GliomaFearLessNCT05604365
FearLess in Cognitively Intact Patients With Glioma
A study testing FearLess Intervention in people with Glioma and Fear of Cancer, run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glioma, Fear of Cancer
- What is being tested?
- FearLess Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2022to 14 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 10Show fewer
- 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+
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
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.
- Conditions
- Glioma, Fear of Cancer
- Being tested
- FearLess Intervention
- Medical subject headings
- Glioma, Pathophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FearLess InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Patients Only Receives: Behavioral: FearLess Intervention |
| Arm 2 | Experimental | Patients and Caregivers Receives: Behavioral: FearLess Intervention |
| Arm 3 | Experimental | Caregivers Only Receives: Behavioral: FearLess Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine feasibility of FearLess recruitment
As evidenced by the number of patients and caregivers that enroll in the trial
Measured: 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
Measured: 12 Weeks
Determine the acceptability of FearLess intervention- Attendance
As evidenced by attendance rate at intervention sessions
Measured: 12 Weeks
Determine the acceptability of FearLess intervention- Retention Rate
As evidenced by the number of patients that complete follow-up measures
Measured: 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
Measured: 12 Weeks
Determine the acceptability of FearLess intervention- Satisfaction- Recommendation
As evidenced by the number of patients that recommend the intervention to others
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start7 Nov 2022
- Primary completion14 Nov 2023
- Study completion14 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashlee Loughan, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604365
- Sponsor's protocol ID
- MCC-22-19485
- Other IDs
- HM20025081
- Acronym
- FearLess
- Status last verified
- Feb 2024
- First submitted
- 26 Oct 2022
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FearLess in Cognitively Intact Patients With Glioma
- ClinicalTrials.gov ID
- NCT05604365
- Acronym / sponsor ID
- FearLess / MCC-22-19485
- Conditions
- Glioma, Fear of Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 14 Nov 2023 (actual)
- Study completion
- 14 Nov 2023 (actual)
- First posted
- 3 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: FearLess InterventionPatients Only |
| Arm 2 | Experimental | Behavioral: FearLess InterventionPatients and Caregivers |
| Arm 3 | Experimental | Behavioral: FearLess InterventionCaregivers Only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
- Inability to attend virtual sessions (e.g. due to lack of stable internet connection, difficulty using technology)
- Inability to understand and provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FearLess Intervention8-12 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. | Behavioural | Arm 1, Arm 2, Arm 3 |
Primary outcome
Determine feasibility of FearLess recruitment
Time frame: 1 Day
As evidenced by the number of patients and caregivers that enroll in the trial
Determine the feasibility of FearLess intervention- Data collection procedures
Time frame: 12 Weeks
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
Time frame: 12 Weeks
As evidenced by attendance rate at intervention sessions
Determine the acceptability of FearLess intervention- Retention Rate
Time frame: 12 Weeks
As evidenced by the number of patients that complete follow-up measures
Determine the acceptability of FearLess intervention- Satisfaction
Time frame: 12 Weeks
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
Time frame: 12 Weeks
As evidenced by the number of patients that recommend the intervention to others
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashlee Loughan, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FearLess Intervention in people with Glioma and Fear of Cancer, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine feasibility of FearLess recruitment (time frame: 1 Day). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.