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* Behavioral: CAU+ (Enhanced Care as Usual)
* Behavioral: Beating the Blues
* Behavioral: SmartCare


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CAU+ (Enhanced Care as Usual)<br>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. | Behavioral: CAU+ (Enhanced Care as Usual)<br>* 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.<br>|
| Experimental: CAU+ and SmartCare<br>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. | Behavioral: CAU+ (Enhanced Care as Usual)<br>* 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.<br>Behavioral: SmartCare<br>* 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.<br>|
| Experimental: CAU+ and Beating the Blues and SmartCare<br>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. | Behavioral: CAU+ (Enhanced Care as Usual)<br>* 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.<br>Behavioral: Beating the Blues<br>* 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.<br>Behavioral: SmartCare<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depression from baseline at 4 months on the shortened CES-D | Depressive symptoms will be measured using the 10-item shortened version of the Center for Epidemiologic Studies - Depression (CES-D). | Baseline and 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in unmet needs from baseline at 4 months on the CNS | Unmet Needs will be measured via the Caregiver Needs Screen (CNS) questionnaire. | Baseline and 4 months | 
| Change in mastery from baseline at 4 months on the Caregiver Mastery Scale | Mastery will be measured using the Caregiver Mastery Scale. | Baseline and 4 months | 
| Change in optimism from baseline at 4 months on the Life Orientation Test | Optimism will be measured using the Life Orientation Test. | Baseline and 4 months | 
| Change spirituality from baseline at 4 months on the FACIT. | Spirituality will measured using the Functional Assessment of Chronic Illness Therapy - Sp (FACIT). | Baseline and 4 months. | 
| Change in oversight demand from baseline at 4 months on the caregiver vigilance scale. | Caregiver oversight demand will be measured using the four item Caregiver Vigilance Scale. | Baseline and 4 months | 
| Change in social support from baseline at 4 months on the ISEL. | Social support will be measured using the Interpersonal Support Evaluation List (ISEL). Subjects rate the availability of three types of social support (appraisal, belonging, and tangible). | Baseline and 4 months. | 
| Change in occupational functioning from baseline at 4 months on the WLQ. | Caregiver occupational functioning will be measured by general questions related to employment status and the Work Limitations Questionnaire (WLQ). | Baseline and 4 months. | 
| Changes in positive aspects of providing care from baseline at 4 months on the PAC. | Positive aspects of providing care will be measured using the Positive Aspects of Caregiving (PAC) scale. | Baseline and 4 months | 
| Change in unmet needs from baseline at 6 months on the CNS | Unmet Needs will be measured via the Caregiver Needs Screen (CNS) questionnaire. | Baseline and 6 months | 
| Change in mastery from baseline at 6 months on the Caregiver Mastery Scale | Mastery will be measured using the Caregiver Mastery Scale. | Baseline and 6 months | 
| Change in optimism from baseline at 6 months on the Life Orientation Test | Optimism will be measured using the Life Orientation Test. | Baseline and 6 months | 
| Change spirituality from baseline at 6 months on the FACIT. | Spirituality will measured using the Functional Assessment of Chronic Illness Therapy - Sp (FACIT). | Baseline and 6 months. | 
| Change in oversight demand from baseline at 6 months on the caregiver vigilance scale. | Caregiver oversight demand will be measured using the four item Caregiver Vigilance Scale. | Baseline and 6 months | 
| Change in social support from baseline at 6 months on the ISEL. | Social support will be measured using the Interpersonal Support Evaluation List (ISEL). Subjects rate the availability of three types of social support (appraisal, belonging, and tangible). | Baseline and 6 months. | 
| Change in occupational functioning from baseline at 6 months on the WLQ. | Caregiver occupational functioning will be measured by general questions related to employment status and the Work Limitations Questionnaire (WLQ). | Baseline and 6 months. | 
| Changes in positive aspects of providing care from baseline at 6 months on the PAC. | Positive aspects of providing care will be measured using the Positive Aspects of Caregiving (PAC) scale. | Baseline and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caregivers, Intervention Research, Representational Approach, Cognitive Behavioral Therapy, Family, Internet, Neuro-oncology