FearLess in Cognitively Intact Patients With Glioma

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Fear of Cancer; Glioma

Treatments: Behavioral: FearLess Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05604365

HM20025081 (Other Identifier)

MCC-22-19485

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

22 participants in 3 patient groups

Arm 1

Experimental group

Description:

Patients Only

Treatment:

Behavioral: FearLess Intervention

Arm 2

Experimental group

Description:

Patients and Caregivers

Treatment:

Behavioral: FearLess Intervention

Arm 3

Experimental group

Description:

Caregivers Only

Treatment:

Behavioral: FearLess Intervention