Phase 2 randomized controlled study using a waitlist control group. The study also has a single arm pre-post test 12-week chair-based exercise arm for those who have received the geriatric assessment in the older adults with cancer clinic (geriatric oncology clinic). Study Duration 2.5 years Study Agent/ Intervention/ Procedure Comprehensive Geriatric Assessment and Management (GAM) combined with online chair-based exercise (CBE) and health education for 12 weeks.
The purpose of this randomized clinical trial is to compare the standard of care alone to using a detailed health assessment for older adults followed by a 12 week program of online physical activity and health education (also called the intervention) plus the standard of care. The addition of the detailed health assessment for older adults followed by a 12 week program of online physical activity and health education to the standard of care could benefit older adults with cancer in terms of improving their physical activity, muscle strength, quality of life, and fatigue. The intervention group will receive a detailed health assessment for older adults followed by a 12- week program of physical activity and health education. During the assessment they will be asked to provide information on current health, mood, weight loss, vision and hearing, memory, fatigue, pain, and a review of medications. Additionally, they will be asked to undergo a few tests that assess walking, grip strength, and balance and complete questionnaires that evaluate quality of life, fatigue, anxiety, depression, and physical function. Two weekly sessions of group-based exercise (20-40) minutes are conducted via Zoom by a qualified exercise professional. These sessions include aerobic exercise for 20 minutes; resistance training, for 10 minutes; balance training 8 minutes, and flexibility training for 7 minutes. They will receive a weekly check-in to discuss the exercises and progress with the QEP who will adjust the exercises based on tolerance. During the first session of each of the 12- weeks, a video about a health topic by an expert will be shown on Zoom so that they can think about it after the class and prepare questions for the discussion with the expert. Their support person are invited to participate in this study. We assume that involving support persons in this study, including exercising together, can improve the health and quality of life of the patient and and their support person. If they or their support person do not have a tablet/laptop to join the class, this will be provided along with training on how to use them. The control group will receive usual care and the option to receive the intervention after 12 weeks. May 2024. We have added a single pre-post test group for patients who receive the geriatric assessment already in the older adults with cancer clinic. These participants will receive the 12 week virtual intervention and will not be randomized. They will be in the study for 12 weeks (no waitlist control period).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
60
geriatric assessment, exercise and health education
online chair-based exercise and health education for 12 weeks
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
RECRUITINGSunybrook Health Sciences Centre, Odette Cancer Centre
Toronto, Ontario, Canada
RECRUITINGFeasability of the study
What is the feasibility of implementation of the study? Feasibility will be measured by recruitment rate which will be the proportion of eligible patients and support persons who agree to enroll in the study, collected from our recruitment log) and measured in percentage with range 0-100. Feasibility of retention will be measured proportion of participants who complete the study data collection, collected from our study log), range 0-100. Feasibility of data outcome collection will be the percentage of patients who have complete data collection (collected from our study log), range 0-100. Feasibility of the study will be defined as recruitment of \>60% of all eligible older adults; retention of \>80% of the dyads; and 3) capture of outcome data of 80% or more.
Time frame: 12 weeks
Acceptability of the intervention and the study
What is the acceptability of the intervention and study? Acceptability will be measured by 1) adherence to the intervention and 2) satisfaction. Adherence to the intervention= 1) adherence to the geriatric assessment recommendations (collected through chart review) and expressed as percentage of recommendations received and implemented by the patient, range 0-100. 2) Adherence to online classes will be measured through the number of sessions missed as documented in the intervention log. A 5-item Likert scale satisfaction with the study scale ranging from very satisfied to very unsatisfied and satisfied and very Satisfied= satisified. Acceptability will be defined as 1) adherence to the intervention of \>85% of participants adhering to at least 80% of the classes and recommendations; 2) satisfaction by 80% of participants.
Time frame: 12 weeks
Effect intervention on Physical function
What are the preliminary estimate of the intervention on physical function? This will be measured with the Short Physical Performance Battery (SPPB). The Short Physical Performance Battery is a test battery comprising of a four-meter gait speed test, a balance test, and 5 timed chair stand tests. The total score ranges between 0-12, and a change of one point is considered the minimal clinically important difference (MCID).
Time frame: 12 weeks
Effect intervention on Grip strength
What are the preliminary estimates of the intervention on grip strength? Grip strength in kilos will be measured with a handheld dynamometer three times in the dominant hand (range 0-80 kg). The maximum score will be used, and the minimal clinically important difference (MCID) is 5 kg.
Time frame: 12 weeks
Effect intervention on Life space Mobility
What are the preliminary estimates of the intervention on Life Space Mobility? Life Space Mobility (LSM) will be measured with the University of Alabama Birmingham Study of Aging Life Space Assessment. The Life Space Mobility total score ranges from 0 (bed-bound) to 120 (daily independent out-of-town mobility). The minimal clinically important difference (MCID)is five points.
Time frame: 12 weeks
Effect intervention on Physical Activity
What are the preliminary estimates of the intervention on Physical Activity? Physical activity will be measured with the Godin Leisure time Exercise questionnaire. It asks how many times in the past seven days the participant has done vigorous, moderate, and light exercise for at least 15 min each time, and how much time the participant spent on the exercise, to calculate the total score. A score of 24+ indicates Active, 14 - 23 indicates Moderately Active, and \<14 indicates inactive/sedentary
Time frame: 12 weeks
Effect intervention on number of self-reported Falls
What are the preliminary estimates of the intervention on the number of self-reported falls? Self-reported falls will be assessed weekly by a phone call by the RA as well as circumstances of the fall and will be scored as the total number of falls (ranging from 0- 200).
Time frame: 12 weeks
Effect of the intervention on Fatigue
What are the preliminary estimates of the intervention on fatigue? This will be measured with the Pittsburgh Fatigability questionnaire (PFS). The Pittsburgh Fatigability questionnaire measures both physical and mental fatigability. Participants rate their tiredness/exhaustion from 0 ("no fatigue") to 5 ("extreme fatigue") for how they expected or imagined they would feel after completing activities ranging in type and intensity (10 items). Continuous scores for each dimension can range from 0 to 50, with higher scores indicating higher fatigability and scores \>25 will be used to indicate severe fatigability.
Time frame: 12 weeks
Effect of the intervention on Quality of life
What are the preliminary estimates of intervention on quality of life? This will be measured with the 12-item Short Form Survey (SF-12) . The 12 items are summarized in a physical subscale ranging from 0-100 and a mental health subscale ranging from 0-100.
Time frame: 12 weeks
Effect of the intervention on treatment toxicity
What are the effect of the intervention on Treatment toxicity ? This will be abstracted from the medical charts and treatment toxicity will be graded using the Common Terminology Criteria for Adverse Events version 5.0. Each toxicity is graded from 0-5. The number of toxicities grade 3-5 will be summed.
Time frame: 12 weeks
Effect of the intervention on unplanned healthcare utilization
What are the effect of the intervention on unplanned Emergency Department (ED) visits and/or hospitalization? This will be abstracted from the medical charts and summarized as the number of unplanned emergency department visits and number of unplanned hospitalizations. Both could range from 0-100.
Time frame: 12 weeks
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