Clinical trial NCT04852575: ReVital-CORE Program
Official title: ReVital Chemotherapy Online Resiliency Evaluation (ReVital-CORE) Program Pilot Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frailty
Cancer
Chemotherapy-Induced Change
Keywords: Frailty
Cancer
Chemotherapy
Care coordination
Online
Prospective surveillance
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
Collaborators: name: Select Medical
First posted: 2021-04-21
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals diagnosed with cancer who are starting a new chemotherapy regimen (note: can be any line of chemotherapy)

Brief summary: Pilot feasibility study of the ReVital Chemotherapy Online Resiliency Evaluation (CORE) program. As part of standard of care, patients starting a new chemotherapy regimen are referred to complete a pre-chemotherapy cancer rehabilitation evaluation (i.e., prehab) and invited to enroll in the ReVital-CORE program study.

Once enrolled in ReVital-CORE, participants will complete a monthly online evaluation for 1 year. If frailty (or pre-frailty) is detected on any survey, physical or occupational therapy will be initiated for standard of care rehabilitation evaluation and treatment.

Detailed description: All patients starting a new chemotherapy regimen will be referred to completed a prehab evaluation with a specialized physical or occupational therapist be and invited to enroll in the ReVital-CORE program for the pilot, feasibility study.

Participants in the ReVital-CORE program study will be emailed an online evaluation each month via for one year. Once completed, the evaluation is automatically scored into: frail, pre-frail or robust categories using a validated frailty index. Any patient categorized as frail or pre-frail will be re-referred to rehabilitation by their cancer care team. For frail and pre-frail individuals, standard of care rehabilitation therapy will include either/and occupational and physical therapy evaluation and treatment and will be billed via their insurance.

The purpose of this pilot study is to evaluate feasibility of the of the ReVital-CORE Program for individuals starting a new chemotherapy regimen. Secondary aims are to evaluate the prevalence, trajectory and predictors of frailty during the first year of chemotherapy treatment; and evaluate the impacts of prehab/rehabilitation for participants identified as frail and pre-frail.

Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older
* English speaking
* Starting new chemotherapy treatment with oncology partner
* Provide informed consent

Exclusion Criteria:

* Eligible for hospice care

Primary outcomes:
measure: Accrual to the ReVital-CORE program.
timeFrame: 02/2022
Secondary outcomes:
measure: Prevalence of frailty at major time points.
timeFrame: 02/2023
measure: Impact of therapy on global quality of life.
timeFrame: 02/2023
measure: Impact of therapy on frailty.
timeFrame: 02/2023
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Institute for Rehabilitation
state: New Jersey
Study officials:
affiliation: Select Medical
name: Mackenzi Pergolotti, PhD
role: PRINCIPAL_INVESTIGATOR
References: