PeRsonalizing the Approach to the Oncologic Frail Individual Through Tailored Assessment and Intervention (PROFIT Study)

NCT05319145 | Unknown

• 1 other identifier: PROFIT Study
• Study Type: interventional
• Target: 268
• Locations: 2 countries
• Sites: 3

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 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

Older Adults; Gastro-Intestinal Cancer; Prostate Cancer; Lung Cancer; Frail Elderly Syndrome

Outcome Measures

Primary Outcomes (1)

• Short Physical Performance Battery (SPPB)

  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 Outcomes (10)

• Barthel

  Pre-intervention (baseline) and post-intervention at follow-ups (at 3, 6, and 12 months)

• ECOG

  Pre-intervention (baseline) and post-intervention at follow-ups (at 3, 6, and 12 months)

• EQoL-5D

  Pre-intervention (baseline) and post-intervention at follow-ups (at 3, 6, and 12 months)

• Edmonton Symptom Assessment System

  Pre-intervention (baseline) and post-intervention at follow-ups (at 3, 6, and 12 months)

• Falls (yes vs. no & number of events)

  Pre-intervention (baseline) and post-intervention at follow-ups (at 3, 6, and 12 months)

Study Arms (2)

Control group

ACTIVE COMPARATOR

Treatment as usual. Mainly based on standard physical rehabilitation.

Other: Control group

Intervention group

EXPERIMENTAL

Based on the results of the CGA, a tailored multidisciplinary intervention will be proposed, focused on a multicomponent physical exercise program with nutritional recommendations.

Behavioral: Intervention group

Interventions

Intervention group BEHAVIORAL

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).

Also known as: Tailored multidisciplinary intervention based on CGA, focused on a multicomponent physical exercise program with nutritional recommendations.

Intervention group

Control group OTHER

General recommendations (written and videos) will be offered.

Also known as: Health psycho-education

Control group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• \) 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.

You may not qualify if:

• \) Participants with moderate-severe cognitive impairment (Reisberg's Global Deterioration Scale ≥5).

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead
• Servicio de Geriatría Complejo Hospitalario de Navarra (CHN): collaborator
• Fundación Miguel Servet - Navarrabiomed: collaborator
• Hospital de la Ribera, Alzira, Valencia: collaborator
• Institut Català d'Oncologia ICO Girona: collaborator
• Vall d'Hebron Institute of Oncology: collaborator
• Servei Andorrà d'Atenció Sanitària (SAAS), Andorra: collaborator
• Gemelli Hospital, Universidad Cattolica del Sacro Cuore, Roma (Italia): collaborator

Study Sites (3)

Servei Andorrà d'Atenció Sanitària

Andorra la Vella, Andorra, AD500, Andorra

Location

NavarraBiomed

Pamplona, Navarre, 31008, Spain

Location

Parc Sanitari Pere Virgili - Vall d'Hebron Institut de Recerca

Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Lung Neoplasms

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: April 8, 2022
• Study Start: May 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: January 31, 2023
• Last Updated: April 13, 2022

Record last verified: 2022-04

Locations

ES (2); AN (1)