Clinical trial · Interventional
PeRsonalizing the Approach to the Oncologic Frail Individual Through Tailored Assessment and Intervention (PROFIT 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 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 measures of frailty (Geriatric 8 questionnaire (G8), Short physical Performance Battery (SPPB) and the IF-VIG), testing their ability to predict survival, functional status (ECOG, Barthel Index), quality of life (EuroQol5D) and resources utilization (visits, hospital admissions, treatments) at 3, 6 and 12 months. The second aim, which motivates the registration in ClinicalTrials.gov, is to conduct a randomized controlled trial (RCT) enrolling N=134 patients per group, with similar characteristics to those enrolled for aim 1, but with mild-moderate frailty (G8≤14 points); we will compare a multi-component CGA-based intervention including physical exercise and nutritional recommendations with usual care, measuring the impact on the same outcomes as for aim 1, at 3 and 6 months. The use of ad hoc eHealth solutions (App/platform for exercise) will foster patients' empowerment and sustainability of the intervention. We will also assess patients, caregivers, and professionals' experience with the intervention through focus groups. Participants will be recruited from outpatients and from post-acute care units.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Frail Elderly Syndrome | — | UNRESOLVED | — |
| Gastro-Intestinal Cancer | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Older Adults | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control group | Other | — | UNRESOLVED |
| Intervention group | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- Treatment as usual. Mainly based on standard physical rehabilitation.
- interventionNames
- Other: Control group
- type
- EXPERIMENTAL
- label
- Intervention group
- description
- Based on the results of the CGA, a tailored multidisciplinary intervention will be proposed, focused on a multicomponent physical exercise program with nutritional recommendations.
- interventionNames
- Behavioral: Intervention group
Primary outcomes (1)
- measure
- Short Physical Performance Battery (SPPB)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 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 Criteria: 1\) Participants with moderate-severe cognitive impairment (Reisberg's Global Deterioration Scale ≥5).
References
Publications (0)
Data not yet available