COPING: COgnitive impairment in People with glioma and distress in the INformal care-Givers

Not Applicable

• Conditions: Glioma; Cognitive Impairment; Cancer - Brain; Neurological - Other neurological disorders

• Registration Number: ACTRN12620000481976
• Lead Sponsor: niversity of Newcastle

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-16
• Last Update Posted: 20 April 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Patients:
1. Aged 18 years or older
2. Have received a confirmed diagnosis of low- or high- grade glioma or glioblastoma
4. Have at least two appointments within a six-month time frame at the study site(s)
5. English proficient

For patients interested in the study, members of the participant’s healthcare team will make a decision with the patient using their best professional judgement about the patient’s capacity to give free and informed consent to this study.

Caregivers: A caregiver does not need to consent to participate for a patient to participate. These participants must be:
1. Aged 18 years or older
2. English Proficient
3. Be planning to attend at least two subsequent appointments in a six-month time frame at the study site(s) with an individual with a confirmed diagnosis of low- or high- grade glioma or glioblastoma
No criteria regarding relationship type (ie: spouse, sibling, adult child) is included.

In order for caregivers to participate, a patient must also participate.

Exclusion Criteria

1. Under the age of 18 years
2. Not English Proficient
3. Cognition is too poor to provide informed consent as deemed by patient’s health care team
4. No confirmed diagnosis

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is to assess the feasibility of a simple, cost-effective and validated, self-administered cognitive assessment Audio Recorded Cognitive Screen (ARCS; www.cognitionhealth.com) for use with brain cancer patients at two to three critical time-points in treatment using ARCS in clinic settings. Feasibility will be assessed by ARCS tool completion rates and patients’ responses to survey items on acceptability. [The primary time-point will be at the 2nd ARCs assessment which will occur 4-6 weeks post radiation therapy depending on appointment timing. ]