SmartCare: Innovations in Caregiving Interventions

NCT02058745 | Completed

• 2 other identifiers: PRO11060487R01NR013170
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Malignant Brain Tumors

Keywords

Neuro-oncology; Caregivers; Intervention Research; Representational Approach; Cognitive Behavioral Therapy; Family; Internet

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

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

  Baseline and 4 months

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

  Baseline and 4 months

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

  Baseline and 4 months

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

  Baseline and 4 months.

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

  Baseline and 4 months

Study Arms (3)

CAU+ (Enhanced Care as Usual)

ACTIVE COMPARATOR

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+ and SmartCare

EXPERIMENTAL

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); Behavioral: SmartCare

CAU+ and Beating the Blues and SmartCare

EXPERIMENTAL

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); Behavioral: Beating the Blues; Behavioral: SmartCare

Interventions

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.

CAU+ (Enhanced Care as Usual); CAU+ and Beating the Blues and SmartCare; CAU+ and SmartCare

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.

CAU+ and Beating the Blues and SmartCare

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.

CAU+ and Beating the Blues and SmartCare; CAU+ and SmartCare

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Pittsburgh, School of Nursing

Pittsburgh, Pennsylvania, 15261, United States

Location

Related Publications (3)

• Sherwood PR, Boele F, Weimer J, Marsland A, Drappatz J, Armstrong TS, Terhorst L, Donovan HS. Neuro-oncology Caregiver Intervention Associated With Changes in C-Reactive Protein. Cancer Nurs. 2025 Apr 22. doi: 10.1097/NCC.0000000000001507. Online ahead of print.

  PMID: 40266659 DERIVED

• Boele FW, Weimer JM, Marsland AL, Armstrong TS, Given CW, Drappatz J, Donovan HS, Sherwood PR. The effects of SmartCare(c) on neuro-oncology family caregivers' distress: a randomized controlled trial. Support Care Cancer. 2022 Mar;30(3):2059-2068. doi: 10.1007/s00520-021-06555-5. Epub 2021 Oct 16.

  PMID: 34655326 DERIVED

• Boele FW, Weimer J, Zamanipoor Najafabadi AH, Murray L, Given CW, Given BA, Donovan HS, Drappatz J, Lieberman FS, Sherwood PR. The Added Value of Family Caregivers' Level of Mastery in Predicting Survival of Glioblastoma Patients: A Validation Study. Cancer Nurs. 2022 Sep-Oct 01;45(5):363-368. doi: 10.1097/NCC.0000000000001027. Epub 2021 Sep 30.

  PMID: 34608049 DERIVED

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Paula R Sherwood, PhD

  University of Pittsburgh, School of Nursing

  PRINCIPAL INVESTIGATOR

• Heidi S Donovan, PhD

  University of Pittsburgh, School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Vice Chair of Research, Dept. of Acute and Tertiary Care, School of Nursing; Professor, Dept. of Neurological Surgery, School of Medicine

Study Record Dates

• First Submitted: November 19, 2013
• First Posted: February 10, 2014
• Study Start: March 1, 2014
• Primary Completion: June 14, 2017
• Study Completion: June 14, 2017
• Last Updated: August 29, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)