Perspectives of Receiving Open Versus Minimally Invasive Surgery

Lung Cancer Clinical Trial

— PROMIS  

Official title:

Perspectives for Receiving Open Versus MIS (PROMIS) - Patients' Perspectives on Surgical Treatment of Lung and Esophageal Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01807390
• Other study ID #: 20120321-01H
• Status: Active, not recruiting
• First received: February 25, 2013
• Last updated: April 13, 2018
• Start date: July 2012
• Est. completion date: December 2018

Study information

• Verified date: April 2018
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. Additionally, it will examine the importance of receiving care close to home and their support system.

Hypotheses:

1. 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.

2. The pain associated with Minimally Invasive Surgery (MIS) will be perceived and documented as lesser than open surgery.

3. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who are surgical candidates for lung or esophageal cancer (entered at pre-op time point)

Exclusion Criteria:

• Below 18 years of age.

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Lung Cancer

Locations

Country	Name	City	State
Canada	Ottawa Hospital Research Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 4 weeks and 6 months
Secondary	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.	Baseline, 4 weeks and 6 months