NCT07859098Toborzás még nem indult
Examining a New Insomnia Treatment for People Living With Secondary Breast Cancer.
Feasibility and Acceptability of a CBT-based Insomnia Intervention for People With Secondary Breast Cancer: a Mixed Methods Randomized Control Trial
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 5.
Rövid összefoglaló (regiszter, angolul)
The purpose of this trial is to evaluate an intervention designed to improve insomnia and sleep in people living with secondary breast cancer. The study will assess whether the intervention is feasible and acceptable to deliver and participate in, and whether it may improve sleep and related outcomes. The main questions the study aims to answer are: 1. Is it feasible to recruit people with secondary breast cancer to take part in the trial?; 2. Is the intervention feasible for people with secondary breast cancer to use and complete?; 3. Is the intervention acceptable to participants?; 4. Does the intervention improve sleep, fatigue, quality of life, and mental health?; Participants will be allocated to one of two groups: 1. Intervention group: Participants will be invited to attend five weekly sessions with a trained facilitator to receive the intervention. 2. Control group: Participants will receive a Sleep Hygiene Education self-help resource to use over a five-week period. Participants will complete questionnaires, sleep diaries, and sleep monitoring using a wearable device at three time points: before treatment, immediately after the five-week treatment period, and three months after treatment. Participants will also be invited to provide feedback about their experiences of taking part in the study and the intervention through either an interview or survey. The results will be used to determine whether the intervention is feasible and acceptable and whether there is evidence of potential benefits for sleep and other outcomes. The findings will help determine whether further research of the intervention is warranted and if there is further intervention development work required.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 50 (tervezett)
- Első benyújtás
- 2026. szept. 23.
- Kezdés
- 2026. szept. 24.
- Elsődleges befejezés
- 2027. dec. 31.
- Fő szponzor
- University of Strathclyde
- Betegségek
- Áttétes emlőrák
- NCT-szám
- NCT07859098
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 50
- 2026. szept. 24. és az elsődleges befejezés (2027. dec. 31.) 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.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Korábbi kezelés
- Are currently receiving, or have completed within the previous 6 months, CBTi or specific components (e.g., sleep restriction therapy, stimulus control, or cognitive therapy) delivered in a live or one-to-one format OR those who participated in the co-production workshop study to develop the intervention;
- Individuals who are currently receiving inpatient hospital treatment, or who are scheduled for inpatient hospital admission during the study intervention period;
Egyéb
- Report active suicidal ideation and/or recent suicide attempts (measured via item 9 of the Patient Health Questionnaire-9);
- Individuals with severe pain that is poorly controlled and/or significantly interferes with the individual's ability to engage safely with the study intervention;
Kiket keres a vizsgálat
- Have a diagnosis of secondary breast cancer;
- Have a prognosis of greater than 6 months;
- Be aged 18 years or over;
- Be willing and able to provide informed consent;
- Meet screening criteria for chronic insomnia, defined as dissatisfaction with sleep quality and/or duration accompanied by associated night-time or daytime symptoms, occurring at least three nights per week for a minimum of three months (assessed by a score of <16 on the Sleep Condition Indicator).
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| University of Strathclyde | Glasgow | Egyesült Királyság | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.