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

NCT ID: NCT05520866

Last Updated: 2025-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-14

Study Completion Date

2026-04-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Colon Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Participants will be randomized in a 2:1 ratio
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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PrehabPal Web app

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 Type EXPERIMENTAL

PrehabPal

Intervention Type BEHAVIORAL

Web based application

Written Surgery Prehabilitation Instructions

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PrehabPal

Web based application

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Male or female \>=65 years of age at time of evaluation for colorectal cancer resection.
2. Documentation of a colorectal diagnosis as evidenced by the following criteria:

a. Biopsy proven colorectal cancer or unresectable neoplastic polyp.
3. 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.
4. Self-reported access to the Internet.
5. Participant has at least seven days prior to surgery date to optimize for surgery.
6. English language proficient.

Exclusion Criteria

1. No English language proficiency.
2. No Internet access.
3. Documented diagnosis of dementia or Alzheimer's disease.
4. Surgery scheduled within 7-days.
5. 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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Emerson Collective

UNKNOWN

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emily Finlayson, MD, MS, FACS

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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Stanford University

Palo Alto, California, United States

Site Status NOT_YET_RECRUITING

University of California, San Francisco

San Francisco, California, United States

Site Status RECRUITING

MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Yukino Nakamura

Role: CONTACT

877-827-3222

Facility Contacts

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Yukino Nakamura

Role: primary

Role: backup

877-827-3222

Mingxuan Xu

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 31968063 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23052535 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39965940 (View on PubMed)

Other Identifiers

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22-37253

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2023-02952

Identifier Type: REGISTRY

Identifier Source: secondary_id

228013

Identifier Type: -

Identifier Source: org_study_id

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