Virtual Exercise Program for Lung Cancer

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Northwell Health

Disqualifiers: Active malignancy, Pregnancy, Extreme fatigue, others

Stay on Your Current Meds

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This is a prospective study providing lung cancer subjects at R.J. Zuckerberg Cancer Center with a customized exercise program provided by Salaso, with the goal of improving functional status and outcomes. This study will assess the feasibility and usability of a virtual exercise platform designed for lung cancer subjects. Subjects will be referred to physical therapy and rehabilitation medicine doctors for evaluation and enrolment in a virtual exercise program tailored specifically to their needs. The virtual exercise program will be available on a digital platform accessible through a personal device. Subjects will undergo a pulmonary function test if not previously completed within 3 months of signing consent, a Six minute walk test (6MWT) and the Sit to Stand Test (STS) at the start and end of the 12- month program. Subjects will also be asked to complete quality of life FACT-L and the Patient Satisfaction questionnaires at 1 month, 3-months, 6-months, and 12-months. Patient satisfactions questionnaires include the System Usability Scale, Net Promotor Score (NPS), and the Technology Acceptance Model. Physicians will also complete a provider satisfaction questionnaire at 1 month, 6 months, 12 months, and 24 months from the time their first patient is enrolled. Subject participation in the trial will last 12 months from the time the subject starts utilizing the platform. If we find that the platform is accepted by subjects and is found to be feasible, a future randomized study will be developed to follow. Eligibility criteria (note that subjects will be allowed to be enrolled in the program as long as it is within 3 weeks of starting treatment): i. Subjects with Non-small cell lung cancer who belong to any of the three cohorts below ii. Have an ECOG PS of 0-2 iii. Can provide informed consent iv. Can engage in a virtual exercise platform v. Commit to all study procedures as per protocol vi. Are deemed appropriate for virtual exercise program by the PM\&R team The following three cohorts of subjects will be eligible for this feasibility study: 1. Cohort A: Peri-operative (subjects starting neoadjuvant chemotherapy or within 4-8 weeks after curative-intent thoracic surgery which could be segmentectomy, lobectomy of pneumonectomy), irrespective of adjuvant treatment). 1. Expected recruitment - 15 subjects 2. Cohort B: Subjects starting definitive chemotherapy and radiation for locally advanced lung cancer. 1. Expected recruitment - 15 subjects 3. 3. Cohort C; Subjects with stage IV metastatic non-small cell lung cancer irrespective of type of treatment. 1. Expected recruitment - 30 subjects

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 focuses on a virtual exercise program for lung cancer patients.

What data supports the effectiveness of the treatment Salaso Virtual Exercise Program for lung cancer?

Exercise programs have been shown to improve exercise capacity and quality of life for people with lung cancer and other chronic conditions. While specific data on the Salaso Virtual Exercise Program is not available, similar exercise programs have been found to be safe and beneficial for lung cancer patients, suggesting potential effectiveness. ^{1 2 3 4 5}

Is the Salaso Virtual Exercise Program safe for humans?

There is limited information on the safety of virtual exercise programs like the Salaso Virtual Exercise Program specifically for lung cancer, but a systematic review suggests that telerehabilitation (remote exercise programs) is generally safe for lung cancer patients. However, more consistent reporting of adverse events in exercise oncology trials is needed to fully understand safety. ^{1 6 7 8 9}

How is the Salaso Virtual Exercise Program treatment different from other treatments for lung cancer?

The Salaso Virtual Exercise Program is unique because it offers a virtual platform for exercise, making it accessible for lung cancer patients who may face barriers to physical activity. This program focuses on improving physical capacity, quality of life, and mental health through guided exercises, which can be tailored to the patient's stage of disease and individual needs. ^{3 7 10 11 12}

Research Team

Eligibility Criteria

This trial is for lung cancer patients at R.J. Zuckerberg Cancer Center who can perform exercises virtually and commit to a 12-month program. It's open to those with Non-small cell lung cancer, an ECOG performance status of 0-2, able to consent, and deemed appropriate by the PM&R team. There are three cohorts: peri-operative patients, those starting chemotherapy and radiation for advanced cancer, and stage IV metastatic patients.

Inclusion Criteria

I am 18 years old or older.

I am able to care for myself and up and about more than 50% of my waking hours.

