Recruiting

Exercise Program

Sponsor:

Northwell Health

Code:

NCT06540495

Conditions

Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Salaso Virtual Exercise Program

Study Details

Brief 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

Conditions

Lung Cancer

Study ID

NCT06540495

Start date

Jun 3, 2024

Status verified date

Aug, 2024

Completion date

Jun 30, 2025

Anticipated

Primary completion date

Jan 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

(1) Adults aged 18 and older (2) Have an ECOG PS of 0-2 (3) Have the ability to provide informed consent (4) Have the ability to engage in a virtual exercise platform (5) Commit to all study procedures as per protocol (6) Are deemed appropriate for virtual exercise program by the PM\&R team (7) English speaking (8) Subjects with non-small cell lung cancer who belong to any of the three cohorts: (i) 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 (ii) Cohort B: Subjects starting definitive chemotherapy and radiation for locally advanced cancer - expected recruitment: 15 subjects (iii) Cohort C: Subjects with stage IV metastatic non-small cell lung cancer irrespective of type of treatment- expected recruitment: 30 subjects

Exclusion Criteria:

1. Unable to render informed consent
2. No other current active malignancy (beside lung cancer) at time of enrollment
3. Any contraindication to participating physically in an exercise program
4. Pregnant or breastfeeding at the time of screening visit
5. Any of the following contraindications to exercise use: acute post-operative subjects (within 8 weeks of operation; subjects with extreme fatigue, anemia, or ataxia; and general cardiovascular and respiratory contraindications for an exercise regimen.
6. Lack of proficiency in English sufficient for comprehension of trial source documents including the protocol, consent, and questionnaires.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Single Arm Study

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

Interventions

Salaso Virtual Exercise Program

Salaso 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.

Primary outcome measure

  • Viability [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Locations

Northwell Health

Recruiting

New Hyde Park, New York, United States, 11042

Contacts

More Information

Sponsor

Northwell Health

Last update posted

Aug 6, 2024

Last verified

Aug, 2024

Keywords

  • Lung Cancer
  • Exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2024-08-06.