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

296 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to determine if family caregivers of neuro-oncology patients feel less burdened by utilizing the Electronic Social Network Assessment Program (eSNAP) + the Caregiver Navigator.

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 data supports the effectiveness of the treatment Caregiver Navigator, eSNAP?

Preliminary data from the first 15 participants in the study suggest that caregivers were satisfied with the Caregiver Navigator intervention and found it helpful. The intervention, which includes a web-based tool to identify social support resources, is one of the first theory-based caregiver support interventions in neuro-oncology and could serve as a model for future caregiver support programs. ^{1 2 3 4 5}

Is the Digital Support System for Brain Cancer Caregivers safe for humans?

There is no specific safety data available for the Digital Support System for Brain Cancer Caregivers, but similar digital tools like the PRO-CTCAE have been used in cancer trials to improve the reporting of adverse events, suggesting they are generally considered safe for use in clinical settings. ^{6 7 8 9 10}

How does the Digital Support System for Brain Cancer Caregivers differ from other treatments for brain cancer caregivers?

This treatment is unique because it uses a digital tool called eSNAP to help caregivers of brain cancer patients visualize and utilize their social support networks. Unlike traditional treatments, it combines technology with personal guidance from a caregiver navigator to enhance social support, which is crucial for reducing caregiver burden and improving their quality of life. ^{1 4 11 12 13}

Research Team

Margaret Byrne, PhD

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Germany 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Neuro-oncology family caregivers' view on keeping track of care issues using eHealth systems: it's a question of time. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Unmet needs and wish for support of family caregivers of primary brain tumor patients. [2023]

4. England pubmed.ncbi.nlm.nih.gov

A randomized wait-list controlled trial of a social support intervention for caregivers of patients with primary malignant brain tumor. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Attitudes and preferences toward monitoring symptoms, distress, and quality of life in glioma patients and their informal caregivers. [2022]

6. England 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). [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Caveat Medicus: Clinician experiences in publishing reports of serious oncology-associated adverse drug reactions. [2020]

8. United States 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. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Patient free text reporting of symptomatic adverse events in cancer clinical research using the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). [2022]

10. Canada 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. [2023]

11. Germany pubmed.ncbi.nlm.nih.gov

Feasibility of implementing an electronic social support and resource visualization tool for caregivers in a neuro-oncology clinic. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Neuro-oncology family caregiving: review and directions for future research. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Outcomes of an electronic social network intervention with neuro-oncology patient family caregivers. [2023]