Virtual Personalized Exercise Program for Lung Cancer Patients

NCT06540495 | Recruiting DMC

• 1 other identifier: 23-0199
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 1.Expected recruitment - 15 subjects
2. 2.Cohort B: Subjects starting definitive chemotherapy and radiation for locally advanced lung cancer.

Conditions

Lung Cancer

Keywords

Lung Cancer; Exercise

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Patient Satistfaction

  12 months

• Provider Satisfaction

  12 months

Other Outcomes (4)

• Functional improvement, objectively determined as 6MWT

  12 months

• Functional improvement, subjectively determined

  12 months

• Functional improvement, objectively determined as PFTs

  12 months

Study Arms (1)

Single Arm Study

EXPERIMENTAL

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

Behavioral: Salaso Virtual Exercise Program

Interventions

Salaso Virtual Exercise Program BEHAVIORAL

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.

Single Arm Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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

You may not qualify if:

• Unable to render informed consent
• No other current active malignancy (beside lung cancer) at time of enrollment
• Any contraindication to participating physically in an exercise program
• Pregnant or breastfeeding at the time of screening visit
• 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.
• Lack of proficiency in English sufficient for comprehension of trial source documents including the protocol, consent, and questionnaires.

Sponsors & Collaborators

• Northwell Health: lead
• Salaso: collaborator
• AstraZeneca: collaborator

Study Sites (1)

Northwell Health

New Hyde Park, New York, 11042, United States

RECRUITING

Related Publications (22)

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MeSH Terms

Conditions

Lung Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Behavior

Central Study Contacts

Tracy Green

CONTACT

(516) 734-8900; tgreen22@northwell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, Single Arm (Three Cohorts), Open Label, Feasibility study

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: August 6, 2024
• Study Start: June 3, 2024
• Primary Completion: January 30, 2025
• Study Completion: June 30, 2025
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will become available June 2024 and will be available until June 2026.
• Access Criteria: The data will be accessible by pre-selected members of the research and biostatistics team, as well as the technology staff through RedCap which requires a user name, password and security authorization.

Locations

US (1)