Enabling Remote Access to Breathe Easier: A Novel Approach to Improve Symptom Management (Breathe Easier)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Cancer, Nonsmall Cell; Lung Cancer Stage I; Lung Cancer Stage III; Lung Cancer Stage II
• Intervention / Treatment: Other: Breathe Easier Progressive Web Application

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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Otis Owens, PhD; Phone Number: 803-777-0384; Email: owenso@mailbox.sc.edu
• Study Contact Backup: Name: Karen McDonnell, PhD; Phone Number: 803-777-9866; Email: karenkm@mailbox.sc.edu

Study Locations

• United States
  • South Carolina
    • Columbia, South Carolina, United States, 29208
      • University of South Carolina
      • Contact: Otis Owens, PhD; Phone Number: 803-777-0384; Email: owenso@mailbox.sc.edu
      • Contact: Karen McDonnell, PhD; Phone Number: 803-777-9866; Email: karenkm@mailbox.sc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Participants in this group will use the Breathe Easier progressive web application each day for a period of 8-weeks.	Other: Breathe Easier Progressive Web Application; The Breathe Easier Progressive Web Application is an 8-week, mindfulness based cancer recovery training program consisting of breathing retraining exercises, mindfulness meditation, gentle yoga, and cancer-specific educational activities, guided by a combination of written instructions, video, and audio. The progressive web application can be downloaded onto any mobile device.
No Intervention: Non-intervention Group (Control Group); Participants in this group will receive no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue (FACIT Fatigue Scale v. 4)	13 items measuring individual fatigue during usual activity level over the past 7 days; 4-point Likert scale, ranging from 4 (Not at All Fatigued) to 0 (Very Much Fatigued). Scores range 0-52 (< 30 indicates severe fatigue)	Administered prior to the start of intervention and immediately following the intervention.
Dyspnea (MRC Breathlessness Scale)	1 item, comprised of five statements that describe almost the entire range of respiratory disability from none (Grade 1) to almost complete incapacity (Grade 5). It can be self-administered by asking subjects to choose a phrase that best describes their condition, e.g. 'I only get breathless with strenuous exertion' (Grade 1) or 'I am too breathless to leave the house' (Grade 5)	Administered prior to the start of intervention and immediately following the intervention.
Quality of Life (SF-36 Medical Outcomes Survey)	36 items that are meant to reflect 8 domains of health, including physical functioning, physical role, pain, general health, vitality, social function, emotional role, and mental health. Likert scales and yes/no options are used to assess function and well-being on this 36-item questionnaire.	Administered prior to the start of intervention and immediately following the intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability (System Usability Scale)	10 items measuring usability; 5-point Likert scale, ranging from 1 (Strongly disagree) to 5 (Strongly disagree). Converted scores range from 0 to 100 (> 68 indicates average usability)	Administered only to intervention group immediately following the 8-week intervention
Acceptability (Acceptability of Intervention Measure)	4-items measuring perceived intervention acceptability; 5-point Likert scale ranging from 1 (Completely Disagree) to 5 (Completely Agree). Score is creating by calculated mean across items.	Administered only to intervention group immediately following the 8-week intervention
Intervention Adherence	number of intervention days/activities completed.	Administered only to intervention group immediately following the 8-week intervention

Collaborators and Investigators

• Sponsor: University of South Carolina
• Investigators: Principal Investigator: Otis Owens, PhD, Associate professor; Principal Investigator: Karen McDonnell, PhD, Associate professor

Study record dates

Study Major Dates

• Study Start (Estimated): October 2, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): February 15, 2024

Study Registration Dates

• First Submitted: September 22, 2023
• First Submitted That Met QC Criteria: September 22, 2023
• First Posted (Actual): September 29, 2023

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: lung cancer; mindfulness; technology
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 00122553

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: At this time, there is no plan to make individual participant data available.

Drug and device information, study documents

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