Status:
UNKNOWN
PeRsonalizing the Approach to the Oncologic Frail Individual Through Tailored Assessment and Intervention (PROFIT Study)
Lead Sponsor:
Hospital Universitari Vall d'Hebron Research Institute
Collaborating Sponsors:
Servicio de Geriatría Complejo Hospitalario de Navarra (CHN)
Fundación Miguel Servet - Navarrabiomed
Conditions:
Older Adults
Gastro-Intestinal Cancer
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
The PROFIT study has two complementary aims. The first aim is to compare, in a cohort study enrolling N=257 older adults (\>65 years) with lung, gastrointestinal and prostate cancer, different easy me...
Detailed Description
The impact of the aging of population on cancer incidence and consequences is clear: in very few years, more than 50% of older adults will be diagnosed with malignant tumors, with a relevant increase ...
Eligibility Criteria
Inclusion
- 1\) Older adults (≥65 years) 2) Diagnosed with solid tumors (specifically, prostate, lung, colon, rectal, hepatic-biliary, pancreatic, and esophagus-gastric cancers), an extension of T2, T3, T4, involving or not lymph nodes, and either metastatic or not (M0-1), who might or might not underwent onco-specific treatments or await for new treatments 3) Evidence of functional impact (ECOG≥2) but overall maintained functional status (Barthel≥50) 4) Life expectancy ≥3 months 5) Patients with mild-moderate frailty (G8\<14) 5) Willing to provide informed consent to participate.
Exclusion
- 1\) Participants with moderate-severe cognitive impairment (Reisberg's Global Deterioration Scale ≥5).
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2023
Estimated Enrollment :
268 Patients enrolled
Trial Details
Trial ID
NCT05319145
Start Date
May 1 2022
End Date
January 31 2023
Last Update
April 13 2022
Active Locations (3)
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1
Servei Andorrà d'Atenció Sanitària
Andorra la Vella, Andorra, Andorra, AD500
2
NavarraBiomed
Pamplona, Navarre, Spain, 31008
3
Parc Sanitari Pere Virgili - Vall d'Hebron Institut de Recerca
Barcelona, Spain, 08035