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Moving on After Breast Cancer Trial for Depressed Breast Cancer Survivors in Pakistan

RecruitingNAAges 18 Years - anyFemalePakistan Institute of Living and Learning
NCT07015944 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 c

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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). Exclusion Criteria: * 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 * Currently receiving psychological therapy or taking antidepressant medications (e.g., SSRIs, SNRIs, or other prescribed antidepressants)
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What it tests

  • Non-specialist delivered Low intensity guided self-help (Khushi and Khatoon)
  • Moving on After Breast Cancer (ABC) plus
  • Standardised pharmacological treatment (antidepressants)
  • Enhanced Treatment As Usual (E-TAU)
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Where

1 site
Pakistan Institute of Living and Learning
Karachi, Pakistan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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