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Geriatric Assessment and Exercise for Gastrointestinal Cancer (SOAR Trial)

N/A
Recruiting
Led By Martine Puts, RN PhD
Research Sponsored by Martine Puts
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

SOAR Trial Summary

This trial is studying how well a combination of geriatric assessment and management, online chair-based exercise, and health education works in improving health and function in older adults.

Who is the study for?
This trial is for people aged 70 or older with lung or gastrointestinal cancer, starting first or second-line chemo or immunotherapy. Participants must be frail as indicated by a score >3 on the VES-13 survey, have a life expectancy of over 6 months, be physically inactive, and able to understand English. Those with severe dementia or recent geriatrician visits are excluded.Check my eligibility
What is being tested?
The SOAR Study tests if adding Comprehensive Geriatric Assessment and Management (GAM) along with online chair-based exercise and health education can benefit older adults undergoing cancer treatment. It's a Phase 2 study where participants are randomly assigned to start immediately or wait.See study design
What are the potential side effects?
Since this trial focuses on assessments and exercises rather than medication, side effects may include typical exercise-related issues such as muscle soreness or fatigue but should generally be minimal.

SOAR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability of the intervention and the study
Feasability of the study
Secondary outcome measures
Effect intervention on Grip strength
Effect intervention on Life space Mobility
Effect intervention on Physical Activity
+6 more

SOAR Trial Design

2Treatment groups
Active Control
Group I: Intervention groupActive Control1 Intervention
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 II: Waitlist control groupActive Control1 Intervention
Wait list, receiving standard of care and option to receive intervention after treatment.

Find a Location

Who is running the clinical trial?

Martine PutsLead Sponsor
University Health Network, TorontoOTHER
1,475 Previous Clinical Trials
485,030 Total Patients Enrolled
Sunnybrook Health Sciences CentreOTHER
656 Previous Clinical Trials
1,551,248 Total Patients Enrolled

Media Library

Comprehensive Geriatric Assessment and Management (GAM) Clinical Trial Eligibility Overview. Trial Name: NCT05509751 — N/A
Gastrointestinal Cancer Research Study Groups: Intervention group, Waitlist control group
Gastrointestinal Cancer Clinical Trial 2023: Comprehensive Geriatric Assessment and Management (GAM) Highlights & Side Effects. Trial Name: NCT05509751 — N/A
Comprehensive Geriatric Assessment and Management (GAM) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05509751 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What aim is this experiment trying to achieve?

"This study will be monitored for a period of 12 weeks with the primary goal being to gauge its feasability. Secondary objectives include evaluating the intervention's impact on grip strength, physical function and physical activity. Grip strength is quantified by measuring kilos using a handheld dynamometer with an MCID threshold of 5 kg. Physical function is assessed through SPPB (Short Physical Performance Battery) which has scores ranging from 0-12 with 1 point considered significant change; while physical activity analyses are conducted through Godin Leisure time Exercise questionnaire, which assigns Active status to participants scoring 24+, Moderately Active at 14 - 23 and <14 as inactive/"

Answered by AI

Are individuals still able to sign up for participation in this research?

"Data posted on clinicaltrials.gov attests that this trial is not currently taking in patients, with the project having been initially published on January 1st 2023 and last modified November 2nd 2022. Despite this study's conclusion, there are still 546 other studies requiring participants at present."

Answered by AI
~40 spots leftby Sep 2025