Oncology Clinical Trial
Official title:
Implementation of a Prehabilitation Pilot Program for Individuals With Frailty Undergoing Oncologic Surgery
NCT number | NCT05377970 |
Other study ID # | 1855206 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 25, 2022 |
Est. completion date | July 31, 2024 |
Verified date | October 2023 |
Source | MaineHealth |
Contact | Laura Nicolais |
Phone | 207-662-2515 |
LNicolais[@]mmc.org | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Maine Medical Center | Portland | Maine |
Lead Sponsor | Collaborator |
---|---|
MaineHealth | Tufts Medical Center |
United States,
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 |
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