Simulation-Based Caregiving Skills Training for Family Members of High Grade Glioma Patients

Last updated: August 25, 2025
Sponsor: M.D. Anderson Cancer Center
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Neurofibromatosis

Brain Cancer

Cancer

Treatment

Questionnaires

Caregiver Assessment

Clinical Study ID

NCT05511324
2022-0377
NCI-2022-07002
R21CA273782
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • FCGs (e.g., spouse/partner, parent, adult child) of patients diagnosed with HGGreceiving any form of cancer treatment (including palliative intent) at MDACC.

  • Patients must have a Karnofsky Performance Status (KPS) of 100 to 50. If thepatient's Karnofsky Performance Status drops below 50 both patient and caregiverwill be removed from the study.

  • Both FCGs and patients must be willing to participate and (1) ≥18 years old and ableto (2) read and speak English and (3) provide informed consent.

Exclusion

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-reportsurveys 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 andsymptom 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 excludepregnant patients (medical notes). It is unlikely that patients diagnosed with anHGG will be pregnant. Moreover, the current caregiver intervention is not designedto address the care needs of pregnant cancer patients.

Study Design

Total Participants: 124
Treatment Group(s): 2
Primary Treatment: Questionnaires
Phase:
Study Start date:
October 21, 2022
Estimated Completion Date:
August 31, 2026

Study 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.

Connect with a study center

  • M D Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • M D Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

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