120 Participants Needed

Caregiving Skills Training for Brain Cancer

KM
Overseen ByKathryn Milbury, MA,PHD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Is Simulation-Based Caregiving Skills Training safe for humans?

The study 'Building Family Caregiver Skills Using a Simulation-Based Intervention' evaluated the safety of a psychoeducational intervention for family caregivers and found it to be safe.12345

How is the Simulation-Based Caregiving Skills Training treatment unique for brain cancer caregivers?

This treatment is unique because it focuses on training caregivers of brain cancer patients through simulation-based methods, helping them gain the necessary skills and confidence to provide care, which addresses a major unmet need in this area.56789

What data supports the effectiveness of the treatment Simulation-Based Caregiving Skills Training for caregivers of brain cancer patients?

Research shows that providing education and skills training to caregivers can reduce their burden and improve their well-being. For example, a study found that standardized education for caregivers of cancer patients improved their overall well-being, suggesting that similar training could be beneficial for caregivers of brain cancer patients.156810

Who Is on the Research Team?

KM

Kathryn Milbury, MA,PHD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am a close family member of someone with high-grade glioma being treated at MDACC.
I can take care of myself but may not be able to do active work.

Exclusion Criteria

I am under 18 years old.
I regularly see a licensed therapist for psychotherapy.
Pregnant patients
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete a baseline assessment of questionnaires including demographic information and psychological and physical health

1 week
1 visit (in-person)

Caregiver Intervention Sessions

Caregivers participate in 4 intervention sessions, with the first 2 sessions at the Simulation Center and the remaining 2 sessions remotely via videoconference

4 weeks
2 visits (in-person), 2 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Simulation-Based Caregiving Skills Training
Trial Overview 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.
How Is the Trial Designed?
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

A study involving 271 caregivers of cancer patients found that their average caring ability score was 91.86 out of a possible higher score, indicating a lack of necessary knowledge and skills for effective caregiving.
The study revealed that caregivers' ability was significantly correlated with the type of cancer and the duration of care, suggesting that targeted support and training for caregivers, especially those with long-term responsibilities, is essential for improving care quality.
Caring ability and its related factors in the family caregivers of patients with cancer.Rassouli, M., Beiranvand, S., Karami, M., et al.[2023]
A new model of family caregiving skill was developed through qualitative research involving 44 caregiver/patient dyads and 63 individual caregivers, highlighting the unique skills needed for caregivers of cancer patients.
The model emphasizes the interaction between the demands of the illness, caregiving patterns, and the responses of both caregivers and patients, providing a framework for understanding how caregivers can effectively support their loved ones.
A transactional model of cancer family caregiving skill.Schumacher, KL., Beidler, SM., Beeber, AS., et al.[2022]
An online intervention designed for carers of people with high-grade glioma showed high usability (5.1 to 6.7 out of 7) and acceptability (76.3 out of 100) based on evaluations from 10 carers, indicating it is a user-friendly resource.
The intervention has the potential to reduce depression among carers, suggesting it could be an effective support tool, although further research with a larger sample size is needed to confirm these findings.
Exploratory multi-methods evaluation of an online intervention for carers of people with high-grade glioma.Haydon, HM., Blackler, A., Nowak, AK., et al.[2023]

Citations

Caring ability and its related factors in the family caregivers of patients with cancer. [2023]
A transactional model of cancer family caregiving skill. [2022]
Exploratory multi-methods evaluation of an online intervention for carers of people with high-grade glioma. [2023]
Guiding research in family care: a new approach to oncology caregiving. [2022]
The impact of education on caregiver burden on two inpatient oncology units. [2022]
Building Family Caregiver Skills Using a Simulation-Based Intervention: A Randomized Pilot Trial. [2020]
Family caregiving skill: development of the concept. [2019]
Toward Engaging Caregivers: Inclusion in Care and Receipt of Information and Training among Caregivers for Cancer Patients Who Have Been Hospitalized. [2021]
Neuro-oncology family caregiving: review and directions for future research. [2022]
Caregiver survey in glioblastoma focused on cognitive dysfunction: development and results from a multicenter study. [2023]
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