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

Primary Purpose

Colon Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PrehabPal
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colon Cancer focused on measuring Web app, Older Adult, Prehabilitation

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Stanford University
  • University of California, San FranciscoRecruiting
  • MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PrehabPal Web app

Written Surgery Prehabilitation Instructions

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Median Length of Stay (LOS)
The median time from surgery until discharge from hospital will be reported.
Readmission Rate
The proportion of participants who were re-admitted to the hospital within 30 days of surgery will be reported.
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

Full Information

First Posted
August 26, 2022
Last Updated
May 18, 2023
Sponsor
University of California, San Francisco
Collaborators
Emerson Collective
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1. Study Identification

Unique Protocol Identification Number
NCT05520866
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 14, 2023 (Actual)
Primary Completion Date
January 30, 2025 (Anticipated)
Study Completion Date
April 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Emerson Collective

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
Web app, Older Adult, Prehabilitation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Participants will be randomized in a 2:1 ratio
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PrehabPal Web app
Arm Type
Experimental
Arm 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.
Arm Title
Written Surgery Prehabilitation Instructions
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
PrehabPal
Intervention Description
Web based application
Primary Outcome Measure Information:
Title
Proportion of days before surgery engaged in prehabilitation
Description
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.
Time Frame
Up to 14 days
Secondary Outcome Measure Information:
Title
Proportion of participants with reported Surgical Complications
Description
Incidence of reported adverse events 30 days after surgery will be classified according to the Clavien-Dindo complications index.
Time Frame
30 days following surgery
Title
Median Length of Stay (LOS)
Description
The median time from surgery until discharge from hospital will be reported.
Time Frame
Post procedure until discharge, approximately 2 days
Title
Readmission Rate
Description
The proportion of participants who were re-admitted to the hospital within 30 days of surgery will be reported.
Time Frame
30 days following surgery
Title
Change in Mean score on the SF-36
Description
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
Time Frame
Up to 8 weeks
Other Pre-specified Outcome Measures:
Title
Median Satisfaction Scores
Description
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.
Time Frame
8 weeks post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yukino Nakamura
Phone
877-827-3222
Email
Yukino.Nakamura@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Finlayson, MD, MS, FACS
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yukino Nakamura
Email
Yukino.Nakamura@ucsf.edu
Phone
877-827-3222
Email
cancertrials@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Emily Finlayson, MD, MS, FACS
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
73030
Country
United States
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31968063
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. Erratum In: JAMA Surg. 2020 Mar 1;155(3):269.
Results Reference
background
PubMed Identifier
23052535
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.
Results Reference
background

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

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