RECRUITING

Virtual Personalized Exercise Program for Lung Cancer Patients

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Virtual Personalized Exercise Program for Subjects With Lung Cancer: a Feasibility Study

Quick Facts

Study Start:2024-06-03
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06540495

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. 1. Unable to render informed consent
  2. 2. No other current active malignancy (beside lung cancer) at time of enrollment
  3. 3. Any contraindication to participating physically in an exercise program
  4. 4. Pregnant or breastfeeding at the time of screening visit
  5. 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. 6. Lack of proficiency in English sufficient for comprehension of trial source documents including the protocol, consent, and questionnaires.

Contacts and Locations

Study Contact

Tracy Green
CONTACT
(516) 734-8900
tgreen22@northwell.edu

Study Locations (Sites)

Northwell Health
New Hyde Park, New York, 11042
United States

Collaborators and Investigators

Sponsor: Northwell Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-03
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2024-06-03
Study Completion Date2025-06-30

Terms related to this study

Keywords Provided by Researchers

  • Lung Cancer
  • Exercise

Additional Relevant MeSH Terms

  • Lung Cancer