I can understand and agree to the study's procedures and risks.

Exclusion Criteria

I have lung cancer but no other active cancers.

Lack of proficiency in English sufficient for comprehension of trial source documents including the protocol, consent, and questionnaires

Any contraindication to participating physically in an exercise program

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-3 weeks

Baseline Assessment

Participants undergo pulmonary function test, Six minute walk test (6MWT), and Sit to Stand Test (STS) if not previously completed within 3 months of signing consent

1 week

1 visit (in-person)

Virtual Exercise Program

Participants engage in a virtual personalized exercise program tailored to their needs, accessible through a digital platform

12 months

Monthly virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after the exercise program, including quality of life assessments and provider satisfaction

12 months

4 visits (virtual)

Treatment Details

Interventions

• Salaso Virtual Exercise Program (Behavioural Intervention)

Trial Overview The Salaso Virtual Exercise Program is being tested for its feasibility and impact on lung cancer patients' functional status and quality of life. Participants will use a digital platform for personalized exercise regimens over a year, with evaluations including pulmonary function tests, walking endurance tests (6MWT), strength assessments (STS), and satisfaction surveys.

Participant Groups

Group I: Single Arm Study Experimental Treatment 1 Intervention

Cohort A: Peri-operative (subjects starting neoadjuvant chemotherapy or within 4-8 weeks after curative-intent thoracic surgery which could be segmentectomy, lobectomy of pneumonectomy), irrespective of adjuvant treatment - expected recruitment: 15 subjects Cohort B: Subjects Subjects starting definitive chemotherapy and radiation for locally advanced lung cancer- expected recruitment: 15 subjects Cohort C: Subjects with stage IV metastatic non-small cell lung cancer irrespective of type of treatment - expected recruitment: 30 subjects

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

Michael Dowling

Northwell Health

Chief Executive Officer since 2002

Bachelor's and Master's degrees from University College Cork, Ireland

Dr. David Battinelli

Northwell Health

Chief Medical Officer since 2022

MD from Georgetown University School of Medicine

AstraZeneca

Industry Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Salaso

Collaborator

Trials

1

Recruited

60+

Findings from Research

The study assessed the feasibility of an 8-week hospital-based exercise program for 25 patients with advanced non-small cell lung cancer, finding that while 80% started the program, only 44% completed all sessions.

Patients who completed the exercise program reported significant improvements in lung cancer symptoms without any decline in their functional capacity, suggesting that structured exercise can be beneficial for those who can adhere to it.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A structured exercise program for patients with advanced non-small cell lung cancer. Temel, JS., Greer, JA., Goldberg, S., et al.[2021]

Exercise training significantly improves exercise capacity in individuals who have undergone lung resection for non-small cell lung cancer (NSCLC), with increases in peak oxygen uptake (VO2peak) and six-minute walk distance (6MWD) observed in a review of eight randomized controlled trials involving 450 participants.

Participants who engaged in exercise training also reported better physical health-related quality of life (HRQoL) and reduced feelings of dyspnoea, highlighting the importance of incorporating exercise into postoperative care for NSCLC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training undertaken by people within 12 months of lung resection for non-small cell lung cancer. Cavalheri, V., Burtin, C., Formico, VR., et al.[2021]

Exercise training can significantly improve exercise capacity in individuals who have undergone lung resection for non-small cell lung cancer (NSCLC), with a mean increase of 50.4 meters in the six-minute walk distance compared to control groups.

However, the evidence regarding improvements in health-related quality of life (HRQoL) and lung function (FEV1) was inconclusive, indicating that while exercise training may help with physical capacity, its effects on overall quality of life and lung function need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training undertaken by people within 12 months of lung resection for non-small cell lung cancer. Cavalheri, V., Tahirah, F., Nonoyama, M., et al.[2022]

In a study of 41 lung cancer patients undergoing lung resection, those who participated in supervised systemic pulmonary rehabilitation (PR) showed significant improvements in pain and quality of life after more than 3 months, indicating the efficacy of this intervention.

Patients receiving systemic PR also demonstrated significant enhancements in forced vital capacity (FVC) after 6 months, suggesting that supervised rehabilitation can effectively aid recovery of lung function post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Systemic Postoperative Pulmonary Rehabilitation After Lung Resection Surgery. Kim, SK., Ahn, YH., Yoon, JA., et al.[2020]

Telerehabilitation for lung cancer patients is safe and can improve quality of life, muscle mass, and reduce symptoms of depression and anxiety, although it does not significantly enhance physical capacity except in the preoperative phase.

