University of Pittsburgh, School of Nursing
Pittsburgh, Pennsylvania, 15261, United States
NCT Number: NCT02058745
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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Notify Me21 year and older
All sexes
Interventional
Not applicable
Pittsburgh, Pennsylvania, 15261, United States
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:
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.
H1: At 2-months following baseline, caregivers who receive Beating the Blues will display improved psychological and physical responses compared to CAU+.
Exploratory aims:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Care recipient:
Caregiver:
Exclusion criteria
Caregiver:
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.
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
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
Unmet Needs will be measured via the Caregiver Needs Screen (CNS) questionnaire.
Time frame: Baseline and 4 months
Mastery will be measured using the Caregiver Mastery Scale.
Time frame: Baseline and 4 months
Optimism will be measured using the Life Orientation Test.
Time frame: Baseline and 4 months.
Spirituality will measured using the Functional Assessment of Chronic Illness Therapy - Sp (FACIT).
Time frame: Baseline and 4 months
Caregiver oversight demand will be measured using the four item Caregiver Vigilance Scale.
Time frame: 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).
Time frame: Baseline and 4 months.
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
Positive aspects of providing care will be measured using the Positive Aspects of Caregiving (PAC) scale.
Time frame: Baseline and 6 months
Unmet Needs will be measured via the Caregiver Needs Screen (CNS) questionnaire.
Time frame: Baseline and 6 months
Mastery will be measured using the Caregiver Mastery Scale.
Time frame: Baseline and 6 months
Optimism will be measured using the Life Orientation Test.
Time frame: Baseline and 6 months.
Spirituality will measured using the Functional Assessment of Chronic Illness Therapy - Sp (FACIT).
Time frame: Baseline and 6 months
Caregiver oversight demand will be measured using the four item Caregiver Vigilance Scale.
Time frame: 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).
Time frame: Baseline and 6 months.
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
Positive aspects of providing care will be measured using the Positive Aspects of Caregiving (PAC) scale.
University of Pittsburgh
Other
Acronym: SmartCare
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