FearLess in Cognitively Intact Patients With Glioma

Not Applicable

Completed

• Conditions: Glioma; Fear of Cancer
• Interventions: Behavioral: FearLess Intervention

• Registration Number: NCT05604365
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-26
• Study First Submitted QC: 2022-10-27
• Study First Posted: 2022-11-03
• Study Start: 2022-11-07
• Primary Completion: 2023-11-14
• Study Completion: 2023-11-14
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	FearLess Intervention	Patients and Caregivers
Arm 3	FearLess Intervention	Caregivers Only
Arm 1	FearLess Intervention	Patients Only

Primary Outcome Measures

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

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States