Clinical trial NCT05499975: Comprehensive Health Assessment for my Cancer Treatment Plan
Official title: Comprehensive Health Assessment for my Cancer Treatment Plan: Field Validation of a Geriatric Assessment Tool for Cancer Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer
Older Adults
Keywords: geriatric assessment
older adults
cancer
treatment modification
supportive care
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2022-08-12
Enrollment: 180
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single-arm non-randomized study
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Able to speak and understand English.
3. Able to provide informed consent.

Exclusion Criteria:

Primary outcomes:
measure: Completeness of the CHAMP tool
timeFrame: Within one week from medical appointment
measure: Time to fill out the CHAMP tool
timeFrame: Within one week from medical appointment
measure: Satisfaction with the CHAMP tool
timeFrame: Older adults - within one week of their medical appointment. Oncologists - within one week of their last study patient.
Secondary outcomes:
measure: Change in proposed treatment plan
timeFrame: Within 48 hours of their appointment with an older adults who has completed the CHAMP tool
measure: Changes in supportive care strategies
timeFrame: Within 48 hours of their appointment with an older adult who completed the CHAMP tool
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Unity Health
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Shabbir Alibhai, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto
name: Martine Puts, PhD
role: PRINCIPAL_INVESTIGATOR
References: