Clinical trial · Interventional
Interest of a Geriatric Intervention Plan Associated to a Comprehensive Geriatric Assessment on Autonomy, Quality of Life and Survival of Patients Aged 70 Years Old and More Surgically Treated for a Resectable Cancer (Thoracic, Digestive or Urologic). Randomized Multicentric Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The curative treatment of thoracic (lung and oesophagus), digestive (gastric, pancreatic, hepatic, colorectal), and urologic (renal, bladder, prostatic) cancers needs a surgical resection. For patients aged of 70 years old and more, this surgery is associated to an increased morbid-mortality especially because of more frequent co-morbidities. Comprehensive geriatric assessment (CGA) allows distinguishing patients for whom a resection surgery can be complicated by high morbid-mortality or a loss of autonomy. It has been proved that for old patient population without cancer, CGA associated with a geriatric intervention plan (GIP) allows autonomy preservation, decrease of institution admission, and survival improvement. The reference study showed that a CGA associated to a GIP improves survival of old patients who had a cancer surgery. However this study included patients from 60 years old and the GIP consisted in 3 home visits and 5 phone calls during the 4 weeks following hospital discharge. We propose to perform a prospective and randomized study to evaluate the impact of a CGA with GIP in 70 years old and more patients with a thoracic, digestive or urologic cancer resection, respectively 1, 3, 6 and 12 months after discharge. CGA and GIP will focus on 8 distinct fields: autonomy, co-morbidities, co-medication, mobility, nutritional status, depression, cognitive function and social status. The impact of such a strategy on autonomy and survival has never been studied.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| comprehensive geriatric assessment (CGA) | Other | — | UNRESOLVED |
| Geriatric intervention plan (GIP) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- standard strategy
- interventionNames
- Other: comprehensive geriatric assessment (CGA)
- type
- EXPERIMENTAL
- label
- experimental strategy
- interventionNames
- Other: comprehensive geriatric assessment (CGA)
- Other: Geriatric intervention plan (GIP)
Primary outcomes (1)
- measure
- the 6-month autonomy after surgery
- timeFrame
- 24 MONTHS
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female aged 70 years old or more * Patient with a resectable cancer( thoracic, digestive ore urologic); * Patients who have to undergo a surgery with general anaesthesia; * Patients treated in one of the partner programme unit ; * Patient able to fill in an auto-questionnaire alone or with some help; * Patient who have signed an informed consent and who commits himself or herself to respect the protocol instructions. Exclusion Criteria: * Patient younger than 70 years old; * Patient who is not registered to the social ; * Patient for whom surgery is performed under local anaesthesia; * Patient unable to fill-in alone an autoquestionnaire (because of an inability to read French language or severe cognitive troubles); * Patient treated with neuroleptic or lithium ; * Patient with already known cognitive impairment (Alzheimer, dementia, neurologic sequel); * Patient under legal protection; * Patient who has not signed informed consent.
References
Publications (0)
Data not yet available