Clinical trial NCT05377970: Implementation of a Prehabilitation Program for Surgical Patients
Official title: Implementation of a Prehabilitation Pilot Program for Individuals With Frailty Undergoing Oncologic Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prehabilitation
Oncology
Surgical Oncology
Lead sponsor: MaineHealth
Sponsor class: OTHER
Collaborators: name: Tufts Medical Center
First posted: 2022-05-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Participant adherence to prehab program
timeFrame: Through study completion, on average 3 months
measure: Correlation between patient pre-program self-efficacy evaluation and measured adherence to study prehabilitation program
timeFrame: Through study completion, on average 3 months
measure: Patient Satisfaction
timeFrame: Last day of prehabilitation program (within week prior to surgery)
measure: Quality of Life (Short Form- 36 Survey)
timeFrame: Completed at Day 0, Two weeks, Four weeks and Last day of prehabilitation program (within week prior to surgery)
measure: Frailty (Risk Analysis Index)
timeFrame: Evaluated on Day 0 and at last visit prior to surgery, an average of 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
Study officials:
References: