Comprehensive Health Assessment for My Plan: Initial Implementation Study (CHAMP Implementation Study)

NCT06464471 | Recruiting

• 1 other identifier: CTO#4200
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

The current standard preoperative assessment does not consider the needs of older adults undergoing non-oncological surgery. To enhance the treatment decision-making and planning for older adult surgical patients, the British Geriatric Society and the American Society of Colon and Rectal Surgeons recommend the implementation of preoperative GA for all older adults. Geriatric assessment (GA) predicts treatment toxicity and overall mortality in older adults with complex health problems. However, in-person GA may not be feasible in several clinical settings for various reasons, including lack of training, time, or access to advanced geriatric services. These challenges can be minimized through a self-reported online GA that can be completed by patients prior to the participants' medical appointment. In a previous study, the investigators developed a self-reported online GA, known as the Comprehensive Health Assessment for My Cancer treatment Plan (CHAMP), which was used in geriatric oncology to increase accessibility to GA for older adults with cancer. In this study, the aim is to deploy the CHAMP tool to various clinics across 4 institutions and assess feasibility outcomes, as well as the efficacy of the CHAMP tool in the identification of geriatric issues and the development of supportive care.

Conditions

Cancer; Older Adults

Outcome Measures

Primary Outcomes (3)

• Completeness of the CHAMP tool

  Proportion of older adults who consented to the study who completed the CHAMP tool and had a discussion with the participants' physician about the CHAMP results.

  Within one week from medical appointment

• Time to fill out the CHAMP tool

  In minutes, recorded via user interaction logs which will include data such as user's actions and interactions with the actual interface such as clicks, point-an-select actions, use of back button, etc.), and whether the participant completed it alone or needed help.

  Within one week from medical appointment

• Satisfaction with the CHAMP tool

  Measured via open-ended questions and a brief survey.

  Older adults - within one week of the participants' medical appointment. physicians - within one week of the last study patient.

Secondary Outcomes (2)

• Change in proposed treatment plan

  Within 48 hours of the appointment with an older adults who has completed the CHAMP tool

• Changes in supportive care strategies

  Within 48 hours of the appointment with an older adult who completed the CHAMP tool

Study Arms (1)

Older adults completing the CHAMP tool before treatment decision is made

EXPERIMENTAL

Eligible participants who consent to the study will be asked to complete questionnaires about socio-demographic characteristics, literacy, and technology comfort. Subsequently, participants will be asked to complete the CHAMP tool at home or in the clinic before the participants' medical appointment with the clinician. Next, participants will see the clinician for the consultation. Approximately one week after the consultation, participants will be asked to complete 3 questionnaires about the participants' experience and satisfaction with the CHAMP tool.

Other: Self-reported online geriatric assessment (CHAMP)

Interventions

Self-reported online geriatric assessment (CHAMP) OTHER

The CHAMP tool is a self reported online tool that has been developed to increase patients' accessibility to geriatric assessment and improve treatment decision making. The tool includes questions about function, mobility, cognition, nutrition, social support, depression substance use disorders, and miscellaneous items. Based on usability testing in the previous phase of this study, the tool can be completed in approximately 10-15 minutes. The tool generates a summary report with recommendations for patients and clinicians.

Older adults completing the CHAMP tool before treatment decision is made

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients aged 70 years old and over who have been referred to any kind of non-oncological surgery
• Able to speak English
• Able to provide informed consent

Sponsors & Collaborators

• University of Toronto: lead
• University Health Network, Toronto: collaborator
• Sunnybrook Health Sciences Centre: collaborator
• Unity Health: collaborator

Study Sites (1)

University Health Network

Toronto, Ontario, M5G2C4, Canada

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Martine Puts, PhD RN

  University of Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martine Puts, PhD RN

CONTACT

416-978-6059; martine.puts@utoronto.ca

Shabbir Alibhai, MD MSc

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: This is a single-arm non-randomized study

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 18, 2024
• Study Start: March 18, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)