ReVital-CORE Program (ReVital-CORE)

November 16, 2023 updated by: Mackenzi Pergolotti, Kessler Foundation

ReVital Chemotherapy Online Resiliency Evaluation (ReVital-CORE) Program Pilot Feasibility Study

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

141

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • West Orange, New Jersey, United States, 07052
        • Kessler Institute for Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accrual to the ReVital-CORE program.
Time Frame: 02/2022
Proportion of patients who consent to enroll, out of the total number invited.
02/2022

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of frailty at major time points.
Time Frame: 02/2023
Proportion of participants at all major timepoints (pre-chemo, and monthly following start of chemo for 12 months) who are identified as frail or pre-frail by a patient-reported frailty index.
02/2023
Impact of therapy on global quality of life.
Time Frame: 02/2023
Change from baseline to discharge in quality of life as measured by the Patient Reported Outcomes Measuring System (PROMIS)-global 10-item questionnaire.
02/2023
Impact of therapy on frailty.
Time Frame: 02/2023
Change from baseline to discharge in frailty as measured by a patient-reported frailty index.
02/2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kessler Foundation

Collaborators

Select Medical

Investigators

  • Principal Investigator: Mackenzi Pergolotti, PhD, Select Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2021

Primary Completion (Actual)

January 25, 2023

Study Completion (Actual)

January 25, 2023

Study Registration Dates

First Submitted

March 1, 2021

First Submitted That Met QC Criteria

April 17, 2021

First Posted (Actual)

April 21, 2021

Study Record Updates

Last Update Posted (Estimated)

November 20, 2023

Last Update Submitted That Met QC Criteria

November 16, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-1132-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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