NCT05956782Completed
Breathe Easier II: A Dyad-based Multiple Behavior Intervention
A Dyad-based Multiple Behavior Intervention for Reducing Lung Cancer Symptoms - a Pilot Randomized Control Trial (Breathe Easier II)
Source: ClinicalTrials.gov · Last updated 8 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 19 May 2023
- Start date
- 15 Jun 2022
- Primary completion date
- 30 Apr 2024
- Lead sponsor
- University of South Carolina
- Diseases
- COPD, Lung cancer
- NCT number
- NCT05956782
What you commit to
- Study type: Interventional
- Participants enrolled: 40
- From 15 Jun 2022 to the primary completion date, 30 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- A known diagnosis of advanced lung cancer (stage IV)
- A history of recurrent falls
- A substantial mobility impairment related to rheumatoid arthritis, cerebral palsy, muscular dystrophy, multiple sclerosis, paralysis, Parkinson's disease, stroke
Other
- Physical activity is not recommended
Who the study is looking for
- 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
Criteria the registry did not label
- Vulnerable populations: Three groups (prisoners, pregnant women and unborn fetuses, and children) will not be included in this study because there may be unknown risks. Prisoners will be excluded because if a survivor or a family member were a current prisoner, it would be impractical to expect an individual to fully participate for 6 months.
- Pregnant women and unborn fetuses will be excluded because there may be unknown risks.
- Inclusion of adolescents and children: Adolescents and children will be excluded also because they are younger than the Inclusion Criteria requirement of 21 years of age. Strategies to obtain representation of children in this study would not be appropriate, as they do not get the disease. Also, they will be excluded from participating as family members.
- Table 3. Inclusion and Exclusion Criteria
Age in the registry: 21 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of South Carolina Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.