Clinical trial NCT06060964: Enabling Remote Access to Breathe Easier: A Novel Approach to Improve Symptom Management
Official title: Enabling Remote Access to Breathe Easier: A Novel Approach to Improve Symptom Self-Management and Wellness for Survivors of Lung Cancer and Their Family Members
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Lung Cancer, Nonsmall Cell
Lung Cancer Stage I
Lung Cancer Stage II
Lung Cancer Stage III
Keywords: mindfulness
lung cancer
technology
Lead sponsor: University of South Carolina
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to evaluate the preliminary affects of "Breathe Easier," an evidence-based multi-level mindfulness intervention (i.e., progressive web application) for survivors of lung cancer. The key aims of this study are to (1) Evaluate the feasibility (usability, acceptability intervention adherence) of the "Breathe Easier" and (2) assess the impact of the intervention on dyspnea, fatigue, and quality of life among survivors of lung cancer. Participants in the intervention group will use the "Breathe Easier" progressive web application for a period of 8-weeks, while participants in the control group will receive no intervention. Researchers will compare the intervention and control groups to see if there are salient differences in dyspnea, fatigue, and quality of life between the two groups.

Detailed description: Cancer, a major health problem worldwide, is the second leading cause of death in the United States. As cancer death rates drop, the population of survivors of cancer is growing, projected to reach 18 million by 2022, with an estimated 800,000 of those being long-term survivors. Lung cancer is the second-most diagnosed cancer, accounting for more cancer deaths than breast, colorectal, and prostate cancers combined. Approximately 80% of patients with lung cancer will be diagnosed with non-small cell lung cancer (NSCLC), and about 25% will present with early-stage or localized disease (stages I-III). Lower prevalence of cigarette smoking, screening improvements, and treatment advances are improving five-year survival rates (currently 59% for stages I-II, 32% for stage III) \[1-3\]. Survivors of lung cancer will not only be more numerous but will be living longer. A diagnosis of lung cancer provides an opportunity to introduce targeted, effective, family-focused interventions. Developing interventions for self-managing lung cancer as a chronic illness is imperative. This project supports the strategic research priorities of the National Institute of Nursing Research (NINR) and National Cancer Institute (NCI) by developing and testing an evidence-based multi-level mindfulness intervention, Breathe Easier (BE), using the ORBIT model for behavioral intervention development and a theory-guided approach based on the individual and family self-management theory (IFSMT). BE empowers survivors and family members to manage symptoms and change unhealthy behaviors together.

SPECIFIC AIMS: The long-term goal of our research is to improve outcomes for survivors of NSCLC, stages I-III, and their family members. Our specific aims are as follows:

(1) Evaluate the feasibility (usability, acceptability intervention adherence) of BE and (2) Assess the preliminary effects (dyspnea, fatigue, quality of life) among survivors of lung cancer who receive the intervention as compared with those who do not receive BE.

Eligibility criteria: Inclusion Criteria:

* Must be a White or African-American survivor of NSCLC, stages I-III, have access to a smart phone, have internet access, and be willing and able to use a mobile application and participate in daily meditations/gentle movement exercises for 8-weeks.

Exclusion Criteria:

* Persons not meeting all inclusion criteria will be excluded.

Primary outcomes:
measure: Fatigue (FACIT Fatigue Scale v. 4)
timeFrame: Administered prior to the start of intervention and immediately following the intervention.
measure: Dyspnea (MRC Breathlessness Scale)
timeFrame: Administered prior to the start of intervention and immediately following the intervention.
measure: Quality of Life (SF-36 Medical Outcomes Survey)
timeFrame: Administered prior to the start of intervention and immediately following the intervention.
Secondary outcomes:
measure: Usability (System Usability Scale)
timeFrame: Administered only to intervention group immediately following the 8-week intervention
measure: Acceptability (Acceptability of Intervention Measure)
timeFrame: Administered only to intervention group immediately following the 8-week intervention
measure: Intervention Adherence
timeFrame: Administered only to intervention group immediately following the 8-week intervention
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
Study officials:
affiliation: Associate Professor
name: Otis Owens, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor
name: Karen McDonnell, PhD
role: PRINCIPAL_INVESTIGATOR
References: