PrehabPal Digital Tool for Surgery Preparation in Colorectal Cancer

Recruiting at 2 trial locations

Overseen By Yukino Nakamura

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Dementia, Alzheimer's, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

132 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{1 2 3 6 7}

How 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. ^{1 2 3 7 8}

Research Team

Emily Finlayson, MD, MS, FACS

Principal Investigator

University of California, San Francisco

Eligibility 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

Exclusion Criteria

No Internet access

My surgery is scheduled within the next week.

I have been diagnosed with dementia or Alzheimer's disease.

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

Treatment Details

Interventions

• PrehabPal

Trial Overview 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.

Participant Groups

Group I: PrehabPal Web app Experimental Treatment 1 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 Instructions Active Control 1 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.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Emerson Collective

Collaborator

Trials

3

Recruited

700+

Findings from Research

A personalized multimodal prehabilitation program for 49 patients awaiting colorectal cancer surgery led to significant improvements in functional outcomes, such as increased physical activity and reduced fatigue, over a median duration of 24 days.

Patients who underwent prehabilitation experienced a lower rate of postoperative complications (50%) compared to a control group (67%), indicating that prehabilitation may enhance recovery and reduce risks associated with major surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal prehabilitation service for patients with colorectal cancer: the challenges of implementation. Boyle, H., Fullbrook, A., Wills, A., et al.[2023]

A feasibility study involving 8 frail patients with colorectal cancer showed that a multimodal prehabilitation program, including high-intensity interval training and nutritional support, can be successfully implemented before surgery, with 87% adherence to training sessions.

Despite challenges in measuring compliance with high-intensity training, the study indicates that this approach is manageable for elderly patients, suggesting potential benefits for improving surgical outcomes in high-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fit for Surgery-feasibility of short-course multimodal individualized prehabilitation in high-risk frail colon cancer patients prior to surgery. Bojesen, RD., Jørgensen, LB., Grube, C., et al.[2022]

The Defining Standards in Colorectal Optimisation Study aims to create a consensus on key standards for reporting prehabilitation research in colorectal surgery, addressing the current variation in endpoints reported by different healthcare professionals.

The study will involve a systematic review and a Delphi process to ensure that both healthcare professionals and patients contribute to defining important standards, ultimately enhancing the quality and comparability of future prehabilitation studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining standards in colorectal optimisation: a Delphi study protocol to achieve international consensus on key standards for colorectal surgery prehabilitation. Pearson, I., Blackwell, S., Fish, R., et al.[2021]

A qualitative study involving 15 older patients, 13 informal caregivers, and 9 healthcare providers identified key barriers to preoperative exercise for colorectal cancer surgery, including limited time, misunderstanding of information, and physical ailments.

Facilitators for engaging in preoperative exercise included clear communication from healthcare providers, low-cost programs, and the need for exercise to be tailored to individual preferences and easily accessible, highlighting the importance of personalized approaches in prehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"I am busy surviving" - Views about physical exercise in older adults scheduled for colorectal cancer surgery. Agasi-Idenburg, CS., Zuilen, MK., Westerman, MJ., et al.[2021]

A pilot study involving 22 patients showed that a smartwatch-delivered prehabilitation program significantly increased daily physical activity and improved functional fitness, as measured by the 6-minute walk test, compared to a control group.

The prehabilitation group demonstrated a notable improvement in walking distance (+85.6 m) compared to the control group (+13.23 m), suggesting that technology-assisted prehabilitation can enhance pre-operative fitness in patients undergoing major abdominal cancer surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation with wearables versus standard of care before major abdominal cancer surgery: a randomised controlled pilot study (trial registration: NCT04047524). Waller, E., Sutton, P., Rahman, S., et al.[2022]

A 4-week multimodal prehabilitation program for colorectal cancer patients over 64 years old was found to be feasible, with 91.7% compliance in exercise training and 66.7% compliance in nutritional intervention.

No adverse events were reported during the program, indicating that it is a safe approach to potentially reduce postoperative complications in elderly patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Efficiency of the BEFORE (Better Exercise and Food, Better Recovery) Prehabilitation Program. Tweed, TTT., Sier, MAT., Van Bodegraven, AA., et al.[2021]

A bimodal tele-prehabilitation program for high-risk colorectal cancer patients showed high feasibility, with an 81% participation rate and a 100% retention rate, indicating that patients were able to complete the program without any adverse events.

Participants demonstrated significant improvements in physical fitness, as evidenced by an increase in the number of repetitions on the 30-second chair-stand test, suggesting that tele-prehabilitation may enhance preoperative fitness, although further research is needed to confirm its overall effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a tele-prehabilitation program in high-risk patients with colon or rectal cancer undergoing elective surgery: a feasibility study. Franssen, RFW., Bongers, BC., Vogelaar, FJ., et al.[2022]

Home-based prehabilitation for colorectal cancer patients significantly reduced postoperative complications and hospital stay compared to standard care, with a complication rate of 17.4% in the prehabilitation group versus 33.3% in the standard care group.

Patients who underwent prehabilitation showed a notable improvement in physical condition, as evidenced by a significant increase in the 6-minute walk test distance (+68.9 m) six weeks after surgery, indicating enhanced recovery and functional capacity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based prehabilitation improves physical conditions measured by ergospirometry and 6MWT in colorectal cancer patients: a randomized controlled pilot study. Triguero-Cánovas, D., López-Rodríguez-Arias, F., Gómez-Martínez, M., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Multimodal prehabilitation service for patients with colorectal cancer: the challenges of implementation. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Fit for Surgery-feasibility of short-course multimodal individualized prehabilitation in high-risk frail colon cancer patients prior to surgery. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Defining standards in colorectal optimisation: a Delphi study protocol to achieve international consensus on key standards for colorectal surgery prehabilitation. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

"I am busy surviving" - Views about physical exercise in older adults scheduled for colorectal cancer surgery. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Prehabilitation with wearables versus standard of care before major abdominal cancer surgery: a randomised controlled pilot study (trial registration: NCT04047524). [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility and Efficiency of the BEFORE (Better Exercise and Food, Better Recovery) Prehabilitation Program. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Feasibility of a tele-prehabilitation program in high-risk patients with colon or rectal cancer undergoing elective surgery: a feasibility study. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Home-based prehabilitation improves physical conditions measured by ergospirometry and 6MWT in colorectal cancer patients: a randomized controlled pilot study. [2023]