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

Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05520866
• Other study ID #: 228013
• Secondary ID: 22-37253NCI-2023
• Status: Recruiting
• Phase: N/A
• Start date: March 14, 2023
• Est. completion date: April 15, 2026

Study information

• Verified date: April 2024
• Source: University of California, San Francisco
• Contact: Yukino Nakamura
• Phone: 877-827-3222
• Email: Yukino.Nakamura[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: April 15, 2026
• Est. primary completion date: January 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Intervention

Behavioral:
• PrehabPal
Web based application

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas
United States	Stanford University	Palo Alto	California
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Emerson Collective

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Erratum In: JAMA Surg. 2020 Mar 1;155(3):269. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Median Satisfaction Scores	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.	8 weeks post-surgery
Primary	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	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.	30 days following surgery
Secondary	Median Length of Stay (LOS)	The median time from surgery until discharge from hospital will be reported.	Post procedure until discharge, approximately 2 days
Secondary	Readmission Rate	The proportion of participants who were re-admitted to the hospital within 30 days of surgery will be reported.	30 days following surgery
Secondary	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	Up to 8 weeks