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

NCT06060964 | Unknown Early Phase 1

• 1 other identifier: 00122553
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

mindfulness; lung cancer; technology

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Usability (System Usability Scale)

  Administered only to intervention group immediately following the 8-week intervention

• Acceptability (Acceptability of Intervention Measure)

  Administered only to intervention group immediately following the 8-week intervention

• Intervention Adherence

  Administered only to intervention group immediately following the 8-week intervention

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Non-intervention Group (Control Group)

NO INTERVENTION

Participants in this group will receive no intervention.

Interventions

Breathe Easier Progressive Web Application 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.

Intervention Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of South Carolina: lead

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Otis Owens, PhD

  Associate Professor

  PRINCIPAL INVESTIGATOR

• Karen McDonnell, PhD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Otis Owens, PhD

CONTACT

803-777-0384; owenso@mailbox.sc.edu

Karen McDonnell, PhD

CONTACT

803-777-9866; karenkm@mailbox.sc.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: September 29, 2023
• Study Start: October 2, 2023
• Primary Completion: December 1, 2023
• Study Completion: February 15, 2024
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)