Resiliency Among Older Adults Receiving Lung Cancer Treatment (ROAR-LCT)
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| ClinicalTrials.gov Identifier: NCT04229381 |
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Recruitment Status :
Recruiting
First Posted : January 18, 2020
Last Update Posted : January 18, 2020
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Sponsor:
Ohio State University Comprehensive Cancer Center
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Carolyn Presley, Ohio State University Comprehensive Cancer Center
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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 |
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 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 Genetics related topics:
Lung cancer
MedlinePlus related topics:
Health Checkup
| Arm | Intervention/treatment |
|---|---|
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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.
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Procedure: Physical Therapy
Undergo physical therapy
Other Names:
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 |
Primary Outcome Measures :
- 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.
- 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.
- 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 :
- 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.
- 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).
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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.
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
| Contact: The Ohio State University Comprehensive Cancer Center | 1-800-293-5066 | OSUCCCClinicaltrials@osumc.edu | |
| Contact: Madison Grogan | Madison.Grogan@osumc.edu |
Locations
| 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
| Principal Investigator: | Carolyn J Presley, MD, MHS | Ohio State University Comprehensive Cancer Center |
Additional Information:
| 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 |
| 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 |