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Trial Title:
PrehabPal: A Digital Tool to Help Older Adults Prepare for Cancer Surgery
NCT ID:
NCT05520866
Condition:
Colon Cancer
Conditions: Official terms:
Colonic Neoplasms
Conditions: Keywords:
Web app
Older Adult
Prehabilitation
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Single Group Assignment
Intervention model description:
Participants will be randomized in a 2:1 ratio
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
PrehabPal
Description:
Web based application
Arm group label:
PrehabPal Web app
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.
Criteria for 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.
Gender:
All
Minimum age:
65 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Stanford University
Address:
City:
Palo Alto
Zip:
94305
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
University of California, San Francisco
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yukino Nakamura
Email:
Yukino.Nakamura@ucsf.edu
Contact backup:
Phone:
877-827-3222
Email:
cancertrials@ucsf.edu
Investigator:
Last name:
Emily Finlayson, MD, MS, FACS
Email:
Principal Investigator
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
73030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mingxuan Xu
Email:
mxu2@mdanderson.org
Investigator:
Last name:
George Chang, MD, MS, MHCM
Email:
Principal Investigator
Start date:
March 14, 2023
Completion date:
April 15, 2026
Lead sponsor:
Agency:
University of California, San Francisco
Agency class:
Other
Collaborator:
Agency:
Emerson Collective
Agency class:
Other
Source:
University of California, San Francisco
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05520866
