An interventional study of Fearless in Neuro-Oncology in Primary Malignant Brain Tumor, Glioblastoma (GBM) and Astrocytoma, sponsored by Virginia Commonwealth University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Virginia Commonwealth University · Not applicable, Interventional, and Supportive care
Among 1,300 studies in Glioblastoma with a site in United States — 197 open to participants now, 328 under way, 15 of them phase 3. Glioblastoma · United States.
Among the 1,300 studies in Glioblastoma with a site in United States, this one is the 144th largest by planned enrollment of the 1,153 interventional ones, is one of 47 that started in 2025, is one of 90 with no phase, reaches primary completion later than 252 of the 322 other live ones, and was the 1,229th registered.
2,132 studies on the registry are indexed under Glioblastoma; 464 are open to participants now.
This study's planned enrollment of 112 is above the median of 36 across 1,753 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →197 of the 1,300 studies in Glioblastoma with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 339 Glioblastoma studies recruiting now, 234 (69%) set no upper age limit and 65 (19%) stop at 75 or younger; 27 take children under 18; 13 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →1,300 studies; the count open now beside each. This study's row is marked.
First in 1979; this study’s year is marked. 47 started in 2025.
Median enrollment 33 across the 1,153 interventional studies, 60 across the 79 observational. Of the 881 that completed or were terminated, 344 (39%) have results posted.
321 of 1,300 have an industry lead sponsor. The 10 most frequent:
Virginia Commonwealth University is the lead sponsor of 648 studies on the registry; 80 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 64 (71%) have results posted.
Virginia Commonwealth University has 4 studies filed under Glioblastoma — fewer than ten, so there is no comparison to draw.
108 of the studies in Glioblastoma with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05271240Phase 3Northwell HealthRepeated Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab With Temozolomide and Radiation Compared to Temozolomide and Radiation Alone in Newly Diagnosed GBM | 2027-04-01 |
| NCT03743662Memorial Sloan Kettering Cancer CenterNivolumab With Radiation Therapy and Bevacizumab for Recurrent MGMT Methylated Glioblastoma | 2026-11 |
| NCT05052957Leland MethenyhSTAR GBM (Hematopoetic Stem Cell (HPC) Rescue for GBM) | 2026-11-01 |
| NCT06910306Alpha Tau Medical LTD.Alpha Radiation Emitters Device (DaRT) for the Treatment of Recurrent Glioblastoma | 2026-11-01 |
| NCT03975829Novartis PharmaceuticalsPediatric Long-Term Follow-up and Rollover Study | 2026-11-05 |
Among the 1,300 studies in Glioblastoma with a site in United States, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients:
Caregivers:
Exclusion Criteria:
Patient / Caregiver Exclusion:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Fearless in Neuro-Oncology
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.
Behavioral: Fearless in Neuro-Oncology
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At 12-week assessment in the Immediate Intervention arm; at 24-week assessment in the Delayed Treatment Control arm
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for Dec 2028, 42 months after the start.
Of 131 non-industry interventional studies with no phase under Glioblastoma, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 97. This study's planned 42 months is below that.
Counting every sponsor, half of 149 studies reached it within 54 months; a quarter within 36 and three quarters within 88.
How these figures are worked out, and which studies are left out of them.
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