Virtual Personalized Exercise Program for Lung Cancer Patients
NCT Number: NCT06540495
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lung Cancer
Interventions: BEHAVIORAL: Salaso Virtual Exercise Program
Sponsor: Northwell Health
Collaborators: Salaso|AstraZeneca
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-03
Completion Date: 2025-06-30
Locations: Northwell Health, New Hyde Park, New York, 11042, United States

Summary:
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

Primary Outcome Measures: Viability, Feasibility of enabling patients to utilize a virtual exercise program, as assessed by percentage of eligible subjects who agree to enroll in the program, and percentage of enrolees who complete the program. Our objective is to have 50% of those who enroll complete the program at 12-months., 12 months
Secondary Outcome Measures: Patient Satistfaction, Level of satisfaction in the ExerciseRx program as assessed by the Patient Satisfaction questionnaires, 12 months|Provider Satisfaction, Provider satisfaction as assessed by provider satisfaction questionnaire to oncologists and PM\&R physicians to determine whether they will use this platform to manage subjects, 12 months
Other Outcome Measures: Functional improvement, objectively determined as 6MWT, Physical endurance as assessed by the Six minute walk test (6MWT, measured in meters), 12 months|Functional improvement, subjectively determined, Change or maintenance of HRQoL as determined by FACT-L questionnaire which is a 36 -item self-report instrument that measures multidimensional quality of life. Score range is 0-28 and the sum of the individual scores is multiplied by 7 and then divided by the number of items answered. The higher the score, the better the QOL., 12 months|Functional improvement, objectively determined as PFTs, Improvement or maintenance of pulmonary function (PFT) as measured by DLCO (cc of CO/sec/mm of Hg), FVC (measured in liters), FEV1 (measured in liters over 1 second), 12 months|Functional improvement, objectively determined as STS, Sit to Stand Test (STS) measured in seconds, 12 months