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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05511324
Other study ID # 2022-0377
Secondary ID NCI-2022-07002R2
Status Recruiting
Phase N/A
First received
Last updated
Start date October 21, 2022
Est. completion date August 31, 2024

Study information

Verified date February 2024
Source M.D. Anderson Cancer Center
Contact Kathryn Milbury, MA,PHD
Phone (713) 745-2868
Email kmilbury@mdanderson.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date August 31, 2024
Est. primary completion date August 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Questionnaires
Participants will be asked to complete this assessment on your own time, and it should take about 40 minutes.
Caregiver Assessment
These sessions will involve simulation-based, caregiving skill training, and your caregiver will be taught skills to help support you (such as feeding, hygiene, mobility, medication administration, and care coordination).

Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary M. D. Anderson Symptom Inventory (MDASI) questionnaires M. D. Anderson Symptom Inventory (MDASI) questionnaires score scale ranges ( 0-10) 0 has not been present been and 10 is bad as you can imagine. through study completion and average of 1 year.
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