CompletedNot Applicable

FearLess in Cognitively Intact Patients With Glioma

United States22 participantsStarted 2022-11-07

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Determine feasibility of FearLess recruitment

Timeframe: 1 Day

Determine the feasibility of FearLess intervention- Data collection procedures

Timeframe: 12 Weeks

Determine the acceptability of FearLess intervention- Attendance

Timeframe: 12 Weeks

Determine the acceptability of FearLess intervention- Retention Rate

Timeframe: 12 Weeks

Determine the acceptability of FearLess intervention- Satisfaction

Timeframe: 12 Weeks

Determine the acceptability of FearLess intervention- Satisfaction- Recommendation

Timeframe: 12 Weeks

Trial details

NCT IDNCT05604365

SponsorVirginia Commonwealth University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-14

View on ClinicalTrials.gov More Glioma trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Determine feasibility of FearLess recruitment

Timeframe: 1 Day

Determine the feasibility of FearLess intervention- Data collection procedures

Timeframe: 12 Weeks

Determine the acceptability of FearLess intervention- Attendance

Timeframe: 12 Weeks

Determine the acceptability of FearLess intervention- Retention Rate

Timeframe: 12 Weeks

Determine the acceptability of FearLess intervention- Satisfaction

Timeframe: 12 Weeks

Determine the acceptability of FearLess intervention- Satisfaction- Recommendation

Timeframe: 12 Weeks