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| ID | Type | Description | Link |
|---|---|---|---|
| HM20025081 | Other Identifier | Virginia Commonwealth University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Patients Only |
|
| Arm 2 | Experimental | Patients and Caregivers |
|
| Arm 3 | Experimental | Caregivers Only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FearLess Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Determine the efficacy of FearLess intervention- Baseline to post intervention - fear scale | 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. | 12 Weeks |
Inclusion Criteria:
Patient inclusion:
Caregiver Inclusion:
Exclusion Criteria:
Patient:
Caregiver:
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| Name | Affiliation | Role |
|---|---|---|
| Ashlee Loughan, PhD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 12, 2022 | Feb 7, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| C000719212 | Pathophobia |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |