Lung CancerPROMISNCT01807390
Perspectives of Receiving Open Versus Minimally Invasive Surgery
An observational study of Lung Cancer and Esophageal Cancer, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
This study will examine the perspectives of patients' undergoing surgery for lung or esophageal cancer. It will examine both pre-op and post-op patient perspectives and opinions regarding pain and surgical complications. This study will also assess a general health related quality of life pre-op and post-op. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Esophageal Cancer
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2012to Dec 2018
- Phase
- Observational
- 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
Study population: Patients at the Ottawa Hospital General Campus who are surgical candidates for lung or esophageal cancer over the age of 18.
Who may be able to join
- Patients who are surgical candidates for lung or esophageal cancer (entered at pre-op time point)
Who cannot join
- Below 18 years of age.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perspectives for Receiving Open Versus MIS (PROMIS) - Patients' Perspectives on Surgical Treatment of Lung and Esophageal Cancer
This study will examine the perspectives of patients' undergoing surgery for lung or esophageal cancer. It will examine both pre-op and post-op patient perspectives and opinions regarding pain and surgical complications. This study will also assess a general health related quality of life pre-op and post-op. Additionally, it will examine the importance of receiving care close to home and their support system.
Hypotheses:
- The data will allow investigators to better understand the willingness of patients to participate in prospective, randomized studies comparing minimally invasive and open thoracic surgery. Patients will not be willing to undergo randomization to an open versus minimally invasive surgical procedure.
- The pain associated with Minimally Invasive Surgery (MIS) will be perceived and documented as lesser than open surgery.
- Patients may be willing to accept a higher risk of complications or more post-operative pain if they were given the option to be cared for closer to their home.
- Conditions
- Lung Cancer, Esophageal Cancer
- Keywords
- Minimally invasive surgery, Patient perspectives, Lung cancer, Esophageal cancer, Pain
- Medical subject headings
- Lung Neoplasms, Esophageal Neoplasms, Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain perceptions
Patients will rate their perceptions of pain associated with surgery both pre-op and at 4 weeks and 6 months post-op.
Measured: Baseline, 4 weeks and 6 months
Secondary outcomes (1)
Change in general health related quality of life
Patients will rate their general health related quality of life at pre-op, and post-op (4 weeks and 6 months) time points.
Measured: Baseline, 4 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study startJul 2012
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sebastien Gilbert, MD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807390
- Sponsor's protocol ID
- 20120321-01H
- Acronym
- PROMIS
- Status last verified
- Apr 2018
- First submitted
- 25 Feb 2013
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perspectives for Receiving Open Versus MIS (PROMIS) - Patients' Perspectives on Surgical Treatment of Lung and Esophageal Cancer
- ClinicalTrials.gov ID
- NCT01807390
- Acronym / sponsor ID
- PROMIS / 20120321-01H
- Conditions
- Lung Cancer, Esophageal Cancer
- Keywords
- Minimally invasive surgery, Patient perspectives, Lung cancer, Esophageal cancer, Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 8 Mar 2013 (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.
This study will examine the perspectives of patients' undergoing surgery for lung or esophageal cancer. It will examine both pre-op and post-op patient perspectives and opinions regarding pain and surgical complications. This study will also assess a general health related quality of life pre-op and post-op. Additionally, it will examine the importance of receiving care close to home and their support system.
Hypotheses:
- The data will allow investigators to better understand the willingness of patients to participate in prospective, randomized studies comparing minimally invasive and open thoracic surgery. Patients will not be willing to undergo randomization to an open versus minimally invasive surgical procedure.
- The pain associated with Minimally Invasive Surgery (MIS) will be perceived and documented as lesser than open surgery.
- Patients may be willing to accept a higher risk of complications or more post-operative pain if they were given the option to be cared for closer to their home.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at the Ottawa Hospital General Campus who are surgical candidates for lung or esophageal cancer over the age of 18.
Key inclusion criteria (1 listed)
- Patients who are surgical candidates for lung or esophageal cancer (entered at pre-op time point)
Key exclusion criteria (1 listed)
- Below 18 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in pain perceptions
Time frame: Baseline, 4 weeks and 6 months
Patients will rate their perceptions of pain associated with surgery both pre-op and at 4 weeks and 6 months post-op.
1 secondary outcome
Change in general health related quality of life
Time frame: Baseline, 4 weeks and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Individual participant dataSharing planned: Undecided
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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.
Sebastien Gilbert, MD principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Esophageal Cancer, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 17 Apr 2018. 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 Canada. 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?
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?
Change in pain perceptions (time frame: Baseline, 4 weeks and 6 months). 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 17 Apr 2018.