Breathe Easier II: A Dyad-based Multiple Behavior Intervention
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.
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This describes the study’s primary purpose.
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These are broad labels—not an eligibility decision.
Checked against the public recordLast updated May 8, 2024 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Supportive Care
- Study type
- Interventional
- Phase
- Not applicable
- Sponsor
- University of South Carolina
- Interventions being studied
- Behavioral: Breathe Easier
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
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 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
- Inclusion Criteria: Survivors
- 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 Inclusion Criteria: Family Members or Friends
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of South CarolinaColumbia, South Carolina
Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 8, 2024. Always confirm current availability with the study team.