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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
240
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 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.
University of Pittsburgh, School of Nursing
Pittsburgh, Pennsylvania, United States
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).
Time frame: Baseline and 4 months
Change in unmet needs from baseline at 4 months on the CNS
Unmet Needs will be measured via the Caregiver Needs Screen (CNS) questionnaire.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
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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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: Baseline and 6 months