Resiliency Among Older Adults Receiving Lung Cancer Treatment

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.

• Physical Therapy (Procedure), also known as Physiatric Procedure, Physical Medicine Procedure, Physical Therapeutics, Physical Therapy Procedure, Physiotherapy, Physiotherapy Procedure, PT: Undergo physical therapy
• Quality-of-Life Assessment (Other), also known as Quality of Life Assessment: Ancillary studies
• Questionnaire Administration (Other): Ancillary studies
• Relaxation Therapy (Procedure): Undergo progressive muscle relaxation

Primary outcomes

• 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 outcomes

• 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.
• 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).

Sex: All, ages: 60 Years to any

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.

Participant flow

Outcome results

• Recruitment Rates (Primary), Count of participants, Participants: Supportive Care (Physical Therapy, Muscle Relaxation) 11
• Adherence Rate (Primary), Count of participants, Participants: Supportive Care (Physical Therapy, Muscle Relaxation) 11
• Retention Rates (Primary), Count of participants, Participants: Supportive Care (Physical Therapy, Muscle Relaxation) 16
• Functional Trajectories (Secondary)
• Factors Associated With Resiliency (Secondary)

Adverse events

Time frame: A minimum of 12 weeks or through study completion, an average of 1 year

Limitations and caveats: 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.

• Study Protocol and Statistical Analysis Plan (PDF, 2021-03-01)
• Informed Consent Form (PDF, 2021-04-01)

• Carolyn J Presley, MD, MHS, Principal investigator, Ohio State University Comprehensive Cancer Center

NIH grants: R03AG064374