Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05499975 |
| Other study ID # |
4011 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 24, 2023 |
| Est. completion date |
February 1, 2025 |
Study information
| Verified date |
December 2023 |
| Source |
University Health Network, Toronto |
| Contact |
Shabbir Alibhai, MD |
| Phone |
+416-340-5125 |
| Email |
shabbir.alibhai[@]uhn.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
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.
