Advanced Lung CarcinomaROAR-LCTNCT04229381

Resiliency Among Older Adults Receiving Lung Cancer Treatment

A study testing Physical Therapy, Quality-of-Life Assessment and Questionnaire Administration in people with Advanced Lung Carcinoma and Extensive Stage Lung Small Cell Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 60 years and older
Conditions the study is for: Advanced Lung Carcinoma, Extensive Stage Lung Small Cell Carcinoma, Stage IIIA Lung Cancer AJCC v8
What is being tested?: Physical Therapy, Quality-of-Life Assessment and Questionnaire Administration
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: 22 Jan 2020to 22 Jun 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Diagnosed with 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.
Willingness to participate and adhere to the study intervention program.
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.

United States1 site

Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: Resiliency Among Older Adults Receiving Lung Cancer Treatment (ROAR-LCT): Physical Therapy and Progressive Muscle Relaxation in Improving Physical Performance and Mood in Older Patients With Stage IIIA-B or IV Lung Cancer Undergoing Treatment

This trial studies how well physical therapy and progressive muscle relaxation works in improving physical performance and mood in older patients with stage IIIA-B or IV lung cancer who are undergoing treatment. Improving physical performance and mood may help older patients maintain an independent lifestyle by helping to improve their resilience, the ability to bounce back to normal functioning after a stressor or intervening health event such as treatment or disease progression. Giving physical therapy and progressive muscle relaxation may work in improving symptoms and quality of life in patients with lung cancer.

Read the detailed description

PRIMARY OBJECTIVES:

To assess the feasibility of a novel, weekly supervised virtual health-assisted physical therapy plus relaxation intervention delivered to older adults with advanced thoracic malignancy (N=20).

OUTLINE:

Patients participate physical therapy sessions consisting of cardiovascular and resistance training exercises in person or online and also undergo progressive muscle relaxation sessions once weekly for up to 12 weeks.

After completion of study therapy, patients are followed up at 24 weeks, and then periodically for up to 24 months.

Conditions: Advanced Lung 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, Stage IVA Lung Cancer AJCC v8
Being tested: Physical Therapy, Quality-of-Life Assessment, Questionnaire Administration, Relaxation Therapy
Medical subject headings: Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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 muscle relaxation

Study groups in NCT04229381
Study group	Role	What they receive
Supportive Care (physical therapy, muscle relaxation)	Experimental	Patients participate physical therapy sessions consisting of cardiovascular and resistance training exercises in person or online and also undergo progressive muscle relaxation sessions once weekly for up to 12 weeks. Receives: Procedure: Physical Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Relaxation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Recruitment Rates
Recruitment rates will be defined as the proportion of screened older adults accrued relative to those approached in the Ohio State University Comprehensive Cancer Center (OSUCCC) Thoracic Oncology Clinic. Successful recruitment rates will be defined as >= 50% of older adults (>= 60 years) approached agree to participate.
Measured: Up to 24 weeks
Adherence Rate
Study adherence will be defined as the completion of >= 70% of the program sessions, repeated assessments, and collection of bio specimens either at the end of the study period or death, whichever occurs first.
Measured: Up to 24 weeks
Retention Rates
Retention rates will be defined as the percentage of participants not lost to follow-up.
Measured: Up to 24 weeks

Secondary outcomes (2)

Functional Trajectories
Evaluated using generalized linear mixed models (GLMMS). GLMMs can determine whether factors affect all patient trajectories in similar ways or whether they affect individual trajectories differently. To allow for possible changes in functional status over time (e.g., a change-point analysis) the 'segmented' package in R will be used. Participants' functional status scores will be modeled using a segmented mixed model with random change points. Estimating the change point identifies the point in time that patients' functional status scores change during the 12-months post-diagnosis.
Measured: At 12 months
Factors Associated With Resiliency
Evaluated using GLMMS. Resiliency will be defined as the ability to maintain or regain at least 50% of baseline functional status at any point during the 12 months after diagnosis with specific emphasis at 3 and 6-months post- the start of treatment. The association between resiliency and clinical factors will be evaluated with appropriate statistical techniques for the specific measure (e.g. Chi-square tests will compare categorical variables between participants demonstrating resiliency vs. worsening functional status; a two-sample t-test or Wilcoxon Rank Sum test will compare continuous variables).
Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jan 202022 Jun 2022

First posted18 Jan 2020
Study start22 Jan 2020
Primary completion22 Jun 2021
Study completion22 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Advanced Lung 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04229381
Sponsor's protocol ID: OSU-19115
Other IDs: NCI-2019-04722, R03AG064374
Acronym: ROAR-LCT
Status last verified: Oct 2023
First submitted: 26 Nov 2019
Last updated: 15 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
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Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
RecruitingPhase 3
Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)
NSCLC (Non-small Cell Lung Cancer), Non-Small Cell Lung Cancer
RecruitingPhase 2
A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer

