100 Participants Needed

Supportive Care for Lung Cancer

TO
Overseen ByThe Ohio State University Comprehensive Cancer Center
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Ohio State University Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems likely that you can continue them, as there are no specific exclusions related to medications.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on supportive care interventions like physical therapy and relaxation, so it's likely you can continue your current treatments, but you should confirm with the trial coordinators.

What data supports the idea that Supportive Care for Lung Cancer is an effective treatment?

The available research shows that Supportive Care for Lung Cancer, which includes exercise and physical therapy, is effective in improving the quality of life for patients. One study found that patients who participated in pulmonary rehabilitation experienced less difficulty breathing and improved mobility compared to those who did not. Another study highlighted that this type of care can enhance exercise tolerance and overall health-related quality of life. Additionally, a review of various studies confirmed that pulmonary rehabilitation helps improve lung function and physical activity levels, making it a beneficial treatment for lung cancer patients.12345

What data supports the effectiveness of the treatment for lung cancer?

Research shows that pulmonary rehabilitation, which includes exercise and physical therapy, can improve exercise capacity, reduce breathing difficulties, and enhance quality of life for lung cancer patients. These benefits are seen both during and after cancer treatment, suggesting that similar supportive care interventions could be effective.12345

What safety data exists for supportive care treatments in lung cancer?

The safety of supportive care treatments, such as exercise interventions, for lung cancer patients is generally supported by existing research. Studies indicate that exercise-based interventions, including prehabilitation and pulmonary rehabilitation, are safe and can improve physical and psychological health. Prehabilitation, in particular, is noted to be a safe intervention without side effects, although its impact on reducing postoperative complications and mortality is still under discussion. Overall, these interventions are considered safe and beneficial, especially for high-risk patients with impaired lung function.56789

Is supportive care for lung cancer, including exercise and rehabilitation programs, safe for humans?

Exercise and rehabilitation programs for lung cancer patients are generally safe and can improve physical and psychological health. These programs have shown benefits like increased exercise capacity and reduced risk of complications, with no significant side effects reported.56789

Is pulmonary rehabilitation a promising treatment for lung cancer?

Yes, pulmonary rehabilitation is a promising treatment for lung cancer. It helps improve exercise tolerance, quality of life, and surgical readiness. It also reduces complications from surgery and allows patients to be more active, enhancing their ability to participate in family life and manage their condition better.510111213

How is pulmonary rehabilitation different from other treatments for lung cancer?

Pulmonary rehabilitation is unique because it is a non-medication treatment that focuses on improving exercise tolerance, quality of life, and surgical outcomes for lung cancer patients. It includes exercise programs, breathing retraining, and self-management skills, which help patients become more active and manage symptoms like breathlessness, unlike traditional drug therapies.510111213

Research Team

Carolyn J Presley, MD | Medical ...

Carolyn J. Presley, MD, MHS

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

This trial is for adults aged 60 or older with advanced lung cancer (stage IIIA, IIIB, or IV non-small cell lung cancer or extensive stage small cell lung cancer). They must be able to understand and sign a consent form, have a certain level of physical function, and plan to receive treatment at the Ohio State University Comprehensive Cancer Center. Prisoners are not eligible.

Inclusion Criteria

My lung cancer is at an advanced stage and cannot be surgically removed.
I can join the study at any stage of my treatment at OSU.
You have a score of 2 or higher on the three functional questions of the EQ5D5L patient survey.
See 3 more

Exclusion Criteria

My health status, lab values, past cancers, other illnesses, or brain metastases do not disqualify me.
Prisoners are excluded from participation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the ROAR-LCT intervention or standard of care for 12 weeks. The ROAR-LCT intervention includes weekly physical therapy visits and progressive muscle relaxation exercises.

12 weeks
Weekly visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of functional status and psychological symptoms.

12 months

Long-term follow-up

Participants are followed up for up to 24 months after the date of study enrollment to assess long-term outcomes.

