Clinical trial NCT05509751: The SOAR Study: a Study of Geriatric Assessment and Exercise for Older Adults and Their Support Person
Official title: Supporting Older Adults With Cancer and Their Support Person Through Geriatric Assessment and Remote Exercise and Education: the SOAR Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Gastro-intestinal Cancer
Genito-Urinary Cancer
Breast Cancer
Gynecologic Cancer
Lymphoma
Keywords: comprehensive geriatric assessment
chair-based exercise
health education
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: University Health Network, Toronto
name: Sunnybrook Health Sciences Centre
First posted: 2022-08-22
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

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.

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).

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.

Primary outcomes:
measure: Feasability of the study
timeFrame: 12 weeks
measure: Acceptability of the intervention and the study
timeFrame: 12 weeks
Secondary outcomes:
measure: Effect intervention on Physical function
timeFrame: 12 weeks
measure: Effect intervention on Grip strength
timeFrame: 12 weeks
measure: Effect intervention on Life space Mobility
timeFrame: 12 weeks
measure: Effect intervention on Physical Activity
timeFrame: 12 weeks
measure: Effect intervention on number of self-reported Falls
timeFrame: 12 weeks
measure: Effect of the intervention on Fatigue
timeFrame: 12 weeks
measure: Effect of the intervention on Quality of life
timeFrame: 12 weeks
measure: Effect of the intervention on treatment toxicity
timeFrame: 12 weeks
measure: Effect of the intervention on unplanned healthcare utilization
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunybrook Health Sciences Centre, Odette Cancer Centre
state: Ontario
Study officials:
affiliation: University of Toronto
name: Martine Puts, RN PhD
role: PRINCIPAL_INVESTIGATOR
References: