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FearLess in Cognitively Intact Patients With Glioma (FearLess)

Primary Purpose

Glioma, Fear of Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FearLess Intervention
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Glioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Virginia Commonwealth UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

Patients Only

Patients and Caregivers

Caregivers Only

Outcomes

Primary Outcome Measures

Determine feasibility of FearLess recruitment
As evidenced by the number of patients and caregivers that enroll in the trial
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
Determine the acceptability of FearLess intervention- Attendance
As evidenced by attendance rate at intervention sessions
Determine the acceptability of FearLess intervention- Retention Rate
As evidenced by the number of patients that complete follow-up measures
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
Determine the acceptability of FearLess intervention- Satisfaction- Recommendation
As evidenced by the number of patients that recommend the intervention to others

Secondary Outcome Measures

Full Information

First Posted
October 26, 2022
Last Updated
December 16, 2022
Sponsor
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT05604365
Brief Title
FearLess in Cognitively Intact Patients With Glioma
Acronym
FearLess
Official Title
FearLess in Cognitively Intact Patients With Glioma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 7, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma, Fear of Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Patients Only
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
Patients and Caregivers
Arm Title
Arm 3
Arm Type
Experimental
Arm Description
Caregivers Only
Intervention Type
Behavioral
Intervention Name(s)
FearLess Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Determine feasibility of FearLess recruitment
Description
As evidenced by the number of patients and caregivers that enroll in the trial
Time Frame
1 Day
Title
Determine the feasibility of FearLess intervention- Data collection procedures
Description
As evidenced by the number of participants that complete the baseline assessment, post-intervention assessment, and the exit interview
Time Frame
12 Weeks
Title
Determine the acceptability of FearLess intervention- Attendance
Description
As evidenced by attendance rate at intervention sessions
Time Frame
12 Weeks
Title
Determine the acceptability of FearLess intervention- Retention Rate
Description
As evidenced by the number of patients that complete follow-up measures
Time Frame
12 Weeks
Title
Determine the acceptability of FearLess intervention- Satisfaction
Description
As evidenced by the number of patients with a satisfaction rating greater than 7 on a 10 point scale
Time Frame
12 Weeks
Title
Determine the acceptability of FearLess intervention- Satisfaction- Recommendation
Description
As evidenced by the number of patients that recommend the intervention to others
Time Frame
12 Weeks
Other Pre-specified Outcome Measures:
Title
Determine the efficacy of FearLess intervention- Baseline to post intervention - fear scale
Description
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.
Time Frame
12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ashlee Loughan, PhD
Phone
804-828-9815
Email
ashlee.loughan@vcuhealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Autumn Lanoye, PhD
Email
lanoyeam@vcu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashlee Loughan, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashlee Loughan, PhD
Phone
804-828-4178
Email
ashlee.loughan@vcuhealth.org
First Name & Middle Initial & Last Name & Degree
Autumn Lanoy
Email
lanoyeam@vcu.edu
First Name & Middle Initial & Last Name & Degree
Ashlee Loughan, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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FearLess in Cognitively Intact Patients With Glioma

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