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Resiliency Among Older Adults Receiving Lung Cancer Treatment (ROAR-LCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04229381
Recruitment Status : Recruiting
First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Carolyn Presley, Ohio State University Comprehensive Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
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 Stage IVB Lung Cancer AJCC v8 Unresectable Lung Carcinoma Unresectable Lung Non-Small Cell Carcinoma Procedure: Physical Therapy Other: Quality-of-Life Assessment Other: Questionnaire Administration Procedure: Relaxation Therapy Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : January 8, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arms and Interventions
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Arm Intervention/treatment
Experimental: Supportive Care (physical therapy, muscle relaxation)
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.
 Procedure: Physical Therapy
Undergo physical therapy
Other Names:
  • Physiatric Procedure
  • Physical Medicine Procedure
  • Physical Therapeutics
  • Physical Therapy Procedure
  • Physiotherapy
  • Physiotherapy Procedure
  • PT

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Procedure: Relaxation Therapy
Undergo progressive muscle relaxation


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Retention rates [ Time Frame: Up to 24 weeks ]
    Retention rates will be defined as the percentage of participants not lost to follow-up.


Secondary Outcome Measures :
  1. Functional trajectories [ Time Frame: 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.

  2. Factors associated with Resiliency [ Time Frame: 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).


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04229381


Contacts
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Contact: The Ohio State University Comprehensive Cancer Center 1-800-293-5066 OSUCCCClinicaltrials@osumc.edu
Contact: Madison Grogan Madison.Grogan@osumc.edu

Locations
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United States, Ohio
Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Carolyn J. Presley, MD, MHS    614-293-6786    carolyn.presley@osumc.edu   
Principal Investigator: Carolyn J. Presley, MD, MHS         
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Carolyn J Presley, MD, MHS Ohio State University Comprehensive Cancer Center
More Information
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Additional Information:

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Responsible Party: Carolyn Presley, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT04229381    
Other Study ID Numbers: OSU-19115
NCI-2019-04722 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA016058 ( U.S. NIH Grant/Contract )
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Carcinoma, Small Cell
Small Cell Lung Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Coal Tar
Keratolytic Agents
Dermatologic Agents