Advanced Lung Non-Small Cell CarcinomaNCT05339022
Supportive Care Intervention (ROAR-LCT) for Patients With Stage IIIA, IIIB, and IV Lung Cancer, ROAR-LCT Trial
A study testing Best Practice, Exercise Intervention and Physical Therapy in people with Advanced Lung Non-Small Cell Carcinoma and Advanced Lung Small Cell Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This phase II trial tests whether a supportive care intervention (Resiliency among Older Adults Receiving Lung Cancer Treatment [ROAR-LCT]) is effective in improving physical and emotional wellbeing in patients with stage IIIA, IIIB, and IV lung cancer undergoing cancer treatment. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Advanced Lung Non-Small Cell Carcinoma, Advanced Lung Small Cell Carcinoma, Extensive Stage Lung Small Cell Carcinoma
- What is being tested?
- Best Practice, Exercise Intervention and Physical Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2022to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 60 years
- 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)
- Intent to receive treatment from the Ohio State University Comprehensive Cancer Center (OSUCCC) Thoracic Oncology Clinic
- A score of 2 or higher on the three functional items of the European Quality of Life Five Dimension Five Level Scale (EQ5D5L) patient reported outcome (PRO) assessment
- Patients are eligible at any time point during their treatment here at Ohio State University (OSU). Rationale for this timeframe is due to the overwhelming nature of the first few visits and uncertainty around an eventual treatment plan. Patients at any stage of their treatment can participate and benefit from a physical therapy and psychosocial intervention. Patients will be approached at their initial visit but the investigators can also offer enrollment at any one of the patients regularly scheduled clinic visits or via phone or email
- Ability to understand and willingness to sign an informed consent document (or indicate approval or disapproval by another means)
Who cannot join
- Prisoners are excluded from participation
- There is NO exclusion criteria pertaining to Eastern Cooperative Oncology Group (ECOG) performance status, laboratory values, prior cancer diagnoses, presence of comorbidities or brain metastases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Resiliency Among Older Adults Receiving Lung Cancer Treatment (ROAR-LCT): A Phase II Randomized Supportive Care Intervention Clinical Trial
This phase II trial tests whether a supportive care intervention (Resiliency among Older Adults Receiving Lung Cancer Treatment [ROAR-LCT]) is effective in improving physical and emotional wellbeing in patients with stage IIIA, IIIB, and IV lung cancer undergoing cancer treatment. Lung cancers are one of the most common cancers. Lung cancers occur in the chest and often cause symptoms for patients. Poor physical performance and negative mood are two risk factors for a decline in functional status. Targeted interventions may address these two risk factors and improve functional status and resilience. Physical therapy and relaxation interventions (i.e. progressive muscle relaxation) are two such interventions that may improve symptoms and quality of life for patients with cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the potential effectiveness of a novel, supervised virtual health-assisted physical therapy plus relaxation intervention vs. standard of care on the primary outcomes: functional status and overall feasibility of the study design.
SECONDARY OBJECTIVE:
- To determine the potential effectiveness of the intervention on secondary outcomes: psychological symptoms, and physical capability among older adults with an advanced lung cancer (N=100).
EXPLORATORY OBJECTIVE:
- Lung cancer symptom burden, treatment toxicity, and smoking cessation.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: 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.
ARM II: Patients receive standard of care for 12 weeks.
After completion of study intervention, patients are followed up for up to 24 months after date of study enrollment.
- Conditions
- Advanced Lung Non-Small Cell Carcinoma, Advanced Lung Small Cell Carcinoma, Extensive Stage Lung Small Cell Carcinoma, Stage IIIA Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8
- Being tested
- Best Practice, Exercise Intervention, Physical Therapy, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive standard of care
Undergo exercise intervention
Physical TherapyProcedure or surgery
Also called Physiatric Procedure, Physical Medicine Procedure, Physical Therapeutics, Physical Therapy Procedure
Undergo physical therapy
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Relaxation TherapyProcedure or surgery
Undergo progressive muscles relaxation exercises
| Study group | Role | What they receive |
|---|---|---|
| Arm I (ROAR-LCT intervention) | Experimental | 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. Receives: Other: Exercise Intervention; Procedure: Physical Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Relaxation Therapy |
| Arm II (standard of care) | Active comparator | Patients receive standard of care for 12 weeks. Receives: Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study adherence
Study adherence will be defined as the completion of 70% of the program sessions, repeated assessments, and collection of biospecimens either at the end of the study period or death, whichever occurs first.
