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

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ClinicalTrials.gov Identifier: NCT03299270
Recruitment Status : Unknown
Verified May 2019 by AUSL ROMAGNA, AUSL Romagna Rimini.
Recruitment status was:  Active, not recruiting
First Posted : October 3, 2017
Last Update Posted : May 9, 2019
Sponsor:
Collaborators:
European Society of Surgical Oncology
International Society of Geriatric Oncology
IRST (Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori)
Information provided by (Responsible Party):
AUSL ROMAGNA, AUSL Romagna Rimini

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.


Condition or disease Intervention/treatment
Elderly Solid Malignancy 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).

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Study Type : Observational
Actual Enrollment : 1004 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : February 27, 2017
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

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




Primary Outcome Measures :
  1. Quality of Life (QoL) [ Time Frame: 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 :
  1. Functional recovery (FR) [ Time Frame: 6 months ]
    To evaluate FR in terms of nutritional status, restoration of daily activities and cognitive status

  2. Morbidity [ Time Frame: 6 months ]
    To evaluate 3 and 6 months postoperative morbidity

  3. Mortality [ Time Frame: 6 months ]
    To evaluate 3 and 6 months postoperative mortality

  4. Prognostic factors [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03299270


Locations
Show Show 28 study locations
Sponsors and Collaborators
AUSL ROMAGNA
European Society of Surgical Oncology
International Society of Geriatric Oncology
IRST (Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori)
Investigators
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Principal Investigator: Giampaolo Giampaolo, MD AUSL Romagna
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Responsible Party: AUSL ROMAGNA, Azienda USL della Romagna, AUSL Romagna Rimini
ClinicalTrials.gov Identifier: NCT03299270    
Other Study ID Numbers: GOSAFE
First Posted: October 3, 2017    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AUSL ROMAGNA, AUSL Romagna Rimini:
Surgery
Solid malignancy
Elderly
Functional recovery
Additional relevant MeSH terms:
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Neoplasms