FearLess in Cognitively Intact Patients With Glioma

Glioma Clinical Trial

— FearLess  

Official title:

FearLess in Cognitively Intact Patients With Glioma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05604365
• Other study ID #: MCC-22-19485
• Secondary ID: HM20025081
• Status: Completed
• Phase: N/A
• Start date: November 7, 2022
• Est. completion date: November 14, 2023

Study information

• Verified date: February 2024
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 14, 2023
• Est. primary completion date: November 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fear of Cancer
• Glioma

Intervention

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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Determine feasibility of FearLess recruitment	As evidenced by the number of patients and caregivers that enroll in the trial	1 Day
Primary	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
Primary	Determine the acceptability of FearLess intervention- Attendance	As evidenced by attendance rate at intervention sessions	12 Weeks
Primary	Determine the acceptability of FearLess intervention- Retention Rate	As evidenced by the number of patients that complete follow-up measures	12 Weeks
Primary	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
Primary	Determine the acceptability of FearLess intervention- Satisfaction- Recommendation	As evidenced by the number of patients that recommend the intervention to others	12 Weeks