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

NCT ID: NCT05339022

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-14
• Study Completion Date: 2025-10-01

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.

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Exercise Intervention

Intervention Type: OTHER

Undergo exercise intervention

Physical Therapy

Intervention Type: PROCEDURE

Undergo physical therapy

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Relaxation Therapy

Intervention Type: PROCEDURE

Undergo progressive muscles relaxation exercises

Arm II (standard of care)

Patients receive standard of care for 12 weeks.

Group Type: ACTIVE_COMPARATOR

Best Practice

Intervention Type: OTHER

Receive standard of care

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Best Practice

Receive standard of care

Intervention Type: OTHER

Exercise Intervention

Undergo exercise intervention

Intervention Type: OTHER

Physical Therapy

Undergo physical therapy

Intervention Type: PROCEDURE

Quality-of-Life Assessment

Ancillary studies

Intervention Type: OTHER

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Relaxation Therapy

Undergo progressive muscles relaxation exercises

Intervention Type: PROCEDURE

Other Intervention Names

standard of care; standard therapy; Physiatric Procedure; Physical Medicine Procedure; Physical Therapeutics; Physical Therapy Procedure; Physiotherapy; Physiotherapy Procedure; PT; Quality of Life Assessment

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Carolyn Presley

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carolyn J Presley, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Locations

Carolyn Presley

Columbus, Ohio, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Related Links

http://cancer.osu.edu

The Jamesline

Other Identifiers

NCI-2021-14061

Identifier Type: REGISTRY

Identifier Source: secondary_id

5K76AG074923-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

OSU-21218

Identifier Type: -

Identifier Source: org_study_id