Digital Support System for Brain Cancer Caregivers

Overseen By Deanna Witte

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Disqualifiers: Acute distress, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a digital support system can reduce stress for family caregivers of brain cancer patients. It evaluates the eSNAP program and the Caregiver Navigator, tools designed to assist caregivers. Participants will either use these tools or join a waitlist to receive them later. This trial suits English-speaking primary caregivers of patients diagnosed with a brain tumor within the last 9 months who are currently receiving care. As an unphased trial, it provides caregivers with access to potentially helpful resources and allows them to contribute to research that may benefit others in similar situations.

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 digital support system is safe for caregivers?

Research has shown that the Caregiver Navigator and eSNAP tool are safe for users. One study found that many caregivers found these tools helpful. Out of 81 caregivers, 88% used the eSNAP at least once, and 73% explored several topics with the Caregiver Navigator. This indicates that the tools were well-received and likely easy to use.

No reports of negative effects or problems arose from using these tools. They focus on providing support through social networks and helping caregivers solve problems. These findings suggest that the tools are not only safe but also effective in supporting caregivers of brain cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Digital Support System for Brain Cancer Caregivers because it offers innovative tools like the Caregiver Navigator and eSNAP to enhance caregiver support. Unlike traditional approaches that often involve in-person support groups or counseling, this system provides digital, personalized assistance and resources that caregivers can access at any time. This flexibility and accessibility are crucial for caregivers who need support on their own schedules. The digital nature of these tools means they can offer tailored advice and stress management techniques, potentially improving the mental health and effectiveness of caregivers in real-time.

What evidence suggests that the eSNAP and Caregiver Navigator are effective for reducing caregiver burden in brain cancer care?

Research has shown that the eSNAP and Caregiver Navigator program can ease stress for family members caring for brain cancer patients. In this trial, participants in the experimental arm will receive both the eSNAP and Caregiver Navigator interventions. Studies have found that caregivers using this program felt more supported and confident in their roles. One study revealed that 87% of caregivers completed an 8-week assessment, indicating high engagement with the program. The program connects caregivers with both informal and formal support networks, making it easier to manage their duties. Overall, these findings suggest that the eSNAP and Caregiver Navigator effectively improve caregiver well-being. ^{1 2 6 7 8}

Who Is on the Research Team?

Margaret Byrne, PhD

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

This trial is for English-speaking family caregivers of patients with new or recurrent primary brain tumors, secondary brain tumors, or leptomeningeal disease diagnosed within the last 9 months. Caregivers must be providing care at home and able to complete questionnaires. Patients should have visited Moffitt at least once and have a life expectancy of over 9 months.

Inclusion Criteria

I was diagnosed with a brain tumor or leptomeningeal disease in the last 9 months and have a life expectancy of at least 9 months.

I am the main person helping someone with a brain tumor without being paid.

English-speaking/reading/writing

Exclusion Criteria

Patients may not participate without a consenting FCG, but FCGs may participate without a consenting patient

Patients and FCGs who are experiencing acute distress will be excluded from enrollment and referred directly to social work, per Moffitt policy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the eSNAP intervention plus questionnaires or are assigned to a waitlist control condition for 8 weeks

8 weeks

Follow-up

Participants are monitored for caregiver and neuro patient well-being using various scales

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Caregiver Navigator
• eSNAP

Trial Overview The study tests if using the Electronic Social Network Assessment Program (eSNAP) along with a Caregiver Navigator helps reduce the burden on family caregivers of neuro-oncology patients.

How Is the Trial Designed?

Group I: eSNAP & Caregiver Navigator Experimental Treatment 2 Interventions

eSNAP intervention plus questionnaires

Group II: Waitlist Control Condition Active Control 1 Intervention

Participants randomly assigned to the waitlist control condition will only complete questionnaires during the 8-week study period. After the 8 weeks, they will then have access to the eSNAP, including completion of questionnaires and 8 weeks of Caregiver Navigator sessions as needed.

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a multicenter clinical trial involving 152 lung cancer patients, the use of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) allowed for high compliance in self-reporting adverse events, particularly during treatment (86% compliance).

The study demonstrated that patients were willing to self-report their symptoms using tablet computers, and identified that improving data collection methods, such as allowing electronic reporting between visits, could further enhance compliance and data quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Patient Reporting of Symptomatic Adverse Events via the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in a Chemoradiotherapy Cooperative Group Multicenter Clinical Trial. Basch, E., Pugh, SL., Dueck, AC., et al.[2022]

The I-Can Manage program was developed through a user-centered co-design process involving 16 cancer patients and 19 clinicians, focusing on self-management of treatment toxicities with evidence-based content and features tailored to patient needs.

