Lung CancerSOARNCT05509751
The SOAR Study: a Study of Geriatric Assessment and Exercise for Older Adults and Their Support Person
A study testing GAM, exercise, health education and online chair-based exercise combined with health education in people with Lung Cancer and Gastro-intestinal Cancer, run by Martine Puts at 2 sites in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Lung Cancer, Gastro-intestinal Cancer, Genito-Urinary Cancer
- What is being tested?
- GAM, exercise, health education and online chair-based exercise combined with health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Oct 2023to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged 65+ years.
- 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:
- Identified by the older adult as their support person.
Show all 9Show fewer
- Aged 18 years and over.
- Able to speak and understand English.
- Able to give informed consent.
Who cannot join
- Severe neuropsychiatric abnormalities (e.g., moderate-severe dementia) per the treating physician; and
- Clinic visit with a geriatrician in the previous 12 months (they have already received part of the intervention).
- Chest tube in-situ.
- Not able to give informed consent.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Princess Margaret Cancer Centre
Toronto, Ontario, M5G2C4
Sunybrook Health Sciences Centre, Odette Cancer Centre
Toronto, Ontario
About this study
Official title: Supporting Older Adults With Cancer and Their Support Person Through Geriatric Assessment and Remote Exercise and Education: the SOAR Study
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.
Read the 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).
- Conditions
- Lung Cancer, Gastro-intestinal Cancer, Genito-Urinary Cancer, Breast Cancer, Gynecologic Cancer, Lymphoma
- Being tested
- GAM, exercise, health education, online chair-based exercise combined with health education
- Keywords
- comprehensive geriatric assessment, chair-based exercise, health education
- Medical subject headings
- Lung Neoplasms, Urogenital Neoplasms, Breast Neoplasms, Lymphoma, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GAM, exercise, health educationBehavioural
Also called Comprehensive Geriatric Assessment and Management (GAM) combined with online chair-based exercise (CBE) and health education for 12 weeks.
geriatric assessment, exercise and health education
online chair-based exercise combined with health educationBehavioural
online chair-based exercise and health education for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | geriatric assessment (GAM) and remote exercise and education prior to and during curative/adjuvant or first/second line palliative chemotherapy /immunotherapy or targeted therapy Receives: Behavioral: GAM, exercise, health education |
| Waitlist control group | No intervention | Wait list, receiving standard of care and option to receive intervention after treatment. |
| single arm pre-post test study for participants recruited from geriatric oncology clinic | Experimental | They will receive the 12 week virtual chair-based exercise and health education intervention except no geriatric assessment Receives: Behavioral: online chair-based exercise combined with health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasability of the study
What is the feasibility of implementation of the study? Feasibility will be measured by recruitment rate which will be the proportion of eligible patients and support persons who agree to enroll in the study, collected from our recruitment log) and measured in percentage with range 0-100. Feasibility of retention will be measured proportion of participants who complete the study data collection, collected from our study log), range 0-100.
Feasibility of data outcome collection will be the percentage of patients who have complete data collection (collected from our study log), range 0-100.
Feasibility of the study will be defined as recruitment of >60% of all eligible older adults; retention of >80% of the dyads; and 3) capture of outcome data of 80% or more.
Measured: 12 weeks
Acceptability of the intervention and the study
What is the acceptability of the intervention and study? Acceptability will be measured by 1) adherence to the intervention and 2) satisfaction. Adherence to the intervention= 1) adherence to the geriatric assessment recommendations (collected through chart review) and expressed as percentage of recommendations received and implemented by the patient, range 0-100. 2) Adherence to online classes will be measured through the number of sessions missed as documented in the intervention log.
A 5-item Likert scale satisfaction with the study scale ranging from very satisfied to very unsatisfied and satisfied and very Satisfied= satisified.
Acceptability will be defined as 1) adherence to the intervention of >85% of participants adhering to at least 80% of the classes and recommendations; 2) satisfaction by 80% of participants.
