NCT07015944Toboroz
Moving on After Breast Cancer Trial for Depressed Breast Cancer Survivors in Pakistan
Clinical and Cost-effectiveness of an Integrated Psychosocial Care Plan for Comorbid Depression in Breast Cancer Survivors In Pakistan: A Sequential Multiple Assignment Randomised Trial
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. márc. 18.
Rövid összefoglaló (regiszter, angolul)
Breast cancer is the most common cancer among women worldwide, and many survivors experience comorbid mental health conditions such as depression and anxiety, which can significantly worsen health outcomes and increase mortality. This large-scale trial in Pakistan aims to evaluate the clinical and cost-effectiveness of a three-stage adaptive intervention to manage depression among breast cancer survivors. Using a Sequential, Multiple Assignment, Randomised Trial (SMART) design, the study will recruit 26,372 participants aged 18 and above who have completed initial breast cancer treatment (surgery and/or chemotherapy or radiotherapy). Participants will be identified through primary care units, outpatient departments, oncology clinics in public hospitals, and charitable organisations across Pakistan. Depression will be screened using the Patient Health Questionnaire PHQ-9, with diagnosis confirmed by the Structured Clinical Interview Schedule of DSM (SCID). Those randomised to the intervention arm will receive adaptive interventions: starting with low-intensity guided self-help, followed by a high-intensity cognitive behavioural therapy-based programme called "Moving On After Breast Cancer Plus" (Moving on ABC Plus), and for non-responders, an additional pharmacological component will be introduced. Participants in both adaptive intervention and enhance usual care groups will be assessed at multiple time points-baseline, 6, 18, 30, and 48 weeks post-randomisation-using validated tools to measure depression (primary outcome), and anxiety, self-esteem, intrusive thoughts, health-related quality of life, satisfaction with services, and health resource use (secondary outcomes). The study will also include qualitative interviews and focus groups discussions with patients, caregivers, healthcare providers, and policymakers to identify barriers and facilitators to implementation and ensure the intervention is both contextually appropriate and scalable.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 26376 (tervezett)
- Első benyújtás
- 2025. jún. 3.
- Kezdés
- 2025. jún. 13.
- Elsődleges befejezés
- 2028. dec. 30.
- Fő szponzor
- Pakistan Institute of Living and Learning
- Betegségek
- Depresszió
- NCT-szám
- NCT07015944
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 26376
- 2025. jún. 13. és az elsődleges befejezés (2028. dec. 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.
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
- Currently receiving psychological therapy or taking antidepressant medications (e.g., SSRIs, SNRIs, or other prescribed antidepressants)
Más betegség
- Lacking capacity to provide informed consent, such as those identified by clinicians as having intellectual disabilities, dementia, or severe medical and/or psychiatric illnesses requiring hospitalisation
- Unable to engage in assessments or interventions, including those with stage 4 breast cancer experiencing significant symptoms (e.g., metastatic lesions in the lungs, liver, or bones requiring daily treatment for symptomatic relief, such as the daily use of two or more painkillers), which restrict their capacity to participate
Kiket keres a vizsgálat
- Women
- Aged 18 years and above
- Diagnosed with breast cancer (any stage)
- Completed initial treatment (i.e., surgery and/or radiotherapy or chemotherapy) for breast cancer (even if they are currently on hormonal therapy post-initial treatment)
- Total score of 10 or above on the Patient Health Questionnaire (PHQ-9)
- Diagnosis of current Major Depressive Episode (MDE) confirmed using the Structured Clinical Interview for DSM-5 (SCID).
Életkor a regiszterben: 18 év – - · Nem: csak nők · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Pakistan Institute of Living and Learning Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Karachi | Pakisztán | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.