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

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

Interventions

BEHAVIORAL

Intervention group

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

Control group

General recommendations (written and videos) will be offered.

Sponsors & Collaborators

• Servicio de Geriatría Complejo Hospitalario de Navarra (CHN)

  collaborator UNKNOWN

• Fundación Miguel Servet - Navarrabiomed

  collaborator UNKNOWN

• Hospital de la Ribera, Alzira, Valencia

  collaborator UNKNOWN

• Institut Català d'Oncologia ICO Girona

  collaborator UNKNOWN

• Vall d'Hebron Institute of Oncology

  collaborator OTHER

• Servei Andorrà d'Atenció Sanitària (SAAS), Andorra

  collaborator UNKNOWN

• Gemelli Hospital, Universidad Cattolica del Sacro Cuore, Roma (Italia)

  collaborator UNKNOWN

• Hospital Universitari Vall d'Hebron Research Institute

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-05-01

Primary Completion

2022-12-01

Completion

2023-01-31

Countries

• Andorra
• Spain

Study Locations