Clinical trial NCT02058745: SmartCare: Innovations in Caregiving Interventions
Official title: SmartCare: Innovations in Caregiving Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Malignant Brain Tumors
Keywords: Neuro-oncology
Caregivers
Intervention Research
Representational Approach
Cognitive Behavioral Therapy
Family
Internet
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2014-02-10
Enrollment: 240
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Change in depression from baseline at 4 months on the shortened CES-D
timeFrame: Baseline and 4 months
Secondary outcomes:
measure: Change in unmet needs from baseline at 4 months on the CNS
timeFrame: Baseline and 4 months
measure: Change in mastery from baseline at 4 months on the Caregiver Mastery Scale
timeFrame: Baseline and 4 months
measure: Change in optimism from baseline at 4 months on the Life Orientation Test
timeFrame: Baseline and 4 months
measure: Change spirituality from baseline at 4 months on the FACIT.
timeFrame: Baseline and 4 months.
measure: Change in oversight demand from baseline at 4 months on the caregiver vigilance scale.
timeFrame: Baseline and 4 months
measure: Change in social support from baseline at 4 months on the ISEL.
timeFrame: Baseline and 4 months.
measure: Change in occupational functioning from baseline at 4 months on the WLQ.
timeFrame: Baseline and 4 months.
measure: Changes in positive aspects of providing care from baseline at 4 months on the PAC.
timeFrame: Baseline and 4 months
measure: Change in unmet needs from baseline at 6 months on the CNS
timeFrame: Baseline and 6 months
measure: Change in mastery from baseline at 6 months on the Caregiver Mastery Scale
timeFrame: Baseline and 6 months
measure: Change in optimism from baseline at 6 months on the Life Orientation Test
timeFrame: Baseline and 6 months
measure: Change spirituality from baseline at 6 months on the FACIT.
timeFrame: Baseline and 6 months.
measure: Change in oversight demand from baseline at 6 months on the caregiver vigilance scale.
timeFrame: Baseline and 6 months
measure: Change in social support from baseline at 6 months on the ISEL.
timeFrame: Baseline and 6 months.
measure: Change in occupational functioning from baseline at 6 months on the WLQ.
timeFrame: Baseline and 6 months.
measure: Changes in positive aspects of providing care from baseline at 6 months on the PAC.
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh, School of Nursing
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh, School of Nursing
name: Paula R Sherwood, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh, School of Nursing
name: Heidi S Donovan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.