Comprehensive Health Assessment for Cancer

(CHAMP-F Trial)

Not currently recruiting at 2 trial locations

Overseen By Sara Durbano, MSc

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: None specified

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new online tool called CHAMP, designed to help older adults with cancer complete a geriatric assessment (a health check-up for seniors) from home. The goal is to determine if this tool can assist doctors in making better treatment decisions and improving care for older patients. Individuals aged 65 or older who speak English and are visiting certain hospitals in Canada for cancer treatment might find this trial suitable. Participants will answer questions about their background and use the CHAMP tool before their medical appointment. Afterward, they will provide feedback on their experience with the tool. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance cancer care for seniors.

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 prior data suggests that this self-reported online geriatric assessment (CHAMP) is safe for older adults with cancer?

Research shows that the CHAMP tool is an online questionnaire for older adults with cancer, designed to predict how well they might handle cancer treatments and assess their overall health.

The CHAMP tool poses no safety concerns. It includes questions about health topics such as movement, diet, and social support, and can be completed online, either at home or in the clinic.

As this tool gathers information rather than providing medication or treatments, it poses no direct health risks. It is similar to filling out a survey or answering questions at a doctor's office.

The goal is to enhance cancer care decisions for older adults by collecting vital health information. Based on available research, the CHAMP tool is considered safe to use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CHAMP tool because it offers a personalized, patient-centered approach to cancer treatment planning. Unlike traditional methods that may not fully consider a patient's unique social and technological factors, the CHAMP tool allows older adults to self-report important aspects of their health and personal circumstances before making treatment decisions. This approach aims to enhance communication between patients and their oncologists, potentially leading to more tailored and satisfactory treatment plans. By integrating technology and personal assessment, CHAMP seeks to improve patient experiences and outcomes in cancer care.

What evidence suggests that the CHAMP tool is effective for improving treatment decision making in older adults with cancer?

Research shows that the Comprehensive Health Assessment for My Cancer Treatment Plan (CHAMP) helps improve cancer treatment decisions in older adults. In this trial, participants will complete the CHAMP tool before their medical appointment with the oncologist. Studies have found that online assessments like CHAMP, which patients fill out themselves, can help predict treatment side effects and overall survival in older cancer patients. This tool enables patients to complete a geriatric assessment online before visiting their doctor. Early results suggest that using CHAMP can enhance treatment planning and support for older adults with cancer. Major cancer organizations recommend this approach, as it can provide better care for older patients when in-person assessments aren't possible. ^{1 2 3 6 7}

Who Is on the Research Team?

Shabbir Alibhai, MD

Principal Investigator

University Health Network, Toronto

Martine Puts, PhD

Principal Investigator

University of Toronto

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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 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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05499975

Comprehensive Health Assessment for my Cancer ... Surveys will be used to assess patients' and oncologists' satisfaction with the tool. Official Title. Comprehensive Health Assessment for my Cancer Treatment ...

2. geriatriconcology.net geriatriconcology.net/article/S1879-4068(22)00232-6/abstract

The development of an electronic geriatric assessment tool The development of an electronic geriatric assessment tool: Comprehensive health assessment for my plan (CHAMP). Simon Cook.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1879406822002326

The development of an electronic geriatric assessment tool We developed a self-reported, electronic geriatric assessment tool: Comprehensive Assessment for My Plan (CHAMP).

4. withpower.com withpower.com/trial/phase-malignancies-8-2022-32e44

Comprehensive Health Assessment for Cancer (CHAMP ... The Comprehensive Assessment for My Plan (CHAMP) is a self-reported electronic geriatric assessment tool designed to improve cancer treatment decision-making ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36216760/

The development of an electronic geriatric assessment tool We developed a self-reported, electronic geriatric assessment tool: Comprehensive Assessment for My Plan (CHAMP).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12019282/

Application of comprehensive geriatric assessment in ... Comprehensive geriatric assessment (CGA) is a multidimensional tool designed to evaluate the physical, psychological, social, and functional status of elderly ...

7. careacross.com careacross.com/clinical-trials/trial/NCT05499975

Comprehensive Health Assessment for my Cancer ... The tool includes questions about function, mobility, cognition, nutrition, social support, depression substance use disorders, and miscellaneous items. Based ...