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

NCT07015944 | Recruiting DMC

• 2 other identifiers: Moving On ABC PlusNIHR205561
• Study Type: interventional
• Target: 26,376
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder (MDD); Breast Cancer Survivor

Keywords

Breast Cancer; LMICs; Depression; Multimorbidity; SMART; Adaptive interventions; Cognitive Behaviour Therapy; Low intensity intervention

Outcome Measures

Primary Outcomes (1)

• Hamilton Rating Scale for Depression

  Primary outcome will be depression remission at 48 weeks. This is a 17 item, clinician administered assessment measure to assess severity of depressive symptoms over past week. Total score of 0-7 is considered as "normal" (clinical remission), and a total score of 20 or higher is considered as moderate to severe.

  Change in total score from baseline to week 48

Secondary Outcomes (7)

• Generalized Anxiety Disorder

  Change in Total Score from baseline to week 6, 18, 30 and 48

• EuroQol-5 Dimensions

  Change in total score from baseline to week 6, 18, 30 ans 48

• Functional Assessment of Cancer Therapy - Breast

  Change in total score from baseline to week 6, 18, 30 and 48

• Rosenberg Self Esteem Scale

  Change in total score from baseline to week 6, 18, 30 and 48

• Multidimensional Scale for Perceived Social Support

  Change in total score from baseline to week 6, 18, 30 and 48

Study Arms (2)

Adaptive interventions

EXPERIMENTAL

The adaptive interventions include: 1. Non-specialist delivered Low intensity guided self-help (Khushi and Khatoon) 2. Moving on After Breast cancer Plus (Moving on ABC Plus) 3. Standard pharmacological intervention

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

Enhanced Treatment As Usual (E-TAU)

OTHER

Participants in this arm will continue to follow their routine visits to healthcare facilities. They will be regularly monitored by trained research team and will be assessed at weeks 6,18,30, and 48. In addition to psychological assessment at each follow-up, this will include information leaflets based on a brief psychoeducational module to educate participants about the risks, symptoms, management, and referral support information for anxiety and depression.

Other: Enhanced Treatment As Usual (E-TAU)

Interventions

Enhanced Treatment As Usual (E-TAU) OTHER

Participants in this arm will continue to follow their routine visits to healthcare facilities. They will be regularly monitored by trained research team and will be assessed at weeks 6,18,30, and 48. In addition to psychological assessment at each follow-up, this will include information leaflets based on a brief psychoeducational module to educate participants and families about the risks, symptoms, management, and referral support information for anxiety and depression

Adaptive interventions; Enhanced Treatment As Usual (E-TAU)

Non-specialist delivered Low intensity guided self-help (Khushi and Khatoon) OTHER

This is a manualised intervention comprising of 8 chapters. This is being further co-adapted to contexualise this for breast cancer survivours. The original manual is focused on stories of two breast cancer survivors , Mrs Khushi, means happiness) and Khatoon, means woman in Urdu, with depression and anxiety, describing how they help themselves using CBT strategies.

Adaptive interventions

Moving on After Breast Cancer (ABC) plus OTHER

This is a high intensity manualised intervention consisting of 12 sessions (60-90 minutes). This manual offers practical support and advice on life after breast cancer, managing difficulties, mindfulness, addressing fatigue, understanding the participant's model of illness, improving personal effectiveness and social relationships. The sessions also include therapist delivered psychoeducation using a CBT model of case formulation and goal setting: identification and formulation of predisposing, precipitating, perpetuating and protective factors of depression and/or anxiety, helping participants to identify core beliefs, where necessary, using downward arrow technique, identifying, and challenging unhealthy thinking patterns at the level of core beliefs using cognitive restructuring, and problem-solving techniques

Adaptive interventions

Standardised pharmacological treatment (antidepressants) DRUG

Patients will begin 12 weeks of sertraline treatment initiated at a daily dose of 50 mg for the first 4 weeks. After that, flexible titation of sertraline will be permitted, by 50mg increment every 1 to 2 weeks, as clinically indicated and tolerated to a maximum daily dose of 200 mg

Adaptive interventions

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Sheffield: collaborator
• Pakistan Institute of Living and Learning: lead
• University of Manchester: collaborator

Study Sites (1)

Pakistan Institute of Living and Learning

Karachi, Sindh, 75600, Pakistan

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Breast Neoplasms; Depression

Interventions

abacavir; Antidepressive Agents

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Nasim Chaudhry, MD

  Pakistan Institute of Living and Learning

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tayyeba Kiran, PhD

CONTACT

0923328262142; tayyaba.kiran@pill.org.pk

Nasim Chaudhry, MD

CONTACT

0922135371084; nasim.chaudhry@pill.org.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Trial investigators and trial statistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 11, 2025
• Study Start: June 13, 2025
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Once the trial results are published
• Access Criteria: Requests should be made to Principal Investigator

Locations

PA (1)