Breathe Easier II: A Dyad-based Multiple Behavior Intervention

NCT05956782 | Completed DMC

• 1 other identifier: Pro00112653
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot randomized control trial (RCT) will test a 12-week, multiple behavior intervention physical activity and stress management for survivors with early stage lung cancer (stages I-III) and their family members (1 survivor + 1 family member or friend = 1 dyad). The long-term goal of this research is to improve health outcomes for survivors of lung cancer and their family members. The goals of the intervention, Breathe Easier, are symptom reduction (less breathlessness, less fatigue, less stress) and change in multiple behaviors (increase in stress management and increase in physical activity, and decrease tobacco use - if appropriate). Our aim is: To conduct a 6-month, two-group, pilot randomized control trial intervention study with a pre- and post-test study design to estimate preliminary intervention effects on (a) reduction of symptoms (breathlessness, fatigue, and stress) in survivors of non small cell lung cancer (stages I-III) and family members or friends; (b) increase in physical activity behaviors immediately following the intervention and at 3-months; (c) increase in stress management strategies immediately following the intervention and at 3-months; (d) reduction in smoking behavior among participants who smoke tobacco products at study entry immediately following the intervention at 3-months.

Conditions

Lung Cancer, Nonsmall Cell; COPD; Self-Management; Physical Inactivity; Stress; Quality of Life

Keywords

Cancer Survivorship

Outcome Measures

Primary Outcomes (17)

• Physical function behavior change

  Measured by self-reported step counting using a pedometer and documented on a daily log.

  Daily for 6 months

• Physical function behavior change

  Objectively measured by wearing an Accelerometer (on the participant's wrist with a velcro band) for 7 days. Measures physical activity intensity (sedentary, light, moderate, vigorous, and very vigorous).

  Pre-intervention (Baseline) and post 3-months

• Physical function behavior change

  Objectively measured by wearing an Accelerometer (on the participant's wrist with a velcro band) for 7 days. Measures physical activity intensity (sedentary, light, moderate, vigorous, and very vigorous).

  Pre-intervention (Baseline) and post 6-months

• Physical function behavior change

  Objectively measured by a Six-minutes Walk Test. Specifically measures physical activity/exercise tolerance. Score = distance traveled in 6 min. measured in meters.

  Pre-intervention (Baseline) and post 3-months

• Physical function behavior change

  Objectively measured by a Six-minutes Walk Test. Specifically measures physical activity/exercise tolerance. Score = distance traveled in 6 min. measured in meters.

  Pre-intervention (Baseline) and post 6-months

• Stress management behavior change

  Measured by self-reported practice of breathing exercises documented on daily logs.

  Daily for 6 months

• Stress management behavior change

  Measured by self-reported meditation practice documented on daily logs.

  Daily for 6 months

• Change in the symptom of dyspnea

  As measured by a validated instrument: Functional Assessment of Chronic Illness Therapy (FACIT)-Dyspnea Short Form (Part 1) Measured by 10 items with a 4-point rating scale measuring shortness of breath (SOB) over the past 7 days (0 = not SOB; 1 = mildly SOB; 2= moderately SOB; 3 = severe SOB). Total score range 0 to 40. The higher the score measures worse SOB.

  Pre-intervention (Baseline) and post 3-months

• Change in the symptom of dyspnea

  As measured by a validated instrument: Functional Assessment of Chronic Illness Therapy (FACIT)-Dyspnea Short Form (Part 1) Measured by 10 items with a 4-point rating scale measuring shortness of breath (SOB) over the past 7 days (0 = not SOB; 1 = mildly SOB; 2= moderately SOB; 3 = severe SOB). Total score range 0 to 40. The higher the score measures worse SOB.

  Pre-intervention (Baseline) and post 6-months

• Change in the symptom of dyspnea

  As measured by a validated instrument: Functional Assessment of Chronic Illness Therapy (FACIT)-Dyspnea Short Form (Part 2). Measured by 10 items with a 4-point rating scale measuring functional limitations due to shortness of breath (SOB) over the past 7 days (0 = no difficulty, 1 = little difficulty; 2= some difficulty; 3 = much difficulty). Total score range 0 to 40. The higher the score measures greater functional difficulty due to SOB.

  Pre-intervention (Baseline) and post 3-months

• Change in the symptom of dyspnea

  As measured by a validated instrument: Functional Assessment of Chronic Illness Therapy (FACIT)-Dyspnea Short Form (Part 2). Measured by 10 items with a 4-point rating scale measuring functional limitations due to shortness of breath (SOB) over the past 7 days (0 = no difficulty, 1 = little difficulty; 2= some difficulty; 3 = much difficulty). Total score range 0 to 40. The higher the score measures greater functional difficulty due to SOB.

  Pre-intervention (Baseline) and post 6-months

• Change in the symptom of breathlessness

  As measured by validated instrument: Modified Medical Research Council - Dyspnea (mMRC) measures respiratory disability. 1 item measures perceived breathlessness. There are 5 statements describing respiratory disability. Scores range from 1 to 5. No disability = "I only get breathless with strenuous exercise" (Grade 1) to "I am too breathless to leave the house" (Grade 5). The higher the score the greater the disability.

  Pre-intervention (Baseline) and post 3-months

• Change in the symptom of breathlessness

  As measured by validated instrument: Modified Medical Research Council - Dyspnea (mMRC) measures respiratory disability. 1 item measures perceived breathlessness. There are 5 statements describing respiratory disability. Scores range from 1 to 5. No disability = "I only get breathless with strenuous exercise" (Grade 1) to "I am too breathless to leave the house" (Grade 5). The higher the score the greater the disability.

