Geriatric Oncology Surgical Assessment and Functional rEcovery After Surgery

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).

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