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

Primary Purpose

Lung Cancer, Gastro-intestinal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
GAM, exercise, health education
Sponsored by
Martine Puts
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Cancer focused on measuring comprehensive geriatric assessment, chair-based exercise, health education

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Aged 70+ years.
  2. Score >3 (indicating frailty) using the Vulnerable Elders Survey-13 (VES-13);
  3. Diagnosed with lung or gastrointestinal (GI) cancer who are referred for first or second-line 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).

Exclusion criteria support person:

Not able to give informed consent.

Sites / Locations

  • Princess Margaret Cancer CentreRecruiting
  • Sunybrook Health Sciences Centre, Odette Cancer CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention group

Waitlist control group

Arm Description

geriatric assessment (GAM) and remote exercise and education prior to and during curative/adjuvant or first/second line palliative chemotherapy /immunotherapy or targeted therapy

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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).
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.
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.
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
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).
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.
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.
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.
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.

Full Information

First Posted
August 15, 2022
Last Updated
August 16, 2023
Sponsor
Martine Puts
Collaborators
University Health Network, Toronto, Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT05509751
Brief Title
The SOAR Study: a Study of Geriatric Assessment and Exercise for Older Adults and Their Support Person
Acronym
SOAR
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 16, 2023 (Anticipated)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Martine Puts
Collaborators
University Health Network, Toronto, Sunnybrook Health Sciences Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Phase 2 randomized controlled study using a waitlist control group. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Gastro-intestinal Cancer
Keywords
comprehensive geriatric assessment, chair-based exercise, health education

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Outcomes Assessor
Masking Description
The study statistician will be blinded to group allocation
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
geriatric assessment (GAM) and remote exercise and education prior to and during curative/adjuvant or first/second line palliative chemotherapy /immunotherapy or targeted therapy
Arm Title
Waitlist control group
Arm Type
No Intervention
Arm Description
Wait list, receiving standard of care and option to receive intervention after treatment.
Intervention Type
Behavioral
Intervention Name(s)
GAM, exercise, health education
Other Intervention Name(s)
Comprehensive Geriatric Assessment and Management (GAM) combined with online chair-based exercise (CBE) and health education for 12 weeks.
Intervention Description
geriatric assessment, exercise and health education
Primary Outcome Measure Information:
Title
Feasability of the study
Description
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.
Time Frame
12 weeks
Title
Acceptability of the intervention and the study
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Effect intervention on Physical function
Description
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).
Time Frame
12 weeks
Title
Effect intervention on Grip strength
Description
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.
Time Frame
12 weeks
Title
Effect intervention on Life space Mobility
Description
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.
Time Frame
12 weeks
Title
Effect intervention on Physical Activity
Description
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
Time Frame
12 weeks
Title
Effect intervention on number of self-reported Falls
Description
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).
Time Frame
12 weeks
Title
Effect of the intervention on Fatigue
Description
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.
Time Frame
12 weeks
Title
Effect of the intervention on Quality of life
Description
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.
Time Frame
12 weeks
Title
Effect of the intervention on treatment toxicity
Description
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.
Time Frame
12 weeks
Title
Effect of the intervention on unplanned healthcare utilization
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 70+ years. Score >3 (indicating frailty) using the Vulnerable Elders Survey-13 (VES-13); Diagnosed with lung or gastrointestinal (GI) cancer who are referred for first or second-line chemotherapy or immunotherapy and have not received > 4 weeks of systemic treatment. Have a physician estimated life expectancy of >6 months. 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). Able to speak and understand English. Able to give informed consent. 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. Aged 18 years and over. Able to speak and understand English. Able to give informed consent. Exclusion Criteria: 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). Exclusion criteria support person: Not able to give informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martine Puts, RN PhD
Phone
416-978-6059
Email
martine.puts@utoronto.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Shabbir Alibhai, MD MSc
Phone
416-3405125
Email
shabbir.alibhai@uhn.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martine Puts, RN PhD
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G2C4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shabbir Alibhai
Email
shabbir.alibhai@uhn.ca
First Name & Middle Initial & Last Name & Degree
Shabbir M Alibhai, MD MSc
Facility Name
Sunybrook Health Sciences Centre, Odette Cancer Centre
City
Toronto
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Urban Emmenegger, MD
Phone
416-480-6100
Ext
4928
Email
urban.emmenegger@sunnybrook.ca
First Name & Middle Initial & Last Name & Degree
Ines Menjak, MD
Phone
416-480-6100
Email
Ines.Menjak@sunnybrook.ca

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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