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Clinical Trials/NCT05377970
NCT05377970
Recruiting
N/A

Implementation of a Prehabilitation Pilot Program for Individuals With Frailty Undergoing Oncologic Surgery

MaineHealth1 site in 1 country20 target enrollmentJune 25, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Prehabilitation
Sponsor
MaineHealth
Enrollment
20
Locations
1
Primary Endpoint
Patient Satisfaction
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

Frailty is a state of increased vulnerability to stressors with increased rates of poor outcomes. Surgery is one of these stressors, and previous research has therefore shown increased rates of morbidity and mortality in frail patients undergoing surgery. Prehabilitation programs can help mitigate the negative outcomes associated with frailty. The investigators hope to implement a newly developed prehabilitation pilot program in the Maine Medical Center Surgical Oncology Clinic to initially evaluate adherence, self-efficacy, and health-related quality of life.

Detailed Description

Frailty is a state of increased vulnerability to stressors with increased rates of poor outcomes. Surgery is one of these stressors, and previous research has therefore shown increased rates of morbidity and mortality in frail patients undergoing surgery. Prehabilitation programs can help mitigate the negative outcomes associated with frailty. The investigators hope to implement a newly developed prehabilitation pilot program in the Maine Medical Center Surgical Oncology Clinic to initially evaluate adherence, self-efficacy, and health-related quality of life. The investigators now hope to implement this prehabilitation program in the clinics at Maine Medical Center. Our long term goal is the introduce this program in all surgical specialties; but first, the investigators plan to assess adherence, patient self-efficacy, frailty and health-related quality of life through a pilot study in the surgical oncology clinic.

Registry
clinicaltrials.gov
Start Date
June 25, 2022
End Date
July 31, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Laura Nicolais

Timothy Fitzgerald: Associate Medical Director. Oncology

MaineHealth

Eligibility Criteria

Inclusion Criteria

  • Subjects ≥18 years old
  • Evaluated at Maine Medical Center by surgical oncology service
  • Planned surgical intervention for gastrointestinal oncologic condition
  • Score ≥40 on Risk Analysis Index frailty screening
  • Physically able to participate in prehabilitation exercises
  • Home internet access and established email account
  • Able to understand the English language

Exclusion Criteria

  • Patients unable to participate in exercises included in prehabilitation program
  • Patients with impaired decision making capacity
  • Those in a high risk community: prisoners and pregnant women
  • Those who do not meet the above inclusion criteria

Outcomes

Primary Outcomes

Patient Satisfaction

Time Frame: Last day of prehabilitation program (within week prior to surgery)

Assess patient satisfaction and barriers to adherence through a post prehab program survey.

Frailty (Risk Analysis Index)

Time Frame: Evaluated on Day 0 and at last visit prior to surgery, an average of 3 months

Evaluate change in frailty using Risk Analysis Index before and after participation in the prehabilitation program.

Participant adherence to prehab program

Time Frame: Through study completion, on average 3 months

Evaluate adherence through analysis of patient maintained exercise logs via number of days completed

Correlation between patient pre-program self-efficacy evaluation and measured adherence to study prehabilitation program

Time Frame: Through study completion, on average 3 months

Assess self-efficacy by evaluating the relationship between pre-program Self-Efficacy for Home Exercise Program Scale (0-72) score and adherence.

Quality of Life (Short Form- 36 Survey)

Time Frame: Completed at Day 0, Two weeks, Four weeks and Last day of prehabilitation program (within week prior to surgery)

Evaluate change in health-related quality of life before and after participation in the prehabilitation program.

Study Sites (1)

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