This is a multi-center, randomized trial investigating the use of PrehabPal web app versus a written surgery prehabilitation instructions among individuals aged 65 years and older preparing for colon cancer surgery. PrehabPal is a web app designed with, and for, older adults preparing for surgery at University of California, San Francisco (UCSF). This app has the potential to fill a crucial clinical gap for older cancer patients by designing an individualized prehabilitation program and providing prehabilitation coaching.
PRIMARY OBJECTIVE: I. Determine the effectiveness of PrehabPal in delivering prehabilitation and improving outcomes for elders who undergo colorectal cancer surgery. SECONDARY OBJECTIVES: I. Determine the impact of PrehabPal on surgical outcomes and functional recovery compared to standard written surgery prehabilitation materials. OUTLINE: Participants will be randomly assigned to 1 of 2 conditions. Study participation will continue for up to 12 weeks, with intervention 7-21 days before surgery and a follow-up visit 8 weeks after surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
132
Web based application
Stanford University
Palo Alto, California, United States
University of California, San Francisco
San Francisco, California, United States
MD Anderson Cancer Center
Houston, Texas, United States
Proportion of days before surgery engaged in prehabilitation
The proportion of days before surgery engaged in prehabilitation between subjects randomized to the PrehabPal Web App and written prehabilitation materials using logistic regression. Since sites may not balance, all relevant sociodemographic and clinical characteristics of the subjects may be included in the models which will include other factors that are not balanced between the sites.
Time frame: Up to 14 days
Proportion of participants with reported Surgical Complications
Incidence of reported adverse events 30 days after surgery will be classified according to the Clavien-Dindo complications index.
Time frame: 30 days following surgery
Median Length of Stay (LOS)
The median time from surgery until discharge from hospital will be reported.
Time frame: Post procedure until discharge, approximately 2 days
Readmission Rate
The proportion of participants who were re-admitted to the hospital within 30 days of surgery will be reported.
Time frame: 30 days following surgery
Change in Mean score on the SF-36
Short Form 36 (SF-36) Health Survey: includes 36 items or questions that assess functional health and well-being from the perspective of the patient. The items contribute to eight health domains of physical functioning, role limitations due to physical problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems and mental health. The eight domains all contribute to physical component summary (PCS) and mental component summary (MCS) scores Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability. The calculated composite scores of the Physical Component Scale (PCS) and the Mental Component Scale (MCS) scores of the SF-36 will be measured at baseline and 8 weeks post surgery
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Time frame: Up to 8 weeks