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Behavioural Intervention
Breathe Easier Intervention for Lung Cancer Survivors (BE Trial)
N/A
Recruiting
Led By Karen K McDonnell, PhD
Research Sponsored by University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up daily for 6 months
Awards & highlights
BE Trial Summary
This trial tests a 12-week intervention to reduce symptoms & change behaviors in lung cancer survivors & their family members, w/the goal of improving health outcomes.
Who is the study for?
This trial is for early-stage lung cancer survivors (stages I-III) and a family member or friend, both willing to try a new lifestyle program. They must speak English, be over 21, able to consent, use text messages, and have healthcare provider approval. It's not for those with advanced lung cancer (stage IV), mobility issues due to certain diseases, or who are advised against physical activity.Check my eligibility
What is being tested?
The 'Breathe Easier' intervention in this pilot study aims to reduce symptoms like breathlessness and stress while promoting physical activity and better stress management among lung cancer survivors and their companions. The study involves face-to-face sessions, phone calls over 12 weeks, plus follow-ups at three months.See study design
What are the potential side effects?
Since 'Breathe Easier' focuses on lifestyle changes rather than medication or medical procedures, side effects may include muscle soreness from increased physical activity or emotional discomfort as participants adjust to new stress management techniques.
BE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ daily for 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~daily for 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in perceived stress
Change in the symptom of breathlessness
Change in the symptom of dyspnea
+3 moreSecondary outcome measures
Tobacco use abstinence
Other outcome measures
Affective balance change
Cognition change
Emotional response to dyspnea change
+4 moreBE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: BE Intervention GroupExperimental Treatment1 Intervention
The BE Manual is an educational resource for Managing Stress, Increasing Physical Activity (PA) and Stopping Smoking and Staying Smoke free.
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..
Breathing Exercises and Meditations are incorporated into the BE Manual and sent by a link via text messages.
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.
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.
Group II: Attention ControlActive Control1 Intervention
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".
Telephone "Chats": The primary purpose is study retention. After the first 12-week period ends the weekly chats will be tapered for 12 weeks.
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).
Find a Location
Who is running the clinical trial?
Brown UniversityOTHER
456 Previous Clinical Trials
563,021 Total Patients Enrolled
University of South CarolinaLead Sponsor
211 Previous Clinical Trials
120,399 Total Patients Enrolled
Karen K McDonnell, PhDPrincipal InvestigatorUniversity of South Carolina
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your family members or friends are open to making changes in their behavior.You have finished the main treatment for early-stage lung cancer (stages I-III), including any additional therapy you may be getting afterwards.You are not allowed to engage in physical activity.You have significant difficulty moving because of certain health conditions like arthritis, cerebral palsy, or paralysis.You have been diagnosed with advanced stage IV lung cancer.You have a history of falling down multiple times.
Research Study Groups:
This trial has the following groups:- Group 1: BE Intervention Group
- Group 2: Attention Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities for potential participants to join this trial?
"Affirmative. Data on clinicaltrials.gov makes clear that this trial is still looking for patient participants and was initially posted on June 15th 2022, with the most recent update taking place July 11th 2023. 60 volunteers are sought from one location."
Answered by AI
How many participants have been recruited for this clinical research?
"Affirmative. The clinical trial portal confirms that this medical research, posted on June 15th 2022 and modified recently on July 11th 2023, is still in the process of recruiting their participants; the goal being 60 people from a single location."
Answered by AI
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