Clinical trial NCT05520866: PrehabPal: A Digital Tool to Help Older Adults Prepare for Cancer Surgery
Official title: PrehabPal: A Digital Tool to Help Frail Elders Prepare for Cancer Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colon Cancer
Keywords: Web app
Older Adult
Prehabilitation
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Emerson Collective
First posted: 2022-08-30
Enrollment: 132
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Participants will be randomized in a 2:1 ratio
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of days before surgery engaged in prehabilitation
timeFrame: Up to 14 days
Secondary outcomes:
measure: Proportion of participants with reported Surgical Complications
timeFrame: 30 days following surgery
measure: Median Length of Stay (LOS)
timeFrame: Post procedure until discharge, approximately 2 days
measure: Readmission Rate
timeFrame: 30 days following surgery
measure: Change in Mean score on the SF-36
timeFrame: Up to 8 weeks
Other outcomes:
measure: Median Satisfaction Scores
timeFrame: 8 weeks post-surgery
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: University of California, San Francisco
name: Emily Finlayson, MD, MS, FACS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.