AzTrials
AzTrials

Colon CancerNCT05520866

PrehabPal: A Digital Tool to Help Older Adults Prepare for Cancer Surgery

A study testing PrehabPal in people with Colon Cancer, run by University of California, San Francisco at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Colon Cancer
What is being tested?
PrehabPal
Could I receive a placebo?
No, everyone receives an active treatment
How many people
132 participants
Where
3 sitesUnited States
Study dates
14 Mar 2023to 31 May 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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:
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • MD Anderson Cancer Center

    Houston, Texas, 73030

  • Stanford University

    Palo Alto, California, 94305

  • University of California, San Francisco

    San Francisco, California, 94143

Other trials in United States

About this study

Official title: PrehabPal: A Digital Tool to Help Frail Elders Prepare for Cancer Surgery

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. Determine the effectiveness of PrehabPal in delivering prehabilitation and improving outcomes for elders who undergo colorectal cancer surgery.

SECONDARY OBJECTIVES:

  1. 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.

Conditions
Colon Cancer
Being tested
PrehabPal
Keywords
Web app, Older Adult, Prehabilitation
Medical subject headings
Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PrehabPalBehavioural

    Web based application

Study groups in NCT05520866
Study groupRoleWhat they receive
PrehabPal Web appExperimentalWeb 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.
Receives: Behavioral: PrehabPal
Written Surgery Prehabilitation InstructionsNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 14 days

Secondary outcomes (4)

  1. 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.

    Measured: 30 days following surgery

  2. Median Length of Stay (LOS)

    The median time from surgery until discharge from hospital will be reported.

    Measured: Post procedure until discharge, approximately 2 days

  3. Readmission Rate

    The proportion of participants who were re-admitted to the hospital within 30 days of surgery will be reported.

    Measured: 30 days following surgery

  4. 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

    Measured: Up to 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2022
  2. Study start14 Mar 2023
  3. Primary completion31 May 2026
  4. Study completion31 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Single group
Model description
Participants will be randomized in a 2:1 ratio
Masking
None (open label)
Enrolment
132 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05520866
Sponsor's protocol ID
228013
Other IDs
22-37253, NCI-2023-02952
Status last verified
Jun 2026
First submitted
26 Aug 2022
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31968063

  • 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.

    PubMed 23052535

  • 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.

    PubMed 39965940

Questions about this trial

What is this clinical trial studying?

A study testing PrehabPal in people with Colon Cancer, run by University of California, San Francisco at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of days before surgery engaged in prehabilitation (time frame: Up to 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05520866, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in