Measured: 12 weeks
Secondary outcomes (9)
Effect intervention on Physical function
What are the preliminary estimate of the intervention on physical function? This will be measured with the Short Physical Performance Battery (SPPB). The Short Physical Performance Battery is a test battery comprising of a four-meter gait speed test, a balance test, and 5 timed chair stand tests. The total score ranges between 0-12, and a change of one point is considered the minimal clinically important difference (MCID).
Measured: 12 weeks
Effect intervention on Grip strength
What are the preliminary estimates of the intervention on grip strength? Grip strength in kilos will be measured with a handheld dynamometer three times in the dominant hand (range 0-80 kg). The maximum score will be used, and the minimal clinically important difference (MCID) is 5 kg.
Measured: 12 weeks
Effect intervention on Life space Mobility
What are the preliminary estimates of the intervention on Life Space Mobility? Life Space Mobility (LSM) will be measured with the University of Alabama Birmingham Study of Aging Life Space Assessment. The Life Space Mobility total score ranges from 0 (bed-bound) to 120 (daily independent out-of-town mobility). The minimal clinically important difference (MCID)is five points.
Measured: 12 weeks
Effect intervention on Physical Activity
What are the preliminary estimates of the intervention on Physical Activity? Physical activity will be measured with the Godin Leisure time Exercise questionnaire. It asks how many times in the past seven days the participant has done vigorous, moderate, and light exercise for at least 15 min each time, and how much time the participant spent on the exercise, to calculate the total score. A score of 24+ indicates Active, 14 - 23 indicates Moderately Active, and <14 indicates inactive/sedentary
Measured: 12 weeks
Effect intervention on number of self-reported Falls
What are the preliminary estimates of the intervention on the number of self-reported falls? Self-reported falls will be assessed weekly by a phone call by the RA as well as circumstances of the fall and will be scored as the total number of falls (ranging from 0- 200).
Measured: 12 weeks
Effect of the intervention on Fatigue
What are the preliminary estimates of the intervention on fatigue? This will be measured with the Pittsburgh Fatigability questionnaire (PFS). The Pittsburgh Fatigability questionnaire measures both physical and mental fatigability. Participants rate their tiredness/exhaustion from 0 ("no fatigue") to 5 ("extreme fatigue") for how they expected or imagined they would feel after completing activities ranging in type and intensity (10 items). Continuous scores for each dimension can range from 0 to 50, with higher scores indicating higher fatigability and scores >25 will be used to indicate severe fatigability.
Measured: 12 weeks
Effect of the intervention on Quality of life
What are the preliminary estimates of intervention on quality of life? This will be measured with the 12-item Short Form Survey (SF-12) . The 12 items are summarized in a physical subscale ranging from 0-100 and a mental health subscale ranging from 0-100.
Measured: 12 weeks
Effect of the intervention on treatment toxicity
What are the effect of the intervention on Treatment toxicity ? This will be abstracted from the medical charts and treatment toxicity will be graded using the Common Terminology Criteria for Adverse Events version 5.0. Each toxicity is graded from 0-5. The number of toxicities grade 3-5 will be summed.
