Comprehensive Health Assessment for Cancer

(CHAMP-F Trial)

Recruiting at 2 trial locations

Overseen By Sara Durbano, MSc

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

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

Compensation: Varies

Number of Visits: 3

180 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Self-reported online geriatric assessment (CHAMP) for cancer?

The CHAMP tool is designed to make geriatric assessments more accessible for older adults with cancer, helping to tailor treatment decisions based on individual health needs. Research suggests that geriatric assessments can uncover hidden health issues and improve treatment planning, which may lead to better health outcomes for older adults with cancer. ^{1 2 3 4 5}

Is the Comprehensive Health Assessment for Cancer safe for humans?

The Comprehensive Health Assessment for Cancer, also known as CHAMP, is a tool used to help make treatment decisions for older adults with cancer. It is generally considered safe as it involves self-reported assessments to guide care, rather than direct medical interventions. ^{1 6 7 8 9}

How is the CHAMP treatment different from other cancer treatments?

The CHAMP treatment is unique because it is a self-reported, electronic geriatric assessment tool designed to help older adults with cancer make informed treatment decisions. Unlike traditional geriatric assessments that require specialized staff and resources, CHAMP increases accessibility by allowing patients to complete the assessment online, making it more feasible for widespread use. ^{1 2 3 5 10}

Research Team

Shabbir Alibhai, MD

Principal Investigator

University Health Network, Toronto

Martine Puts, PhD

Principal Investigator

University of Toronto

Eligibility Criteria

This trial is for adults aged 65 and over with cancer, who are referred to oncology departments at specific hospitals. Participants must speak English and be able to give informed consent. It's not specified who can't join.

Inclusion Criteria

Able to provide informed consent

Able to speak and understand English

I am 65 or older and referred to a cancer specialist at a specified hospital.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Consultation Assessment

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

1 week

1 visit (in-person or virtual)

Consultation and Treatment Planning

Oncologists review CHAMP results and determine treatment plans, potentially modifying them based on the tool's recommendations

1 week

1 visit (in-person)

Follow-up

Participants are monitored for changes in supportive care strategies and treatment plans, and satisfaction with the CHAMP tool is assessed

1 week

1 visit (in-person or virtual)

Treatment Details

Interventions

• Self-reported online geriatric assessment (CHAMP)

Trial Overview The CHAMP tool, an online self-reported geriatric assessment designed to help older adults with cancer, is being tested in this study. Its impact on treatment plans and supportive care strategies will be evaluated across four institutions.

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 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

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

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 new self-administered geriatric assessment measure for older cancer patients was developed and successfully completed by 78% of participants without assistance, indicating its feasibility for use in clinical settings.

The assessment took an average of 27 minutes to complete, and 90% of patients reported satisfaction with its length, suggesting it is both efficient and well-received by older patients undergoing chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a cancer-specific geriatric assessment: a feasibility study. Hurria, A., Gupta, S., Zauderer, M., et al.[2010]

A systematic review identified 63 cancer clinical trials using geriatric assessment (GA) from a total of 320 studies, highlighting its potential to improve understanding of cancer treatment outcomes in older adults.

The most common use of GA was to explore how impairments in physical status and comorbidities affect clinical outcomes, indicating that consistent GA implementation could enhance the representation and treatment of older adults in cancer research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of geriatric assessment in cancer clinical trials: A systematic review. Lee, W., Cheng, SJ., Grant, SJ., et al.[2023]

In a randomized phase II trial involving 61 patients aged 70 and older with advanced cancer, Geriatric Assessment (GA) did not show significant differences in health status or healthcare utilization compared to standard care.

