Esophageal CancerQUESTNCT01044511
Quality of Life With Esophageal Stent Trial
A study testing Home visits and standard in people with Esophageal Cancer and Gastro-esophageal Junction Cancer, run by Michael Bau Mortensen at 1 site in Denmark.
Trial summary
The aim of this study is to compare, specialist nurse home visits in patients with inoperable cancer in the esophagus or cardia, who are palliated with Self Expanding Metal Stent, to standard patient contact with regards to quality of life, number and character of reinterventions and cost-effectiveness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Gastro-esophageal Junction Cancer
- What is being tested?
- Home visits and standard
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2010to Mar 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Malignant obstruction of esophagus or cardia treated with SEMS due to non-operable disease.
Who cannot join
- Mentally unable to fill out questionaire
Trial locations and contacts
1 site in 1 country.
Michael B Mortensen, MD, PhD contact
Denmark1 site, 1 recruiting
- Recruiting
Afd A, OUH
Odense, Fyn, 5000
Bjerring, MD, steenbjerring@gmail.com
Mortensen, MD, PhD, m.bau@dadlnet.dk
About this study
Official title: Prospective, Randomized Trial of the Effects on HRQoL, Cost-Utility and Reintervention Rate, of Nurse Home Visits, in Patients With SEMS Treated Malignant Disease in the Esophagus and Cardia.
The aim of this study is to compare, specialist nurse home visits in patients with inoperable cancer in the esophagus or cardia, who are palliated with Self Expanding Metal Stent, to standard patient contact with regards to quality of life, number and character of reinterventions and cost-effectiveness.
Read the detailed description
The aim of this study is to compare, specialist nurse home visits in patients with inoperable cancer in the esophagus or gastro-esophageal junction (cardia), who are palliated with Self Expanding Metal Stent, to standard patient contact with regards to quality of life, number and character of reinterventions and cost-effectiveness.
- Being tested
- Home visits, standard
- Keywords
- Esophageal cancer, Cardia cancer, Health Related quality of Life, SEMS, Home visits
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home visitsBehavioural
Also called Home visit,, pro active nurse care
home visits by specialist nurse 2 times and 1 phonecall
standardBehavioural
Also called Phone Hotline, After hours phone line
hotline
| Study group | Role | What they receive |
|---|---|---|
| Home visit | Experimental | After SEMS placement, 2 home visits and a phonecall are made by a specialist nurse Receives: Behavioral: Home visits |
| Standard | Active comparator | Standard contact via Hotline and traditional referring methods Receives: Behavioral: standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
HRQoL, EORTC C-30, EOS-18
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2011 (estimated)
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michael Bau Mortensen
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital
- Responsible party
- Sponsor-investigator, Michael Bau Mortensen, Odense University Hospital
- Investigators
- Michael B Mortensen, MD,PhD, Study director, Afd A, OUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01044511
- Sponsor's protocol ID
- QUEST- AFD A
- Acronym
- QUEST
- Status last verified
- Nov 2011
- First submitted
- 4 Jan 2010
- Last updated
- 23 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Trial of the Effects on HRQoL, Cost-Utility and Reintervention Rate, of Nurse Home Visits, in Patients With SEMS Treated Malignant Disease in the Esophagus and Cardia.
- ClinicalTrials.gov ID
- NCT01044511
- Acronym / sponsor ID
- QUEST / QUEST- AFD A
- Keywords
- Esophageal cancer, Cardia cancer, Health Related quality of Life, SEMS, Home visits
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Michael Bau MortensenUniversity, hospital or other
- Collaborators
- Odense University Hospital
- Study start
- Jan 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 8 Jan 2010 (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.
The aim of this study is to compare, specialist nurse home visits in patients with inoperable cancer in the esophagus or cardia, who are palliated with Self Expanding Metal Stent, to standard patient contact with regards to quality of life, number and character of reinterventions and cost-effectiveness.
Detailed description
The aim of this study is to compare, specialist nurse home visits in patients with inoperable cancer in the esophagus or gastro-esophageal junction (cardia), who are palliated with Self Expanding Metal Stent, to standard patient contact with regards to quality of life, number and character of reinterventions and cost-effectiveness.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home visit | Experimental | Behavioral: Home visitsAfter SEMS placement, 2 home visits and a phonecall are made by a specialist nurse |
| Standard | Active comparator | Behavioral: standardStandard contact via Hotline and traditional referring methods |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Malignant obstruction of esophagus or cardia treated with SEMS due to non-operable disease.
Key exclusion criteria (1 listed)
- Mentally unable to fill out questionaire
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 |
|---|---|---|
| Home visitsAlso: Home visit,, pro active nurse carehome visits by specialist nurse 2 times and 1 phonecall | Behavioural | Home visit |
| standardAlso: Phone Hotline, After hours phone linehotline | Behavioural | Standard |
Primary outcome
HRQoL, EORTC C-30, EOS-18
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2011.
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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.
Michael B Mortensen, MD, PhD contact
Michael B Mortensen, MD,PhD study director
Afd A, OUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home visits and standard in people with Esophageal Cancer and Gastro-esophageal Junction Cancer, run by Michael Bau Mortensen at 1 site in Denmark.
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 1 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: status not confirmed, as of the sponsor's last update on 23 Nov 2011. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ole Steen Bjerring, MD (+ 45 23 84 06 96, steenbjerring@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HRQoL, EORTC C-30, EOS-18 (time frame: 2 years). 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 23 Nov 2011.