Geriatric Oncology Surgical Assessment and Functional rEcovery After Surgery
- Conditions
- Solid MalignancyElderly
- Interventions
- Other: Questionnaires
- Registration Number
- NCT03299270
- Lead Sponsor
- AUSL ROMAGNA
- Brief Summary
Multicenter, international, prospective, observational study, designed to evaluate the postoperative results in terms of quality of life and functional recovery of elderly patients after major cancer surgery.
The global expected duration of the study is 3 years, during which cancer patients over 70 years old undergoing major surgery will be evaluated before and after the surgical intervention, at 30 days, 3- and 6-months follow-up. The study is non-for-profit. Given the observational nature of the study, the original treatment plan, as designed by each individual recruiting centre, will not be altered or affected by the study inclusion. Inclusion in the study does not imply any deviation from the current standard of practice, and no change is expected to the perioperative treatment at any point. Patients will be only asked to complete simple screening/assessment tests.
- Detailed Description
GOSAFE study is a prospective international collaborative high-quality registry aiming to gain knowledge about postoperative outcomes in older cancer patients with a particular emphasis on QoL and FR. The target is to obtain meaningful data to assist clinicians in tailoring the care, avoiding under/over-treatment, providing robust data to identify new strategies to improve functional outcomes in older cancer patients.
Recruiting centers will collect data prospectively. Recruited patients will be followed for 6 months after their surgery.
The original treatment plan, as designed by each individual recruiting centre, will not be altered or affected by the study inclusion.
Centers should ensure that they would make every possible effort to include all consecutive eligible patients during the study period and provide completeness of data entry to ensure a 'real-life' study.
Patients both gender, both gender, aged ≥70, affected by solid malignancy undergoing elective major surgical procedures with curative or palliative intent are eligible.
Inclusion in the study does not imply any deviation from the current standard of practice, and no change is expected to the perioperative treatment at any point. Patients will be only asked to complete simple screening/assessment tests.
For every eligible patient, demographic data will be collected at baseline followed by a fast preoperative functional assessment. Data regarding surgical procedures and perioperative measures will be collected. Complications will be reported and graded according to Clavien-Dindo Classification. Three- and six-month follow up data will be collected after surgery within a range of 2 weeks from the due date.
The Full Analysis Set (FAS) consists of all registered patients. The primary endpoint will be measured for all registered subjects who fulfill preoperative and postoperative EQ VAS. Demographic and baseline patient characteristics will be summarized for all patients in the FAS. Continuous-scaled variables (e.g., age) will be summarized with means, medians, standard deviations, quartiles, and minimum and maximum values. Categorical variables (e.g., sex) will be summarized using patient counts and percentages. Study endpoints and variables will be evaluated using descriptive statistics, and the key figures of the distributions will be presented in tables. Univariate analyses will allow for a first overview of potentially influential factors.
Multiple linear regression models will be performed in order to evaluate predictors of functional recovery at 3 months and 6 months after surgery.
Exploratory subgroup analyses will be performed. Missing values will be replaced and estimated using multiple imputations. Furthermore, sensitivity analysis will be executed using complete-case analysis.
A sample size of 265 patients who completed pre and postoperative EQ VAS questionnaires will have a 90% power to detect an effect size of 0,2 between pre and post surgery ,using a paired t-test with a 0,05 two sided significance level.
Given a potential loss to follow-up (about 10%), uncompleted questionnaires (about 10%) and postoperative mortality (about 15%), the sample size will be increased to 350-400 patients (see ref 18 and 19).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1004
- All consecutive patients, both gender, aged ≥70
- Patients affected by solid malignancy
- Patients undergoing elective major surgical procedures with curative or palliative intent (all major procedures including any resection, for any cancer, via any operative approach, open, laparoscopic, robotic, etc...)
- Informed consent obtainment
- Patients undergoing emergent/urgent surgical procedures
- Planned hospital stay less than 48 hours
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 Questionnaires Elderly patiences with solid malignancy
- Primary Outcome Measures
Name Time Method Quality of Life (QoL) 6 months To evaluate the effects of surgery on patients' life perception by comparing pre- and post-operative QoL in elderly patients undergoing major surgery for solid malignancies using a self-reported Quality of Life assessment tool
- Secondary Outcome Measures
Name Time Method Functional recovery (FR) 6 months To evaluate FR in terms of nutritional status, restoration of daily activities and cognitive status
Morbidity 6 months To evaluate 3 and 6 months postoperative morbidity
Mortality 6 months To evaluate 3 and 6 months postoperative mortality
Prognostic factors 6 months To obtain prognostic factors for postoperative functional recovery which will assist in the treatment planning /intervention of future elderly patients who are offered surgery for cancer
Trial Locations
- Locations (28)
IRCCS Ospedale S. Martino Genova, Clinica Chirurgica 1
🇮🇹Genova, Liguria, Italy
Medical School, Aristotle University of Thessaloniki
🇬🇷ThessalonÃki, Greece
Ospedale S. Andrea
🇮🇹Roma, Lazio, Italy
IRCCS Ospedale S. Martino Genova, Chirurgia Generale ad indirizzo oncologico
🇮🇹Genova, Liguria, Italy
Ospedale S. Matteo degli Infermi
🇮🇹Spoleto, Perugia, Italy
General Surgery Unit
🇮🇹Faenza, Ravenna, Italy
Ospedale di Riccione
🇮🇹Riccione, Rimini, Italy
Groeningen University Hospital
🇳🇱Groningen, Netherlands
Unidade Local de Saúde do Litoral Alentejano (ULSLA)
🇵🇹Santiago do Cacém, Portugal
Cleveland Clinic Florida
🇺🇸Weston, Florida, United States
University of Pennsylvenia Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Roger William Medical Centre
🇺🇸Providence, Rhode Island, United States
Ospedale di Forlì
🇮🇹Forlì, Forli-Cesena, Italy
Rabin Medical Center
🇮🇱Petah Tikva, Israel
Humanitas
🇮🇹Rozzano, Milano, Italy
Ospedale di Desio
🇮🇹Desio, Monza E Brianza, Italy
IstitutoTumori Giovanni Paolo II
🇮🇹Bari, Puglia, Italy
Jagiellonian University Medical College
🇵🇱Kraków, Poland
Clinica S. Rita
🇮🇹Vercelli, Italy
Ospedale Niguarda
🇮🇹Milano, Italy
Ospedale di Piacenza
🇮🇹Piacenza, Italy
General Surgery dept,Hospital Sao Francisco Xavier (CHLO)
🇵🇹Lisbon, Portugal
Institute of clinical medicine
🇳🇴Oslo, Norway
Universidad Miguel Hernández. Elche. Alicante
🇪🇸Alicante, Spain
Hospital Universitario y Politécnico La Fe
🇪🇸Valencia, Spain
Dept. of Surgical Oncology - St. Helens Hospital of Liverpool
🇬🇧Liverpool, United Kingdom
Manchester Royal Infirmary, University of Manchester
🇬🇧Manchester, United Kingdom