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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

No Placebo-Only Group

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of the intervention and the study

Feasability of the study

Secondary study objectives

Effect intervention on Grip strength

Effect intervention on Life space Mobility

Effect intervention on Physical Activity

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: single arm pre-post test study for participants recruited from geriatric oncology clinicExperimental Treatment1 Intervention

They will receive the 12 week virtual chair-based exercise and health education intervention except no geriatric assessment

Group II: 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 III: Waitlist control groupActive Control1 Intervention

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

Do I qualify?Apply below to find out