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Completed

NCT Number: NCT05604365

FearLess in Cognitively Intact Patients With Glioma

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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Key information

Conditions

Glioma Fear of Cancer Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Pathophobia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Determine feasibility of FearLess recruitment

    Time frame: 1 Day

    As evidenced by the number of patients and caregivers that enroll in the trial

  2. 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

  3. Determine the acceptability of FearLess intervention- Attendance

    Time frame: 12 Weeks

    As evidenced by attendance rate at intervention sessions

  4. Determine the acceptability of FearLess intervention- Retention Rate

    Time frame: 12 Weeks

    As evidenced by the number of patients that complete follow-up measures

  5. 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

  6. 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

Other outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Acronym: FearLess

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 3, 2022
Registry last updated
Feb 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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