Clinical trial NCT07015944: Moving on After Breast Cancer Trial for Depressed Breast Cancer Survivors in Pakistan
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Major Depressive Disorder (MDD)
Breast Cancer Survivor
Keywords: Breast Cancer
LMICs
Depression
Multimorbidity
SMART
Adaptive interventions
Cognitive Behaviour Therapy
Low intensity intervention
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
Collaborators: name: University of Sheffield
name: University of Manchester
First posted: 2025-06-11
Enrollment: 26376
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Sequential, Multiple Assignment, Randomized Trial (SMART). The SMART design allows investigators to evaluate the effects of different intervention options and develop an adaptive approach to better meet participants' needs
Primary purpose: TREATMENT

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.

Detailed description: Problem statement: Breast cancer is the most prevalent cancer among women globally. The comorbidity of mental health conditions, such as depression and anxiety, significantly increases mortality rates in this population. Despite the complex rehabilitation needs of breast cancer survivors, there is limited knowledge on how to provide individualised support effectively.

Aims/Objectives: The overarching aim of this trial is to evaluate the clinical and cost-effectiveness of a three-stage adaptive intervention for co-morbid depression among breast cancer survivors in Pakistan.

Methods: This study will use a Sequential, Multiple Assignment, Randomised Trial (SMART) design to recruit 26,372 breast cancer survivors who have completed initial treatment (surgery and/or radiotherapy or chemotherapy). Participants, aged 18 years and older, will be recruited from primary care units, medical outpatient units, oncology clinics in public hospitals, and charitable organisations across Pakistan. Eligible participants will be screened for Major Depressive Episode (MDE) using the Patient Health Questionnaire (PHQ-9), with a score of 10 or above indicating potential depression. Diagnosis will be confirmed through the Structured Clinical Interview Schedule (SCID). Participants randomised to the intervention arm will receive a three-stage adaptive intervention, progressing through the following levels based on response: First adaptive intervention - Low-intensity guided self-help. Second adaptive intervention - High intensity "Moving On After Breast Cancer Plus" (Moving on ABC Plus), incorporating Cognitive Behavioural Therapy (CBT). Third adaptive intervention - Moving on ABC Plus combined with pharmacological intervention. All participants, regardless of randomisation, will be assessed at baseline, 6-, 18-, 30-, and 48-weeks post-randomisation using standardised questionnaires to measure: Primary outcome: Depression. Secondary outcomes: Anxiety, self-esteem, intrusive thoughts, health-related quality of life, satisfaction with services, and resource utilisation. Additionally, in-depth interviews and focus group discussions (FGDs) will be conducted with multiple stakeholders-including healthcare providers, policymakers, patients, and caregivers-to explore barriers and facilitators of intervention implementation.

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)

Primary outcomes:
measure: Hamilton Rating Scale for Depression
timeFrame: Change in total score from baseline to week 48
Secondary outcomes:
measure: Generalized Anxiety Disorder
timeFrame: Change in Total Score from baseline to week 6, 18, 30 and 48
measure: EuroQol-5 Dimensions
timeFrame: Change in total score from baseline to week 6, 18, 30 ans 48
measure: Functional Assessment of Cancer Therapy - Breast
timeFrame: Change in total score from baseline to week 6, 18, 30 and 48
measure: Rosenberg Self Esteem Scale
timeFrame: Change in total score from baseline to week 6, 18, 30 and 48
measure: Multidimensional Scale for Perceived Social Support
timeFrame: Change in total score from baseline to week 6, 18, 30 and 48
measure: Client Satisfaction Questionnaire
timeFrame: Change in total score from baseline to week 6, 18, 30 and 48.
measure: Client Service Receipt Inventory
timeFrame: Change in score from baseline to week 6, 18, 30 and 48
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Pakistan Institute of Living and Learning
state: Sindh
Study officials:
affiliation: Pakistan Institute of Living and Learning
name: Nasim Chaudhry, MD
role: PRINCIPAL_INVESTIGATOR
References: