Comprehensive Health Assessment for my Cancer Treatment Plan (CHAMP-F)
Comprehensive Health Assessment for my Cancer Treatment Plan: Field Validation of a Geriatric Assessment Tool for Cancer Patients
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada
- Sunnybrook Health Sciences Centre
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Toronto, Ontario, Canada
- Princess Margaret Cancer Centre
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Toronto, Ontario, Canada
- Unity Health
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Older adults completing the CHAMP tool before treatment decision is made
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
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Completeness of the CHAMP tool
Time Frame: Within one week from medical appointment
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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.
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Within one week from medical appointment
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Time to fill out the CHAMP tool
Time Frame: Within one week from medical appointment
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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.
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Within one week from medical appointment
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Satisfaction with the CHAMP tool
Time Frame: Older adults - within one week of their medical appointment. Oncologists - within one week of their last study patient.
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Measured via open-ended questions and a brief survey.
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Older adults - within one week of their medical appointment. Oncologists - within one week of their last study patient.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in proposed treatment plan
Time Frame: Within 48 hours of their appointment with an older adults who has completed the CHAMP tool
|
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.
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Within 48 hours of their appointment with an older adults who has completed the CHAMP tool
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Changes in supportive care strategies
Time Frame: Within 48 hours of their appointment with an older adult who completed the CHAMP tool
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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.
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Within 48 hours of their appointment with an older adult who completed the CHAMP tool
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Collaborators and Investigators
Investigators
- Principal Investigator: Martine Puts, PhD, University of Toronto
- Principal Investigator: Shabbir Alibhai, MD, University Health Network, Toronto
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4011 (USANA Health Sciences)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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