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

NCT ID: NCT06060964

Last Updated: 2023-09-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-02
• Study Completion Date: 2024-02-15

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.

Conditions

Lung Cancer, Nonsmall Cell; Lung Cancer Stage I; Lung Cancer Stage II; Lung Cancer Stage III

Keywords

mindfulness; lung cancer; technology

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

Participants in this group will use the Breathe Easier progressive web application each day for a period of 8-weeks.

Group Type: EXPERIMENTAL

Breathe Easier Progressive Web Application

Intervention Type: OTHER

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.

Non-intervention Group (Control Group)

Participants in this group will receive no intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Otis (Shaun) Owens

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Otis Owens, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Karen McDonnell, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

University of South Carolina

Columbia, South Carolina, United States

Countries

United States

Central Contacts

Otis Owens, PhD

Role: CONTACT

Phone: 803-777-0384

Email: owenso@mailbox.sc.edu

Karen McDonnell, PhD

Role: CONTACT

Phone: 803-777-9866

Email: karenkm@mailbox.sc.edu

Facility Contacts

Otis Owens, PhD

Role: primary

Karen McDonnell, PhD

Role: backup

Other Identifiers

00122553

Identifier Type: -

Identifier Source: org_study_id