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Virtual Personalized Exercise Program for Lung Cancer Patients

NCT06540495 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-08-06

No results posted yet for this study

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

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

  • Salaso

    collaborator UNKNOWN

  • AstraZeneca

    collaborator INDUSTRY

  • Northwell Health

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-03
Primary Completion
2025-01-30
Completion
2025-06-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06540495 on ClinicalTrials.gov