Implementing geriatric assessment and management for older Canadians with cancer: Adherence to and satisfaction with the intervention, results of the 5C study.

INTRODUCTION: Geriatric assessment and management (GAM) is recommended by professional organizations and recently several randomized controlled trials (RCTs) demonstrated benefits in multiple health outcomes. GAM typically leads to one or more recommendations for the older adult on how to optimize their health. However, little is known about how well recommendations are adhered to. Understanding these issues is vital to designing GAM trials and clinical programs. Therefore, the aim of this study was to examine the number of GAM recommendations made and adherence to and satisfaction with the intervention in a multicentre RCT of GAM for older adults with cancer. MATERIALS AND METHODS: The 5C study was a two-group parallel RCT conducted in eight hospitals across Canada. Each centre kept a detailed recruitment and retention log. The intervention teams documented adherence to their recommendations. Medical records were also reviewed to assess which recommendations were adhered to. Twenty-three semi-structured interviews were conducted with 12 members of the intervention teams and 11 oncology team members to assess implementation of the study and the intervention. RESULTS: Of the 350 participants who were enrolled, 173 were randomized to the intervention arm. Median number of recommendations was seven. Mean adherence to recommendations based on the GAM was 69%, but it varied by type of recommendation, ranging from 98% for laboratory tests to 28% for psychosocial/psychiatry oncology referrals. There was no difference in the number of recommendations or non-adherence to recommendations by sex, level of frailty, or functional status. Oncologists and intervention team members were satisfied with the study implementation and intervention delivery. DISCUSSION: Adherence to recommendations was variable. Adherence to laboratory investigations and further imaging were generally high but much lower for recommendations regarding psychosocial support. Further collaborative work with older adults with cancer is needed to understand how to optimize the intervention to be consistent with patient goals, priorities, and values to ensure maximal impact on health outcomes.

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

INTRODUCTION: Geriatric assessment (GA) provides information on key health domains of older adults and is recommended to help inform cancer treatment decisions and cancer care. However, GA is not feasible in many health institutions due to lack of geriatric staff and/or resources. To increase accessibility to GA and improve treatment decision making for older adults with cancer (≥65 years), we developed a self-reported, electronic geriatric assessment tool: Comprehensive Assessment for My Plan (CHAMP). MATERIALS AND METHODS: Older adults with cancer were invited to join user-centered design sessions to develop the layout and content of the tool. Subsequently, they participated in usability testing to test the usability of the tool (ease of use, acceptability, etc.). Design sessions were also conducted with oncology clinicians (oncologists and nurses) to develop the tool's clinician interface. GA assessment questions and GA recommendations were guided by a systematic review and Delphi expert panel. RESULTS: A total of seventeen older adults participated in the study. Participants were mainly males (82.4%) and 75% were aged 75 years and older. Nine oncology clinicians participated in design sessions. Older adults and clinicians agreed that the tool was user-friendly. Domains in the final CHAMP tool (with questions and recommendations) included functional status, falls risk, cognitive impairment, nutrition, medication review, social supports, depression, substance use disorder, and miscellaneous items. DISCUSSION: CHAMP was designed for use by older adults and oncologists and may enhance access to GA for older adults with cancer. The next phase of the CHAMP study will involve field validation in oncology clinics.

Impact of Geriatric Assessment and Management on Quality of Life, Unplanned Hospitalizations, Toxicity, and Survival for Older Adults With Cancer: The Randomized 5C Trial.

