Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT05509751
Status:
RECRUITING
Last Update Posted:
2024-11-08
First Post:
2022-08-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The SOAR Study: a Study of Geriatric Assessment and Exercise for Older Adults and Their Support Person
Sponsor:
Martine Puts
Organization:
Study Overview
Official Title:
Supporting Older Adults With Cancer and Their Support Person Through Geriatric Assessment and Remote Exercise and Education: the SOAR Study
Status:
RECRUITING
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOAR
Brief Summary:
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.
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.
Detailed Description:
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).
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: