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NCT Number: NCT05520866

PrehabPal: A Digital Tool to Help Older Adults 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.

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University, Palo Alto, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

PrehabPal

Behavioral

Web based application

Primary outcomes

  1. Proportion of days before surgery engaged in prehabilitation

    Time frame: Up to 14 days

    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.

Secondary outcomes

  1. Proportion of participants with reported Surgical Complications

    Time frame: 30 days following surgery

    Incidence of reported adverse events 30 days after surgery will be classified according to the Clavien-Dindo complications index.

  2. Median Length of Stay (LOS)

    Time frame: Post procedure until discharge, approximately 2 days

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

  3. Readmission Rate

    Time frame: 30 days following surgery

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

  4. Change in Mean score on the SF-36

    Time frame: Up to 8 weeks

    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

Other outcomes

  1. Median Satisfaction Scores

    Time frame: 8 weeks post-surgery

    Patient-participant reported satisfaction with the PrehabPal web app and the paper-mode activities diary will be measured via a survey created by the investigators in REDCap.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Emerson Collective

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 30, 2022
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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