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Trial Title: The SOAR Study: a Study of Geriatric Assessment and Exercise for Older Adults and Their Support Person

NCT ID: NCT05509751

Condition: Lung Cancer
Gastro-intestinal Cancer
Genito-Urinary Cancer
Breast Cancer
Gynecologic Cancer
Lymphoma

Conditions: Official terms:
Intestinal Neoplasms
Gastrointestinal Neoplasms
Urogenital Neoplasms

Conditions: Keywords:
comprehensive geriatric assessment
chair-based exercise
health education

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Sequential Assignment

Primary purpose: Supportive Care

Masking: Single (Outcomes Assessor)

Masking description: The study statistician will be blinded to group allocation

Intervention:

Intervention type: Behavioral
Intervention name: GAM, exercise, health education
Description: geriatric assessment, exercise and health education
Arm group label: Intervention group

Other name: Comprehensive Geriatric Assessment and Management (GAM) combined with online chair-based exercise (CBE) and health education for 12 weeks.

Intervention type: Behavioral
Intervention name: online chair-based exercise combined with health education
Description: online chair-based exercise and health education for 12 weeks
Arm group label: single arm pre-post test study for participants recruited from geriatric oncology clinic

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.

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).

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Aged 65+ years. 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: 1. Severe neuropsychiatric abnormalities (e.g., moderate-severe dementia) per the treating physician; and 2. Clinic visit with a geriatrician in the previous 12 months (they have already received part of the intervention). 3. Chest tube in-situ. Exclusion criteria support person: Not able to give informed consent.

Gender: All

Minimum age: 65 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Princess Margaret Cancer Centre

Address:
City: Toronto
Zip: M5G2C4
Country: Canada

Status: Recruiting

Contact:
Last name: Shabbir Alibhai
Email: shabbir.alibhai@uhn.ca

Investigator:
Last name: Shabbir M Alibhai, MD MSc
Email: Principal Investigator

Facility:
Name: Sunybrook Health Sciences Centre, Odette Cancer Centre

Address:
City: Toronto
Country: Canada

Status: Recruiting

Contact:
Last name: Urban Emmenegger, MD

Phone: 416-480-6100

Phone ext: 4928
Email: urban.emmenegger@sunnybrook.ca

Contact backup:
Last name: Ines Menjak, MD

Phone: 416-480-6100
Email: Ines.Menjak@sunnybrook.ca

Start date: October 1, 2023

Completion date: December 2025

Lead sponsor:
Agency: Martine Puts
Agency class: Other

Collaborator:
Agency: University Health Network, Toronto
Agency class: Other

Collaborator:
Agency: Sunnybrook Health Sciences Centre
Agency class: Other

Source: University of Toronto

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05509751

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