Measured: Up to 12 weeks
Retention
Retention rates will be defined as the percentage of participants not lost to follow-up at 1.5 months,
Measured: 1.5 month
Retention
Retention rates will be defined as the percentage of participants not lost to follow-up at 3 months
Measured: 3 Month
Retention
Retention rates will be defined as the percentage of participants not lost to follow-up at 6 months
Measured: 6 Month
Amount and duration of therapy that participants were able to complete
sessions completed, weeks it takes to complete all 12 session; missed sessions; reasons for missed sessions
Measured: Week 12
Amount and duration of therapy that participants were able to complete
sessions completed, weeks it takes to complete all 12 session; missed sessions; reasons for missed sessions
Measured: Week 24
Preliminary effect on functional status
A joint model using group-based trajectory modeling will be used to estimate clinically distinct trajectories of functional status and attrition probability (death or dropout). These models will be used to evaluate differences in change of functional scores between study arms through 3 months of follow-up. Additionally, generalized linear mixed models (GLMMs) will be used to model change in functional status from baseline to 3 months to explore if the intervention has both an immediate and sustained impact on function.
Measured: 3 Month
Preliminary effect on functional status
A joint model using group-based trajectory modeling will be used to estimate clinically distinct trajectories of functional status and attrition probability (death or dropout). These models will be used to evaluate differences in change of functional scores between study arms through 6 months of follow-up. Additionally, generalized linear mixed models (GLMMs) will be used to model change in functional status from baseline 6 months to explore if the intervention has both an immediate and sustained impact on function.
Measured: 6 Month
Preliminary effect on functional status
A joint model using group-based trajectory modeling will be used to estimate clinically distinct trajectories of functional status and attrition probability (death or dropout). These models will be used to evaluate differences in change of functional scores between study arms through 12 months of follow-up. Additionally, generalized linear mixed models (GLMMs) will be used to model change in functional status from baseline to 12 months to explore if the intervention has both an immediate and sustained impact on function.
Measured: 12 month
Secondary outcomes (6)
Physical capability
Functional Status Assessment: This is a 16-item questionnaire that includes seven Activities of Daily Living (ADL) measures, 5 Instrumental Activities of Daily Living (IADL) measures, and 3 mobility activities. For each activity, disability is defined as the need for personal assistance or inability to perform the activity. Activities are scored as 0 being no help, 1 being with help, and 2 meaning unable to perform the activity. Higher scores indicate greater disability or a lower functional status.
Measured: Up to 12 weeks
Incidence and severity of toxicity
Toxicity assessment completed at the end of each chemotherapy or immunotherapy treatment cycle using the CTCAE V5; (irAEs, AEs, SAEs) Toxicities will be graded 1-5 with grade 5 being the worst and grade 1 being less severe.
Measured: Up to 12 weeks
Psychological symptoms
GAD-7; This assessment is a 7 item questionnaire that asks patients how often in the past 2 weeks, have they been bothered by each symptom. The responses are scored as 0 being "not at all," 1 being "several days," 2 being "more than half the days", and 3 being "nearly every day," for an aggregate score of 21. Higher scores indicate a higher prevalence of anxiety and are strongly associated with multiple domains of functional impairment and disability days.33
Measured: Up to 12 weeks
Psychological Symptoms
PHQ-9; This is a 9-item depression segment which assesses the severity of depressive symptoms within the last two weeks. Patients will complete the PHQ-9 approximately every 6 weeks administered by the CRC. Items are scored from 0-3 with higher scores indicating greater levels of depression. If 5 or more of the 9 symptoms have been present for "more than half the days," then major depression is indicated. Other depression is indicated if 2, 3, or 4 of the symptoms have been present at least "more than half the days" in the past 2 weeks, and 1 of the symptoms is depressed mood or anhedonia.
