Moving on After Breast Cancer: support for breast cancer survivors with depression 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
This trial will test a three-stage adaptive program to see if it helps breast cancer survivors in Pakistan who have major depression feel better and lowers care costs.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 26376 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Pakistan Institute of Living and Learning Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Karachi, Sindh) |
| Trial ID | NCT07015944 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Women aged 18 or older who are breast cancer survivors who have completed initial treatment and have a PHQ-9 score of 10 or more with a current Major Depressive Episode confirmed by SCID are ideal candidates.
Not a fit: Patients with severe medical or psychiatric conditions preventing participation (including those with advanced symptomatic metastatic disease requiring daily symptom control), those lacking capacity to consent, or those without current depression are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the program could reduce depressive symptoms and improve daily functioning while providing a scalable, affordable care model for breast cancer survivors in Pakistan.
How similar studies have performed: Task-shared, low-intensity psychological interventions and stepped-care models have shown benefit for depression in LMICs and general medical populations, but large-scale SMART trials specifically for breast cancer survivors in LMICs are novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Karachi, Sindh
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.