Resiliency Among Older Adults Receiving Lung Cancer Treatment

Stage IV Lung Cancer AJCC v8 Clinical Trial

— ROAR-LCT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04229381
• Other study ID #: OSU-19115
• Secondary ID: NCI-2019-04722R0
• Status: Completed
• Phase: N/A
• Start date: January 22, 2020
• Est. completion date: June 22, 2022

Study information

• Verified date: October 2023
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 22, 2022
• Est. primary completion date: June 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

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.

Related Conditions & MeSH terms

• Advanced Lung Carcinoma
• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Carcinoma, Small Cell
• Extensive Stage Lung Small Cell Carcinoma
• Lung Neoplasms
• Small Cell Lung 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
• Stage IVB Lung Cancer AJCC v8
• Unresectable Lung Carcinoma
• Unresectable Lung Non-Small Cell Carcinoma

Intervention

Procedure:
• Physical Therapy
Undergo physical therapy

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Procedure:
• Relaxation Therapy
Undergo progressive muscle relaxation

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 24 weeks
Primary	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.	Up to 24 weeks
Primary	Retention Rates	Retention rates will be defined as the percentage of participants not lost to follow-up.	Up to 24 weeks
Secondary	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.	At 12 months
Secondary	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).	Up to 12 months

External Links

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