Fear of Cancer, Glioma
Conditions
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.
Interventions
BEHAVIORALFearLess Intervention
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.
Sponsors
Virginia Commonwealth University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine the acceptability of FearLess intervention- Attendance | 12 Weeks | As evidenced by attendance rate at intervention sessions |
| Determine feasibility of FearLess recruitment | 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 | 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- Satisfaction- Recommendation | 12 Weeks | As evidenced by the number of patients that recommend the intervention to others |
| Determine the acceptability of FearLess intervention- Retention Rate | 12 Weeks | As evidenced by the number of patients that complete follow-up measures |
| Determine the acceptability of FearLess intervention- Satisfaction | 12 Weeks | As evidenced by the number of patients with a satisfaction rating greater than 7 on a 10 point scale |
Other
| Measure | Time frame | Description |
|---|---|---|
| Determine the efficacy of FearLess intervention- Baseline to post intervention - fear scale | 12 Weeks | 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. |
Countries
United States
Outcome results
None listed