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.
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.
Shabbir Alibhai, MD MSc contact
Canada1 site, 1 recruiting
- Recruiting
University Health Network
Toronto, Ontario, M5G2C4
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 group | Role | What they receive |
|---|---|---|
| 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. 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.
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
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
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)
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
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.
- First posted18 Jun 2024
- Study start18 Mar 2025
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto, Sunnybrook Health Sciences Centre, Unity Health
- Responsible party
- Principal investigator, Martine Puts, University of Toronto
- Investigators
- Martine Puts, PhD RN, Principal investigator, University of Toronto
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Health Assessment for My Plan: Implementation Study (CHAMP Implementation Study)
- ClinicalTrials.gov ID
- NCT06464471
- Acronym / sponsor ID
- CTO#4200
- Conditions
- Cancer, Older Adults
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- University Health Network, Toronto, Sunnybrook Health Sciences Centre, Unity Health
- Study start
- 18 Mar 2025 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 18 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm non-randomized study
| Arm | Type | Receives |
|---|---|---|
| Older adults completing the CHAMP tool before treatment decision is made | Experimental | Other: Self-reported online geriatric assessment (CHAMP)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 may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-reported online geriatric assessment (CHAMP)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. | Other | Older adults completing the CHAMP tool before treatment decision is made |
Primary outcome
Completeness of the CHAMP tool
Time frame: Within one week from medical appointment
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.
Time to fill out the CHAMP tool
Time frame: Within one week from medical appointment
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.
Satisfaction with the CHAMP tool
Time frame: Older adults - within one week of the participants' medical appointment. physicians - within one week of the last study patient.
Measured via open-ended questions and a brief survey.
2 secondary outcomes
Change in proposed treatment plan
Time frame: Within 48 hours of the appointment with an older adults who has completed the CHAMP tool
Changes in supportive care strategies
Time frame: Within 48 hours of the appointment with an older adult who completed the CHAMP tool
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Individual participant dataSharing planned: No. There is no plan to make the data available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shabbir Alibhai, MD MSc contact
Martine Puts, PhD RN principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
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.