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.
연구 개요
상세 설명
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).
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Thessaloníki, 그리스, 54248
- Medical School, Aristotle University of Thessaloniki
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Groningen, 네덜란드
- Groeningen University Hospital
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Oslo, 노르웨이
- Institute of Clinical Medicine
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Florida
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Weston, Florida, 미국, 33331
- Cleveland Clinic Florida
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Massachusetts
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Boston, Massachusetts, 미국, 02115
- Brigham and Women's Hospital
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- University of Pennsylvenia Medical Center
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Rhode Island
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Providence, Rhode Island, 미국, 02908
- Roger William Medical Centre
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Alicante, 스페인, 03001
- Universidad Miguel Hernández. Elche. Alicante
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Valencia, 스페인, 46700
- Hospital Universitario y Politécnico La Fe
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Liverpool, 영국
- Dept. of Surgical Oncology - St. Helens Hospital of Liverpool
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Manchester, 영국
- Manchester Royal Infirmary, University of Manchester
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Petah Tikva, 이스라엘, 4592500
- Rabin Medical Center
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Milano, 이탈리아, 20162
- Ospedale Niguarda
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Piacenza, 이탈리아, 29121
- Ospedale di Piacenza
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Vercelli, 이탈리아, 13100
- Clinica S. Rita
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Forli-Cesena
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Forlì, Forli-Cesena, 이탈리아, 47121
- Ospedale di Forlì
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Lazio
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Roma, Lazio, 이탈리아, 00100
- Ospedale S. Andrea
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Liguria
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Genova, Liguria, 이탈리아, 16121
- IRCCS Ospedale S. Martino Genova, Chirurgia Generale ad indirizzo oncologico
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Genova, Liguria, 이탈리아, 16121
- IRCCS Ospedale S. Martino Genova, Clinica Chirurgica 1
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Milano
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Rozzano, Milano, 이탈리아, 20089
- Humanitas
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Monza E Brianza
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Desio, Monza E Brianza, 이탈리아, 20039
- Ospedale di Desio
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Perugia
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Spoleto, Perugia, 이탈리아, 06049
- Ospedale S. Matteo degli Infermi
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Puglia
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Bari, Puglia, 이탈리아, 70121
- IstitutoTumori Giovanni Paolo II
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Ravenna
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Faenza, Ravenna, 이탈리아, 48018
- General Surgery Unit
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Rimini
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Riccione, Rimini, 이탈리아, 47838
- Ospedale di Riccione
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Lisbon, 포르투갈
- General Surgery dept,Hospital Sao Francisco Xavier (CHLO)
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Santiago do Cacém, 포르투갈, 7500
- Unidade Local de Saúde do Litoral Alentejano (ULSLA)
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Kraków, 폴란드
- Jagiellonian University Medical College
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients undergoing emergent/urgent surgical procedures
- Planned hospital stay less than 48 hours
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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Group 1
Elderly patiences with solid malignancy
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Quality of Life and Functional recovery questionnaires
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Quality of Life (QoL)
기간: 6 months
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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
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6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Functional recovery (FR)
기간: 6 months
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To evaluate FR in terms of nutritional status, restoration of daily activities and cognitive status
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6 months
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Morbidity
기간: 6 months
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To evaluate 3 and 6 months postoperative morbidity
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6 months
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Mortality
기간: 6 months
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To evaluate 3 and 6 months postoperative mortality
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6 months
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Prognostic factors
기간: 6 months
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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
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6 months
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공동 작업자 및 조사자
스폰서
협력자
수사관
- 수석 연구원: Giampaolo Giampaolo, MD, AUSL Romagna
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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