Implementation of a Prehabilitation Program for Surgical Patients

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

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.

Study Overview

• Status: Recruiting
• Conditions: Oncology; Prehabilitation; Surgical Oncology
• Intervention / Treatment: Other: Thinkific Prehabilitation Exercise Program

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura Nicolais; Phone Number: 207-662-2515; Email: LNicolais@mmc.org

Study Locations

• United States
  • Maine
    • Portland, Maine, United States, 04101
      • Recruiting
      • Maine Medical Center
      • Contact: Timothy Fitzgerald

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prehabilitation Intervention Program; Patients enrolled in this arm will receive the preabilitation intervention program prior to their surgery to complete	Other: Thinkific Prehabilitation Exercise Program; Prehabilitation exercise program through the Thinkific platform

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant adherence to prehab program	Evaluate adherence through analysis of patient maintained exercise logs via number of days completed	Through study completion, on average 3 months
Correlation between patient pre-program self-efficacy evaluation and measured adherence to study prehabilitation program	Assess self-efficacy by evaluating the relationship between pre-program Self-Efficacy for Home Exercise Program Scale (0-72) score and adherence.	Through study completion, on average 3 months
Patient Satisfaction	Assess patient satisfaction and barriers to adherence through a post prehab program survey.	Last day of prehabilitation program (within week prior to surgery)
Quality of Life (Short Form- 36 Survey)	Evaluate change in health-related quality of life before and after participation in the prehabilitation program.	Completed at Day 0, Two weeks, Four weeks and Last day of prehabilitation program (within week prior to surgery)
Frailty (Risk Analysis Index)	Evaluate change in frailty using Risk Analysis Index before and after participation in the prehabilitation program.	Evaluated on Day 0 and at last visit prior to surgery, an average of 3 months

Collaborators and Investigators

• Sponsor: MaineHealth
• Collaborators: Tufts Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2022
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: April 8, 2022
• First Submitted That Met QC Criteria: May 11, 2022
• First Posted (Actual): May 17, 2022

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 22, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 1855206

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No