NCT05499975

Brief Summary

Geriatric assessment (GA) predicts treatment toxicity and overall mortality in older adults with cancer. To improve treatment decision making in older adults with cancer, the American Society of Clinical Oncology (ASCO) and the International Society of Geriatric Oncology recommend implementation of GA for all older adults with cancer. However, in-person GA may not be feasible in several institutions for various reasons, including lack of geriatricians and/or lack of time or resources. These challenges can be minimized through a self-reported online GA that can be completed by patients prior to their 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) that be used in geriatric oncology to increase accessibility to GA for older adults with cancer. In this study, our aim is to deploy the CHAMP tool to various oncology clinics across 4 institutions and assess feasibility outcomes, as well as the impact of the CHAMP tool on cancer treatment plan and supportive care strategies.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
2mo left

Started Jul 2023

Typical duration for not_applicable cancer

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Jul 2023Jun 2026

First Submitted

Initial submission to the registry

August 2, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 12, 2022

Completed
12 months until next milestone

Study Start

First participant enrolled

July 24, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

November 28, 2025

Status Verified

November 1, 2025

Enrollment Period

1.8 years

First QC Date

August 2, 2022

Last Update Submit

November 25, 2025

Conditions

Keywords

geriatric assessmentolder adultscancertreatment modificationsupportive care

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 their oncologist 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 they 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 their medical appointment. Oncologists - within one week of their last study patient.

Secondary Outcomes (2)

  • Change in proposed treatment plan

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

  • Changes in supportive care strategies

    Within 48 hours of their 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 their medical appointment with the oncologist. Next, participants will see their oncologist for their consultation. Approximately one week after the consultation, participants will be asked to complete 3 questionnaires about their experience and satisfaction with the CHAMP tool

Other: Self-reported online geriatric assessment (CHAMP)

Interventions

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

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients aged 65 years and over referred to surgical oncology, radiation oncology, medical oncology at Princess Margaret Cancer Centre, St. Michael's Hospital, Sunnybrook Health Sciences, or St. Joseph's Health Centre.
  • Able to speak and understand English.
  • Able to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Location

Unity Health

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Shabbir Alibhai, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR
  • Martine Puts, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: This is a single-arm non-randomized study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2022

First Posted

August 12, 2022

Study Start

July 24, 2023

Primary Completion

April 30, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

November 28, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

The data of this study may be provided by the principal investigator upon reasonable request and upon approval of the IRB.

Locations