Remote Psychosocial Intervention for Brain Tumour Survivors
Feasibility Study of a Remote Psychosocial Intervention for Brain Tumour Survivors
1 other identifier
interventional
10
0 countries
N/A
Brief Summary
Survivors of high grade brain tumours frequently experience increases in distress, cognitive challenges, and lessened quality of life. At the same time a range of barriers can make it challenging for these individuals to come into the clinic for appropriate psychosocial support. The proposed study is therefore a feasibility study that is designed to develop a manualized, remotely delivered psychosocial intervention for this population and then to test the acceptability, feasibility, apparent efficacy, and areas for improvement of the developed intervention. Further, a remote neuropsychological testing procedure will be developed and implemented and analogous questions will be asked around this procedure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable quality-of-life
Started Jul 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2015
CompletedFirst Posted
Study publicly available on registry
May 12, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedMay 13, 2015
May 1, 2015
1 year
May 7, 2015
May 12, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in score on Quality of Life score on the Functional Assessment of Cancer Therapy-Brain
The Functional Assessment of Cancer Therapy-Brain (FACT-Br) is a self report measure designed to assess quality of life in people living with brain malignancy across five dimensions: physical well-being, social/family well-being, emotional well being, functional well-being, and disease specific challenges.
Comparison of scores pre-intervention to immediately post intervention (10 weeks) and 4 month followup
Secondary Outcomes (1)
Changes in scores regarding psychological distress(anxiety, depression and somatization) on the Brief Symptom Inventory -18
Comparison of scores pre-intervention to immediately post intervention (10 weeks) and 4 month followup
Study Arms (1)
Remote psychosocial intervention
EXPERIMENTAL10 sessions of remotely delivered psychoeducation and support
Interventions
Eligibility Criteria
You may qualify if:
- have a WHO grade 3 or 4 brain tumour
- be under the care of a BC Cancer Agency (BCCA) centre for their brain tumour
- have a Karnofsky Performance Score of 70 or more
- be capable of offering informed consent
- have a high speed internet connection in the home
You may not qualify if:
- experiencing levels of distress that will make participation untenable and/or likely counter-productive
- currently experiencing suicidal ideation
- not be capable of speaking English at level such that a translator will be needed to obtain informed consent and/or for the participant to engage appropriately in the intervention/assessments
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Officials
- PRINCIPAL INVESTIGATOR
Douglas P Ozier, PhD
British Columbia Cancer Agency
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2015
First Posted
May 12, 2015
Study Start
July 1, 2015
Primary Completion
July 1, 2016
Study Completion
September 1, 2016
Last Updated
May 13, 2015
Record last verified: 2015-05