Implementation of a Prehabilitation Program for Surgical Patients

Oncology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05377970
• Other study ID #: 1855206
• Status: Recruiting
• Phase: N/A
• Start date: June 25, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: October 2023
• Source: MaineHealth
• Contact: Laura Nicolais
• Phone: 207-662-2515
• Email: LNicolais[@]mmc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Oncology
• Prehabilitation
• Surgical Oncology

Intervention

Other:
• Thinkific Prehabilitation Exercise Program
Prehabilitation exercise program through the Thinkific platform

Locations

Country	Name	City	State
United States	Maine Medical Center	Portland	Maine

Sponsors (2)

Lead Sponsor	Collaborator
MaineHealth	Tufts Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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)
Primary	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)
Primary	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