Despite low recruitment and attendance rates, telerehabilitation serves as a valuable complementary intervention to traditional hospital-based programs, especially for patients unable to attend in-person training due to various barriers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telerehabilitation physical exercise for patients with lung cancer through the course of their disease: A systematic review. Burton, M., Valet, M., Caty, G., et al.[2022]

The ADVANCE study aims to evaluate how adverse events (AEs) are reported in exercise oncology trials, which is crucial for assessing the safety of exercise interventions for cancer patients.

By reviewing published trials and using a standardized checklist for reporting AEs, the study seeks to identify gaps in current practices and inform future research on improving the consistency and transparency of AE reporting in this field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events Reporting of Clinical Trials in Exercise Oncology Research (ADVANCE): Protocol for a Scoping Review. Luo, H., Schumacher, O., Galvão, DA., et al.[2022]

Exercise can significantly benefit lung cancer patients by improving strength, endurance, and emotional well-being, regardless of the stage of their illness.

A structured recovery fitness program that includes breathing exercises, stretching, aerobic activities, and strength training is recommended to support lung cancer survivors and address their diverse needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The importance of exercise in lung cancer treatment. Michaels, C.[2020]

The LUNGEVITY trial will evaluate the effects of different exercise training types on cardiorespiratory fitness (VO2peak) and patient-reported outcomes in 160 post-operative non-small cell lung cancer patients over 16 weeks.

The study aims to determine the most effective exercise regimen (aerobic, resistance, or a combination) for improving fitness and quality of life, which could lead to new rehabilitation guidelines for lung cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The lung cancer exercise training study: a randomized trial of aerobic training, resistance training, or both in postsurgical lung cancer patients: rationale and design. Jones, LW., Eves, ND., Kraus, WE., et al.[2021]

This study will evaluate a 12-week exercise program for 216 patients with advanced lung cancer, focusing on improving physical capacity and quality of life through supervised cardiovascular and strength training.

The primary outcome measured will be maximal oxygen uptake (VO₂peak), with secondary outcomes including muscle strength, functional capacity, lung capacity, and patient-reported anxiety and depression, aiming to provide evidence on the benefits of exercise in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"EXHALE": exercise as a strategy for rehabilitation in advanced stage lung cancer patients: a randomized clinical trial comparing the effects of 12 weeks supervised exercise intervention versus usual care for advanced stage lung cancer patients. Quist, M., Langer, SW., Rørth, M., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

A structured exercise program for patients with advanced non-small cell lung cancer. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Exercise training undertaken by people within 12 months of lung resection for non-small cell lung cancer. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

Physical activity and lung cancer survivorship. [2015]

4. England pubmed.ncbi.nlm.nih.gov

Exercise training undertaken by people within 12 months of lung resection for non-small cell lung cancer. [2022]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Efficacy of Systemic Postoperative Pulmonary Rehabilitation After Lung Resection Surgery. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

The Streaming Web-Based Exercise at Home Study for Breast and Prostate Cancer Survivors: A Feasibility Study Protocol. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Telerehabilitation physical exercise for patients with lung cancer through the course of their disease: A systematic review. [2022]

8. England pubmed.ncbi.nlm.nih.gov

"Randomized trial of physical activity on quality of life and lung cancer biomarkers in patients with advanced stage lung cancer: a pilot study". [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse Events Reporting of Clinical Trials in Exercise Oncology Research (ADVANCE): Protocol for a Scoping Review. [2022]

10. China pubmed.ncbi.nlm.nih.gov

The importance of exercise in lung cancer treatment. [2020]

11. England pubmed.ncbi.nlm.nih.gov

The lung cancer exercise training study: a randomized trial of aerobic training, resistance training, or both in postsurgical lung cancer patients: rationale and design. [2021]

12. England pubmed.ncbi.nlm.nih.gov

"EXHALE": exercise as a strategy for rehabilitation in advanced stage lung cancer patients: a randomized clinical trial comparing the effects of 12 weeks supervised exercise intervention versus usual care for advanced stage lung cancer patients. [2021]