NCT05520866

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 30, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

March 14, 2023

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Completed
Last Updated

June 4, 2026

Status Verified

June 1, 2026

Enrollment Period

3.2 years

First QC Date

August 26, 2022

Last Update Submit

June 2, 2026

Conditions

Colon Cancer

Keywords

Web appOlder AdultPrehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 14 days

Secondary Outcomes (4)

  • Proportion of participants with reported Surgical Complications

    30 days following surgery

  • Median Length of Stay (LOS)

    Post procedure until discharge, approximately 2 days

  • Readmission Rate

    30 days following surgery

  • Change in Mean score on the SF-36

    Up to 8 weeks

Other Outcomes (1)

  • Median Satisfaction Scores

    8 weeks post-surgery

Study Arms (2)

PrehabPal Web app

EXPERIMENTAL

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.

Behavioral: PrehabPal

Written Surgery Prehabilitation Instructions

NO 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.

Interventions

PrehabPalBEHAVIORAL

Web based application

PrehabPal Web app

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Male or female \>=65 years of age at time of evaluation for colorectal cancer resection.
  • Documentation of a colorectal diagnosis as evidenced by the following criteria:
  • a. Biopsy proven colorectal cancer or unresectable neoplastic polyp.
  • Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
  • Self-reported access to the Internet.
  • Participant has at least seven days prior to surgery date to optimize for surgery.
  • English language proficient.

You may not qualify if:

  • No English language proficiency.
  • No Internet access.
  • Documented diagnosis of dementia or Alzheimer's disease.
  • Surgery scheduled within 7-days.
  • Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Stanford University

Palo Alto, California, 94305, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MD Anderson Cancer Center

Houston, Texas, 73030, United States

Location

Related Publications (3)

  • Carli F, Bousquet-Dion G, Awasthi R, Elsherbini N, Liberman S, Boutros M, Stein B, Charlebois P, Ghitulescu G, Morin N, Jagoe T, Scheede-Bergdahl C, Minnella EM, Fiore JF Jr. Effect of Multimodal Prehabilitation vs Postoperative Rehabilitation on 30-Day Postoperative Complications for Frail Patients Undergoing Resection of Colorectal Cancer: A Randomized Clinical Trial. JAMA Surg. 2020 Mar 1;155(3):233-242. doi: 10.1001/jamasurg.2019.5474.

    PMID: 31968063BACKGROUND

  • Li C, Carli F, Lee L, Charlebois P, Stein B, Liberman AS, Kaneva P, Augustin B, Wongyingsinn M, Gamsa A, Kim DJ, Vassiliou MC, Feldman LS. Impact of a trimodal prehabilitation program on functional recovery after colorectal cancer surgery: a pilot study. Surg Endosc. 2013 Apr;27(4):1072-82. doi: 10.1007/s00464-012-2560-5. Epub 2012 Oct 9.

    PMID: 23052535BACKGROUND

  • Ogomori K, Broering J, Rogine C, Kin C, Chang GJ, Finlayson E. Evaluating a digital prehabilitation tool in patients with colorectal surgery: protocol for a multisite randomised controlled trial. BMJ Open. 2025 Feb 18;15(2):e088001. doi: 10.1136/bmjopen-2024-088001.

    PMID: 39965940DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Emily Finlayson, MD, MS, FACS

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Participants will be randomized in a 2:1 ratio
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2022

First Posted

August 30, 2022

Study Start

March 14, 2023

Primary Completion

May 31, 2026

Study Completion

May 31, 2026

Last Updated

June 4, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

US(3)