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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34CA286879 | U.S. NIH Grant/Contract | View source | |
| HM20031650 | Other Identifier | Virginia Commonwealth University |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| National Brain Tumor Society | UNKNOWN |
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The overarching goal of this project is to assess the feasibility, acceptability, and appropriateness of recruitment methods, target population, and a waitlist design to finalize the protocol of FearLess in primary malignant brain tumor patients and caregivers
The purpose of this study is to assess the feasibility, acceptability, appropriateness (FAA) of recruitment methods, study population, and waitlist design to finalize the protocol of FearLess, a psychological intervention targeting fear of cancer recurrence in primary malignant brain tumor patients and caregivers. Eligible participants (N=112) will be randomized to either: 1) immediate intervention or 2) delayed treatment control. Assessments will take place at baseline, Week 12, and Week 26.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fearless Immediate Treatment Arm | Experimental | FearLess is a newly developed, empirically-rooted, manualized psychological intervention consisting of an intake + 8 sessions delivered over a 12-week time period. It consists of weekly individual 60- to 90-minute virtual therapy sessions. FearLess will be delivered immediately following enrollment in this arm. |
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| FearLess Delayed Control Arm | Other | FearLess is a newly developed, empirically-rooted, manualized psychological intervention consisting of an intake + 8 sessions delivered over a 12-week time period. It consists of weekly individual 60- to 90-minute virtual therapy sessions. In this arm, the FearLess intervention will begin following a 12-week no-treatment period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fearless in Neuro-Oncology | Behavioral | FearLess is a newly developed, empirically-rooted, manualized psychological intervention consisting of an intake + 8 sessions delivered over a 12-week time period. It consists of weekly individual 60- to 90-minute virtual therapy sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility - Study Enrollment | Feasibility of study enrollment using a multimodal recruitment approach will be assessed by comparing observed rates of screening completion, trial eligibility, trial enrollment (i.e., informed consent), and randomization allocation to pre-specified benchmarks. | From screening to randomization allocation |
| Feasibility - Study Retention at 12 Weeks | Study retention will be measured by comparing observed rates of 12-week assessment completion to pre-specified benchmarks. | From baseline assessment to 12 weeks |
| Feasibility - Study Retention at 24 Weeks | Study retention will be measured by comparing observed rates of 24-week assessment completion to pre-specified benchmarks. | From baseline assessment to 24 weeks |
| Feasibility - Sustained Eligibility (Delayed Treatment Control Arm Only) | Feasibility of sustained trial eligibility will be assessed in the delayed treatment control arm only by comparing the proportion of participants who remain eligible at 12 weeks to a pre-determined threshold. | From baseline to 12-week assessment |
| Acceptability - Intervention | The acceptability of the intervention will be measured by comparing rates of intervention completion to pre-determined thresholds. | From baseline to 12-week assessment in the Immediate Intervention arm; from 12-week assessment to 24-week assessment in the Delayed Treatment Control arm |
| Acceptability - Intervention | The acceptability of the intervention will be measured by comparing participant Acceptability Intervention Measure (AIM) scores to pre-determined thresholds. The AIM is a 4-item questionnaire that measures participant perception that a given treatment is agreeable, palatable, or satisfactory. Items are rated on a Likert scale from 1=Completely Agree to 5=Completely Disagree. |
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Inclusion Criteria:
Patients:
Caregivers:
Exclusion Criteria:
Patient / Caregiver Exclusion:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mary Bridgman | Contact | 804-628-6799 | LiveNOW@vcu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ashlee R Loughan, Ph.D | Virginia Commonwealth University | Principal Investigator |
| Sarah E Braun, Ph.D. | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Recruiting | Richmond | Virginia | 23298 | United States |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D001254 | Astrocytoma |
| D009837 | Oligodendroglioma |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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Delayed treatment control design
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| From baseline to 12-week assessment in the Immediate Intervention arm; from 12-week assessment to 24-week assessment in the Delayed Treatment Control arm |
| Acceptability - Trial Procedures | The acceptability of the trial procedures will be measured by comparing rates of participant satisfaction with randomization methodology and assessment procedures to pre-determined thresholds. The satisfaction measure consists of 4 Likert-scale items and 2 Yes/No items encompassing perceptions of satisfaction regarding randomization, intervention schedule, questionnaire burden, and honorarium. | Week 24 |
| Appropriateness - Interventionist Report | Intervention appropriateness will be assessed by the study interventionists for each participant using the Intervention Appropriateness Measure (IAM). The IAM will be completed following each session; average score will be used for outcome analyses. The IAM is a 4-item standardized scale that measures the perceived fit, relevance, or compatibility of the intervention for a given practice setting, provider, or consumer, and/or perceived fit of the intervention to address a particular issue or problem. Items are rated on a Likert scale from 1=Completely Agree to 5=Completely Disagree. | At 12-week assessment in the Immediate Intervention arm; at 24-week assessment in the Delayed Treatment Control arm |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |