FearLess in Cognitively Intact Patients With Glioma

Virginia Commonwealth University22 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Glioma Fear of Cancer

Interventions

FearLess InterventionBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Virginia Commonwealth University

Richmond, Virginia, United States

Outcomes

Primary Outcomes

Determine feasibility of FearLess recruitment

As evidenced by the number of patients and caregivers that enroll in the trial

Time frame: 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

Time frame: 12 Weeks

Determine the acceptability of FearLess intervention- Attendance

As evidenced by attendance rate at intervention sessions

Time frame: 12 Weeks

Determine the acceptability of FearLess intervention- Retention Rate

As evidenced by the number of patients that complete follow-up measures

Time frame: 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

Time frame: 12 Weeks

Determine the acceptability of FearLess intervention- Satisfaction- Recommendation

As evidenced by the number of patients that recommend the intervention to others

Time frame: 12 Weeks

Data from ClinicalTrials.gov

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