Implementation of a Prehabilitation Program for Surgical Patients

NCT05377970 | Unknown

• 1 other identifier: 1855206
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Prehabilitation; Oncology; Surgical Oncology

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

Prehabilitation Intervention Program

EXPERIMENTAL

Patients enrolled in this arm will receive the preabilitation intervention program prior to their surgery to complete

Other: Thinkific Prehabilitation Exercise Program

Interventions

Thinkific Prehabilitation Exercise Program OTHER

Prehabilitation exercise program through the Thinkific platform

Prehabilitation Intervention Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MaineHealth: lead
• Tufts Medical Center: collaborator

Study Sites (1)

Maine Medical Center

Portland, Maine, 04101, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Laura Nicolais

CONTACT

207-662-2515; LNicolais@mmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Timothy Fitzgerald: Associate Medical Director. Oncology

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: May 17, 2022
• Study Start: June 25, 2022
• Primary Completion: June 30, 2024
• Study Completion: July 31, 2024
• Last Updated: October 24, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)