ReVital-CORE Program

Cancer Clinical Trial

— ReVital-CORE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04852575
• Other study ID #: E-1132-20
• Status: Completed
• Start date: January 25, 2021
• Est. completion date: January 25, 2023

Study information

• Verified date: November 2023
• Source: Kessler Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: January 25, 2023
• Est. primary completion date: January 25, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Chemotherapy-Induced Change
• Frailty

Locations

Country	Name	City	State
United States	Kessler Institute for Rehabilitation	West Orange	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Kessler Foundation	Select Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accrual to the ReVital-CORE program.	Proportion of patients who consent to enroll, out of the total number invited.	02/2022
Secondary	Prevalence of frailty at major time points.	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
Secondary	Impact of therapy on global quality of life.	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
Secondary	Impact of therapy on frailty.	Change from baseline to discharge in frailty as measured by a patient-reported frailty index.	02/2023