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

University of California San Francisco (UCSF)

Status: Enrolling

Conditions: Colon Cancer

Treatments: Behavioral: PrehabPal

Study type: Interventional

Funder types: Other

Identifiers

NCT05520866

228013

22-37253

NCI-2023-02952 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 132 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

132 participants in 2 patient groups

PrehabPal Web app

Experimental group

Description:

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.

Treatment:

Behavioral: PrehabPal

Written Surgery Prehabilitation Instructions

No Intervention group

Description:

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.