PURPOSE: American Society of Clinical Oncology recommends that older adults with cancer being considered for chemotherapy receive geriatric assessment (GA) and management (GAM), but few randomized controlled trials have examined its impact on quality of life (QOL). PATIENTS AND METHODS: The 5C study was a two-group parallel 1:1 single-blind multicenter randomized controlled trial of GAM for 6 months versus usual oncologic care. Eligible patients were age 70+ years, diagnosed with a solid tumor, lymphoma, or myeloma, referred for first-/second-line chemotherapy or immunotherapy or targeted therapy, and had an Eastern Cooperative Oncology Group performance status of 0-2. The primary outcome QOL was measured with the global health scale of the European Organisation for the Research and Treatment of Cancer QOL questionnaire and analyzed with a pattern mixture model using an intent-to-treat approach (at 6 and 12 months). Secondary outcomes included functional status, grade 3-5 treatment toxicity; health care use; satisfaction; cancer treatment plan modification; and overall survival. RESULTS: From March 2018 to March 2020, 350 participants were enrolled. Mean age was 76 years and 40.3% were female. Fifty-four percent started treatment with palliative intent. Eighty-one (23.1%) patients died. GAM did not improve QOL (global QOL of 4.4 points [95% CI, 0.9 to 8.0] favoring the control arm). There was also no difference in survival, change in treatment plan, unplanned hospitalization/emergency department visits, and treatment toxicity between groups. CONCLUSION: GAM did not improve QOL. Most intervention group participants received GA on or after treatment initiation per patient request. Considering recent completed trials, GA may have benefit if completed before treatment selection. The COVID-19 pandemic may have affected our QOL outcome and intervention delivery for some participants.

Feasibility and efficacy of a remotely delivered fall prevention exercise program for community-dwelling older adults with cancer: Protocol for the STABLE trial.

Falls are a major issue in older adults with cancer due to the effects of cancer and its treatments. Ample evidence in the general population of older adults has demonstrated the effectiveness of strength and balance training in reducing fall rates in older adults. However, data on effective fall prevention interventions in the oncology setting are lacking. The objective of this study is to evaluate the feasibility and efficacy of a remotely delivered, partially-supervised, resistance and balance training program on lower body strength, balance, and falls in community-dwelling older adults with cancer. The proposed study is an observer-blinded, parallel group (intervention group vs. control group) randomized controlled trial (ClinicalTrials.gov Identifier: NCT04518098). This study will recruit 74 eligible community-dwelling older adults with cancer from a comprehensive cancer centre. Intervention includes a remotely delivered exercise program for 3 months. Outcome measures include feasibility measures, lower body strength, balance, and fall rates. Research ethics approval has been granted by the Biomedical Research Ethics Boards of the University of Saskatchewan. If found effective, findings from this study will inform a subsequent, phase III definitive trial, with the ultimate goal to reduce falls and reduce impact on cancer treatment. Study findings will be disseminated through presentation at community level and scientific conferences, and in scientific journals. Trial registration: ClinicalTrials.gov identifier: NCT04518098.

Feasibility of a Remotely Delivered Strength and Balance Training Program for Older Adults with Cancer.

Falls are a major issue among older adults with cancer and lead to interruptions in cancer treatment. Resistance and balance training can prevent falls in older adults, but minimal evidence is available regarding the older cancer population, who often have unique risk factors. We used a pre-post design to assess the feasibility of a remotely delivered exercise program that progressed in difficulty and its efficacy on lower body strength, balance, and falls in older adults with cancer who had prior in-person exercise experience. Twenty-six older adults with cancer completed the intervention. Attendance rate for the virtual component was 97.6% and for the independent component was 84.7%. Participants perceived the program as rewarding and enjoyable (100%), felt this program prepared them to exercise on their own (92%), were confident to continue exercising on their own (81%), and would recommend the program to other patients (100%). The median balance score at baseline and end-of-study was 4 (IQR = 0). The median chair-stand time decreased from 9.2 s (IQR = 3.13) to 7.7 s (IQR = 4.6). A statistically significant difference in lower body strength (r = 0.68, p = 0.001) was detected post-intervention. The findings from this study can inform the design of a larger randomized trial.

The Canadian Frailty Priority Setting Partnership: Research Priorities for Older Adults Living with Frailty.

