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

NCT05339022 | Completed DMC

• 3 other identifiers: OSU-21218NCI-2021-140615K76AG074923-03
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Lung Non-Small Cell Carcinoma; Advanced Lung Small Cell 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 Non-Small Cell Carcinoma; Unresectable Lung Small Cell Carcinoma

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (6)

• Physical capability

  Up to 12 weeks

• Incidence and severity of toxicity

  Up to 12 weeks

• Psychological symptoms

  Up to 12 weeks

• Psychological Symptoms

  Up to 12 weeks

• Physical function

  Up to 12 weeks

Study Arms (2)

Arm I (ROAR-LCT intervention)

EXPERIMENTAL

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: Exercise Intervention; Procedure: Physical Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Relaxation Therapy

Arm II (standard of care)

ACTIVE COMPARATOR

Patients receive standard of care for 12 weeks.

Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Best Practice OTHER

Receive standard of care

Also known as: standard of care, standard therapy

Arm II (standard of care)

Exercise Intervention OTHER

Undergo exercise intervention

Arm I (ROAR-LCT intervention)

Physical Therapy PROCEDURE

Undergo physical therapy

Also known as: Physiatric Procedure, Physical Medicine Procedure, Physical Therapeutics, Physical Therapy Procedure, Physiotherapy, Physiotherapy Procedure, PT

Arm I (ROAR-LCT intervention)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (ROAR-LCT intervention); Arm II (standard of care)

Questionnaire Administration OTHER

Ancillary studies

Arm I (ROAR-LCT intervention); Arm II (standard of care)

Relaxation Therapy PROCEDURE

Undergo progressive muscles relaxation exercises

Arm I (ROAR-LCT intervention)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Prisoners are excluded from participation

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Carolyn Presley

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care; Physical Therapy Modalities; Relaxation Therapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Therapeutics; Rehabilitation; Mind-Body Therapies; Complementary Therapies; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Carolyn J Presley, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: April 21, 2022
• Study Start: April 14, 2022
• Primary Completion: September 30, 2025
• Study Completion: October 1, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)