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ReVital-CORE Program

Sponsor
Kessler Foundation (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04852575
Collaborator
Select Medical (Other)
141
Enrollment
1
Location
35.2
Anticipated Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    141 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    ReVital Chemotherapy Online Resiliency Evaluation (ReVital-CORE) Program Pilot Feasibility Study
    Actual Study Start Date :
    Jan 25, 2021
    Anticipated Primary Completion Date :
    Jan 25, 2023
    Anticipated Study Completion Date :
    Jan 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Accrual to the ReVital-CORE program. [02/2022]

      Proportion of patients who consent to enroll, out of the total number invited.

    Secondary Outcome Measures

    1. Prevalence of frailty at major time points. [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.

    2. Impact of therapy on global quality of life. [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.

    3. Impact of therapy on frailty. [02/2023]

      Change from baseline to discharge in frailty as measured by a patient-reported frailty index.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kessler Institute for Rehabilitation West Orange New Jersey United States 07052

    Sponsors and Collaborators

    • Kessler Foundation
    • Select Medical

    Investigators

    • Principal Investigator: Mackenzi Pergolotti, PhD, Select Medical

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mackenzi Pergolotti, Senior Director, Research and Clinical Development, Kessler Foundation
    ClinicalTrials.gov Identifier:
    NCT04852575
    Other Study ID Numbers:
    • E-1132-20
    First Posted:
    Apr 21, 2021
    Last Update Posted:
    Aug 17, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mackenzi Pergolotti, Senior Director, Research and Clinical Development, Kessler Foundation
    Frailty
    Cancer
    Chemotherapy
    Care coordination
    Online
    Prospective surveillance
    Additional relevant MeSH terms:
    Frailty

    Study Results

    No Results Posted as of Aug 17, 2022