Usability testing showed high patient satisfaction with the program, indicated by a mean score of 3.75 on the Post-Study System Usability Questionnaire, suggesting it effectively supports patients in managing their cancer treatment side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Web-Based Cancer Self-Management Program (I-Can Manage) Targeting Treatment Toxicities and Health Behaviors: Human-Centered Co-design Approach and Cognitive Think-Aloud Usability Testing. Howell, D., Bryant Lukosius, D., Avery, J., et al.[2023]

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 new support intervention for caregivers of brain tumor patients was developed, utilizing a caregiver navigator to help them access social support and formal services, which is crucial given the unmet needs of these caregivers.

Preliminary data from the first 15 participants indicate high satisfaction and perceived helpfulness of the intervention, suggesting that caregiver navigation could be an effective model for future support programs in neuro-oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing a critical need for caregiver support in neuro-oncology: development of a caregiver navigation intervention using eSNAP social resource visualization. Reblin, M., Wells, KJ., Otto, A., et al.[2022]

A survey of 727 stakeholders in cancer clinical research revealed that 93% believe patient-reported outcomes (PROs) for adverse events would enhance understanding of patient experiences during treatment.

The majority of respondents (88%) felt that using the PRO-CTCAE would improve the quality and efficiency of symptom data collection, indicating strong support for its implementation in clinical trials to inform treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stakeholder perspectives on implementing the National Cancer Institute's patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Bruner, DW., Hanisch, LJ., Reeve, BB., et al.[2022]

A study involving 14 clinicians revealed that motivations for reporting serious oncology-associated adverse drug reactions included scientific curiosity and public health concerns, but feedback from pharmaceutical manufacturers was predominantly negative.

The research highlights the need for improved pharmacovigilance mechanisms, such as big data and registries, to enhance the reporting and documentation of adverse drug events, addressing barriers like complacency and indifference among clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caveat Medicus: Clinician experiences in publishing reports of serious oncology-associated adverse drug reactions. Bennett, CL., Schooley, B., Taylor, MA., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6126960/

OUTCOMES OF AN ELECTRONIC SOCIAL NETWORK ... A longitudinal, two-group randomized design was used to compare the eSNAP intervention in caregivers of patients with primary brain tumor against controls who ...

2. academic.oup.com academic.oup.com/nop/advance-article-abstract/doi/10.1093/nop/npaf048/8124509

CARING intervention for neuro-oncology family caregivers Of those enrolled, 87% of caregivers and 77% of patients completed the Week-8 assessment. Of the 81 caregivers assigned to CARING, 88% used ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9546415/

Training cancer caregiver navigators - PubMed Central - NIH We developed the eSNAP and Caregiver Navigator Intervention to help cancer family caregivers identify and capitalize on informal and formal social support ...

4. academic.oup.com academic.oup.com/nop/advance-article/doi/10.1093/nop/npaf074/8220637

CARING intervention for neuro-oncology family caregivers ... Primary outcomes collected at 8 weeks were caregiver support and self-efficacy. Secondary outcomes were caregiver burden, personal gain, and ...

5. bmchealthservres.biomedcentral.com bmchealthservres.biomedcentral.com/articles/10.1186/s12913-021-06372-w

A randomized wait-list controlled trial of a social support ... The primary analysis will evaluate the efficacy of eSNAP + Navigator support intervention on caregiver well-being. This can be performed most ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8922391/

Addressing a critical need for caregiver support in neuro- ... This paper describes the development of a caregiver navigation intervention designed to support caregivers of patients with primary brain tumor.

7. maps.cancer.gov maps.cancer.gov/overview/DCCPSGrants/abstract.jsp?applId=10199965&term=CA236034

Division of Cancer Control & Population Sciences - Grant Details The Caregiver Navigator will problem-solve with caregivers and make arrangements/referrals in ongoing phone consultations. The Caregiver Navigator's goal is to ...

8. researchgate.net researchgate.net/publication/391436219_The_CARING_intervention_for_neuro-oncology_family_caregivers_Randomized_controlled_trial_feasibility_eSNAPcaregiver_navigation_engagement_and_acceptability

Randomized controlled trial feasibility, eSNAP/caregiver ... Of the 81 caregivers assigned to CARING, 88% used eSNAP at least once and 73% engaged with 6+ navigation topics. At 8 weeks, 77% of caregivers reported that ...