All Advanced Lung Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2023. 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): Physical Therapy and Progressive Muscle Relaxation in Improving Physical Performance and Mood in Older Patients With Stage IIIA-B or IV Lung Cancer Undergoing Treatment
ClinicalTrials.gov ID: NCT04229381
Acronym / sponsor ID: ROAR-LCT / OSU-19115
Conditions: Advanced Lung 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, Stage IVA Lung Cancer AJCC v8
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: 22 Jan 2020 (actual)
Primary completion: 22 Jun 2021 (actual)
Study completion: 22 Jun 2022 (actual)
First posted: 18 Jan 2020 (actual)
Results: Posted 15 Nov 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

To assess the feasibility of a novel, weekly supervised virtual health-assisted physical therapy plus relaxation intervention delivered to older adults with advanced thoracic malignancy (N=20).

OUTLINE:

After completion of study therapy, patients are followed up at 24 weeks, and then periodically for up to 24 months.

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Supportive Care (physical therapy, muscle relaxation)	Experimental	Procedure: Physical Therapy, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Procedure: Relaxation TherapyPatients participate physical therapy sessions consisting of cardiovascular and resistance training exercises in person or online and also undergo progressive muscle relaxation sessions once weekly for up to 12 weeks.

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Diagnosed with 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.
Willingness to participate and adhere to the study intervention program.
Ability to understand and willingness to sign an informed consent document (or indicate approval or disapproval by another means).

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
Physical TherapyAlso: Physiatric Procedure, Physical Medicine Procedure, Physical Therapeutics, Physical Therapy ProcedureUndergo physical therapy	Procedure or surgery	Supportive Care (physical therapy, muscle relaxation)
Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies	Other	Supportive Care (physical therapy, muscle relaxation)
Questionnaire AdministrationAncillary studies	Other	Supportive Care (physical therapy, muscle relaxation)
Relaxation TherapyUndergo progressive muscle relaxation	Procedure or surgery	Supportive Care (physical therapy, muscle relaxation)

Primary outcome

Recruitment Rates
Time frame: Up to 24 weeks
Recruitment rates will be defined as the proportion of screened older adults accrued relative to those approached in the Ohio State University Comprehensive Cancer Center (OSUCCC) Thoracic Oncology Clinic. Successful recruitment rates will be defined as >= 50% of older adults (>= 60 years) approached agree to participate.
Adherence Rate
Time frame: Up to 24 weeks
Study adherence will be defined as the completion of >= 70% of the program sessions, repeated assessments, and collection of bio specimens either at the end of the study period or death, whichever occurs first.
Retention Rates
Time frame: Up to 24 weeks
Retention rates will be defined as the percentage of participants not lost to follow-up.

2 secondary outcomes

Functional Trajectories
Time frame: At 12 months
Factors Associated With Resiliency
Time frame: Up to 12 months

Results and safety

Results posted to the registry on 15 Nov 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Supportive Care (Physical Therapy, Muscle Relaxation)	18	18

Primary outcome: Recruitment Rates

Time frame: Up to 24 weeks. Count of participants. Unit: Participants

Measure	Supportive Care (Physical Therapy, Muscle Relaxation) n = 18
Value	11

Primary outcome: Adherence Rate

Time frame: Up to 24 weeks. Count of participants. Unit: Participants

Measure	Supportive Care (Physical Therapy, Muscle Relaxation) n = 18
Value	11

Primary outcome: Retention Rates

Time frame: Up to 24 weeks. Count of participants. Unit: Participants

Measure	Supportive Care (Physical Therapy, Muscle Relaxation) n = 18
Value	16

Population analysed: 22 patients were consented and enrolled. 4 of the patients that underwent informed consent withdrew from the study prior to completing any study activities. This leaves a total of 18 evaluable participants analyzed for study adherence and retention. Acceptability was defined as completing at least 70 percent of all study visits and not lost to follow up. 2 patients withdrew from the study after beginning the ROAR intervention.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: A minimum of 12 weeks or through study completion, an average of 1 year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Supportive Care (Physical Therapy, Muscle Relaxation)	0 of 18 (0%)	0 of 18 (0%)	0 of 18

Limitations and caveats (from the sponsor): Study opened in February of 2020 and COVID-19 lockdown in Ohio occurred in March of 2020. We had participants already in this first month of accrual who did decide to dropout due to COVID-19 related concerns. The study design was modified as most patients were being seen via virtual health for standard oncology care visits. The first and final intervention sessions were in-person with the remainder conducted via virtual health.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
The JameslineLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Advanced Lung Carcinoma

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
RecruitingPhase 3
Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)
NSCLC (Non-small Cell Lung Cancer), Non-Small Cell Lung Cancer
RecruitingPhase 2
A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer

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, MHS 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?

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 4 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 15 Nov 2023. 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?

Yes. Results are posted in the registry (first posted 15 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Recruitment Rates (time frame: Up to 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04229381.

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 15 Nov 2023.