FearLess in Cognitively Intact Patients With Glioma

• Sponsor: Virginia Commonwealth University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05604365
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 13.8
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glioma; Fear of Cancer	Behavioral: FearLess Intervention	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 24 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: FearLess in Cognitively Intact Patients With Glioma
• Actual Study Start Date: Nov 7, 2022
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Determine feasibility of FearLess recruitment [1 Day]

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

2. 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

3. Determine the acceptability of FearLess intervention- Attendance [12 Weeks]

   As evidenced by attendance rate at intervention sessions

4. Determine the acceptability of FearLess intervention- Retention Rate [12 Weeks]

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

5. 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

6. Determine the acceptability of FearLess intervention- Satisfaction- Recommendation [12 Weeks]

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

Other Outcome Measures

1. Determine the efficacy of FearLess intervention- Baseline to post intervention - fear scale [12 Weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Virginia Commonwealth University	Richmond	Virginia	United States	23298

Sponsors and Collaborators

• Virginia Commonwealth University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Virginia Commonwealth University
• ClinicalTrials.gov Identifier: NCT05604365
• Other Study ID Numbers: MCC-22-19485; HM20025081
• First Posted: Nov 3, 2022
• Last Update Posted: Dec 19, 2022
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Glioma

Study Results

No Results Posted as of Dec 19, 2022