Oncologists expressed satisfaction with GA but desired clearer recommendations and quicker access to GA results, indicating a need for improved integration of GA in treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health status, emergency department visits, and oncologists' feedback: An analysis of secondary endpoints from a randomized phase II geriatric assessment trial. Sattar, S., Alibhai, SMH., Brennenstuhl, S., et al.[2020]

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]

A frailty index developed from patient-reported geriatric assessments can effectively identify older adults with cancer who are at higher risk for worse overall survival, functional decline, and severe treatment-related toxicities, based on a study of 589 patients with a median age of 69.

Specifically, frail patients had a 1.83 times higher risk of mortality and were three times more likely to experience significant functional decline and severe non-hematologic toxicities compared to robust patients, highlighting the importance of assessing frailty in cancer treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported geriatric assessment-based frailty index among older adults with gastrointestinal malignancies. Giri, S., Al-Obaidi, M., Harmon, C., et al.[2023]

A predictive model for chemotherapy toxicity in older adults was validated in a study of 250 patients aged 65 and older, showing that 58% experienced significant toxicity (grade ≥ 3).

The model effectively stratified risk levels, with higher risk scores correlating with increased toxicity rates (36.7% low, 62.4% medium, 70.2% high risk), suggesting it can help guide treatment decisions for older cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of a Prediction Tool for Chemotherapy Toxicity in Older Adults With Cancer. Hurria, A., Mohile, S., Gajra, A., et al.[2022]

A geriatric assessment (GA) intervention significantly reduced the incidence of moderate to severe symptomatic toxicity in older patients (age ≥ 70) with advanced cancer, as shown in a study of 706 patients.

Patients receiving the GA intervention reported fewer grade ≥ 2 symptoms compared to those receiving usual care (88.9% vs 94.8%), indicating that tailored management recommendations can improve patient experiences during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Geriatric Assessment Intervention on Patient-Reported Symptomatic Toxicity in Older Adults With Advanced Cancer. Culakova, E., Mohile, SG., Peppone, L., et al.[2023]

In a study of 301 patients aged 70 and older with solid cancers, over half (53.8%) experienced severe adverse events (AEs ≥ Grade 3) during their first chemotherapy cycle, highlighting the high risk of toxicity in older patients.

A predictive model was developed using six key factors, such as serum protein levels and psychological stress, which can classify patients into risk groups for severe AEs, helping to better manage and anticipate treatment-related complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting cumulative incidence of adverse events in older patients with cancer undergoing first-line palliative chemotherapy: Korean Cancer Study Group (KCSG) multicentre prospective study. Kim, JW., Lee, YG., Hwang, IG., et al.[2019]

Comprehensive geriatric assessments (CGA) are recommended for older adults considering cancer therapy, as they provide a more thorough evaluation of a patient's ability to tolerate treatment compared to standard assessments.

Incorporating CGA can help predict chemotherapy tolerability, treatment completion, and survival outcomes, addressing the limitations of age and performance status alone in assessing older cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of the Comprehensive Geriatric Assessment in the Evaluation of the Older Cancer Patient. Blanquicett, C., Cohen, JB., Flowers, C., et al.[2020]

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

Developing a cancer-specific geriatric assessment: a feasibility study. [2010]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Use of geriatric assessment in cancer clinical trials: A systematic review. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Health status, emergency department visits, and oncologists' feedback: An analysis of secondary endpoints from a randomized phase II geriatric assessment trial. [2020]

5. Canada pubmed.ncbi.nlm.nih.gov

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

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

Patient-reported geriatric assessment-based frailty index among older adults with gastrointestinal malignancies. [2023]

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

Validation of a Prediction Tool for Chemotherapy Toxicity in Older Adults With Cancer. [2022]

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

Effects of a Geriatric Assessment Intervention on Patient-Reported Symptomatic Toxicity in Older Adults With Advanced Cancer. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Predicting cumulative incidence of adverse events in older patients with cancer undergoing first-line palliative chemotherapy: Korean Cancer Study Group (KCSG) multicentre prospective study. [2019]

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

The Role of the Comprehensive Geriatric Assessment in the Evaluation of the Older Cancer Patient. [2020]