Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06540495

Virtual Personalized Exercise Program for Lung Cancer Patients

Led by Northwell Health ยท Updated on 2024-08-06

60

Participants Needed

1

Research Sites

56 weeks

Total Duration

On this page

Sponsors

N

Northwell Health

Lead Sponsor

S

Salaso

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Virtual Personalized Exercise Program for Lung Cancer Patients

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 and older
  • ECOG performance status of 0-2
  • Ability to provide informed consent
  • Ability to engage in a virtual exercise platform
  • Commitment to all study procedures as per protocol
  • Deemed appropriate for virtual exercise program by the PM&R team
  • English speaking
  • Diagnosed with non-small cell lung cancer in one of three cohorts: (i) peri-operative (starting neoadjuvant chemotherapy or within 4-8 weeks after curative-intent thoracic surgery), (ii) starting definitive chemotherapy and radiation for locally advanced cancer, (iii) stage IV metastatic non-small cell lung cancer
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent
  • Presence of other active malignancies besides lung cancer at enrollment
  • Any contraindication to physical exercise participation
  • Pregnant or breastfeeding at screening
  • Contraindications to exercise including acute post-operative status within 8 weeks, extreme fatigue, anemia, ataxia, or cardiovascular/respiratory issues
  • Insufficient English proficiency to understand study documents and questionnaires

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Northwell Health

New Hyde Park, New York, United States, 11042

Actively Recruiting

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Research Team

T

Tracy Green

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Virtual Personalized Exercise Program for Lung Cancer Patients | DecenTrialz