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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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).

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
The study statistician will be blinded to group allocation

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

Group Type ACTIVE_COMPARATOR

GAM, exercise, health education

Intervention Type BEHAVIORAL

geriatric assessment, exercise and health education

Waitlist control group

Wait list, receiving standard of care and option to receive intervention after treatment.

Group Type NO_INTERVENTION

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

Group Type EXPERIMENTAL

online chair-based exercise combined with health education

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

online chair-based exercise combined with health education

online chair-based exercise and health education for 12 weeks

Intervention Type BEHAVIORAL

Other Intervention Names

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

Eligibility Criteria

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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.


Not able to give informed consent.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role collaborator

Martine Puts

OTHER

Sponsor Role lead

Responsible Party

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Martine Puts

Professor

Responsibility Role SPONSOR_INVESTIGATOR

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

Site Status RECRUITING

Sunybrook Health Sciences Centre, Odette Cancer Centre

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Martine Puts, RN PhD

Role: CONTACT

416-978-6059

Shabbir Alibhai, MD MSc

Role: CONTACT

416-3405125

Facility Contacts

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Shabbir Alibhai

Role: primary

Urban Emmenegger, MD

Role: primary

416-480-6100 ext. 4928

Ines Menjak, MD

Role: backup

416-480-6100

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.

Reference Type DERIVED
PMID: 39909737 (View on PubMed)

Other Identifiers

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CTO#4087

Identifier Type: -

Identifier Source: org_study_id

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