Primary Malignant Brain Tumors
Conditions
Keywords
Neuro-oncology, Caregivers, Intervention Research, Representational Approach, Cognitive Behavioral Therapy, Family, Internet
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.
Interventions
BEHAVIORALCAU+ (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.
BEHAVIORALBeating 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.
BEHAVIORALSmartCare
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.
Sponsors
National Institute of Nursing Research (NINR)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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 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 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. |
| 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. |
Countries
United States
Outcome results
None listed