NCT07015944 Moving on After Breast Cancer Trial for Depressed Breast Cancer Survivors in Pakistan
| NCT ID | NCT07015944 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pakistan Institute of Living and Learning |
| Condition | Major Depressive Disorder (MDD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 26,376 participants |
| Start Date | 2025-06-13 |
| Primary Completion | 2028-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 26,376 participants in total. It began in 2025-06-13 with a primary completion date of 2028-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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)
Contact & Investigator
Nasim Chaudhry, MD
PRINCIPAL INVESTIGATOR
Pakistan Institute of Living and Learning
Frequently Asked Questions
Who can join the NCT07015944 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Major Depressive Disorder (MDD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07015944 currently recruiting?
Yes, NCT07015944 is actively recruiting participants. Contact the research team at tayyaba.kiran@pill.org.pk for enrollment information.
Where is the NCT07015944 trial being conducted?
This trial is being conducted at Karachi, Pakistan.
Who is sponsoring the NCT07015944 clinical trial?
NCT07015944 is sponsored by Pakistan Institute of Living and Learning. The principal investigator is Nasim Chaudhry, MD at Pakistan Institute of Living and Learning. The trial plans to enroll 26,376 participants.