Geriatric Oncology Surgical Assessment and Functional rEcovery After Surgery (GOSAFE)

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

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.

Study Overview

• Status: Unknown
• Conditions: Elderly; Solid Malignancy
• Intervention / Treatment: Other: Questionnaires

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).

• Study Type: Observational
• Enrollment (Actual): 1004

Contacts and Locations

Study Locations

• Greece
  • Thessaloníki, Greece, 54248
    • Medical School, Aristotle University of Thessaloniki
• Israel
  • Petah Tikva, Israel, 4592500
    • Rabin Medical Center
• Italy
  • Milano, Italy, 20162
    • Ospedale Niguarda
  • Piacenza, Italy, 29121
    • Ospedale di Piacenza
  • Vercelli, Italy, 13100
    • Clinica S. Rita
  • Forli-Cesena
    • Forlì, Forli-Cesena, Italy, 47121
      • Ospedale di Forlì
  • Lazio
    • Roma, Lazio, Italy, 00100
      • Ospedale S. Andrea
  • Liguria
    • Genova, Liguria, Italy, 16121
      • IRCCS Ospedale S. Martino Genova, Chirurgia Generale ad indirizzo oncologico
    • Genova, Liguria, Italy, 16121
      • IRCCS Ospedale S. Martino Genova, Clinica Chirurgica 1
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Humanitas
  • Monza E Brianza
    • Desio, Monza E Brianza, Italy, 20039
      • Ospedale di Desio
  • Perugia
    • Spoleto, Perugia, Italy, 06049
      • Ospedale S. Matteo degli Infermi
  • Puglia
    • Bari, Puglia, Italy, 70121
      • IstitutoTumori Giovanni Paolo II
  • Ravenna
    • Faenza, Ravenna, Italy, 48018
      • General Surgery Unit
  • Rimini
    • Riccione, Rimini, Italy, 47838
      • Ospedale di Riccione
• Netherlands
  • Groningen, Netherlands
    • Groeningen University Hospital
• Norway
  • Oslo, Norway
    • Institute of clinical medicine
• Poland
  • Kraków, Poland
    • Jagiellonian University Medical College
• Portugal
  • Lisbon, Portugal
    • General Surgery dept,Hospital Sao Francisco Xavier (CHLO)
  • Santiago do Cacém, Portugal, 7500
    • Unidade Local de Saúde do Litoral Alentejano (ULSLA)
• Spain
  • Alicante, Spain, 03001
    • Universidad Miguel Hernández. Elche. Alicante
  • Valencia, Spain, 46700
    • Hospital Universitario y Politecnico La Fe
• United Kingdom
  • Liverpool, United Kingdom
    • Dept. of Surgical Oncology - St. Helens Hospital of Liverpool
  • Manchester, United Kingdom
    • Manchester Royal Infirmary, University of Manchester
• United States
  • Florida
    • Weston, Florida, United States, 33331
      • Cleveland Clinic Florida
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvenia Medical Center
  • Rhode Island
    • Providence, Rhode Island, United States, 02908
      • Roger William Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Elderly patiences with solid malignancy	Other: Questionnaires; Quality of Life and Functional recovery questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional recovery (FR)	To evaluate FR in terms of nutritional status, restoration of daily activities and cognitive status	6 months
Morbidity	To evaluate 3 and 6 months postoperative morbidity	6 months
Mortality	To evaluate 3 and 6 months postoperative mortality	6 months
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

Collaborators and Investigators

• Sponsor: AUSL ROMAGNA
• Collaborators: International Society of Geriatric Oncology; European Society of Surgical Oncology; IRST (Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori)
• Investigators: Principal Investigator: Giampaolo Giampaolo, MD, Ausl Romagna

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2017
• Primary Completion (Anticipated): February 1, 2020
• Study Completion (Anticipated): February 1, 2020

Study Registration Dates

• First Submitted: September 20, 2017
• First Submitted That Met QC Criteria: September 27, 2017
• First Posted (Actual): October 3, 2017

Study Record Updates

• Last Update Posted (Actual): May 9, 2019
• Last Update Submitted That Met QC Criteria: May 7, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Elderly; Surgery; Functional recovery; Solid malignancy
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: GOSAFE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No