24 months

Treatment Details

Interventions

  • Exercise Intervention
  • Physical Therapy
  • Relaxation Therapy
Trial OverviewThe ROAR-LCT trial is testing a supportive care intervention aimed at improving physical and emotional wellbeing in patients undergoing treatment for advanced lung cancer. It includes questionnaires, quality-of-life assessments, relaxation therapy like muscle relaxation exercises, best practice guidelines adherence, and an exercise program managed by physical therapists.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (ROAR-LCT intervention)Experimental Treatment5 Interventions
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 II: Arm II (standard of care)Active Control3 Interventions
Patients receive standard of care for 12 weeks.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials
350
Recruited
295,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Findings from Research

A study of 47 patients with non-small cell lung cancer (NSCLC) showed that participating in a multidisciplinary pulmonary rehabilitation program significantly improved their lung function and exercise capacity after cancer treatment, with notable increases in forced expiratory volume and 6-minute walk test distance.
The improvements in pulmonary function and exercise capacity were consistent regardless of the presence of chronic obstructive pulmonary disease (COPD) or whether patients had undergone thoracic surgery, indicating that pulmonary rehabilitation can be beneficial for a broad range of NSCLC patients.
Pulmonary rehabilitation in non-small cell lung cancer patients after completion of treatment.Glattki, GP., Manika, K., Sichletidis, L., et al.[2012]
Pulmonary rehabilitation in patients with chronic obstructive pulmonary disease (COPD) significantly improves symptoms like shortness of breath (dyspnea), exercise capacity, and overall quality of life, as well as reducing healthcare resource use.
The effectiveness of exercise training during rehabilitation can be enhanced by using bronchodilators, supplemental oxygen, and noninvasive ventilatory support, allowing patients to train at higher intensities for better outcomes.
The roles of bronchodilators, supplemental oxygen, and ventilatory assistance in the pulmonary rehabilitation of patients with chronic obstructive pulmonary disease.ZuWallack, RL.[2008]
Pulmonary rehabilitation significantly improves lung function, exercise capacity, and quality of life in lung cancer patients undergoing chest surgery, as shown by a comprehensive review of studies.
This intervention is effective in enhancing respiratory and peripheral muscle function, lung mechanics, and overall physical activity, making it a crucial component of care for patients with lung cancer and related respiratory conditions.
Effectiveness and quality of life in lung cancer, pre-, post- and perioperative rehabilitation - A review.Abidi, Y., Fekete, M., Farkas, Á., et al.[2023]

References

Pulmonary rehabilitation in non-small cell lung cancer patients after completion of treatment. [2012]
The roles of bronchodilators, supplemental oxygen, and ventilatory assistance in the pulmonary rehabilitation of patients with chronic obstructive pulmonary disease. [2008]
Effectiveness and quality of life in lung cancer, pre-, post- and perioperative rehabilitation - A review. [2023]
Pulmonary Rehabilitation in Advanced Lung Cancer Patients During Chemotherapy. [2016]
[Pulmonary rehabilitation in the management of patients with lung cancer]. [2021]
Exercise across the Lung Cancer Care Continuum: An Overview of Systematic Reviews. [2023]
Evaluation of the Structure and Health Impacts of Exercise-Based Cardiac and Pulmonary Rehabilitation and Prehabilitation for Individuals With Cancer: A Systematic Review and Meta-Analysis. [2023]
Systematic Review and Meta-Analysis of Randomized, Controlled Trials on Preoperative Physical Exercise Interventions in Patients with Non-Small-Cell Lung Cancer. [2020]
Prehabilitation in thoracic surgery. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
Pulmonary Rehabilitation and Palliative Care for the Lung Cancer Patient. [2022]
[Efficacy of pulmonary rehabilitation and clinical practice]. [2011]
[Pulmonary rehabilitation in respiratory disorders other than COPD : an individualized approach]. [2019]
Physical activity for people with lung cancer. [2020]