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CancerNCT06464471

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

A study testing Self-reported online geriatric assessment (CHAMP) in people with Cancer and Older Adults, run by University of Toronto at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Cancer, Older Adults
What is being tested?
Self-reported online geriatric assessment (CHAMP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
1 siteCanada
Study dates
18 Mar 2025to 1 Aug 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Martine Puts, PhD RN contact

416-978-6059

martine.puts@utoronto.ca

Shabbir Alibhai, MD MSc contact

Canada1 site, 1 recruiting
  • University Health Network

    Toronto, Ontario, M5G2C4

    Recruiting

Other trials in Canada

About this study

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

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.

Read the detailed description

Introduction:

The aging population in Canada is greatly contributing to the growing number of older adults undergoing elective surgery. Approximately 48% of inpatient surgeries in Canada were aged at least 65 years old in 2021. Currently, the standard preoperative assessment does not include evaluations designed to address the needs of older adults. Increasing age is associated with changing physiology along with increasing comorbidity, polypharmacy, functional impairment, and cognitive impairment. Frailty (reduced physiologic reserve) is common but not universal. However, frailty in surgical settings vary between 13% to 84%, depending on the frailty evaluation tool used. Various systematic reviews have also identified an association between frailty and adverse events after surgery, including increased rates of postoperative complications, mortality, and discharge to a location other than home. The British Geriatric Society and the American Society of Colon and Rectal Surgeons thus recommend GA for OAs requiring non-oncological surgery. A GA has 8 key assessment domains (i.e. comorbidity, functional status, medications, falls risk, nutrition, social supports, cognition, mood), each of which is relevant to the "staging of the aging" and development of personalized treatment plans for older adults. In non-oncological surgery settings, GA can help reduce the risk of adverse outcomes of surgery, and optimize the health and functional status of older adults in the preoperative stage. However, GA has not been widely implemented in surgical settings due to the lack of time, training, and access to advanced geriatric services. An innovative, scalable solution is a patient self-completed electronic GA tool.

The investigators designed the CHAMP tool, a self-reported online GA that can be completed by older adults at home or in the clinic prior to the participants' medical appointment. The process for developing CHAMP included the following steps: i) a systematic review and a Delphi Panel of expert clinicians to select the final domains and items/questionnaires; ii) design sessions with older adults with cancer to develop the layout and contact of the tool; iii) usability sessions with older adults with cancer to finalize the tool; and iv) design sessions with oncology clinicians to develop the tool's clinician interface. The CHAMP tool is now ready for field testing.

The study objectives are to measure feasibility outcomes and efficacy of the tool in the identification of geriatric issues and development of care plan strategies.

Methods:

A total of 210 older adults (70+y) who have been referred to any kind of non-oncological surgery will be recruited from 4 centres -University Health Network, Sunnybrook Health Sciences Centre, St. Michael's Hospital and Mount Sinai Hospital. Older adults who agree to participate will be asked to provide information on sociodemographic characteristics and comfort with technology prior to completing the CHAMP tool. Subsequently, participants will be asked to complete the tool either prior to clinic (at home via internet) or in clinic (via iPad) prior to the participants' consultation with the clinician. Following completion of the CHAMP tool and prior to treatment decision making visit with the clinician, a member of the research team will provide the CHAMP results to the clinician. The clinician will be asked the proposed treatment plan and whether the patient is fit, vulnerable, or frail using standard definitions. Then, the clinician will be asked of whether the treatment plan intent is being modified based on the CHAMP tool. The CHAMP tool also contains evidence-based recommendations for clinicians on strategies to reduce risk and address geriatric domains. Surveys will be used to assess participants' and clinicians' satisfaction with the tool.

Conditions
Cancer, Older Adults
Being tested
Self-reported online geriatric assessment (CHAMP)
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT06464471
Study groupRoleWhat they receive
Older adults completing the CHAMP tool before treatment decision is madeExperimentalEligible 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.
Receives: Other: Self-reported online geriatric assessment (CHAMP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Within one week from medical appointment

  2. 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.

    Measured: Within one week from medical appointment

  3. Satisfaction with the CHAMP tool

    Measured via open-ended questions and a brief survey.

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

Secondary outcomes (2)
  1. Change in proposed treatment plan

    The impact of the CHAMP tool on proposed treatment plan will be measured through an adapted questionnaire which the investigators used in previous studies. It measures if treatment was changed at all (yes/no), and if changed, then modified intensity, alternate modality, best supportive care only, or other.

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

  2. Changes in supportive care strategies

    The impact of the the CHAMP tool on supportive care strategies will be measured through a survey that will be completed by the treating clinician. Additionally, the investigators will record the number of geriatric issues identified in the CHAMP summary and the number and type of recommendations provided to older adults and clinicians. The investigators will then review the charts of all older adults who completed CHAMP to abstract data on recommendations made by clinicians, referrals made to geriatrics and other health care providers, and other tests requested based on the recommendations.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2024
  2. Study start18 Mar 2025
  3. Primary completion1 Jan 2026 (estimated)
  4. Study completion1 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
This is a single-arm non-randomized study
Masking
None (open label)
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06464471
Sponsor's protocol ID
CTO#4200
Status last verified
Mar 2025
First submitted
12 Jun 2024
Last updated
28 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan to make the data available to other researchers

Questions about this trial

What is this clinical trial studying?

A study testing Self-reported online geriatric assessment (CHAMP) in people with Cancer and Older Adults, run by University of Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Martine Puts, PhD RN (416-978-6059, martine.puts@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Completeness of the CHAMP tool (time frame: Within one week from medical appointment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.

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