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Caregiving Skills Training for Brain Cancer
N/A
Recruiting
Led By Kathryn Milbury, MA,PHD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion and average of 1 year.
Awards & highlights
Study Summary
This trial will test whether a caregiving skills intervention can improve the psychological health of caregivers and patients, as well as reduce patient cancer symptoms and healthcare utilization.
Who is the study for?
This trial is for family caregivers of patients with high-grade gliomas (HGG). Caregivers can be spouses, parents, or adult children. Both the caregiver and patient must be over 18, speak English, and consent to participate. Patients should have a moderate ability to perform daily activities (KPS of 50-100). Excluded are caregivers in regular psychotherapy, patients with cognitive issues affecting survey completion, minors under 18 years old, and pregnant patients.Check my eligibility
What is being tested?
The study tests a training program designed to help family caregivers manage their caregiving responsibilities better. It aims to improve psychological health for both caregiver and patient while enhancing caregiving skills and adjusting to the caregiver role. The intervention also seeks to reduce cancer-related symptoms in patients.See study design
What are the potential side effects?
Since this trial involves questionnaires and assessments rather than medical treatments or drugs, there are no typical side effects like those associated with medications or surgical procedures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion and average of 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion and average of 1 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
M. D. Anderson Symptom Inventory (MDASI) questionnaires
Trial Design
2Treatment groups
Experimental Treatment
Group I: Caregiver Intervention SessionsExperimental Treatment1 Intervention
Caregiver will take part in 4 caregiver intervention sessions. The first 2 sessions will take place in the Simulation Center at the hospital when you are scheduled for treatment or a follow-up appointment. The remaining 2 sessions will be done remotely using a videoconference platform (such as Zoom) and will focus on discussing your caregiver's role and experiences and suggesting coping and self-care strategies.
Group II: Baseline AssessmentExperimental Treatment1 Intervention
Participants will be asked to complete a baseline assessment of questionnaires that will ask:
Demographic information (such as your age, sex, and race)
Psychological and physical health
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Questionnaires
2013
Completed Phase 2
~3330
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,734 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,270 Total Patients Enrolled
Kathryn Milbury, MA,PHDPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 18 years old.I am a close family member of someone with high-grade glioma being treated at MDACC.I regularly see a licensed therapist for psychotherapy.I am over 18, speak English, and can give informed consent.I can take care of myself but may not be able to do active work.
Research Study Groups:
This trial has the following groups:- Group 1: Caregiver Intervention Sessions
- Group 2: Baseline Assessment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are applications currently being accepted for this experiment?
"According to the information on clinicaltrials.gov, this research study is presently in search of participants. The initial post was published October 21st 2022 and an update occurred November 1st 2022."
Answered by AI
What is the scale of this medical experiment in terms of patient numbers?
"Affirmative. Clinicaltrials.gov records show that this medical experiment, which was initially posted on October 21st 2022, is presently recruiting participants. There are 120 individuals required to participate at a single trial location."
Answered by AI
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