PrehabPal Digital Tool for Surgery Preparation in Colorectal Cancer
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 65+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, San Francisco
Disqualifiers: Dementia, Alzheimer's, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial is testing the PrehabPal web app to see if it better helps people aged 65 and older prepare for colon cancer surgery. The app offers personalized exercise plans and coaching to improve their readiness and recovery. Prehabilitation has experienced significant growth in the field of colon cancer treatment for elderly patients.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What data supports the effectiveness of the treatment PrehabPal for surgery preparation in colorectal cancer?
Research shows that prehabilitation, which includes exercise, nutrition, and psychological support, can improve recovery after major surgery by reducing hospital stay and complications. Patients who underwent prehabilitation had better physical and mental health outcomes and fewer post-surgery complications compared to those who did not.
12345Is the PrehabPal Digital Tool for Surgery Preparation in Colorectal Cancer safe for humans?
The studies on prehabilitation programs, including those similar to PrehabPal, show that they are generally safe for patients, with no adverse events reported in the research.
12367How is the PrehabPal treatment different from other treatments for colorectal cancer?
PrehabPal is unique because it is a digital tool designed to help patients prepare for colorectal cancer surgery by improving their physical and psychological resilience through a personalized prehabilitation program. Unlike traditional treatments, it combines home-based exercises with tele-monitoring to enhance patient engagement and adherence, potentially reducing postoperative complications and hospital stay.
12378Eligibility Criteria
This trial is for individuals aged 65 or older who are preparing for colorectal cancer surgery and have at least a week before their operation. They must be able to understand English, provide consent, and have internet access. Those with dementia, Alzheimer's disease, surgeries within 7 days, or conditions that risk safety/data quality cannot participate.Inclusion Criteria
Self-reported access to the Internet
I am 65 years or older and being evaluated for colorectal cancer surgery.
English language proficient
+3 more
Exclusion Criteria
No Internet access
My surgery is scheduled within the next week.
I have been diagnosed with dementia or Alzheimer's disease.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Prehabilitation
Participants engage in prehabilitation activities using either the PrehabPal web app or written instructions, focusing on exercise, nutrition, anxiety reduction, home preparation, and advanced care planning.
1-3 weeks
Daily engagement monitored through app or diary
Surgery
Participants undergo colorectal cancer surgery.
1 day
Follow-up
Participants are monitored for surgical outcomes, functional recovery, and adverse events.
8 weeks
1 follow-up visit 8 weeks post-surgery
Participant Groups
The study compares the PrehabPal web app against written instructions for pre-surgery preparation in older adults facing colon cancer surgery. The aim is to see if PrehabPal can better individualize prehabilitation programs and offer coaching support.
2Treatment groups
Experimental Treatment
Active Control
Group I: PrehabPal Web appExperimental Treatment1 Intervention
Web app based initial geriatric assessment will be given followed by daily tailored prehabilitation activities in the domains of exercise, nutrition, anxiety reduction, home preparation, and advanced care planning. Each participant is paired with a central health coach who monitors engagement and provides support through the Web app portal.
Group II: Written Surgery Prehabilitation InstructionsActive Control1 Intervention
Participants will be provided paper-based prehabilitation instructions that include information about exercise, nutrition, anxiety reduction, home preparation, and advanced care planning. A paper diary is provided to record any prehabilitation activities.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
MD Anderson Cancer CenterHouston, TX
University of California, San FranciscoSan Francisco, CA
Stanford UniversityPalo Alto, CA
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Who Is Running the Clinical Trial?
University of California, San FranciscoLead Sponsor
Emerson CollectiveCollaborator
References
Multimodal prehabilitation service for patients with colorectal cancer: the challenges of implementation. [2023]Prehabilitation has been shown to improve outcomes for patients undergoing major surgery; benefits include reductions in length of hospital stay and postoperative complications. Multimodal prehabilitation programmes lead to improved patient engagement and experience. This report describes implementation of a personalised multimodal prehabilitation programme for patients awaiting colorectal cancer surgery. We aim to highlight the successes, challenges and future direction of our programme.Patients listed for colorectal cancer surgery were referred for initial prehabilitation assessment. The prehabilitation group were assessed by specialist physiotherapists, dieticians and psychologists. An individualised programme was developed for each patient, aiming to optimise preoperative functional capacity and enhance physical and psychological resilience. Clinical primary outcome measures were recorded and compared with contemporaneous controls. For those undergoing prehabilitation, a set of secondary functional, nutritional and psychological outcomes were recorded at initial assessment and on completion of the programme.61 patients were enrolled in the programme from December 2021 to October 2022. 12 patients were excluded as they received less than 14 days prehabilitation or had incomplete data. The remaining 49 patients received a median duration of 24 days prehabilitation (range 15-91 days). The results show statistically significant improvements in the following functional outcome measures after prehabilitation: Rockwood scores, maximal inspiratory pressures, International Physical Activity Questionnaire Score and Functional Assessment of Chronic Illness - Fatigue Score. There was a lower postoperative complication rate in the prehabilitation group when compared with a control group (50% vs 67%).This quality improvement project has 3 Plan-Do-Study-Act (PDSA) cycles. PDSA 1 demonstrates prehabilitation can be successfully imbedded within a colorectal surgical unit and that patients are grateful for the service. PDSA 2 provides the project's first complete data set and demonstrates functional improvements in patients undergoing prehabilitation. The third PDSA cycle is ongoing and aims to refine the prehabilitation interventions and improve clinical outcomes for patients undergoing colorectal cancer surgery.
