- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05319145
PeRsonalizing the Approach to the Oncologic Frail Individual Through Tailored Assessment and Intervention (PROFIT Study) (PROFIT)
Study Overview
Status
Intervention / Treatment
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 in mortality compared to younger adults, and a dramatic burden of disability. Many of these patients will be potential candidates for oncospecific treatments, either curative, adjuvants or palliative. Despite this scenario, many trials on cancers still exclude patients based on their age or set survival and treatments' toxicity as the main outcomes, neglecting other meaningful outcomes such as functional status or quality of life. Therefore, clinical decisions regarding this specific population are not always based on real-life data. Moreover, older adults are a highly heterogeneous population, based on clinical, functional, and psychosocial aspects. This is why, in such a population group, the individualization of treatments is pivotal.
Frailty has been proposed as a better marker of biological age than chronological age. This concept indicates a reversible state of risk of increased vulnerability to external or internal stressors, exposing the patients to a higher risk of adverse events, including disability and mortality. However, there is no agreement on the most suitable frailty tools to be used in practice. In older adults with cancer, frailty, which is easily measured in any setting through quick clinical scales, could be an ideal trigger to select candidate patients for a subsequent more extensive comprehensive geriatric assessment (onwards, CGA) and potential interventions. Among these interventions, multi-component approaches including physical exercise and nutritional recommendations have shown a positive impact on both mortality and functional status in patients with different cancers and could be proposed for either pre-habilitation or re-habilitation in older cancer patients with mild-moderate frailty.
Considering these premises, 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 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.
The PROFIT study will add relevant evidence for the management of older cancer patients. The impact, for the individual and the society, is high, in light of the aging of the population: the results will allow providing oncologists and other professionals with tools to improve the personalization of treatments, to finally provide adequate and tailored care programs. This might contribute to avoid the exclusion of patients who could benefit from active treatments and, on the other hand, reducing overtreatment for those who will likely not benefit from it. The clinical trial will also provide information on the most suitable content and on the impact of an intervention aimed at strengthening the functional status and improving the quality of life in older cancer patients with mild-moderate frailty, who might be potential candidates for subsequent onco-specific treatments. The project will also deliver adapted materials and eHealth solutions to be potentially scaled up for this profile of users, as a benefit for the society even beyond this project.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Control group
Treatment as usual.
Mainly based on standard physical rehabilitation.
|
General recommendations (written and videos) will be offered.
Other Names:
|
EXPERIMENTAL: Intervention group
Based on the results of the CGA, a tailored multidisciplinary intervention will be proposed, focused on a multicomponent physical exercise program with nutritional recommendations.
|
1) Multi-component exercise intervention program based on Vivifrail©.
It consists of 1 daily-30 minutes session, twice a week, for 10 consecutive weeks supervised by an experienced exercise specialist.
Exercises (resistance, gait retraining, balance training) are personalized depending on the person's functional capacity (evaluated by the SPPB and a walking speed test) and the risk of falling.
Between sessions, individual, unsupervised training by the own patient, supported in the case by the caregiver, will be stimulated, through the recommendations of ViviFrail©.
2) Nutrition.
Personalized recommendations according to nutritional and medical status (active oncologic treatment, remission, or palliative stage) will be offered according to the ESPEN recommendations for cancer patients, aimed at compensating for inadequate energy intake, improving patients' malnutrition risk stage (assessed by means of the MNA-SF).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Short Physical Performance Battery (SPPB)
Time Frame: Pre-intervention (baseline) and post-intervention at follow-ups (at 3, 6, and 12 months)
|
Change in physical function, measured by the difference on SPPB between follow-ups, hand grip and maximum resistance.
|
Pre-intervention (baseline) and post-intervention at follow-ups (at 3, 6, and 12 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Barthel
Time Frame: Pre-intervention (baseline) and post-intervention at follow-ups (at 3, 6, and 12 months)
|
Functional status and disability
|
Pre-intervention (baseline) and post-intervention at follow-ups (at 3, 6, and 12 months)
|
ECOG
Time Frame: Pre-intervention (baseline) and post-intervention at follow-ups (at 3, 6, and 12 months)
|
Functional status and disability
|
Pre-intervention (baseline) and post-intervention at follow-ups (at 3, 6, and 12 months)
|
EQoL-5D
Time Frame: Pre-intervention (baseline) and post-intervention at follow-ups (at 3, 6, and 12 months)
|
Quality of life
|
Pre-intervention (baseline) and post-intervention at follow-ups (at 3, 6, and 12 months)
|
Edmonton Symptom Assessment System
Time Frame: Pre-intervention (baseline) and post-intervention at follow-ups (at 3, 6, and 12 months)
|
Intensity of specific symptoms related to cancer
|
Pre-intervention (baseline) and post-intervention at follow-ups (at 3, 6, and 12 months)
|
Falls (yes vs. no & number of events)
Time Frame: Pre-intervention (baseline) and post-intervention at follow-ups (at 3, 6, and 12 months)
|
Potential adverse effects of the intervention
|
Pre-intervention (baseline) and post-intervention at follow-ups (at 3, 6, and 12 months)
|
Fractures (yes vs. no & number of events)
Time Frame: Pre-intervention (baseline) and post-intervention at follow-ups (at 3, 6, and 12 months)
|
Potential adverse effects of the intervention
|
Pre-intervention (baseline) and post-intervention at follow-ups (at 3, 6, and 12 months)
|
Pain (0-10 VAS)
Time Frame: Pre-intervention (baseline) and post-intervention at follow-ups (at 3, 6, and 12 months)
|
Potential adverse effects of the intervention
|
Pre-intervention (baseline) and post-intervention at follow-ups (at 3, 6, and 12 months)
|
Cardiovascular events (yes vs. no & number of events)
Time Frame: Pre-intervention (baseline) and post-intervention at follow-ups (at 3, 6, and 12 months)
|
Collecting ocurrence of angina, myocardial infarction, TIA and/or stroke
|
Pre-intervention (baseline) and post-intervention at follow-ups (at 3, 6, and 12 months)
|
Readmissions to the acute hospital
Time Frame: Post-intervention at follow-ups (at 3, 6, and 12 months)
|
Potential adverse effects
|
Post-intervention at follow-ups (at 3, 6, and 12 months)
|
Days spent at home (number of days)
Time Frame: Post-intervention at follow-ups (at 3, 6, and 12 months)
|
Related to process & resources utilization
|
Post-intervention at follow-ups (at 3, 6, and 12 months)
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PROFIT Study
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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