NCT05956782Befejeződött
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)
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2024. máj. 8.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 40 (tényleges)
- Első benyújtás
- 2023. máj. 19.
- Kezdés
- 2022. jún. 15.
- Elsődleges befejezés
- 2024. ápr. 30.
- Fő szponzor
- University of South Carolina
- Betegségek
- Tüdőrák, Krónikus obstruktív tüdőbetegség (COPD)
- NCT-szám
- NCT05956782
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 40
- 2022. jún. 15. és az elsődleges befejezés (2024. ápr. 30.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Más betegség
- 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
Egyéb
- Physical activity is not recommended
Kiket keres a vizsgálat
- 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
A regiszterben nem jelölt feltételek
- 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
Életkor a regiszterben: 21 év – - · Nem: nők és férfiak · Egészséges önkénteseket is fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| University of South Carolina | Columbia | Egyesült Államok | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.