SmartCare: Innovations in Caregiving Interventions

Primary Malignant Brain Tumors Clinical Trial

— SmartCare  

Official title:

SmartCare: Innovations in Caregiving Interventions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02058745
• Other study ID #: PRO11060487
• Secondary ID: R01NR013170
• Status: Completed
• Phase: N/A
• First received: November 19, 2013
• Last updated: August 28, 2017
• Start date: March 1, 2014
• Est. completion date: June 14, 2017

Study information

• Verified date: August 2017
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: June 14, 2017
• Est. primary completion date: June 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Primary Malignant Brain Tumors

Intervention

Behavioral:
• CAU+ (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.
• Beating 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.
• SmartCare
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.

Locations

Country	Name	City	State
United States	University of Pittsburgh, School of Nursing	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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