SmartCare: Innovations in Caregiving Interventions

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by University of Pittsburgh
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Paula Sherwood, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT02058745
First received: November 19, 2013
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Primary Malignant Brain Tumors
Behavioral: CAU+ (Enhanced Care as Usual)
Behavioral: Beating the Blues
Behavioral: SmartCare

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: SmartCare: Innovations in Caregiving Interventions

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Change in depression from baseline at 4 months on the shortened CES-D [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: No ]
    Depressive symptoms will be measured using the 10-item shortened version of the Center for Epidemiologic Studies - Depression (CES-D).

  • Change in anxiety from baseline at 4 months on the shortened POMS [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: No ]
    Anxiety will be measured using the 3-item shortened version of the anxiety subscale of the Profile of Moods States (POMS- A)

  • Change in burden from baseline at 4 months on the CRA [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: No ]
    Caregiver burden will be measured via the 17 item Caregiver Reaction Assessment (CRA) to indicate the impact of providing care on five areas of life.

  • Change in physical symptoms from baseline at 4 months reported on the symptom checklist [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: No ]
    Physical symptoms will be measured using the Symptom Checklist.

  • Change in overall physical health from baseline at 4 months on the SF-36 [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: No ]
    Overall physical health will be measured using the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36).

  • Change in co-morbid conditions from baseline at 4 months on the AHEAD items [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: No ]
    Change in co-morbid conditions will be measured by items taken from Assets and Health Dynamics of the Oldest-Old (AHEAD).

  • Change in sleep from baseline at 4 months on the PSQI [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: No ]
    Sleep will be measured through self-report using the Pittsburgh Sleep Quality Index.

  • Change in inflammatory response from baseline at 4 months measured by IL-6 and IL-1β. [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: No ]
    Inflammatory responses will be measured by stimulated and circulating levels of IL-6 and IL-1β.

  • Change in depression from baseline at 6 months on the shortened CES-D [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Depressive symptoms will be measured using the 10-item shortened version of the Center for Epidemiologic Studies - Depression (CES-D).

  • Change in anxiety from baseline at 6 months on the shortened POMS [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Anxiety will be measured using the 3-item shortened version of the anxiety subscale of the Profile of Moods States (POMS- A)

  • Change in burden from baseline at 6 months on the CRA [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Caregiver burden will be measured via the 17 item Caregiver Reaction Assessment (CRA) to indicate the impact of providing care on five areas of life.

  • Change in physical symptoms from baseline at 6 months reported on the symptom checklist [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Physical symptoms will be measured using the Symptom Checklist.

  • Change in overall physical health from baseline at 6 months on the SF-36 [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Overall physical health will be measured using the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36).

  • Change in co-morbid conditions from baseline at 6 months on the AHEAD items [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Change in co-morbid conditions will be measured by items taken from Assets and Health Dynamics of the Oldest-Old (AHEAD).

  • Change in sleep from baseline at 6 months on the PSQI [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Sleep will be measured through self-report using the Pittsburgh Sleep Quality Index.

  • Change in inflammatory response from baseline at 6 months measured by IL-6 and IL-1β. [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Inflammatory responses will be measured by stimulated and circulating levels of IL-6 and IL-1β.


Secondary Outcome Measures:
  • Change in unmet needs from baseline at 4 months on the CNS [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: No ]
    Mastery will be measured using the Caregiver Mastery Scale.

  • Change in optimism from baseline at 4 months on the Life Orientation Test [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: No ]
    Optimism will be measured using the Life Orientation Test.

  • Change spirituality from baseline at 4 months on the FACIT. [ Time Frame: Baseline and 4 months. ] [ Designated as safety issue: No ]
    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. [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: No ]
    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. [ Time Frame: Baseline and 4 months. ] [ Designated as safety issue: No ]
    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. [ Time Frame: Baseline and 4 months. ] [ Designated as safety issue: No ]
    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. [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Mastery will be measured using the Caregiver Mastery Scale.

  • Change in optimism from baseline at 6 months on the Life Orientation Test [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Optimism will be measured using the Life Orientation Test.

  • Change spirituality from baseline at 6 months on the FACIT. [ Time Frame: Baseline and 6 months. ] [ Designated as safety issue: No ]
    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. [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    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. [ Time Frame: Baseline and 6 months. ] [ Designated as safety issue: No ]
    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. [ Time Frame: Baseline and 6 months. ] [ Designated as safety issue: No ]
    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. [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Positive aspects of providing care will be measured using the Positive Aspects of Caregiving (PAC) scale.


Estimated Enrollment: 420
Study Start Date: February 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
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.
Experimental: CAU+ and 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.
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.
Behavioral: 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.
Experimental: CAU+ and Beating the Blues and 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.
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.
Behavioral: 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.
Behavioral: 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.

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.
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02058745

Contacts
Contact: Jason M Weimer, MA 412-624-1316 jmw154@pitt.edu
Contact: Howard R Stein, MS 412-624-1853 hos12@pitt.edu

Locations
United States, Pennsylvania
University of Pittsburgh, School of Nursing Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15261
Contact: Jason M Weimer, MA    412-624-1316    jmw154@pitt.edu   
Principal Investigator: Paula R Sherwood, PhD         
Principal Investigator: Heidi S Donovan, PhD         
United States, Texas
University of Texas Houston, MDAnderson Cencer Center Not yet recruiting
Houston, Texas, United States, 77030
Contact: Alvina A Acquaye, MS    713-563-0174    AAAcquaye@mdanderson.org   
Principal Investigator: Terry S Armstrong, PhD         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Paula R Sherwood, PhD University of Pittsburgh, School of Nursing
Principal Investigator: Heidi S Donovan, PhD University of Pittsburgh, School of Nursing
  More Information

No publications provided

Responsible Party: Paula Sherwood, Professor, Vice Chair of Research, Dept. of Acute and Tertiary Care, School of Nursing; Professor, Dept. of Neurological Surgery, School of Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02058745     History of Changes
Other Study ID Numbers: PRO11060487, R01NR013170
Study First Received: November 19, 2013
Last Updated: February 6, 2014
Health Authority: United States: Data and Safety Monitoring Board

Keywords provided by University of Pittsburgh:
Neuro-oncology
Caregivers
Intervention Research
Representational Approach
Cognitive Behavioral Therapy
Family
Internet

Additional relevant MeSH terms:
Brain Neoplasms
Brain Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Neoplasms
Neoplasms by Site
Nervous System Diseases
Nervous System Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014