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Respiratory Tract Diseases

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Small Cell Lung Cancer

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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.

Physical Therapy

Quality-of-Life Assessment

Questionnaire Administration

Relaxation Therapy

Carolyn J Presley, MD, MHS

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.

PRIMARY OBJECTIVES:

I. 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.

Resiliency Among Older Adults Receiving Lung Cancer Treatment

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

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.

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 will be defined as the percentage of participants not lost to follow-up.

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.

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).

National Institute on Aging (NIA)

Ohio State University Comprehensive Cancer Center

Principal Investigator

Adverse event information was collected for study patients form baseline through study completion utilizing the CTCAE Version 4.0 to determine the severity of the event through study completion.

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.

Physical Therapy: Undergo physical therapy

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Relaxation Therapy: Undergo progressive muscle relaxation

Supportive Care (Physical Therapy, Muscle Relaxation)

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Non-Small Cell Lung Cancer (NSCLC)

Small Cell Lung Cancer (SCLC)

Lung Cancer Type

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.

Dr. Carolyn Presley

Recruitment Rates

Adherence Rate

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.

Retention Rates

Functional Trajectories

Factors Associated With Resiliency

Overall Study

Antineoplastic Agents

Durvalumab

Tumor samples will be collected as standard diagnostic procedure at diagnosis. Plasma samples from whole blood extractions will also be collected at diagnosis, after chemoradiotherapy, and every 3 months from there until completing one year of follow-up.

Sample collection

Genomic alterations of tumor tissue samples will be analyzed locally by next-generation sequencing when material is adequate, as standard diagnostic procedure.

Characterization of the tumoral tissue genomic alterations

Patients will be treated with standard chemotherapy (following the clinical practice at each institution). Radiotherapy will be delivered concurrently when feasible with a total dose of 60-66 Gy. In selected cases, due to frailty of the patient or impaired pulmonary function, radiotherapy will be delivered sequentially. In tumors with positive PD-L1 expression, a year of durvalumab 10 mg/m2 every 2 weeks will be administered if there are no contraindications.

Chemoradiation treatment regimen and maintenance (if amenable)

Blood samples for ctDNA genomic and methylation analysis (4 mL of plasma for each sample) will be sent to the Guardant Health Laboratories in the US and analyzed after Contractual Agreement signature, using the Guardant Reveal test.

This liquid biopsy test uses ctDNA to detect presence of MRD and monitor for recurrence after definitive surgical/systemic therapy for patients with cancer. It has been validated in early-stage colorectal cancer and integrates assessment of somatic alterations with an epigenomic cancer signature to identify the presence of methylation signatures associated with cancer versus normal DNA.

Genomic and methylation analysis in liquid biopsy

Edurne Arriola

Pedro Rocha

Multi-center observational clinical study to evaluate the application value of ctDNA monitoring in efficacy assessment and relapse prediction in patients diagnosed with unresectable, locally advanced NSCLC receiving CRT with or without durvalumab maintenance treatment.

Newly diagnosed, histologically confirmed, unresectable stage III NSCLC patients, amenable to receive standard of care chemoradiotherapy with or without durvalumab maintenance, will be enrolled in this study. Whole blood collection will be conducted during the treatment for ctDNA detection in specific time-points of interest. Next-generation sequencing using commercially available panels, and analysis of ctDNA aberrant methylation will be performed. Results will be correlated to patients' recurrence times and survival outcomes.

Tumor samples from tissue biopsy or citology. Whole blood samples.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Resiliency Among Older Adults Receiving Lung Cancer Treatment	NCT04229381	Advanced Lung C... Extensive Stage... Stage IIIA Lung... Stage IIIB Lung... Stage IV Lung C... Stage IVA Lung ... Stage IVB Lung ... Unresectable Lu... Unresectable Lu...	Physical Therap... Quality-of-Life... Questionnaire A... Relaxation Ther...	60 Years -	Ohio State University Comprehensive Cancer Center
Molecular Profiling and Dynamic Changes of ctDNA in Unresectable Locally Advanced NSCLC	NCT05641870	Lung Cancer Stage III Lung ... Unresectable Lu...	Sample collecti... Characterizatio... Chemoradiation ... Genomic and met...	18 Years -	Parc de Salut Mar
Molecular Profiling and Dynamic Changes of ctDNA in Unresectable Locally Advanced NSCLC	NCT05641870	Lung Cancer Stage III Lung ... Unresectable Lu...	Sample collecti... Characterizatio... Chemoradiation ... Genomic and met...	18 Years -	Parc de Salut Mar
Resiliency Among Older Adults Receiving Lung Cancer Treatment	NCT04229381	Advanced Lung C... Extensive Stage... Stage IIIA Lung... Stage IIIB Lung... Stage IV Lung C... Stage IVA Lung ... Stage IVB Lung ... Unresectable Lu... Unresectable Lu...	Physical Therap... Quality-of-Life... Questionnaire A... Relaxation Ther...	60 Years -	Ohio State University Comprehensive Cancer Center
Molecular Profiling and Dynamic Changes of ctDNA in Unresectable Locally Advanced NSCLC	NCT05641870	Lung Cancer Stage III Lung ... Unresectable Lu...	Sample collecti... Characterizatio... Chemoradiation ... Genomic and met...	18 Years -	Parc de Salut Mar

Spots Global Cancer Trial Database for unresectable lung carcinoma