Perspectives of Receiving Open Versus Minimally Invasive Surgery

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01807390

Acronym

PROMIS

Enrollment

200

Registered

2013-03-08

Start date

2012-07-31

Completion date

2018-12-31

Last updated

2018-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer, Lung Cancer

Keywords

Minimally invasive surgery, Patient perspectives, Lung cancer, Esophageal cancer, Pain

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in pain perceptions	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.

Secondary

Measure	Time frame	Description
Change in general health related quality of life	Baseline, 4 weeks and 6 months	Patients will rate their general health related quality of life at pre-op, and post-op (4 weeks and 6 months) time points.

Countries

Canada

Outcome results