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Remote Psychosocial Intervention for Brain Tumour Survivors

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ClinicalTrials.gov Identifier: NCT02439931
Recruitment Status : Unknown
Verified May 2015 by British Columbia Cancer Agency.
Recruitment status was:  Not yet recruiting
First Posted : May 12, 2015
Last Update Posted : May 13, 2015
Sponsor:
Information provided by (Responsible Party):
British Columbia Cancer Agency

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.

Condition or disease Intervention/treatment Phase
Quality of Life Behavioral: Remote psychosocial intervention Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study of a Remote Psychosocial Intervention for Brain Tumour Survivors
Study Start Date : July 2015
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Arm Intervention/treatment
Experimental: Remote psychosocial intervention
10 sessions of remotely delivered psychoeducation and support
Behavioral: Remote psychosocial intervention



Primary Outcome Measures :
  1. Change from baseline in score on Quality of Life score on the Functional Assessment of Cancer Therapy-Brain [ Time Frame: Comparison of scores pre-intervention to immediately post intervention (10 weeks) and 4 month followup ]
    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.


Secondary Outcome Measures :
  1. Changes in scores regarding psychological distress(anxiety, depression and somatization) on the Brief Symptom Inventory -18 [ Time Frame: Comparison of scores pre-intervention to immediately post intervention (10 weeks) and 4 month followup ]
    The Brief Symptom Inventory -18 is a commonly used self report measure of psychological distress in oncology patients.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02439931


Contacts
Contact: Douglas P Ozier, PhD. 604-877-6000 ext 2185 dozier@bccancer.bc.ca

Sponsors and Collaborators
British Columbia Cancer Agency
Investigators
Principal Investigator: Douglas P Ozier, PhD British Columbia Cancer Agency

Responsible Party: British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT02439931     History of Changes
Other Study ID Numbers: H15-00959
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: May 13, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases