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Trial Title:
Comprehensive Health Assessment for My Plan: Initial Implementation Study (CHAMP Implementation Study)
NCT ID:
NCT06464471
Condition:
Cancer
Older Adults
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
This is a single-arm non-randomized study
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Self-reported online geriatric assessment (CHAMP)
Description:
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.
Arm group label:
Older adults completing the CHAMP tool before treatment decision is made
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 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
-
Gender:
All
Minimum age:
70 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
January 1, 2025
Completion date:
August 1, 2026
Lead sponsor:
Agency:
University of Toronto
Agency class:
Other
Collaborator:
Agency:
University Health Network, Toronto
Agency class:
Other
Collaborator:
Agency:
Sunnybrook Health Sciences Centre
Agency class:
Other
Collaborator:
Agency:
Unity Health
Agency class:
Other
Source:
University of Toronto
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06464471
