Supportive Care Intervention (ROAR-LCT) for Patients With Stage IIIA, IIIB, and IV Lung Cancer, ROAR-LCT Trial

Resiliency Among Older Adults Receiving Lung Cancer Treatment (ROAR-LCT): A Phase II Randomized Supportive Care Intervention Clinical Trial

This phase II trial tests whether a supportive care intervention (Resiliency among Older Adults Receiving Lung Cancer Treatment [ROAR-LCT]) is effective in improving physical and emotional wellbeing in patients with stage IIIA, IIIB, and IV lung cancer undergoing cancer treatment. Lung cancers are one of the most common cancers. Lung cancers occur in the chest and often cause symptoms for patients. Poor physical performance and negative mood are two risk factors for a decline in functional status. Targeted interventions may address these two risk factors and improve functional status and resilience. Physical therapy and relaxation interventions (i.e. progressive muscle relaxation) are two such interventions that may improve symptoms and quality of life for patients with cancer.

Study Overview

• Status: Recruiting
• Conditions: Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8; Stage IIIA Lung Cancer AJCC v8; Stage IIIB Lung Cancer AJCC v8; Extensive Stage Lung Small Cell Carcinoma; Unresectable Lung Non-Small Cell Carcinoma; Advanced Lung Non-Small Cell Carcinoma; Advanced Lung Small Cell Carcinoma; Unresectable Lung Small Cell Carcinoma
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Best Practice; Procedure: Physical Therapy; Other: Exercise Intervention; Procedure: Relaxation Therapy

Detailed Description

PRIMARY OBJECTIVE:

I. To determine the potential effectiveness of a novel, supervised virtual health-assisted physical therapy plus relaxation intervention vs. standard of care on the primary outcomes: functional status and overall feasibility of the study design.

SECONDARY OBJECTIVE:

I. To determine the potential effectiveness of the intervention on secondary outcomes: psychological symptoms, and physical capability among older adults with an advanced lung cancer (N=100).

EXPLORATORY OBJECTIVE:

I. Lung cancer symptom burden, treatment toxicity, and smoking cessation.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive ROAR-LCT intervention weekly for 12 weeks consisting of physical therapy visits and an exercise intervention. Patients also undergo progressive muscles relaxation exercises over 20 minutes for 12 weeks.

ARM II: Patients receive standard of care for 12 weeks.

After completion of study intervention, patients are followed up for up to 24 months after date of study enrollment.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: The Ohio State University Comprehensive Cancer Center; Phone Number: 800-293-5066; Email: OSUCCCClinicaltrials@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Carolyn Presley
      • Contact: Carolyn J. Presley, MD, MHS; Phone Number: 614-293-6786; Email: carolyn.presley@osumc.edu
      • Contact: Madison Grogan; Email: madison.grogan@osumc.edu
      • Principal Investigator: Carolyn J. Presley