Fit for Surgery-feasibility of short-course multimodal individualized prehabilitation in high-risk frail colon cancer patients prior to surgery. [2022]Prehabilitation is a promising modality for improving patient-related outcomes after major surgery; however, very little research has been done for those who may need it the most: the elderly and the frail. This study aimed to investigate the feasibility of a short course multimodal prehabilitation prior to primary surgery in high-risk, frail patients with colorectal cancer and WHO performance status I and II.
Defining standards in colorectal optimisation: a Delphi study protocol to achieve international consensus on key standards for colorectal surgery prehabilitation. [2021]Prehabilitation in colorectal surgery is evolving and may minimise postoperative morbidity and mortality. With many different healthcare professionals contributing to the prehabilitation literature, there is significant variation in reported primary endpoints that restricts comparison. In addition, there has been limited work on patient-related outcome measures suggesting that patients with colorectal cancer needs and issues are being overlooked. The Defining Standards in Colorectal Optimisation Study aims to achieve international consensus from all stakeholders on key standards to provide a framework for reporting future prehabilitation research.
"I am busy surviving" - Views about physical exercise in older adults scheduled for colorectal cancer surgery. [2021]Seventy percent of patients with colorectal cancer (CRC) are aged 65 years or older. Netherlands Comprehensive Cancer Organization (n.d.) [1] Surgery is an important treatment modality, depending on cancer stage and the resectability of the tumor. Frail older patients are at an increased risk for complications and reduced self-care capacity after surgery. Increasing physical fitness preoperatively (prehabilitation) might improve treatment outcomes, but challenges remain with regard to uptake, attrition, and non-compliance. The objectives of this study were to investigate the barriers, facilitators, and preferences for preoperative exercise programs in older patients scheduled for CRC surgery.
Prehabilitation with wearables versus standard of care before major abdominal cancer surgery: a randomised controlled pilot study (trial registration: NCT04047524). [2022]Prehabilitation aims to improve post-operative outcomes by enhancing pre-operative fitness but is labour-intensive. This pilot study aimed to assess the efficacy of a tri-modal prehabilitation programme delivered by smartwatches for improving functional fitness prior to major abdominal cancer surgery.
Feasibility and Efficiency of the BEFORE (Better Exercise and Food, Better Recovery) Prehabilitation Program. [2021]Prehabilitation has been postulated as an effective preventive intervention to reduce postoperative complications, particularly for elderly patients with a relatively high risk of complications. To date, it remains to be determined whether prehabilitation increases physical capacity and reduces postoperative complications. The aim of this study was to assess the feasibility of a 4-week multimodal prehabilitation program consisting of a personalized, supervised training program and nutritional intervention with daily fresh protein-rich food for colorectal cancer patients aged over 64 years prior to surgery. The primary outcome was the feasibility of this prehabilitation program defined as ≥80% compliance with the exercise training program and nutritional intervention. The secondary outcomes were the organizational feasibility and acceptability of the prehabilitation program. A compliance rate of ≥80% to both the exercise and nutritional intervention was accomplished by 6 patients (66.7%). Attendance of ≥80% at all 12 training sessions was achieved by 7 patients (77.8%); all patients (100%) attended ≥80% of the available training sessions. Overall, compliance with the training was 91.7%. Six patients (66.7%) accomplished compliance of ≥80% with the nutritional program. The median protein intake was 1.2 (g/kg/d). No adverse events occurred. This multimodal prehabilitation program was feasible for the majority of patients.
Feasibility of a tele-prehabilitation program in high-risk patients with colon or rectal cancer undergoing elective surgery: a feasibility study. [2022]Prehabilitation appears to be an effective strategy to reduce postoperative complications and enhance recovery after colorectal surgery. Although many patients prefer (unsupervised) home-based prehabilitation, adherence can be problematic. Combining home-based prehabilitation with tele-monitoring might demonstrate a higher adherence than unsupervised prehabilitation; however, evidence on its feasibility and effectiveness in patients with colorectal cancer scheduled for elective surgery who are at high risk for postoperative complications is lacking. The aim of this study was to assess the feasibility of a bimodal tele-prehabilitation program in patients with colorectal cancer at high risk for postoperative complications.
Home-based prehabilitation improves physical conditions measured by ergospirometry and 6MWT in colorectal cancer patients: a randomized controlled pilot study. [2023]Prehabilitation aims to improve physical condition in the preoperative period and, therefore, decrease the loss of cardiopulmonary capacity postoperatively, with the aim of reducing complications and promoting an early recovery. This study aims to evaluate the impact of home-based prehabilitation on the physical condition of patients treated surgically for colorectal cancer.