Pulmonary Rehabilitation in Advanced Lung Cancer Survivors

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCase Comprehensive Cancer Center

About this trial

This study is for people who have previously been diagnosed with advanced stage non-small cell lung cancer (NSCLC). Many people with advanced stage NSCLC have trouble breathing and feel tired. People may be eligible for this study if they have advanced stage NSCLC and feel short of breath some of the time. NSCLC survivors may also experience things like fatigue and a lower quality of life. Pulmonary rehabilitation is a type of supportive treatment that may improve these symptoms.

This study has two parts. The first part is a randomized trial where half of the participants receive eight weeks of pulmonary rehabilitation. The other half of participants do not do pulmonary rehabilitation and instead receive the treatment that their doctors would normally recommend. The purpose of this part of the research study is to understand if pulmonary rehabilitation can help people with advanced stage NSCLC have better functioning and less shortness of breath.

The other part of the research study is an interview study. The purpose of doing interviews is to understand any challenges or obstacles that people with advanced stage NSCLC may have regarding pulmonary rehabilitation, as well as oncology care providers have with their participants going to pulmonary rehabilitation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must have histologically confirmed NSCLC, Stages III or IV treated with palliative intent

Adults ≥ 18 years of age

ECOG performance status ≤ 3

Clinical stability: defined as no clinical/radiographic progression within the last three months

Disqualifiers

Participants being treated with curative intent for locally advanced NSCLC or oligometastatic NSCLC with concurrent chemotherapy and radiation will be excluded

Participants have evidence of clinical and/or radiographic progression

Mental impairment leading to inability to complete study requirements

High risk of fracture or spine instability (Mirels score ≥7 or SINS ≥7)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pulmonary Rehabilitation (PR)

    Behavioral

    Participants will complete an 8-week course of PR, administered by certified respiratory therapists. For each week of the course, participants will attend two PR sessions. Each session will review topics such as physical function, nutrition, and psychosocial health. Participants will also be given an "exercise prescription" to complete throughout the 8-week course. The "exercise prescription" will include individualized cardiopulmonary activities.

  • No intervention: Usual care

    Other intervention

    Participants will receive standard-of-care, publicly available education on Nutrition and Cancer Survivors and Physical Activity and Cancer Survivors published by the American Institute for Cancer Research.

Treatment groups

85 Participants
are divided into 3 treatment groups
Group A: Pulmonary Rehabilitation (PR)Experimental treatment 1 intervention
Group B: Usual careActive comparator 1 intervention
Group C: Qualitative interviewsNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in functional capacity of LCS with advanced NSCLC, as measured by the 6-minute walk test (6MWT)

The 6MWT measures the distance (in meters) that a person can walk in 6 minutes, with higher values indicating greater functional capacity

Time frame
Baseline, 8 weeks
2

Change in self-reported dyspnea and quality of life (QoL) in LCS with advanced NSCLC, as measured by the modified Borg scale (MBS)

The MBS is a 1-question scale that is asked after the 6MWT, where participants rank their dyspnea (difficulty breathing) on a scale of 1-10, with greater values indicating greater difficulty.

Time frame
Baseline, 8 weeks
3

Change in self-reported dyspnea and quality of life (QoL) in LCS with advanced NSCLC, as measured by the EORTC QLQ-C30

The EORTC QLQ-C30 is a 30-question questionnaire that captures functional, symptom, global health status, and QoL domains. Questions are answered on a Likert scale with four choices ranging from "Not at all" to "Very much." Greater scores indicate lower quality of life.

Time frame
Baseline, 8 weeks
4

Change in self-reported dyspnea and quality of life (QoL) in LCS with advanced NSCLC, as measured by the EORTC QLQ-LC29

The EORTC QLQ-LC29 is a 29-question questionnaire that captures lung cancer-related symptoms and treatment side effects. Questions are answered on a Likert scale with four choices ranging from "Not at all" to "Very much." Greater scores indicate greater symptoms and side effects.

Time frame
Baseline, 8 weeks

Secondary outcomes

1

Participants' barriers to pulmonary rehabilitation in LCS with advanced NSCLC, as measured by thematic findings from qualitative interviews

Semi-structured, qualitative interviews will be completed and assessed for qualitative, thematic findings.

Time frame
One-time interview between month 6 and 30
2

Thoracic oncology providers' barriers to referral to pulmonary rehabilitation, as measured by thematic findings from qualitative interviews

Semi-structured, qualitative interviews will be completed and assessed for qualitative, thematic findings.

Time frame
One-time interview between month 6 and 30

Other outcomes

Sponsors and contacts

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Case Comprehensive Cancer Center

Lead sponsor

United States Department of Defense

Collaborator