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

Primary Purpose

Older Adults, Gastro-Intestinal Cancer, Prostate Cancer

Status
Enrolling by invitation
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Intervention group
Control group
Sponsored by
Hospital Universitari Vall d'Hebron Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Older Adults

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Servei Andorrà d'Atenció Sanitària
  • NavarraBiomed
  • Parc Sanitari Pere Virgili - Vall d'Hebron Institut de Recerca

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Intervention group

Arm Description

Treatment as usual. Mainly based on standard physical rehabilitation.

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

Outcomes

Primary Outcome Measures

Short Physical Performance Battery (SPPB)
Change in physical function, measured by the difference on SPPB between follow-ups, hand grip and maximum resistance.

Secondary Outcome Measures

Barthel
Functional status and disability
ECOG
Functional status and disability
EQoL-5D
Quality of life
Edmonton Symptom Assessment System
Intensity of specific symptoms related to cancer
Falls (yes vs. no & number of events)
Potential adverse effects of the intervention
Fractures (yes vs. no & number of events)
Potential adverse effects of the intervention
Pain (0-10 VAS)
Potential adverse effects of the intervention
Cardiovascular events (yes vs. no & number of events)
Collecting ocurrence of angina, myocardial infarction, TIA and/or stroke
Readmissions to the acute hospital
Potential adverse effects
Days spent at home (number of days)
Related to process & resources utilization

Full Information

First Posted
March 31, 2022
Last Updated
April 12, 2022
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Collaborators
Servicio de Geriatría Complejo Hospitalario de Navarra (CHN), Fundación Miguel Servet - Navarrabiomed, Hospital de la Ribera, Alzira, Valencia, Institut Català d'Oncologia ICO Girona, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Servei Andorrà d'Atenció Sanitària (SAAS), Andorra, Gemelli Hospital, Universidad Cattolica del Sacro Cuore, Roma (Italia)
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1. Study Identification

Unique Protocol Identification Number
NCT05319145
Brief Title
PeRsonalizing the Approach to the Oncologic Frail Individual Through Tailored Assessment and Intervention (PROFIT Study)
Acronym
PROFIT
Official Title
PeRsonalizing the Approach to the Oncologic Frail Individual Through Tailored Assessment and Intervention (PROFIT Study)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 1, 2022 (Anticipated)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
January 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Collaborators
Servicio de Geriatría Complejo Hospitalario de Navarra (CHN), Fundación Miguel Servet - Navarrabiomed, Hospital de la Ribera, Alzira, Valencia, Institut Català d'Oncologia ICO Girona, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Servei Andorrà d'Atenció Sanitària (SAAS), Andorra, Gemelli Hospital, Universidad Cattolica del Sacro Cuore, Roma (Italia)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Older Adults, Gastro-Intestinal Cancer, Prostate Cancer, Lung Cancer, Frail Elderly Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
268 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Treatment as usual. Mainly based on standard physical rehabilitation.
Arm Title
Intervention group
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Intervention group
Other Intervention Name(s)
Tailored multidisciplinary intervention based on CGA, focused on a multicomponent physical exercise program with nutritional recommendations.
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Control group
Other Intervention Name(s)
Health psycho-education
Intervention Description
General recommendations (written and videos) will be offered.
Primary Outcome Measure Information:
Title
Short Physical Performance Battery (SPPB)
Description
Change in physical function, measured by the difference on SPPB between follow-ups, hand grip and maximum resistance.
Time Frame
Pre-intervention (baseline) and post-intervention at follow-ups (at 3, 6, and 12 months)
Secondary Outcome Measure Information:
Title
Barthel
Description
Functional status and disability
Time Frame
Pre-intervention (baseline) and post-intervention at follow-ups (at 3, 6, and 12 months)
Title
ECOG
Description
Functional status and disability
Time Frame
Pre-intervention (baseline) and post-intervention at follow-ups (at 3, 6, and 12 months)
Title
EQoL-5D
Description
Quality of life
Time Frame
Pre-intervention (baseline) and post-intervention at follow-ups (at 3, 6, and 12 months)
Title
Edmonton Symptom Assessment System
Description
Intensity of specific symptoms related to cancer
Time Frame
Pre-intervention (baseline) and post-intervention at follow-ups (at 3, 6, and 12 months)
Title
Falls (yes vs. no & number of events)
Description
Potential adverse effects of the intervention
Time Frame
Pre-intervention (baseline) and post-intervention at follow-ups (at 3, 6, and 12 months)
Title
Fractures (yes vs. no & number of events)
Description
Potential adverse effects of the intervention
Time Frame
Pre-intervention (baseline) and post-intervention at follow-ups (at 3, 6, and 12 months)
Title
Pain (0-10 VAS)
Description
Potential adverse effects of the intervention
Time Frame
Pre-intervention (baseline) and post-intervention at follow-ups (at 3, 6, and 12 months)
Title
Cardiovascular events (yes vs. no & number of events)
Description
Collecting ocurrence of angina, myocardial infarction, TIA and/or stroke
Time Frame
Pre-intervention (baseline) and post-intervention at follow-ups (at 3, 6, and 12 months)
Title
Readmissions to the acute hospital
Description
Potential adverse effects
Time Frame
Post-intervention at follow-ups (at 3, 6, and 12 months)
Title
Days spent at home (number of days)
Description
Related to process & resources utilization
Time Frame
Post-intervention at follow-ups (at 3, 6, and 12 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Servei Andorrà d'Atenció Sanitària
City
Andorra
ZIP/Postal Code
AD500
Country
Andorra
Facility Name
NavarraBiomed
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Parc Sanitari Pere Virgili - Vall d'Hebron Institut de Recerca
City
Barcelona
ZIP/Postal Code
08035
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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