The SOAR Study: a Study of Geriatric Assessment and Exercise for Older Adults and Their Support Person
NCT ID: NCT05509751
Last Updated: 2024-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2023-10-01
2025-12-31
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Intervention group
geriatric assessment (GAM) and remote exercise and education prior to and during curative/adjuvant or first/second line palliative chemotherapy /immunotherapy or targeted therapy
GAM, exercise, health education
geriatric assessment, exercise and health education
Waitlist control group
Wait list, receiving standard of care and option to receive intervention after treatment.
No interventions assigned to this group
single arm pre-post test study for participants recruited from geriatric oncology clinic
They will receive the 12 week virtual chair-based exercise and health education intervention except no geriatric assessment
online chair-based exercise combined with health education
online chair-based exercise and health education for 12 weeks
Interventions
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GAM, exercise, health education
geriatric assessment, exercise and health education
online chair-based exercise combined with health education
online chair-based exercise and health education for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with lung, gastrointestinal (GI) , breast, Gynecologic or Genitourinary (GU) cancer or lymphoma who are referred for chemotherapy or immunotherapy and have not received \> 4 weeks of systemic treatment.
4\) Have a physician estimated life expectancy of \>6 months. 5) Be physically inactive (no more than 90 min moderate to vigorous activity per week as per GLTEQ and do not currently meet the recommended physical activity volume of 90 min of aerobic exercise/week).
6\) Able to speak and understand English. 7) Able to give informed consent. 8) Are considered safe to participate in the weekly classes as per their treating oncologist.
Eligible support persons are:
1. Identified by the older adult as their support person.
2. Aged 18 years and over.
3. Able to speak and understand English.
4. Able to give informed consent.
Exclusion Criteria
2. Clinic visit with a geriatrician in the previous 12 months (they have already received part of the intervention).
3. Chest tube in-situ.
Not able to give informed consent.
65 Years
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
Sunnybrook Health Sciences Centre
OTHER
Martine Puts
OTHER
Responsible Party
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Martine Puts
Professor
Principal Investigators
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Martine Puts, RN PhD
Role: PRINCIPAL_INVESTIGATOR
University of Toronto
Locations
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Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Sunybrook Health Sciences Centre, Odette Cancer Centre
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Jebanesan N, Alibhai SMH, Santa Mina D, Jones J, Legacy N, Freeman L, Smith A, Cobbing S, Vadali N, Lo S, Godhwani K, Nasiri F, Antonio M, Stephens D, Pitters E, Bennie F, Stephens A, Papadakos J, Cerullo L, Zjadewicz M, Jang R, Eng L, Krzyzanowska M, Matthew A, Durbano S, Mehta R, Menjak I, Emmenegger U, Sattar S, Sun V, Ladham K, Puts M. Supporting older adults with cancer and their support person through geriatric assessment and remote exercise and education: The SOAR study protocol. J Geriatr Oncol. 2025 Apr;16(3):102194. doi: 10.1016/j.jgo.2025.102194. Epub 2025 Feb 5.
Other Identifiers
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CTO#4087
Identifier Type: -
Identifier Source: org_study_id
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