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Supportive Care for Lung Cancer
N/A
Recruiting
Led By Carolyn J Presley
Research Sponsored by Ohio State University Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosed with an advanced lung cancer: unresectable stage IIIA, IIIB, or stage IV non-small cell lung cancer (NSCLC) or extensive stage small cell lung cancer (SCLC)
Age >= 60 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 month
Awards & highlights
Study Summary
This trial is testing whether a supportive care intervention can improve physical and emotional wellbeing in patients with lung cancer. The intervention includes physical therapy and relaxation interventions.
Who is the study for?
This trial is for adults aged 60 or older with advanced lung cancer (stage IIIA, IIIB, or IV non-small cell lung cancer or extensive stage small cell lung cancer). They must be able to understand and sign a consent form, have a certain level of physical function, and plan to receive treatment at the Ohio State University Comprehensive Cancer Center. Prisoners are not eligible.Check my eligibility
What is being tested?
The ROAR-LCT trial is testing a supportive care intervention aimed at improving physical and emotional wellbeing in patients undergoing treatment for advanced lung cancer. It includes questionnaires, quality-of-life assessments, relaxation therapy like muscle relaxation exercises, best practice guidelines adherence, and an exercise program managed by physical therapists.See study design
What are the potential side effects?
Since this trial focuses on supportive care rather than drug treatments, side effects may include discomfort from exercise or relaxation therapy sessions. However, these interventions are generally considered safe and aim to improve symptoms and quality of life.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer is at an advanced stage and cannot be surgically removed.
Select...
I am 60 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Amount and duration of therapy that participants were able to complete
Preliminary effect on functional status
Retention
+1 moreSecondary outcome measures
Incidence and severity of toxicity
Physical Endurance
Physical capability
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (ROAR-LCT intervention)Experimental Treatment5 Interventions
Patients receive ROAR-LCT intervention weekly for 12 weeks consisting of physical therapy visits and an exercise intervention. Patients also undergo progressive muscles relaxation exercises over 20 minutes for 12 weeks.
Group II: Arm II (standard of care)Active Control3 Interventions
Patients receive standard of care for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Physical Therapy
2020
Completed Phase 4
~1280
Relaxation Therapy
2007
Completed Phase 3
~1160
Find a Location
Who is running the clinical trial?
National Institute on Aging (NIA)NIH
1,700 Previous Clinical Trials
28,032,710 Total Patients Enrolled
Ohio State University Comprehensive Cancer CenterLead Sponsor
325 Previous Clinical Trials
290,504 Total Patients Enrolled
Carolyn J PresleyPrincipal InvestigatorOhio State University Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lung cancer is at an advanced stage and cannot be surgically removed.I can join the study at any stage of my treatment at OSU.You have a score of 2 or higher on the three functional questions of the EQ5D5L patient survey.My health status, lab values, past cancers, other illnesses, or brain metastases do not disqualify me.I am 60 years old or older.You plan to get treatment from the Ohio State University Comprehensive Cancer Center (OSUCCC) Thoracic Oncology Clinic.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (ROAR-LCT intervention)
- Group 2: Arm II (standard of care)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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