Advanced Brain CancerNCT00970788
A Pilot Study of Using Video Images in Advance Care Planning in Malignant Glioma Patients
A study testing Video intervention in people with Advanced Brain Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
A randomized controlled trial of a video decision aid in 50 patients with advanced brain cancer. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Advanced Brain Cancer
- What is being tested?
- Video intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Mar 2009
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced brain cancer
- English Speaking
- Able to provide informed consent
Who cannot join
- Folstein mini mental status score of 23 or less
Trial locations and contacts
1 site in 1 country.
About this study
A randomized controlled trial of a video decision aid in 50 patients with advanced brain cancer.
Read the detailed description
A randomized controlled trial of a video decision aid in 50 patients with advanced brain cancer. Subjects will have three options for their goals of care: life prolonging care, basic medical care, or comfort care.
- Conditions
- Advanced Brain Cancer
- Being tested
- Video intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video interventionBehavioural
Video of goals of care
| Study group | Role | What they receive |
|---|---|---|
| verbal group | No intervention | Verbal description of goals of care. |
| Video group | Experimental | Video decision aid. Receives: Behavioral: Video intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
end of life preference at time of interview
Measured: 5 minutes after survey
Secondary outcomes (2)
uncertainty regarding end of life preference at time of interview
Measured: 5 minutes after survey
knowledge of end of life preference at time of interview
Measured: 5 minutes after survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2009 (estimated)
- Study startJul 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Brain CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Informed Medical Decision Making
- Responsible party
- Principal investigator, Angelo E. Volandes, MD, Massachusetts General Hospital
- Investigators
- Angelo Volandes, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00970788
- Sponsor's protocol ID
- 2008-P-000826/6
- Status last verified
- Apr 2012
- First submitted
- 7 Aug 2009
- Last updated
- 1 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Using Video Images in Advance Care Planning in Malignant Glioma Patients
- ClinicalTrials.gov ID
- NCT00970788
- Acronym / sponsor ID
- 2008-P-000826/6
- Conditions
- Advanced Brain Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Foundation for Informed Medical Decision Making
- Study start
- Jul 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 2 Sep 2009 (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.
A randomized controlled trial of a video decision aid in 50 patients with advanced brain cancer.
Detailed description
A randomized controlled trial of a video decision aid in 50 patients with advanced brain cancer. Subjects will have three options for their goals of care: life prolonging care, basic medical care, or comfort care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| verbal group | No intervention | –Verbal description of goals of care. |
| Video group | Experimental | Behavioral: Video interventionVideo decision aid. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Advanced brain cancer
- English Speaking
- Able to provide informed consent
Key exclusion criteria (1 listed)
- Folstein mini mental status score of 23 or less
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 |
|---|---|---|
| Video interventionVideo of goals of care | Behavioural | Video group |
Primary outcome
end of life preference at time of interview
Time frame: 5 minutes after survey
2 secondary outcomes
uncertainty regarding end of life preference at time of interview
Time frame: 5 minutes after survey
knowledge of end of life preference at time of interview
Time frame: 5 minutes after survey
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2012.
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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.
Angelo Volandes, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video intervention in people with Advanced Brain Cancer, run by Massachusetts General Hospital at 1 site in United States.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 1 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
end of life preference at time of interview (time frame: 5 minutes after survey). 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 1 May 2012.