Moving on After Breast Cancer: support for breast cancer survivors with depression in Pakistan

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This large SMART (Sequential, Multiple Assignment, Randomised Trial) will enrol about 26,372 women breast cancer survivors aged 18 and older who completed initial cancer treatment and screen positive for depression (PHQ-9 ≥10) with diagnosis confirmed by SCID. Participants will be recruited from primary care units, outpatient and oncology clinics in public hospitals, and charitable organisations across Pakistan and randomised to a stepped, adaptive intervention pathway versus enhanced usual care. The adaptive pathway uses non-specialist delivered low-intensity guided self-help, a tailored 'Moving on After Breast Cancer (ABC) plus' approach, and standardised antidepressant treatment, with progression determined by response at each stage. Outcomes include clinical depression symptoms and cost-effectiveness of the three-stage program.

Why it matters

Who can join: the full rules

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)

Where it's running

• Pakistan Institute of Living and Learning
  Karachi, Sindh, Pakistan Recruiting

Study contacts

• Principal investigator: Nasim Chaudhry, MD — Pakistan Institute of Living and Learning
• Study coordinator: Tayyeba Kiran, PhD
• Email: tayyaba.kiran@pill.org.pk
• Phone: 0923328262142

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.