Measured: 12 weeks
Effect of the intervention on unplanned healthcare utilization
What are the effect of the intervention on unplanned Emergency Department (ED) visits and/or hospitalization? This will be abstracted from the medical charts and summarized as the number of unplanned emergency department visits and number of unplanned hospitalizations. Both could range from 0-100.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start1 Oct 2023
- Primary completion1 Mar 2026
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Martine Puts
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto, Sunnybrook Health Sciences Centre
- Responsible party
- Sponsor-investigator, Martine Puts, University of Toronto
- Investigators
- Martine Puts, RN PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509751
- Sponsor's protocol ID
- CTO#4087
- Acronym
- SOAR
- Status last verified
- Apr 2026
- First submitted
- 15 Aug 2022
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39909737
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Older Adults With Cancer and Their Support Person Through Geriatric Assessment and Remote Exercise and Education: the SOAR Study
- ClinicalTrials.gov ID
- NCT05509751
- Acronym / sponsor ID
- SOAR / CTO#4087
- Conditions
- Lung Cancer, Gastro-intestinal Cancer, Genito-Urinary Cancer, Breast Cancer, Gynecologic Cancer, Lymphoma
- Keywords
- comprehensive geriatric assessment, chair-based exercise, health education
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Martine PutsUniversity, hospital or other
- Collaborators
- University Health Network, Toronto, Sunnybrook Health Sciences Centre
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 22 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Behavioral: GAM, exercise, health educationgeriatric assessment (GAM) and remote exercise and education prior to and during curative/adjuvant or first/second line palliative chemotherapy /immunotherapy or targeted therapy |
| Waitlist control group | No intervention | –Wait list, receiving standard of care and option to receive intervention after treatment. |
| single arm pre-post test study for participants recruited from geriatric oncology clinic | Experimental | Behavioral: online chair-based exercise combined with health educationThey will receive the 12 week virtual chair-based exercise and health education intervention except no geriatric assessment |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Aged 65+ years.
- 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.
- Identified by the older adult as their support person.
Key exclusion criteria (4 listed)
- Severe neuropsychiatric abnormalities (e.g., moderate-severe dementia) per the treating physician; and
- Clinic visit with a geriatrician in the previous 12 months (they have already received part of the intervention).
- Chest tube in-situ.
- Not able to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GAM, exercise, health educationAlso: Comprehensive Geriatric Assessment and Management (GAM) combined with online chair-based exercise (CBE) and health education for 12 weeks.geriatric assessment, exercise and health education | Behavioural | Intervention group |
| online chair-based exercise combined with health educationonline chair-based exercise and health education for 12 weeks | Behavioural | single arm pre-post test study for participants recruited from geriatric oncology clinic |
Primary outcome
Feasability of the study
Time frame: 12 weeks
What is the feasibility of implementation of the study? Feasibility will be measured by recruitment rate which will be the proportion of eligible patients and support persons who agree to enroll in the study, collected from our recruitment log) and measured in percentage with range 0-100. Feasibility of retention will be measured proportion of participants who complete the study data collection, collected from our study log), range 0-100. Feasibility of data outcome collection will be the percentage of patients who have complete data collection (collected from our study log), range 0-100. Feasibility of the study will be defined as recruitment of >60% of all eligible older adults; retention of >80% of the dyads; and 3) capture of outcome data of 80% or more.
Acceptability of the intervention and the study
Time frame: 12 weeks
What is the acceptability of the intervention and study? Acceptability will be measured by 1) adherence to the intervention and 2) satisfaction. Adherence to the intervention= 1) adherence to the geriatric assessment recommendations (collected through chart review) and expressed as percentage of recommendations received and implemented by the patient, range 0-100. 2) Adherence to online classes will be measured through the number of sessions missed as documented in the intervention log. A 5-item Likert scale satisfaction with the study scale ranging from very satisfied to very unsatisfied and satisfied and very Satisfied= satisified. Acceptability will be defined as 1) adherence to the intervention of >85% of participants adhering to at least 80% of the classes and recommendations; 2) satisfaction by 80% of participants.
9 secondary outcomes
Effect intervention on Physical function
Time frame: 12 weeks
Effect intervention on Grip strength
Time frame: 12 weeks
Effect intervention on Life space Mobility
Time frame: 12 weeks
Effect intervention on Physical Activity
Time frame: 12 weeks
Effect intervention on number of self-reported Falls
Time frame: 12 weeks
Effect of the intervention on Fatigue
Time frame: 12 weeks
Effect of the intervention on Quality of life
Time frame: 12 weeks
Effect of the intervention on treatment toxicity
Time frame: 12 weeks
Effect of the intervention on unplanned healthcare utilization
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Derived from this study: PubMed 39909737Jebanesan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martine Puts, RN PhD principal investigator
University of Toronto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GAM, exercise, health education and online chair-based exercise combined with health education in people with Lung Cancer and Gastro-intestinal Cancer, run by Martine Puts at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasability of the study (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05509751, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.