Geriatric Oncology Surgical Assessment and Functional rEcovery After Surgery

Elderly Clinical Trial

— GOSAFE  

Official title:

GOSAFE Study Geriatric Oncology Surgical Assessment and Functional rEcovery After Surgery An International Prospective Audit to Evaluate Postoperative Functional Outcomes and Quality of Life After Cancer Surgery in Geriatric Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03299270
• Other study ID #: GOSAFE
• Status: Active, not recruiting
• Start date: February 27, 2017
• Est. completion date: February 2020

Study information

• Verified date: May 2019
• Source: AUSL Romagna Rimini
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 1004
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

1. All consecutive patients, both gender, aged =70

2. Patients affected by solid malignancy

3. 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…)

4. Informed consent obtainment

Exclusion Criteria:

1. Patients undergoing emergent/urgent surgical procedures

2. Planned hospital stay less than 48 hours

Related Conditions & MeSH terms

• Elderly
• Neoplasms
• Solid Malignancy

Intervention

Other:
• Questionnaires
Quality of Life and Functional recovery questionnaires

Locations

Country	Name	City	State
Greece	Medical School, Aristotle University of Thessaloniki	Thessaloníki
Israel	Rabin Medical Center	Petah Tikva
Italy	IstitutoTumori Giovanni Paolo II	Bari	Puglia
Italy	Ospedale di Desio	Desio	Monza E Brianza
Italy	General Surgery Unit	Faenza	Ravenna
Italy	Ospedale di Forlì	Forlì	Forli-Cesena
Italy	IRCCS Ospedale S. Martino Genova, Chirurgia Generale ad indirizzo oncologico	Genova	Liguria
Italy	IRCCS Ospedale S. Martino Genova, Clinica Chirurgica 1	Genova	Liguria
Italy	Ospedale Niguarda	Milano
Italy	Ospedale di Piacenza	Piacenza
Italy	Ospedale di Riccione	Riccione	Rimini
Italy	Ospedale S. Andrea	Roma	Lazio
Italy	Humanitas	Rozzano	Milano
Italy	Ospedale S. Matteo degli Infermi	Spoleto	Perugia
Italy	Clinica S. Rita	Vercelli
Netherlands	Groeningen University Hospital	Groningen
Norway	Institute of clinical medicine	Oslo
Poland	Jagiellonian University Medical College	Kraków
Portugal	General Surgery dept,Hospital Sao Francisco Xavier (CHLO)	Lisbon
Portugal	Unidade Local de Saúde do Litoral Alentejano (ULSLA)	Santiago do Cacém
Spain	Universidad Miguel Hernández. Elche. Alicante	Alicante
Spain	Hospital Universitario y Politécnico La Fe	Valencia
United Kingdom	Dept. of Surgical Oncology - St. Helens Hospital of Liverpool	Liverpool
United Kingdom	Manchester Royal Infirmary, University of Manchester	Manchester
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	University of Pennsylvenia Medical Center	Philadelphia	Pennsylvania
United States	Roger William Medical Centre	Providence	Rhode Island
United States	Cleveland Clinic Florida	Weston	Florida

Sponsors (4)

Lead Sponsor	Collaborator
AUSL ROMAGNA	European Society of Surgical Oncology, International Society of Geriatric Oncology, IRST (Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori)

Countries where clinical trial is conducted

United States,  Greece,  Israel,  Italy,  Netherlands,  Norway,  Poland,  Portugal,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life (QoL)	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	6 months
Secondary	Functional recovery (FR)	To evaluate FR in terms of nutritional status, restoration of daily activities and cognitive status	6 months
Secondary	Morbidity	To evaluate 3 and 6 months postoperative morbidity	6 months
Secondary	Mortality	To evaluate 3 and 6 months postoperative mortality	6 months
Secondary	Prognostic factors	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	6 months