BACKGROUND: Patient engagement in research priority-setting is intended to democratize research and increase impact. The objectives of the Canadian Frailty Priority Setting Partnership (PSP) were to engage people with lived or clinical experience of frailty, and produce a list of research priorities related to care, support, and treatment of older adults living with frailty. METHODS: The Canadian Frailty PSP was supported by the Canadian Frailty Network, coordinated by researchers in Toronto, Ontario and followed the methods of the James Lind Alliance, which included establishing a Steering Group, inviting partner organizations, gathering questions related to care, support and treatment of older adults living with frailty, processing the data and prioritizing the questions. RESULTS: In the initial survey, 799 submissions were provided by 389 individuals and groups. The 647 questions that were within scope were categorized, merged, and summarized, then checked against research evidence, creating a list of 41 unanswered questions. Prioritization took place in two stages: first, 146 individuals and groups participated in survey and their responses short-listed 22 questions; and second, an in-person workshop was held on September 26, 2017 in Toronto, Ontario where these 22 questions were discussed and ranked. CONCLUSION: Researchers and research funders can use these results to inform their agendas for research on frailty. Strategies are needed for involving those with lived experience of frailty in research.

Clinical and Cost-effectiveness of a Comprehensive geriatric assessment and management for Canadian elders with Cancer-the 5C study: a study protocol for a randomised controlled phase III trial.

INTRODUCTION: Geriatric assessment and management is recommended for older adults with cancer referred for chemotherapy but no randomised controlled trial has been completed of this intervention in the oncology setting. TRIAL DESIGN: A two-group parallel single blind multi-centre randomised trial with a companion trial-based economic evaluation from both payer and societal perspectives with process evaluation. PARTICIPANTS: A total of 350 participants aged 70+, diagnosed with a solid tumour, lymphoma or myeloma, referred for first/second line chemotherapy, who speak English/French, have an Eastern Collaborative Oncology Group Performance Status 0-2 will be recruited. All participants will be followed for 12 months. INTERVENTION: Geriatric assessment and management for 6 months. The control group will receive usual oncologic care. All participants will receive a monthly healthy ageing booklet for 6 months. OBJECTIVE: To study the clinical and cost-effectiveness of geriatric assessment and management in optimising outcomes compared with usual oncology care. RANDOMISATION: Participants will be allocated to one of the two arms in a 1:1 ratio. The randomisation will be stratified by centre and treatment intent (palliative vs other). OUTCOME: Quality of life. SECONDARY OUTCOMES: (1) Cost-effectiveness, (2) functional status, (3) number of geriatric issues successfully addressed, (4) grades3-5 treatment toxicity, (5) healthcare use, (6) satisfaction, (7) cancer treatment plan modification and (8) overall survival. PLANNED ANALYSIS: For the primary outcome we will use a pattern mixture model using an intent-to-treat approach (at 3, 6 and12 months). We will conduct a cost-utility analysis alongside this clinical trial. For secondary outcomes 2-4, we will use a variety of methods. ETHICS AND DISSEMINATION: Our study has been approved by all required REBs. We will disseminate our findings to stakeholders locally, nationally and internationally and by publishing the findings. TRIAL REGISTRATION NUMBER: NCT03154671.

The Senior Toronto Oncology Panel (STOP) Study: Research Participation for Older Adults With Cancer and Caregivers.

Background: Patient engagement in research may lead to better-designed studies and improved health outcomes. The objectives of this study were to identify the research priorities of older adults with cancer (OAWCs) and their caregivers and examine how to engage these individuals in research teams and what supports are needed. Methods: We conducted 3 public meetings and 7 focus groups to delineate research priorities and the supports needed to facilitate integration of OAWCs and their caregivers on research teams. Results: A total of 33 older adults and 19 caregivers attended a public meeting and 27 older adults and 17 caregivers participated in a focus group. Most of the OAWCs and their caregivers had never participated in research before. Three themes were identified from the focus groups: (1) motivation to be on a team; (2) ability to make meaningful contributions; and (3) logistical considerations to facilitate engagement. Most participants were motivated to be a research team member and be involved in all steps of research if it could benefit them or future patients and caregivers. OAWCs and their caregivers were highly motivated to improve outcomes. Required logistics included flexibility regarding time and location, accessibility to computer technology, transportation support, materials worded in lay language, and attending/having short training sessions, as well as the presence of peer support. Conclusions: OAWCs and their caregivers are very motivated and willing to participate in research and to be research team members. Logistics and the social aspects of being on a team are important.