FearLess in Cognitively Intact Patients With Glioma (FearLess)

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 Overview

• Status: Completed
• Conditions: Glioma; Fear of Cancer
• Intervention / Treatment: Behavioral: FearLess Intervention

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; Patients Only	Behavioral: FearLess Intervention; 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.
Experimental: Arm 2; Patients and Caregivers	Behavioral: FearLess Intervention; 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.
Experimental: Arm 3; Caregivers Only	Behavioral: FearLess Intervention; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the efficacy of FearLess intervention- Baseline to post intervention - fear scale	As determined by the number of patients and caregivers that demonstrate meaningful reductions in self-reported fear of cancer recurrence, utilizing a 49 item scale assessing fear of cancer recurrence.	12 Weeks

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Ashlee Loughan, PhD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2022
• Primary Completion (Actual): November 14, 2023
• Study Completion (Actual): November 14, 2023

Study Registration Dates

• First Submitted: October 26, 2022
• First Submitted That Met QC Criteria: October 27, 2022
• First Posted (Actual): November 3, 2022

Study Record Updates

• Last Update Posted (Actual): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioma
• Other Study ID Numbers: MCC-22-19485; HM20025081 (Other Identifier: Virginia Commonwealth University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No