Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Lung Non-Small Cell Carcinoma | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.80 |
| Advanced Lung Small Cell Carcinoma | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Extensive Stage Lung Small Cell Carcinoma | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IIIA Lung Cancer AJCC v8 | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Lung Cancer AJCC v8 | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
| Stage IVA Lung Cancer AJCC v8 | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
| Stage IVB Lung Cancer AJCC v8 | Malignant Lung Neoplasm |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best Practice | Other | — | UNRESOLVED |
| Exercise Intervention | Other | — | UNRESOLVED |
| Physical Therapy | Procedure | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Relaxation Therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (ROAR-LCT intervention)
- description
- 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.
- interventionNames
- Other: Exercise Intervention
- Procedure: Physical Therapy
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- Procedure: Relaxation Therapy
- type
- ACTIVE_COMPARATOR
- label
- Arm II (standard of care)
- description
- Patients receive standard of care for 12 weeks.
- interventionNames
- Other: Best Practice
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
Primary outcomes (9)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available