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Completed

NCT Number: NCT02058745

SmartCare: Innovations in Caregiving Interventions

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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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh, School of Nursing

Pittsburgh, Pennsylvania, 15261, United States

About this study

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:

  • 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.

  • 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:

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CAU+ (Enhanced Care as Usual)

Behavioral

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

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Change in depression from baseline at 4 months on the shortened CES-D

    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).

Secondary outcomes

  1. Change in unmet needs from baseline at 4 months on the CNS

    Time frame: Baseline and 4 months

    Unmet Needs will be measured via the Caregiver Needs Screen (CNS) questionnaire.

  2. Change in mastery from baseline at 4 months on the Caregiver Mastery Scale

    Time frame: Baseline and 4 months

    Mastery will be measured using the Caregiver Mastery Scale.

  3. Change in optimism from baseline at 4 months on the Life Orientation Test

    Time frame: Baseline and 4 months

    Optimism will be measured using the Life Orientation Test.

  4. Change spirituality from baseline at 4 months on the FACIT.

    Time frame: Baseline and 4 months.

    Spirituality will measured using the Functional Assessment of Chronic Illness Therapy - Sp (FACIT).

  5. Change in oversight demand from baseline at 4 months on the caregiver vigilance scale.

    Time frame: Baseline and 4 months

    Caregiver oversight demand will be measured using the four item Caregiver Vigilance Scale.

  6. Change in social support from baseline at 4 months on the ISEL.

    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).

  7. Change in occupational functioning from baseline at 4 months on the WLQ.

    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).

  8. Changes in positive aspects of providing care from baseline at 4 months on the PAC.

    Time frame: Baseline and 4 months

    Positive aspects of providing care will be measured using the Positive Aspects of Caregiving (PAC) scale.

  9. Change in unmet needs from baseline at 6 months on the CNS

    Time frame: Baseline and 6 months

    Unmet Needs will be measured via the Caregiver Needs Screen (CNS) questionnaire.

  10. Change in mastery from baseline at 6 months on the Caregiver Mastery Scale

    Time frame: Baseline and 6 months

    Mastery will be measured using the Caregiver Mastery Scale.

  11. Change in optimism from baseline at 6 months on the Life Orientation Test

    Time frame: Baseline and 6 months

    Optimism will be measured using the Life Orientation Test.

  12. Change spirituality from baseline at 6 months on the FACIT.

    Time frame: Baseline and 6 months.

    Spirituality will measured using the Functional Assessment of Chronic Illness Therapy - Sp (FACIT).

  13. Change in oversight demand from baseline at 6 months on the caregiver vigilance scale.

    Time frame: Baseline and 6 months

    Caregiver oversight demand will be measured using the four item Caregiver Vigilance Scale.

  14. Change in social support from baseline at 6 months on the ISEL.

    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).

  15. Change in occupational functioning from baseline at 6 months on the WLQ.

    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).

  16. Changes in positive aspects of providing care from baseline at 6 months on the PAC.

    Time frame: Baseline and 6 months

    Positive aspects of providing care will be measured using the Positive Aspects of Caregiving (PAC) scale.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Acronym: SmartCare

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Feb 10, 2014
Registry last updated
Aug 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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