Supportive Care Intervention (ROAR-LCT) for Patients With Stage IIIA, IIIB, and IV Lung Cancer, ROAR-LCT Trial
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About
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.
Full 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.
Enrollment
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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
Trial design
Primary purpose
Allocation
Interventional model
Masking
100 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
The Ohio State University Comprehensive Cancer Center
Data sourced from clinicaltrials.gov
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