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Completed

NCT Number: NCT04852575

ReVital-CORE Program

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.

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Key information

Conditions

Frailty Cancer Chemotherapy-Induced Change Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kessler Institute for Rehabilitation

West Orange, New Jersey, 07052, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Accrual to the ReVital-CORE program.

    Time frame: 02/2022

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

Secondary outcomes

  1. 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.

  2. 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.

  3. Impact of therapy on frailty.

    Time frame: 02/2023

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

Sponsors and collaborators

Lead sponsor

Kessler Foundation

Other

Collaborators

  • Select Medical

Registry information

Official study title

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

Acronym: ReVital-CORE

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 21, 2021
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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