Caregiving Skills Training for Brain Cancer

Overseen By Kathryn Milbury, MA,PHD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Psychotherapy, Cognitive impairment, Children, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist family members caring for loved ones with primary brain tumors. The goal is to train caregivers to enhance their skills, boost confidence, and reduce stress, while also aiding patients in better symptom management. Participants will engage in four sessions, combining in-person and online meetings. Family caregivers of patients undergoing treatment for high-grade glioma (a type of brain cancer) who can read and speak English may be suitable for this trial. As an unphased study, this trial provides a unique opportunity to enhance caregiving skills and improve patient care.

Will I have to stop taking my current medications?

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

What prior data suggests that this caregiving skills training is safe?

Research has shown that training caregivers using simulations is well-received. In one study, seven caregivers completed all the training sessions and found the program helpful. They significantly improved their caregiving skills. No negative effects or problems were reported during the training. This suggests that the training is both effective and safe for caregivers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Simulation-Based Caregiving Skills Training for brain cancer because it focuses on empowering caregivers with practical skills and psychological support, which is a unique approach compared to typical medical treatments. Unlike traditional options that center solely on the patient, this intervention aims to improve the overall caregiving experience and, indirectly, patient outcomes by equipping caregivers with tools for coping and self-care. By offering sessions both in person and via videoconference, it provides flexibility and accessibility, which can help caregivers manage their role more effectively.

What evidence suggests that this caregiving skills training is effective for brain cancer caregivers?

Research has shown that training programs using simulations can benefit caregivers of brain tumor patients. In this trial, caregivers will engage in Simulation-Based Caregiving Skills Training, which includes sessions designed to enhance caregiving skills. One study found that caregivers who completed similar programs reported improved caregiving abilities, reduced stress, and felt more prepared to support their loved ones. This training aims to improve the well-being of both the caregiver and the patient by teaching useful skills and coping strategies. Early results suggest that this approach can help reduce caregiver stress and enhance their ability to provide care. ^{2 3 4 5 6}

Who Is on the Research Team?

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

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?

Group I: Caregiver Intervention Sessions Experimental Treatment 1 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 Assessment Experimental Treatment 1 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

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 new 89-item questionnaire was developed to assess cognitive dysfunction and caregiver burden specifically for those caring for adults with glioblastoma, based on feedback from stakeholders and a pilot study.

Among 185 caregivers surveyed, memory problems were the most reported cognitive dysfunction symptoms, and a clear link was found between the number of cognitive symptoms and increased caregiver burden, highlighting the need for targeted support interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caregiver survey in glioblastoma focused on cognitive dysfunction: development and results from a multicenter study. Au, TH., Willis, C., Reblin, M., et al.[2023]

The study highlights the need to explore how stress responses in family caregivers of brain tumor patients can affect both their emotional and physical health, suggesting a connection between these aspects.

A systematic review of existing literature supports the use of a biobehavioral model to understand the interactions between emotional reactions and physical health changes in caregivers, paving the way for future research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guiding research in family care: a new approach to oncology caregiving. Sherwood, PR., Given, BA., Donovan, H., et al.[2022]

The psychoeducational intervention aimed at improving family caregiver skills was found to be safe and acceptable, with some participants showing improvements in self-efficacy, mental health, anxiety, and depression after the intervention.

However, only 4 out of 9 caregivers completed the program, indicating that the intervention needs refinement to enhance feasibility and adherence among participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Building Family Caregiver Skills Using a Simulation-Based Intervention: A Randomized Pilot Trial. Mazanec, SR., Sandstrom, K., Coletta, D., et al.[2020]

Caregivers of patients with malignant brain tumors experience significant psychological and physical distress, particularly if they are younger, face economic burdens, have unmet needs, or lack social support.

Interventions such as educational programs and cognitive behavioral therapy have shown promise in reducing distress among neuro-oncology caregivers, highlighting the need for targeted support strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuro-oncology family caregiving: review and directions for future research. Sherwood, PR., Cwiklik, M., Donovan, HS.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caring ability and its related factors in the family caregivers of patients with cancer. Rassouli, M., Beiranvand, S., Karami, M., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Standardized education through the Oncology CarePartner Program significantly improved caregivers' overall well-being, as measured by the Bakas Caregiving Outcomes Scale, with notable increases in scores from hospital admission to discharge and 30 days post-discharge.

Despite the positive impact on caregiver well-being, the program did not significantly reduce the time spent or difficulty associated with caregiving tasks, indicating a need for further educational adjustments or different evaluation methods to address these specific challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of education on caregiver burden on two inpatient oncology units. Creedle, C., Leak, A., Deal, AM., et al.[2022]

Cancer caregivers experience a higher frequency of hospitalizations and report significant stress and burden, with 68% indicating high objective burden and 49% finding caregiving highly stressful.

While 60% of cancer caregivers were asked about their needs to assist the patient, only 34% were asked about their own self-care needs, highlighting a gap in caregiver support that could be improved through targeted training methods, such as hands-on skill demonstrations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward Engaging Caregivers: Inclusion in Care and Receipt of Information and Training among Caregivers for Cancer Patients Who Have Been Hospitalized. Longacre, ML., Weber-Raley, L., Kent, EE.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A transactional model of cancer family caregiving skill. Schumacher, KL., Beidler, SM., Beeber, AS., et al.[2022]

The study identified 63 indicators of family caregiving skill through interviews with 30 cancer patients and 29 primary caregivers, highlighting the complexity of care required at home.

Family caregiving skill was defined as the ability to effectively engage in nine core caregiving processes, providing a foundation for measuring and assessing these skills in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family caregiving skill: development of the concept. Schumacher, KL., Stewart, BJ., Archbold, PG., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11241359/

Simulation-based caregiving skills training for family ... In this study, we seek to examine this simulation-based training for caregivers of brain tumor patients. Of note, given that distress and quality of life ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39006525/

Simulation-based caregiving skills training for family members ... Seven caregivers completed all 4 sessions and rated the program as beneficial. Paired t-tests revealed a significant improvement in caregiving ...

3. digitalcommons.library.tmc.edu digitalcommons.library.tmc.edu/cgi/viewcontent.cgi?article=2441&context=uthgsbs_docs

Simulation-Based Caregiving Skills Training for Family ... 16–20 In this study, we seek to examine this simulation-based training for caregivers of brain tumor patients. Of note, given that distress ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05511324/simulation-based-caregiving-skills-training-for-family-members-of-high-grade-glioma-patients

Simulation-Based Caregiving Skills Training for Family ... This project will examine the feasibility and initial evidence for efficacy of a caregiving skills intervention aiming to improve caregiver and ...

5. clinicaltrial.be clinicaltrial.be/en/details/15286?per_page=100&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Simulation-Based Caregiving Skills Training for Family Me... These sessions will involve simulation-based, caregiving skill training, and your caregiver will be taught skills to help support you (such as ...

6. ascopubs.org ascopubs.org/doi/10.1200/JCO.2020.38.15_suppl.TPS12129

Use of simulation for training family caregivers of patients ... The purpose of this clinical trial is to measure the effect of a psychoeducational caregiver intervention that incorporates simulation techniques.