Measured: Up to 12 weeks
Physical function
Short Physical Performance Battery (SPPB);. The SPPB is a validated tool used to assess lower extremity functioning. It is comprised of three objective measures testing for standing balance, normal gait speed, and strength performance by use of a timed sit-to-stand. The participants are asked to stand with their feet side by side, semi tandem, and tandem for 10 seconds each to assess balance. Normal gait speed is tested by asking participants to walk 8 feet at his or her normal speed. Strength performance is tested by asking participants to complete five timed chair sit to stands without the use of hands. These three measures are scored individually from 0 to 4 with an aggregate score ranging from 0 to 12, with higher scores correlating with a greater functional status. The scores are then classified into 4 categories; very low physical function (0-3); low physical function (4-6); moderate physical function (7-9); and high physical function (10-12).
Measured: Up to 12 weeks
Physical Endurance
2-6 min walk test; This is a validated tool used to assess endurance and overall functional exercise capacity. Patients are instructed to walk on a treadmill at their own pace for as long as they are able. At the end of the allotted time, patients are told to stop and the total distance covered is recorded. Participants walking less than 300 meters are considered to have low endurance while those walking over 300 meters are considered to have normal endurance.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start14 Apr 2022
- Primary completion30 Sep 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Lung Non-Small Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Carolyn Presley, Ohio State University Comprehensive Cancer Center
- Investigators
- Carolyn J Presley, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05339022
- Sponsor's protocol ID
- OSU-21218
- Other IDs
- NCI-2021-14061, 5K76AG074923-03
- Status last verified
- Aug 2025
- First submitted
- 1 Mar 2022
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resiliency Among Older Adults Receiving Lung Cancer Treatment (ROAR-LCT): A Phase II Randomized Supportive Care Intervention Clinical Trial
- ClinicalTrials.gov ID
- NCT05339022
- Acronym / sponsor ID
- OSU-21218
- Conditions
- Advanced Lung Non-Small Cell Carcinoma, Advanced Lung Small Cell Carcinoma, Extensive Stage Lung Small Cell Carcinoma, Stage IIIA Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 14 Apr 2022 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 21 Apr 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.
This phase II trial tests whether a supportive care intervention (Resiliency among Older Adults Receiving Lung Cancer Treatment [ROAR-LCT]) is effective in improving physical and emotional wellbeing in patients with stage IIIA, IIIB, and IV lung cancer undergoing cancer treatment. Lung cancers are one of the most common cancers. Lung cancers occur in the chest and often cause symptoms for patients. Poor physical performance and negative mood are two risk factors for a decline in functional status. Targeted interventions may address these two risk factors and improve functional status and resilience. Physical therapy and relaxation interventions (i.e. progressive muscle relaxation) are two such interventions that may improve symptoms and quality of life for patients with cancer.
Detailed description
PRIMARY OBJECTIVE:
- To determine the potential effectiveness of a novel, supervised virtual health-assisted physical therapy plus relaxation intervention vs. standard of care on the primary outcomes: functional status and overall feasibility of the study design.
SECONDARY OBJECTIVE:
- To determine the potential effectiveness of the intervention on secondary outcomes: psychological symptoms, and physical capability among older adults with an advanced lung cancer (N=100).
EXPLORATORY OBJECTIVE:
- Lung cancer symptom burden, treatment toxicity, and smoking cessation.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: 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.
ARM II: Patients receive standard of care for 12 weeks.