  Pre-intervention (Baseline) and post 6-months

• Change in the symptom of fatigue

  As measured by a validated instrument: Functional Assessment of Chronic Illness Therapy Scale (FACIT)-Fatigue (V.4) measures fatigue. Measured by 13-items with a 4-point rating scale (4 = not fatigued at all; 0 = very much fatigued). Score range is 6 to 52. The higher the score the less fatigue.

  Pre-intervention (Baseline) and post 3-months

• Change in the symptom of fatigue

  As measured by a validated instrument: Functional Assessment of Chronic Illness Therapy Scale (FACIT)-Fatigue (V.4) measures fatigue. Measured by 13-items with a 4-point rating scale (4 = not fatigued at all; 0 = very much fatigued). Score range is 6 to 52. The higher the score the less fatigue.

  Pre-intervention (Baseline) and post 6-months

• Change in perceived stress

  As measured by a validated instrument: Perceived Stress Scale measures perceived stress using a 10-item scale. There are 5 response items (0 = never, 1 = almost never, 2 = sometimes, 3 = fairly often, 4 = very often). Score ranges from 0 to 40. The higher the score the greater perceived stress.

  Pre-intervention (Baseline) and post 3-months

• Change in perceived stress

  As measured by a validated instrument: Perceived Stress Scale measures perceived stress using a 10-item scale. There are 5 response items (0 = never, 1 = almost never, 2 = sometimes, 3 = fairly often, 4 = very often). Score ranges from 0 to 40. The higher the score the greater perceived stress.

  Pre-intervention (Baseline) and post 6-months

Secondary Outcomes (6)

• Tobacco use abstinence

  Pre-intervention (Baseline) and post 3-months

• Tobacco use abstinence

  Pre-intervention (Baseline) and post 6-months

• Tobacco use abstinence

  Pre-intervention (Baseline) and post 3-month

• Tobacco use abstinence

  Pre-intervention (Baseline) and post 6-months

• Tobacco use abstinence

  Pre-intervention (Baseline) and post 3-months

Other Outcomes (14)

• Sleep quality change

  Daily for 7 days at Pre-intervention (Baseline) and post 3-months

• Sleep quality change

  Daily for 7 days at Pre-intervention (Baseline) and post 6-months

• Emotional response to dyspnea change

  Daily for 7 days at Pre-intervention (Baseline) and post 3-months

Study Arms (2)

Attention Control

ACTIVE COMPARATOR

1. Education: Each survivor will receive a copy of "Facing Forward; Life After Cancer Treatment" (No. 18-2424, March 2018). Each family member or friend will receive "When Someone You Love is Being Treated for Cancer" (No. 14-5726, May 2014). Specific parts of booklets will be reviewed during the 15-minute/per participant telephone "chat". 2. Telephone "Chats": The primary purpose is study retention. After the first 12-week period ends the weekly chats will be tapered for 12 weeks. 3. One text message delivered weekly by telephone is a reminder of the day and time of the chat(s). Tobacco Use Reduction: Many survivors of lung cancer struggle with nicotine addiction; smoking cessation and relapse prevention content will be made available to current smokers (The FOREVER FREE program - a free, twelve short booklet evidence-based resource created by the H. Lee Moffitt Cancer Center \& Research Institute at the University of South Florida).

Behavioral: Breathe Easier

BE Intervention Group

EXPERIMENTAL

1. The BE Manual is an educational resource for Managing Stress, Increasing Physical Activity (PA) and Stopping Smoking and Staying Smoke free. 2. A timed, weekly telephone counseling session (60 min./dyad max) will be recorded. The purpose is to provide social support with SMART goal setting, adherence monitoring, encouragement.. 3. Breathing Exercises and Meditations are incorporated into the BE Manual and sent by a link via text messages. 4. A Texting Library provides additional education, support, and encouragement daily. There are 5 story lines: BE Active, BE Kind to Yourself, BE Supportive and BE Smoke free (offered to current smokers only). Stay Smoke free will be instituted once tobacco use has stopped. 5. Weekly Logs for tracking goals and progress with behavior changes (PA, breathing practices and meditations) and a pedometer are provided. After 12 weeks, the calls and texts will be tapered.

Behavioral: Breathe Easier

Interventions

Breathe Easier BEHAVIORAL

See Intervention Group (IG) description.

Attention Control; BE Intervention Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Completed primary treatment for localized NSCLC (stages I-III). Survivors receiving adjuvant therapy are eligible.
• Willing to use a cell phone capable of receiving text messages
• Willing to complete a 12-week, home-based intervention program that includes face-to-face and telephone interaction
• Willing to consider behavior change at this time
• A family member or friend is willing to participate who is at least 21 years old
• Able to speak and read English
• Capable of informed consent
• A health clearance form is signed by a health care provider prior to enrollment
• Willing to use a cell phone capable of receiving text messages
• Willing to complete a 12-week, home-based intervention program that includes face-to-face and telephone interaction
• Willing to consider behavior change at this time
• Has an eligible family member willing to participate who is at least 21 years old
• Able to speak and read English
• Capable of informed consent
• A health clearance form signed by a health care provider prior to enrollment

Sponsors & Collaborators

• University of South Carolina: lead
• Brown University: collaborator

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

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MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Pulmonary Disease, Chronic Obstructive; Sedentary Behavior

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Karen K McDonnell, PhD

  University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: One staff person who is the outcome assessor will be blinded to group assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A 6-month, two-group, longitudinal pilot RCT study with a pre- and post-test design. The intervention is 12 weeks followed by a 12 week taper. Two groups include an intervention group and an attention control group.

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: July 21, 2023
• Study Start: June 15, 2022
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Protocol will be submitted for publication in 2024. Data will be shared post statistical analysis by publication in open access journal.
• Access Criteria: Undecided

Locations

US (1)