Virtual Personalized Exercise Program for Lung Cancer Patients
Part of paid clinical trials in New Hyde Park, New York.
- Sponsor
- Northwell Health
- Study ID
- NCT06540495
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Salaso Virtual Exercise Program — BEHAVIORALSalaso is a digital health technology company that has online, mobile and telehealth solutions enabling providers to 'prescribe' evidence-based exercise programs for patients to complete virtually.
Study Details
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
Key Dates
- Start date
- Jun 3, 2024
- Status verified
- Aug 2024
- Primary completion
- Jan 30, 2025
- Completion
- Jun 30, 2025
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Single Arm StudyCohort 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
Primary Outcome Measure
Viability [ Time Frame: 12 months ]
Central Contacts
- Tracy Green(516) 734-8900
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Northwell Health | New Hyde Park | New York | 11042 |
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