After completion of study intervention, patients are followed up for up to 24 months after date of study enrollment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (ROAR-LCT intervention) | Experimental | Other: Exercise Intervention, Procedure: Physical Therapy, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Procedure: Relaxation TherapyPatients 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. |
| Arm II (standard of care) | Active comparator | Other: Best Practice, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients receive standard of care for 12 weeks. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age >= 60 years
- 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)
- Intent to receive treatment from the Ohio State University Comprehensive Cancer Center (OSUCCC) Thoracic Oncology Clinic
- A score of 2 or higher on the three functional items of the European Quality of Life Five Dimension Five Level Scale (EQ5D5L) patient reported outcome (PRO) assessment
- Patients are eligible at any time point during their treatment here at Ohio State University (OSU). Rationale for this timeframe is due to the overwhelming nature of the first few visits and uncertainty around an eventual treatment plan. Patients at any stage of their treatment can participate and benefit from a physical therapy and psychosocial intervention. Patients will be approached at their initial visit but the investigators can also offer enrollment at any one of the patients regularly scheduled clinic visits or via phone or email
Key exclusion criteria (2 listed)
- Prisoners are excluded from participation
- There is NO exclusion criteria pertaining to Eastern Cooperative Oncology Group (ECOG) performance status, laboratory values, prior cancer diagnoses, presence of comorbidities or brain metastases
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 |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive standard of care | Other | Arm II (standard of care) |
| Exercise InterventionUndergo exercise intervention | Other | Arm I (ROAR-LCT intervention) |
| Physical TherapyAlso: Physiatric Procedure, Physical Medicine Procedure, Physical Therapeutics, Physical Therapy ProcedureUndergo physical therapy | Procedure or surgery | Arm I (ROAR-LCT intervention) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (ROAR-LCT intervention), Arm II (standard of care) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (ROAR-LCT intervention), Arm II (standard of care) |
| Relaxation TherapyUndergo progressive muscles relaxation exercises | Procedure or surgery | Arm I (ROAR-LCT intervention) |
Primary outcome
Study adherence
Time frame: Up to 12 weeks
Study adherence will be defined as the completion of 70% of the program sessions, repeated assessments, and collection of biospecimens either at the end of the study period or death, whichever occurs first.
Retention
Time frame: 1.5 month
Retention rates will be defined as the percentage of participants not lost to follow-up at 1.5 months,
Retention
Time frame: 3 Month
Retention rates will be defined as the percentage of participants not lost to follow-up at 3 months
Retention
Time frame: 6 Month
Retention rates will be defined as the percentage of participants not lost to follow-up at 6 months
Amount and duration of therapy that participants were able to complete
Time frame: Week 12
sessions completed, weeks it takes to complete all 12 session; missed sessions; reasons for missed sessions
Amount and duration of therapy that participants were able to complete
Time frame: Week 24
sessions completed, weeks it takes to complete all 12 session; missed sessions; reasons for missed sessions
Preliminary effect on functional status
Time frame: 3 Month
A joint model using group-based trajectory modeling will be used to estimate clinically distinct trajectories of functional status and attrition probability (death or dropout). These models will be used to evaluate differences in change of functional scores between study arms through 3 months of follow-up. Additionally, generalized linear mixed models (GLMMs) will be used to model change in functional status from baseline to 3 months to explore if the intervention has both an immediate and sustained impact on function.
Preliminary effect on functional status
Time frame: 6 Month
A joint model using group-based trajectory modeling will be used to estimate clinically distinct trajectories of functional status and attrition probability (death or dropout). These models will be used to evaluate differences in change of functional scores between study arms through 6 months of follow-up. Additionally, generalized linear mixed models (GLMMs) will be used to model change in functional status from baseline 6 months to explore if the intervention has both an immediate and sustained impact on function.
Preliminary effect on functional status
Time frame: 12 month
A joint model using group-based trajectory modeling will be used to estimate clinically distinct trajectories of functional status and attrition probability (death or dropout). These models will be used to evaluate differences in change of functional scores between study arms through 12 months of follow-up. Additionally, generalized linear mixed models (GLMMs) will be used to model change in functional status from baseline to 12 months to explore if the intervention has both an immediate and sustained impact on function.
6 secondary outcomes
Physical capability
Time frame: Up to 12 weeks
Incidence and severity of toxicity
Time frame: Up to 12 weeks
Psychological symptoms
Time frame: Up to 12 weeks
Psychological Symptoms
Time frame: Up to 12 weeks
Physical function
Time frame: Up to 12 weeks
Physical Endurance
Time frame: Up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- The JameslineLink provided by the sponsor.
- 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.
Carolyn J Presley, MD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Exercise Intervention and Physical Therapy in people with Advanced Lung Non-Small Cell Carcinoma and Advanced Lung Small Cell Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
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 6 inclusion and 2 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: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Study adherence (time frame: Up to 12 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2025.