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AzTrials

CancerCHAMP-FNCT05499975

Comprehensive Health Assessment for my Cancer Treatment Plan

A study testing Self-reported online geriatric assessment (CHAMP) in people with Cancer and Older Adults, run by University Health Network, Toronto at 3 sites in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 65 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
180 participants
Where
3 sitesCanada
Study dates
24 Jul 2023to 30 Jun 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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

None listed.

Trial locations and contacts

3 sites in 1 country.

Canada3 sites
  • Princess Margaret Cancer Centre

    Toronto, Ontario

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario

  • Unity Health

    Toronto, Ontario

Other trials in Canada

About this study

Official title: Comprehensive Health Assessment for my Cancer Treatment Plan: Field Validation of a Geriatric Assessment Tool for Cancer Patients

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.

Read the detailed description

Introduction:

Age, cancer, and under-treatment. Over 60% of cancer diagnoses and 71% of cancer deaths are in older adults (OAs) age 65+y. OAs are under-screened, under-diagnosed, under-staged, and under- treated for cancer compared to middle-aged individuals. 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. The inability of oncologists to accurately 'stage the ageing' and separate frailty from healthy ageing leads to both over- treatment of many frail and under-treatment of many fit older adults around the world. To help clinicians and patients select appropriate cancer treatment(s) and identify issues that may affect treatment delivery, the American Society of Clinical Oncology and the Int'l Society of Geriatric Oncology (SIOG) recommend GA for OAs when cancer treatment is considered. 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 cancer treatment.GA can change treatment decisions in almost 30% of patients, reducing over- and under-treatment, and allowing for personalization of cancer therapy. GA helps predict who is at high risk of treatment toxicity, enabling treatment modifications and/or additional supportive care, leading to reductions in severe toxicity of 10-20% and prolonged time on treatment. However, GA has not been widely implemented in oncology settings in most countries, in large part due to lack or limited availability of timely geriatric expertise. An attractive, scalable solution is a patient self-completed GA.

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 their 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.

Our objectives are to measure feasibility outcomes and determine whether the CHAMP tool impact treatment decisions and supportive care strategies in older adults with cancer.

Methods:

A total of 210 older adults (65+y) with cancer of any type and stage will be recruited from 4 centres - 3 academic (Princess Margaret Cancer Centre, Odette Cancer Centre, St. Michael's) and 1 community site (St. Joseph's Health Centre). 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, older adults will be asked to complete the tool either prior to clinic (at home via internet) or in clinic (via iPad) prior to their consultation with the oncologist. Following completion of the CHAMP tool and prior to recommending therapy, a member of the research team will provide the CHAMP results to the oncologist. The oncologist will be asked the proposed treatment plan and whether the patient is fit, vulnerable, or frail using standard definitions. Then, the oncologist 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 oncologists on strategies to reduce risk and address geriatric domains. Surveys will be used to assess patients' and oncologists' satisfaction with the tool.

Conditions
Cancer, Older Adults
Being tested
Self-reported online geriatric assessment (CHAMP)
Keywords
geriatric assessment, older adults, cancer, treatment modification, supportive care
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 NCT05499975
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 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
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 their oncologist 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 they 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 their medical appointment. Oncologists - within one week of their 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 their 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 their 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 oncologist. 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 oncologists. The investigators will then review the charts of all older adults who completed CHAMP to abstract data on recommendations made by oncologists, referrals made to geriatrics and other health care providers, and other tests requested based on the recommendations.

    Measured: Within 48 hours of their 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 posted12 Aug 2022
  2. Study start24 Jul 2023
  3. Primary completion30 Apr 2025
  4. Study completion30 Jun 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
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05499975
Sponsor's protocol ID
4011
Acronym
CHAMP-F
Status last verified
Nov 2025
First submitted
2 Aug 2022
Last updated
28 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The data of this study may be provided by the principal investigator upon reasonable request and upon approval of the IRB.

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 Health Network, Toronto at 3 sites 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 0 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: under way, not looking for participants, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. 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 Nov 2025.

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