Resiliency Among Older Adults Receiving Lung Cancer Treatment

Not Applicable

Completed

Conditions: Unresectable Lung Carcinoma
Stage IVA Lung Cancer AJCC v8
Stage IVB Lung Cancer AJCC v8
Unresectable Lung Non-Small Cell Carcinoma
Advanced Lung Carcinoma
Extensive Stage Lung Small Cell Carcinoma
Stage IIIA Lung Cancer AJCC v8
Stage IV Lung Cancer AJCC v8
Stage IIIB Lung Cancer AJCC v8

Interventions: Procedure: Physical Therapy
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Procedure: Relaxation Therapy

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

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).

Exclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
Supportive Care (physical therapy, muscle relaxation)	Questionnaire Administration	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.
Supportive Care (physical therapy, muscle relaxation)	Quality-of-Life Assessment	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.
Supportive Care (physical therapy, muscle relaxation)	Relaxation Therapy	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.
Supportive Care (physical therapy, muscle relaxation)	Physical Therapy	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.

Primary Outcome Measures

Name	Time	Method
Recruitment Rates	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	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	Up to 24 weeks	Retention rates will be defined as the percentage of participants not lost to follow-up.

Secondary Outcome Measures

Name	Time	Method
Factors Associated With Resiliency	Up to 12 months	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).
Functional Trajectories	At 12 months	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.