Clinical trial NCT05511324: Simulation-Based Caregiving Skills Training for Family Members of High Grade Glioma Patients
Official title: Simulation-Based Caregiving Skills Training for Family Members of High Grade Glioma Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glioma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-08-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Family caregivers of patients with a primary brain tumor experience a high caregiving load including assistance with activities of daily living without any formal training. It is not surprising that this vulnerable caregiver population reports high levels of distress along with numerous caregiving-related concerns, which may compromise their ability to provide quality care. This project will examine the feasibility and initial evidence for efficacy of a caregiving skills intervention aiming to improve caregiver and patient psychological health; caregiving efficacy and role adjustment; and reduce patient cancer-related symptoms and healthcare utilization.

Detailed description: Trial 1 (single-arm study)

• Aim 1: Examine the usability of the intervention content and trial assessments in 10 caregiver-patient dyads to refine study procedures as needed.

Trial 2 (RCT)

Aim 1 (primary aim): Determine the feasibility of implementing a caregiving intervention using a randomized controlled design in 50 caregiver-HGG patient dyads.

Aim 2: Evaluate the initial evidence for intervention efficacy relative to a WLC group regarding patient and caregiver psychological symptoms (primary outcome), caregiver caregiving efficacy and role adjustment, and patient cancer-related symptoms and healthcare utilization (secondary outcomes).

Aim 3: Understand caregivers' experiences using qualitative methods regarding participation in this study and explore emerging themes as possible intervention mediators/moderators to be examined in future research.

Eligibility criteria: Inclusion Criteria:

* FCGs (e.g., spouse/partner, parent, adult child) of patients diagnosed with HGG receiving any form of cancer treatment (including palliative intent) at MDACC.
* Patients must have a Karnofsky Performance Status (KPS) of 100 to 50. If the patient's Karnofsky Performance Status drops below 50 both patient and caregiver will be removed from the study.
* Both FCGs and patients must be willing to participate and (1) ≥18 years old and able to (2) read and speak English and (3) provide informed consent.

Exclusion Criteria:

* FCGs who regularly participate in psychotherapy with a licensed professional (self-reported).
* Patients with cognitive impairment that would impede ability to complete self-report surveys as documented in the medical record.
* Children under the age of 18 will not be included in this trial. First and foremost, it is unlikely that a person under the age 18 is diagnosed with an HGG.
* Childhood brain tumors tend to be diagnosed in infancy and the caregiving and symptom management needs are vastly different than in the adult patient population. Additionally, the assessment tools are not validated for minors.
* While pregnant caregivers (self-reported) are study eligible, we will also exclude pregnant patients (medical notes). It is unlikely that patients diagnosed with an HGG will be pregnant. Moreover, the current caregiver intervention is not designed to address the care needs of pregnant cancer patients.

Primary outcomes:
measure: M. D. Anderson Symptom Inventory (MDASI) questionnaires
timeFrame: through study completion and average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Kathryn Milbury, MA,PHD
role: PRINCIPAL_INVESTIGATOR
References: