FearLess in Cognitively Intact Patients With Glioma

Study Overview
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Brief Summary
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This study will assess the preliminary feasibility and acceptability of FearLess, a newly-developed psychological intervention for fear of cancer recurrence (FCR) among cognitively-intact patients with glioma.

Official Title
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FearLess in Cognitively Intact Patients With Glioma

Conditions
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Glioma, Fear of Cancer

Intervention / Treatment
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* Behavioral: FearLess Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient inclusion: Confirmed glioma diagnosis (grade II-IV) via histopathology Be a minimum of 2 weeks post surgical repair or biopsy (if applicable) Elevated FCR [> 13 on Fear of Cancer Recurrence Inventory] Primarily English speaking Caregiver Inclusion: Loved one, or non-paid care partner to a patient with a confirmed glioma diagnosis (grade II-IV) via histopathology Elevated FCR [> 13 on Fear of Cancer Recurrence Inventory] Primarily English speaking Age 18+ Exclusion Criteria: Patient: Cognitive impairment [< or equal to 31 on the Telephone Interview for Cognitive Status (TICS)] Inability to attend virtual sessions (e.g. due to lack of stable internet connection, difficulty using technology) Inability to understand and provide informed consent. Caregiver: Inability to attend virtual sessions (e.g. due to lack of stable internet connection, difficulty using technology) Inability to understand and provide informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Patients Only | Behavioral: FearLess Intervention<br>* 8-12 weekly telehealth sessions one hour in length.The intervention includes psychotherapy techniques varying from relaxation response to self-regulation targeted to the specific fears of patients with glioma.<br>|
| Experimental: Arm 2<br>Patients and Caregivers | Behavioral: FearLess Intervention<br>* 8-12 weekly telehealth sessions one hour in length.The intervention includes psychotherapy techniques varying from relaxation response to self-regulation targeted to the specific fears of patients with glioma.<br>|
| Experimental: Arm 3<br>Caregivers Only | Behavioral: FearLess Intervention<br>* 8-12 weekly telehealth sessions one hour in length.The intervention includes psychotherapy techniques varying from relaxation response to self-regulation targeted to the specific fears of patients with glioma.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine feasibility of FearLess recruitment | As evidenced by the number of patients and caregivers that enroll in the trial | 1 Day | 
| Determine the feasibility of FearLess intervention- Data collection procedures | As evidenced by the number of participants that complete the baseline assessment, post-intervention assessment, and the exit interview | 12 Weeks | 
| Determine the acceptability of FearLess intervention- Attendance | As evidenced by attendance rate at intervention sessions | 12 Weeks | 
| Determine the acceptability of FearLess intervention- Retention Rate | As evidenced by the number of patients that complete follow-up measures | 12 Weeks | 
| Determine the acceptability of FearLess intervention- Satisfaction | As evidenced by the number of patients with a satisfaction rating greater than 7 on a 10 point scale | 12 Weeks | 
| Determine the acceptability of FearLess intervention- Satisfaction- Recommendation | As evidenced by the number of patients that recommend the intervention to others | 12 Weeks |