Feasibility of a Hybrid Delivery of Home-based Cluster Set Resistance Training in Lung Cancer

Symptom burden remains a critical concern for individuals with non-small cell lung cancer (NSCLC) following the completion of treatment. Of those, symptom clusters such as dyspnea (shortness of breath) and fatigue, contribute to physical decline, reductions in quality of life, and a higher risk of comorbidities and mortality. It has been proposed that dyspnea is a primary limiter of exercise capacity in individuals with lung cancer, resulting in exercise avoidance and an accelerated physical decline. As such, specifically designing resistance exercise programs with cluster sets, to mitigate feelings of dyspnea and fatigue may result in improved exercise tolerance, resulting in the maintenance of physical function and quality of life.

The purpose of this project is to investigate the feasibility and preliminary efficacy of a hybrid-delivery of home-based cluster-set resistance exercise in individuals with NSCLC. Methods: Individuals with NSCLC (n=15), within 12-months of completion of treatment will be recruited to participate in this single arm feasibility trial. Participants will complete 8-weeks of home-based resistance training (RT) designed to target dyspnea and fatigue. The hybrid-delivery of the program will include supervised sessions in the participants home, and virtual supervision via video conferencing. The primary outcome of feasibility will be measured via recruitment rates, retention, acceptability and intervention fidelity. Exploratory outcomes (dyspnea, fatigue, quality of life, physical function and body composition) will be assessed pre- and post- intervention.

Study Overview

• Status: Completed
• Conditions: Non Small Cell Lung Cancer; Resistance Exercise
• Intervention / Treatment: Behavioral: Resistance Exercise

Detailed Description

Analysis plan. Descriptive statistics (percentages and means (with standard deviations)) will be used to report on feasibility outcomes (recruitment, retention, fidelity etc.). Unless explicitly stated, means and standard deviations will be reported for assessments of exploratory outcomes at baseline and follow-up.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Columbia, South Carolina, United States, 29201
      • University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Completed definitive treatment for localized NSCLC (stages I-III)
• Has access to stable internet access for Zoom participation
• Willing to complete an 8-week, home-based intervention program that includes face-to-face and Zoom interaction.
• Willing to consider behavior change at this time.
• Able to speak and read English.
• Capable of informed consent
• Has obtained medical clearance from medical practitioner or medical team

Exclusion Criteria:

• Individuals with a known diagnosis of advanced lung cancer (stage IV; due to potential added burden) or diagnosis of small-cell lung cancer,
• Anyone for whom physical activity is not recommended.
• aren't comfortable having study staff visit their homes for exercise sessions
• have any neuromuscular, cardiovascular, or psychological condition precluding safe exercise;
• have participated in structured RE ≥2 times/week for the past 6 months;
• are unable to read/understand English.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise Intervention	Behavioral: Resistance Exercise; This is an 8-week exercise program, delivered using a hybrid approach of in-person, in-home supervised exercise, and virtual delivery of exercise via zoom. Individuals will participate in resistance exercise 3 days per week for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment	The recruitment goal of n=15 is reached	Through study completion, an average of 1 year
Retention	If ≥75% of the sample recruited to participate return for follow up testing	Through study completion, an average of 1 year
Intervention Fidelity	Exercise fidelity will be reported using metrics previously outlines by Fairman et al (2019). Specifically, volume load will be calculated as a function of sets x reps for each exercise and summed to give total volume for each session. We will report the proportion of volume achieved relevant to what was prescribed to give a "relative-dose intensity" (RDI) for each person. RDI will then be averaged and used to determine fidelity to the RT intervention.	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability	10-item scale adapted from McDonnell et al (PMID: 33118443). Questions assessing the acceptability of the intervention will be scored on a 4-point Likert-Type scale from "Strongly disagree" to "Strongly Agree". Questions will ask about the utility of virtual exercise sessions, use of technology and level of tailoring the intervention	At post intervention (8-weeks)
Dyspnea	Functional Assessment of Chronic Illness Therapy-Dyspnea (FACIT-D) 10-Item short form (parts 1 and 2). Part 1 assesses Dyspnea and Part 2 assesses dyspnea-associated functional limitations. Min score for each part: 0; max score for each part: 30. Higher scores indicate worse dyspnea/burden	Baseline and post intervention (8-weeks)
Fatigue	Functional Assessment of Chronic Illness Therapy-Fatigue scale 13-item scale. Min score: 0 Max score: 52 Higher scores mean higher quality of life.	Baseline and post intervention (8-weeks)
Lung Cancer Related Quality of Life	Functional Assessment of Cancer Therapy - Lung Cancer Subscale (LCS). Min score: 0; max score: 28. Higher scores indicate better quality of life.	Baseline and post intervention (8-weeks)
Upper Body Muscular Strength	Chest Press five repetition maximum	Baseline and post intervention (8-weeks)
Lower Body Muscular Strength	Leg Press five repetition maximum	Baseline and post intervention (8-weeks)
Physical Function STS	5 times sit-to-stand (in seconds)	Baseline and post intervention (8-weeks)
Physical Function 6MWT	6-minute Walk Test (distance in meters)	Baseline and post intervention (8-weeks)
Fat Mass	Fat mass (kg) Dual Energy X-Ray Absorptiometry	Baseline and post intervention (8-weeks)
Fat Free Mass	Fat Free Mass (kg) Dual Energy X-Ray Absorptiometry	Baseline and post intervention (8-weeks)
Total Mass	Total Mass (kg) Dual Energy X-Ray Absorptiometry	Baseline and post intervention (8-weeks)
Body Fat Percentage	Dual Energy X-Ray Absorptiometry	Baseline and post intervention (8-weeks)
Appendicular Lean Mass	Sum of Arm and Leg Fat Free Mass	Baseline and post intervention (8-weeks)
Bone Mineral Density	Total z-score Dual X-ray Absorptiometry	Baseline and post intervention (8-weeks)
Acceptability	Qualitative interview with participants regarding the acceptability, likes, dislikes about the intervention and potential barriers for future participation.	Post-Intervention (8-weeks)

Collaborators and Investigators

• Sponsor: University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): September 22, 2022
• Study Completion (Actual): September 22, 2022

Study Registration Dates

• First Submitted: July 30, 2021
• First Submitted That Met QC Criteria: August 12, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Physical Activity; Exercise; Lung Cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: Pro00110261

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All de-identified data and code for analyses will be made available as soon as possible with publication of the primary outcome paper. The dataset will include demographic information, and physiological and psychosocial measures outlined in the proposal.
• IPD Sharing Time Frame: All de-identified data and code for analyses will be made available as soon as possible with publication of the primary outcome paper.
• IPD Sharing Access Criteria: We will make the de-identified data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying the data after analyses are completed.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No