Astrocytoma, Caregiver, Glioblastoma (GBM), Oligodendroglioma, Primary Malignant Brain Tumor
Conditions
Keywords
brain tumor
Brief summary
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
Detailed description
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.
Interventions
BEHAVIORALFearless 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.
Sponsors
Virginia Commonwealth University
National Cancer Institute (NCI)
National Brain Tumor Society
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Delayed treatment control design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients: * Self-report a diagnosis of a primary malignant brain tumor (grade II-IV) * \>2 weeks post-cranial resection or biopsy * Elevated Fear of Recurrence Distress Rating * Primarily English speaking * \>/= 18 years of age at the time of enrollment Caregivers: * nonprofessional caregiver to a patient with a primary malignant brain tumor (grade II-IV) * Elevated Fear of Recurrence Distress Rating * Primarily English speaking * \>/= 18 years of age at the time of enrollment
Exclusion criteria
Patient / Caregiver Exclusion: * Cognitive impairment that might prohibit active intervention engagement * Inability to understand and provide informed consent * Inability to attend virtual sessions due to unstable or no internet connection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility - Sustained Eligibility (Delayed Treatment Control Arm Only) | From baseline to 12-week assessment | 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. |
| Acceptability - Intervention | 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 | The acceptability of the intervention will be measured by comparing rates of intervention completion to pre-determined thresholds. |
| Feasibility - Study Enrollment | From screening to randomization allocation | 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. |
| Feasibility - Study Retention at 12 Weeks | From baseline assessment to 12 weeks | Study retention will be measured by comparing observed rates of 12-week assessment completion to pre-specified benchmarks. |
| Feasibility - Study Retention at 24 Weeks | From baseline assessment to 24 weeks | Study retention will be measured by comparing observed rates of 24-week assessment completion to pre-specified benchmarks. |
| Acceptability - Trial Procedures | Week 24 | 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. |
| Appropriateness - Interventionist Report | At 12-week assessment in the Immediate Intervention arm; at 24-week assessment in the Delayed Treatment Control arm | 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. |
Countries
United States
Contacts
CONTACTMary Bridgman
PRINCIPAL_INVESTIGATORAshlee R Loughan, Ph.D
Virginia Commonwealth University
PRINCIPAL_INVESTIGATORSarah E Braun, Ph.D.
Virginia Commonwealth University
Outcome results
None listed