Quality of LifeNCT02439931
Remote Psychosocial Intervention for Brain Tumour Survivors
A study testing Remote psychosocial intervention in people with Quality of Life, run by British Columbia Cancer Agency.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Quality of Life
- What is being tested?
- Remote psychosocial intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Feasibility Study of a Remote Psychosocial Intervention for Brain Tumour Survivors
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.
Read the detailed description
Purpose
There would be strong value in developing a brief, manualized, remotely delivered, intervention capable of simultaneously improving both emotional well being and cognitive functioning in survivors of malignant brain tumour. The proposed study is designed to test the acceptability, feasibility, apparent efficacy, and areas for improvement of a newly developed intervention designed for this purpose. This investigation is being undertaken as a step toward conducting an randomized clinical trial.
Research Questions
As a feasibility study there will be no hypotheses tested in this study. Instead, the research will be conducted in order to answer the following four questions about the intervention:
- How acceptable was the intervention?
- How feasible was the intervention?
- How much apparent efficacy did the intervention have?
- How could the involved processes be improved?
Further the following three questions will be asked around the remote neuropsychological testing procedure:
- How feasible was the remote neuropsychological testing?
- How valid was the remote neuropsychological testing?
- How could the neuropsychological testing processes be improved?
Justification
A general justification for the proposed research will be offered below.
Brain tumour survivors demonstrate very high levels of psychopathology. For example, they have been found to exhibit levels of clinical depression that are three times higher than those found in cancer patients overall. This finding is particularly important because symptoms of depression have also been found to be the strongest single predictor of overall quality of life primary in brain tumour survivors.
The cognitive impacts of brain cancer, which are diverse, also have strongly negative effects on quality of life. Impairments in the areas of memory, attention, and executive functioning are the most common cognitive deficits involved.
Despite this depth of suffering, researchers to date have done relatively little work in developing psychologically based interventions that can help to ameliorate these emotional and cognitive sequelae.
More specifically, the remote aspect of this intervention is justified by the fact that this population faces multiple barriers to coming into the clinic for needed psychosocial care, including: geographical isolation; cognitive impairment; driving prohibition; and fatigue. This reality is reflected in the fact that previous researchers have reported facing faced strong challenges in recruiting participants for time consuming intervention studies of this kind in this population. A remote intervention may offer a means of overcoming this barrier to access.
Finally, due to lengthy wait times and other factors, this is also a population that often struggles to receive needed neuropsychological testing in a timely manner. Therefore, there will also be value in validating a brief, remotely delivered neuropsychological testing procedure in this population, above and beyond the role that doing so will play in validating the particular intervention under investigation here.
Objectives
This study has four primary objectives:
- to develop and deliver a remotely delivered psychosocial intervention to this high needs population
- to develop a neuropsychological battery that can be remotely delivered to this same population
- to answer the four questions listed above in regards to the intervention
- to answer the three questions listed above in regards to the neuropsych assessment process
Research Design
The proposed design will involve a mixed method feasibility study design. A variety of data sources will be used in order to address the 7 research questions listed above. These data sources will include: self report questionnaires; neuropsychological test batteries; fill-in the blank questionnaires; interviews; and focus groups.
- Statistical Analysis
The included types of quantitative data analysis will be: descriptive statistics; effect sizes; and repeated measures ANOVA.
- Conditions
- Quality of Life
- Being tested
- Remote psychosocial intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote psychosocial interventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Remote psychosocial intervention | Experimental | 10 sessions of remotely delivered psychoeducation and support Receives: Behavioral: Remote psychosocial intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The Brief Symptom Inventory -18 is a commonly used self report measure of psychological distress in oncology patients.
