Clinical trial · Interventional
SmartCare: Innovations in Caregiving Interventions
NCT02058745CI-TRIAL-00029334SmartCarecompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Malignant Brain Tumors | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Beating the Blues | Behavioral | — | UNRESOLVED |
| CAU+ (Enhanced Care as Usual) | Behavioral | — | UNRESOLVED |
| SmartCare | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- CAU+ (Enhanced Care as Usual)
- description
- 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.
- interventionNames
- Behavioral: CAU+ (Enhanced Care as Usual)
- type
- EXPERIMENTAL
- label
- CAU+ and SmartCare
- description
- 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.
- interventionNames
- Behavioral: CAU+ (Enhanced Care as Usual)
- Behavioral: SmartCare
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (3)
- DERIVEDSherwood 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
- DERIVEDBoele 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
- DERIVEDBoele 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