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Non Small Cell Lung CancerNCT05014035

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

A study testing Resistance Exercise in people with Non Small Cell Lung Cancer and Resistance Exercise, run by University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Resistance Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteUnited States
Study dates
1 Jan 2022to 22 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of South Carolina

    Columbia, South Carolina, 29201

Other trials in United States

About this study

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.

Read the 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.

Being tested
Resistance Exercise
Keywords
Exercise, Physical Activity, Lung Cancer
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Motor Activity, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Resistance ExerciseBehavioural

    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.

Study groups in NCT05014035
Study groupRoleWhat they receive
Exercise InterventionExperimentalNot described
Receives: Behavioral: Resistance Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment

    The recruitment goal of n=15 is reached

    Measured: Through study completion, an average of 1 year

  2. Retention

    If ≥75% of the sample recruited to participate return for follow up testing

    Measured: Through study completion, an average of 1 year

  3. 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.

    Measured: Through study completion, an average of 1 year

Secondary outcomes (15)

  1. 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

    Measured: At post intervention (8-weeks)

  2. 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

    Measured: Baseline and post intervention (8-weeks)

  3. 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.

    Measured: Baseline and post intervention (8-weeks)

  4. 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.

    Measured: Baseline and post intervention (8-weeks)

  5. Upper Body Muscular Strength

    Chest Press five repetition maximum

    Measured: Baseline and post intervention (8-weeks)

  6. Lower Body Muscular Strength

    Leg Press five repetition maximum

    Measured: Baseline and post intervention (8-weeks)

  7. Physical Function STS

    5 times sit-to-stand (in seconds)

    Measured: Baseline and post intervention (8-weeks)

  8. Physical Function 6MWT

    6-minute Walk Test (distance in meters)

    Measured: Baseline and post intervention (8-weeks)

  9. Fat Mass

    Fat mass (kg) Dual Energy X-Ray Absorptiometry

    Measured: Baseline and post intervention (8-weeks)

  10. Fat Free Mass

    Fat Free Mass (kg) Dual Energy X-Ray Absorptiometry

    Measured: Baseline and post intervention (8-weeks)

  11. Total Mass

    Total Mass (kg) Dual Energy X-Ray Absorptiometry

    Measured: Baseline and post intervention (8-weeks)

  12. Body Fat Percentage

    Dual Energy X-Ray Absorptiometry

    Measured: Baseline and post intervention (8-weeks)

  13. Appendicular Lean Mass

    Sum of Arm and Leg Fat Free Mass

    Measured: Baseline and post intervention (8-weeks)

  14. Bone Mineral Density

    Total z-score Dual X-ray Absorptiometry

    Measured: Baseline and post intervention (8-weeks)

  15. Acceptability

    Qualitative interview with participants regarding the acceptability, likes, dislikes about the intervention and potential barriers for future participation.

    Measured: Post-Intervention (8-weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2021
  2. Study start1 Jan 2022
  3. Primary completion22 Sep 2022
  4. Study completion22 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
Single-arm feasibility trial
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05014035
Sponsor's protocol ID
Pro00110261
Status last verified
May 2023
First submitted
30 Jul 2021
Last updated
12 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Fairman CM, Owens OL, Kendall KL, Steele J, Schumpp AR, Latella C, Jones MT, Marcotte L, Dawson JM, Peddle-McIntyre CMJ, McDonnell KK. Hybrid delivery of cluster-set resistance training for individuals previously treated for lung cancer: the results of a single-arm feasibility trial. Pilot Feasibility Stud. 2023 Oct 17;9(1):177. doi: 10.1186/s40814-023-01405-z.

    PubMed 37848969

Questions about this trial

What is this clinical trial studying?

A study testing Resistance Exercise in people with Non Small Cell Lung Cancer and Resistance Exercise, run by University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment (time frame: Through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05014035, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.

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