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age >= 60 years
• Diagnosed with an 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
• A score of 2 or higher on the three functional items of the European Quality of Life Five Dimension Five Level Scale (EQ5D5L) patient reported outcome (PRO) assessment
• Patients are eligible at any time point during their treatment here at Ohio State University (OSU). Rationale for this timeframe is due to the overwhelming nature of the first few visits and uncertainty around an eventual treatment plan. Patients at any stage of their treatment can participate and benefit from a physical therapy and psychosocial intervention. Patients will be approached at their initial visit but the investigators can also offer enrollment at any one of the patients regularly scheduled clinic visits or via phone or email
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (ROAR-LCT intervention); Patients receive ROAR-LCT intervention weekly for 12 weeks consisting of physical therapy visits and an exercise intervention. Patients also undergo progressive muscles relaxation exercises over 20 minutes for 12 weeks.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Procedure: Physical Therapy; Undergo physical therapy; Other Names: PT; Physiatric Procedure; Physical Medicine Procedure; Physical Therapeutics; Physical Therapy Procedure; Physiotherapy; Physiotherapy Procedure; Other: Exercise Intervention; Undergo exercise intervention; Procedure: Relaxation Therapy; Undergo progressive muscles relaxation exercises
Active Comparator: Arm II (standard of care); Patients receive standard of care for 12 weeks.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Other: Best Practice; Receive standard of care; Other Names: standard of care; standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study adherence	Study adherence will be defined as the completion of 70% of the program sessions, repeated assessments, and collection of biospecimens either at the end of the study period or death, whichever occurs first.	Up to 12 weeks
Retention	Retention rates will be defined as the percentage of participants not lost to follow-up at 1.5 months,	1.5 month
Retention	Retention rates will be defined as the percentage of participants not lost to follow-up at 3 months	3 Month
Retention	Retention rates will be defined as the percentage of participants not lost to follow-up at 6 months	6 Month
Amount and duration of therapy that participants were able to complete	sessions completed, weeks it takes to complete all 12 session; missed sessions; reasons for missed sessions	Week 12
Amount and duration of therapy that participants were able to complete	sessions completed, weeks it takes to complete all 12 session; missed sessions; reasons for missed sessions	Week 24
Preliminary effect on functional status	A joint model using group-based trajectory modeling will be used to estimate clinically distinct trajectories of functional status and attrition probability (death or dropout). These models will be used to evaluate differences in change of functional scores between study arms through 3 months of follow-up. Additionally, generalized linear mixed models (GLMMs) will be used to model change in functional status from baseline to 3 months to explore if the intervention has both an immediate and sustained impact on function.	3 Month
Preliminary effect on functional status	A joint model using group-based trajectory modeling will be used to estimate clinically distinct trajectories of functional status and attrition probability (death or dropout). These models will be used to evaluate differences in change of functional scores between study arms through 6 months of follow-up. Additionally, generalized linear mixed models (GLMMs) will be used to model change in functional status from baseline 6 months to explore if the intervention has both an immediate and sustained impact on function.	6 Month
Preliminary effect on functional status	A joint model using group-based trajectory modeling will be used to estimate clinically distinct trajectories of functional status and attrition probability (death or dropout). These models will be used to evaluate differences in change of functional scores between study arms through 12 months of follow-up. Additionally, generalized linear mixed models (GLMMs) will be used to model change in functional status from baseline to 12 months to explore if the intervention has both an immediate and sustained impact on function.	12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical capability	Functional Status Assessment: This is a 16-item questionnaire that includes seven Activities of Daily Living (ADL) measures, 5 Instrumental Activities of Daily Living (IADL) measures, and 3 mobility activities. For each activity, disability is defined as the need for personal assistance or inability to perform the activity. Activities are scored as 0 being no help, 1 being with help, and 2 meaning unable to perform the activity. Higher scores indicate greater disability or a lower functional status.	Up to 12 weeks
Incidence and severity of toxicity	Toxicity assessment completed at the end of each chemotherapy or immunotherapy treatment cycle using the CTCAE V5; (irAEs, AEs, SAEs) Toxicities will be graded 1-5 with grade 5 being the worst and grade 1 being less severe.	Up to 12 weeks
Psychological symptoms	GAD-7; This assessment is a 7 item questionnaire that asks patients how often in the past 2 weeks, have they been bothered by each symptom. The responses are scored as 0 being "not at all," 1 being "several days," 2 being "more than half the days", and 3 being "nearly every day," for an aggregate score of 21. Higher scores indicate a higher prevalence of anxiety and are strongly associated with multiple domains of functional impairment and disability days.33	Up to 12 weeks
Psychological Symptoms	PHQ-9; This is a 9-item depression segment which assesses the severity of depressive symptoms within the last two weeks. Patients will complete the PHQ-9 approximately every 6 weeks administered by the CRC. Items are scored from 0-3 with higher scores indicating greater levels of depression. If 5 or more of the 9 symptoms have been present for "more than half the days," then major depression is indicated. Other depression is indicated if 2, 3, or 4 of the symptoms have been present at least "more than half the days" in the past 2 weeks, and 1 of the symptoms is depressed mood or anhedonia.	Up to 12 weeks
Physical function	Short Physical Performance Battery (SPPB);. The SPPB is a validated tool used to assess lower extremity functioning. It is comprised of three objective measures testing for standing balance, normal gait speed, and strength performance by use of a timed sit-to-stand. The participants are asked to stand with their feet side by side, semi tandem, and tandem for 10 seconds each to assess balance. Normal gait speed is tested by asking participants to walk 8 feet at his or her normal speed. Strength performance is tested by asking participants to complete five timed chair sit to stands without the use of hands. These three measures are scored individually from 0 to 4 with an aggregate score ranging from 0 to 12, with higher scores correlating with a greater functional status. The scores are then classified into 4 categories; very low physical function (0-3); low physical function (4-6); moderate physical function (7-9); and high physical function (10-12).	Up to 12 weeks
Physical Endurance	2-6 min walk test; This is a validated tool used to assess endurance and overall functional exercise capacity. Patients are instructed to walk on a treadmill at their own pace for as long as they are able. At the end of the allotted time, patients are told to stop and the total distance covered is recorded. Participants walking less than 300 meters are considered to have low endurance while those walking over 300 meters are considered to have normal endurance.	Up to 12 weeks

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Carolyn J Presley, MD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2022
• Primary Completion (Estimated): April 10, 2024
• Study Completion (Estimated): April 10, 2025

Study Registration Dates

• First Submitted: March 1, 2022
• First Submitted That Met QC Criteria: April 14, 2022
• First Posted (Actual): April 21, 2022

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma; Small Cell Lung Carcinoma; Carcinoma, Small Cell; Dermatologic Agents; Keratolytic Agents; Coal Tar
• Other Study ID Numbers: OSU-21218; NCI-2021-14061 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); 5K76AG074923-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No