CHAMP Assessment for Aging Adults

Overseen By Shabbir Alibhai, MD MSc

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Toronto

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

210 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Comprehensive Health Assessment for My Plan (CHAMP) for aging adults?

Research shows that comprehensive geriatric assessments, like CHAMP, can identify unrecognized health issues and improve treatment decisions for older adults, especially in cancer care. While some studies found limited long-term benefits for ambulatory patients, in-home assessments have shown promise in uncovering health deficits and providing valuable health recommendations. ^{1 2 3 4 5}

How is the CHAMP treatment different from other treatments for aging adults?

The CHAMP treatment is unique because it is a self-reported, electronic geriatric assessment tool designed to improve accessibility to comprehensive health assessments for older adults, particularly those with cancer. Unlike traditional assessments that require geriatric staff, CHAMP allows older adults to independently provide information on their health, facilitating better-informed treatment decisions. ^{1 6 7 8 9}

Research Team

Martine Puts, PhD RN

Principal Investigator

University of Toronto

Eligibility Criteria

This trial is for patients aged 70 or older who are referred to non-oncological surgery, can speak English, and are able to give informed consent. It's not specified who cannot join the trial.

Inclusion Criteria

I am 70 or older and referred for non-cancer surgery.

Able to provide informed consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Assessment

Participants complete the CHAMP tool either at home or in the clinic before their medical appointment

1 week

1 visit (in-person or virtual)

Consultation and Treatment Planning

Clinicians review CHAMP results and discuss treatment plans with participants

1 week

1 visit (in-person)

Follow-up

Participants complete satisfaction surveys and clinicians assess changes in treatment plans and supportive care strategies

1 week

Treatment Details

Interventions

• Comprehensive Health Assessment for My Plan (CHAMP)

Trial Overview The CHAMP Implementation Study tests a self-reported online geriatric assessment tool designed to improve preoperative care for aging adults facing surgery by identifying their specific health needs beforehand.

Participant Groups

Group I: Older adults completing the CHAMP tool before treatment decision is made Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials

739

Recruited

1,125,000+

Unity Health

Collaborator

Trials

5

Recruited

22,900+

University Health Network, Toronto

Collaborator

Trials

1,555

Recruited

526,000+

Sunnybrook Health Sciences Centre

Collaborator

Trials

693

Recruited

1,569,000+

Findings from Research

The Comprehensive Assessment for My Plan (CHAMP) is a self-reported electronic geriatric assessment tool designed to improve cancer treatment decision-making for older adults (≥65 years), developed with input from 17 older adults and 9 oncology clinicians.

Usability testing showed that both older adults and clinicians found CHAMP user-friendly, covering important health domains such as functional status, cognitive impairment, and nutrition, which may enhance access to geriatric assessments in oncology settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The development of an electronic geriatric assessment tool: Comprehensive health assessment for my plan (CHAMP). Cook, S., Munteanu, C., Papadopoulos, E., et al.[2023]

A systematic review of 9 studies involving older adults (aged ≥65 years) found that eHealth tools for receiving health test results generally improved satisfaction and quality of life, indicating their potential benefit in cancer treatment decision-making.

Challenges such as poorly designed user interfaces and older adults' lack of confidence in using eHealth tools hindered their uptake, highlighting the need for more intuitive designs tailored to this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Providing Medical Information to Older Adults in a Web-Based Environment: Systematic Review. McLean, B., Hossain, N., Donison, V., et al.[2021]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

The development of an electronic geriatric assessment tool: Comprehensive health assessment for my plan (CHAMP). [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Consultative geriatric assessment for ambulatory patients. A randomized trial in a health maintenance organization. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Implementing a geriatric assessment in cooperative group clinical cancer trials: CALGB 360401. [2021]

4. Italy pubmed.ncbi.nlm.nih.gov

A home-based geriatric assessment, follow-up and health promotion program: design, methods, and baseline findings from a 3-year randomized clinical trial. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

An in-home preventive assessment program for independent older adults: a randomized controlled trial. [2019]

6. England pubmed.ncbi.nlm.nih.gov

The perception of the clinical relevance of the MDS-Home Care(C) tool by trainers in general practice in Belgium. [2019]

7. Canada pubmed.ncbi.nlm.nih.gov

Providing Medical Information to Older Adults in a Web-Based Environment: Systematic Review. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Health outcomes and implementation barriers and facilitators of comprehensive geriatric assessment in community settings: a systematic integrative review [PROSPERO registration no.: CRD42021229953]. [2022]

9. Australia pubmed.ncbi.nlm.nih.gov

Is the Australian 75+ Health Assessment person-centred? A qualitative descriptive study of older people's perceptions. [2022]