Measured: Comparison of scores pre-intervention to immediately post intervention (10 weeks) and 4 month followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by British Columbia Cancer AgencyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Douglas P Ozier, PhD, Principal investigator, British Columbia Cancer Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02439931
- Sponsor's protocol ID
- H15-00959
- Status last verified
- May 2015
- First submitted
- 7 May 2015
- Last updated
- 13 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of a Remote Psychosocial Intervention for Brain Tumour Survivors
- ClinicalTrials.gov ID
- NCT02439931
- Acronym / sponsor ID
- H15-00959
- Conditions
- Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 12 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Purpose
There would be strong value in developing a brief, manualized, remotely delivered, intervention capable of simultaneously improving both emotional well being and cognitive functioning in survivors of malignant brain tumour. The proposed study is designed to test the acceptability, feasibility, apparent efficacy, and areas for improvement of a newly developed intervention designed for this purpose. This investigation is being undertaken as a step toward conducting an randomized clinical trial.
Research Questions
As a feasibility study there will be no hypotheses tested in this study. Instead, the research will be conducted in order to answer the following four questions about the intervention:
- How acceptable was the intervention?
- How feasible was the intervention?
- How much apparent efficacy did the intervention have?
- How could the involved processes be improved?
Further the following three questions will be asked around the remote neuropsychological testing procedure:
- How feasible was the remote neuropsychological testing?
- How valid was the remote neuropsychological testing?
- How could the neuropsychological testing processes be improved?
Justification
A general justification for the proposed research will be offered below.
Brain tumour survivors demonstrate very high levels of psychopathology. For example, they have been found to exhibit levels of clinical depression that are three times higher than those found in cancer patients overall. This finding is particularly important because symptoms of depression have also been found to be the strongest single predictor of overall quality of life primary in brain tumour survivors.
The cognitive impacts of brain cancer, which are diverse, also have strongly negative effects on quality of life. Impairments in the areas of memory, attention, and executive functioning are the most common cognitive deficits involved.
Despite this depth of suffering, researchers to date have done relatively little work in developing psychologically based interventions that can help to ameliorate these emotional and cognitive sequelae.
More specifically, the remote aspect of this intervention is justified by the fact that this population faces multiple barriers to coming into the clinic for needed psychosocial care, including: geographical isolation; cognitive impairment; driving prohibition; and fatigue. This reality is reflected in the fact that previous researchers have reported facing faced strong challenges in recruiting participants for time consuming intervention studies of this kind in this population. A remote intervention may offer a means of overcoming this barrier to access.
Finally, due to lengthy wait times and other factors, this is also a population that often struggles to receive needed neuropsychological testing in a timely manner. Therefore, there will also be value in validating a brief, remotely delivered neuropsychological testing procedure in this population, above and beyond the role that doing so will play in validating the particular intervention under investigation here.
Objectives
This study has four primary objectives:
- to develop and deliver a remotely delivered psychosocial intervention to this high needs population
- to develop a neuropsychological battery that can be remotely delivered to this same population
- to answer the four questions listed above in regards to the intervention
- to answer the three questions listed above in regards to the neuropsych assessment process
Research Design
The proposed design will involve a mixed method feasibility study design. A variety of data sources will be used in order to address the 7 research questions listed above. These data sources will include: self report questionnaires; neuropsychological test batteries; fill-in the blank questionnaires; interviews; and focus groups.
- Statistical Analysis
The included types of quantitative data analysis will be: descriptive statistics; effect sizes; and repeated measures ANOVA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remote psychosocial intervention | Experimental | Behavioral: Remote psychosocial intervention10 sessions of remotely delivered psychoeducation and support |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote psychosocial intervention | Behavioural | Remote psychosocial intervention |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2015.
Related trials for Quality of Life
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Study of a Support Program for Quality of Life in Chinese Cancer Patients and Survivors
Cancer, Survivorship
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas P Ozier, PhD principal investigator
British Columbia Cancer Agency
Questions about this trial
What is this clinical trial studying?
A study testing Remote psychosocial intervention in people with Quality of Life, run by British Columbia Cancer Agency.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Douglas P Ozier, PhD. (604-877-6000 ext. 2185, dozier@bccancer.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2015.