GliomaNCT05511324
Simulation-Based Caregiving Skills Training for Family Members of High Grade Glioma Patients
A study testing Questionnaires and Caregiver Assessment in people with Glioma, run by M.D. Anderson Cancer Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glioma
- What is being tested?
- Questionnaires and Caregiver Assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2022to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Glioma
- Being tested
- Questionnaires, Caregiver Assessment
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesBehavioural
Participants will be asked to complete this assessment on your own time, and it should take about 40 minutes.
Caregiver AssessmentBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Baseline Assessment | Other | 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 Receives: Behavioral: Questionnaires |
| Caregiver Intervention Sessions | Other | 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. Receives: Behavioral: Caregiver Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
M. D. Anderson Symptom Inventory (MDASI) questionnaires
- 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.
Measured: through study completion and average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start21 Oct 2022
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kathryn Milbury, MA,PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511324
- Sponsor's protocol ID
- 2022-0377
- Other IDs
- NCI-2022-07002, R21CA273782
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2022
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simulation-Based Caregiving Skills Training for Family Members of High Grade Glioma Patients
- ClinicalTrials.gov ID
- NCT05511324
- Acronym / sponsor ID
- 2022-0377
- Conditions
- Glioma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 124 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 21 Oct 2022 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 22 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baseline Assessment | Other | Behavioral: QuestionnairesParticipants 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 |
| Caregiver Intervention Sessions | Other | Behavioral: Caregiver AssessmentCaregiver 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesParticipants will be asked to complete this assessment on your own time, and it should take about 40 minutes. | Behavioural | Baseline Assessment |
| Caregiver AssessmentThese 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). | Behavioural | Caregiver Intervention Sessions |
Primary outcome
M. D. Anderson Symptom Inventory (MDASI) questionnaires
Time frame: through study completion and average of 1 year.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn Milbury, MA,PHD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaires and Caregiver Assessment in people with Glioma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
M. D. Anderson Symptom Inventory (MDASI) questionnaires (time frame: through study completion and average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.