SmartCare: Innovations in Caregiving Interventions
- Conditions
- Primary Malignant Brain Tumors
- Interventions
- Behavioral: CAU+ (Enhanced Care as Usual)Behavioral: SmartCareBehavioral: Beating the Blues
- Registration Number
- NCT02058745
- Lead Sponsor
- University of Pittsburgh
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CAU+ and SmartCare CAU+ (Enhanced Care as Usual) 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. CAU+ and SmartCare 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. CAU+ and Beating the Blues and SmartCare CAU+ (Enhanced Care as Usual) 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. CAU+ and Beating the Blues and SmartCare Beating the Blues 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. CAU+ and Beating the Blues and SmartCare 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. CAU+ (Enhanced Care as Usual) 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.
- Primary Outcome Measures
Name Time Method Change in depression from baseline at 4 months on the shortened CES-D Baseline and 4 months Depressive symptoms will be measured using the 10-item shortened version of the Center for Epidemiologic Studies - Depression (CES-D).
- Secondary Outcome Measures
Name Time Method Change in social support from baseline at 4 months on the ISEL. Baseline and 4 months. 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).
Change in unmet needs from baseline at 4 months on the CNS Baseline and 4 months Unmet Needs will be measured via the Caregiver Needs Screen (CNS) questionnaire.
Change in mastery from baseline at 4 months on the Caregiver Mastery Scale Baseline and 4 months Mastery will be measured using the Caregiver Mastery Scale.
Change in optimism from baseline at 4 months on the Life Orientation Test Baseline and 4 months Optimism will be measured using the Life Orientation Test.
Change spirituality from baseline at 4 months on the FACIT. Baseline and 4 months. Spirituality will measured using the Functional Assessment of Chronic Illness Therapy - Sp (FACIT).
Change in oversight demand from baseline at 4 months on the caregiver vigilance scale. Baseline and 4 months Caregiver oversight demand will be measured using the four item Caregiver Vigilance Scale.
Change in social support from baseline at 6 months on the ISEL. Baseline and 6 months. 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).
Change in occupational functioning from baseline at 4 months on the WLQ. Baseline and 4 months. Caregiver occupational functioning will be measured by general questions related to employment status and the Work Limitations Questionnaire (WLQ).
Changes in positive aspects of providing care from baseline at 4 months on the PAC. Baseline and 4 months Positive aspects of providing care will be measured using the Positive Aspects of Caregiving (PAC) scale.
Change in unmet needs from baseline at 6 months on the CNS Baseline and 6 months Unmet Needs will be measured via the Caregiver Needs Screen (CNS) questionnaire.
Change in mastery from baseline at 6 months on the Caregiver Mastery Scale Baseline and 6 months Mastery will be measured using the Caregiver Mastery Scale.
Change in optimism from baseline at 6 months on the Life Orientation Test Baseline and 6 months Optimism will be measured using the Life Orientation Test.
Change spirituality from baseline at 6 months on the FACIT. Baseline and 6 months. Spirituality will measured using the Functional Assessment of Chronic Illness Therapy - Sp (FACIT).
Change in oversight demand from baseline at 6 months on the caregiver vigilance scale. Baseline and 6 months Caregiver oversight demand will be measured using the four item Caregiver Vigilance Scale.
Change in occupational functioning from baseline at 6 months on the WLQ. Baseline and 6 months. Caregiver occupational functioning will be measured by general questions related to employment status and the Work Limitations Questionnaire (WLQ).
Changes in positive aspects of providing care from baseline at 6 months on the PAC. Baseline and 6 months Positive aspects of providing care will be measured using the Positive Aspects of Caregiving (PAC) scale.
Trial Locations
- Locations (1)
University of Pittsburgh, School of Nursing
🇺🇸Pittsburgh, Pennsylvania, United States