NCT05604365

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 3, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

November 7, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2023

Completed
Last Updated

February 9, 2024

Status Verified

February 1, 2024

Enrollment Period

1 year

First QC Date

October 26, 2022

Last Update Submit

February 7, 2024

Conditions

GliomaFear of Cancer

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (1)

  • Determine the efficacy of FearLess intervention- Baseline to post intervention - fear scale

    12 Weeks

Study Arms (3)

Arm 1

EXPERIMENTAL

Patients Only

Behavioral: FearLess Intervention

Arm 2

EXPERIMENTAL

Patients and Caregivers

Behavioral: FearLess Intervention

Arm 3

EXPERIMENTAL

Caregivers Only

Behavioral: FearLess Intervention

Interventions

FearLess InterventionBEHAVIORAL

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.

Arm 1Arm 2Arm 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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+

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

GliomaPathophobia

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Ashlee Loughan, PhD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2022

First Posted

November 3, 2022

Study Start

November 7, 2022

Primary Completion

November 14, 2023

Study Completion

November 14, 2023

Last Updated

February 9, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)