NCT05339022

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Best Practice	Receive standard of care
OTHER	Exercise Intervention	Undergo exercise intervention
PROCEDURE	Physical Therapy	Undergo physical therapy
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
PROCEDURE	Relaxation Therapy	Undergo progressive muscles relaxation exercises

Timeline

• Start date: 2022-04-14
• Primary completion: 2025-09-30
• Completion: 2025-10-01
• First posted: 2022-04-21
• Last updated: 2025-11-21

Locations

1 site across 1 country: United States