NCT06992167

Brief Summary

This cross-sectional study aims to assess the prevalence of depression among primary caregivers of breast cancer patients within low-resource country like Pakistan. Caregiving for individuals with breast cancer can be physically and emotionally demanding, often leading to psychological distress, including depression. However, there is limited data from low- and middle-income countries, including Pakistan, where caregivers may face additional socioeconomic and systemic burdens. This study seeks to quantify the burden of depression in this population and explore associated sociodemographic and caregiving-related factors. Findings will help inform psychosocial support strategies and interventions to improve caregiver well-being in resource-constrained environments.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
402

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2025

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 28, 2025

Completed
Last Updated

May 28, 2025

Status Verified

May 1, 2025

Enrollment Period

12 months

First QC Date

May 17, 2025

Last Update Submit

May 24, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of depression among caregivers of breast cancer patients

    Depression will be assessed using the Patient Health Questionnaire-9 (PHQ-9), a validated screening tool. The PHQ-9 consists of 9 items, each scored from 0 (not at all) to 3 (nearly every day), for a total score range of 0 to 27. Higher scores indicate worse depressive symptoms. Depression severity will be categorized as follows: 0-4: Minimal 5-9: Mild 10-14: Moderate 15-19: Moderately Severe 20-27: Severe The proportion of caregivers falling into each category will be reported.

    At a single time point during caregiver recruitment (cross-sectional assessment within 6 months of study initiation)

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population will consist of primary caregivers of breast cancer patients receiving treatment in public or private healthcare facilities in low-resource settings of Pakistan. Caregivers include family members or individuals who are directly involved in providing physical, emotional, or financial support to the patient.

You may qualify if:

  • Primary caregiver of a patient diagnosed with breast cancer at any stage
  • Male or female caregiver
  • Aged 15 years or older
  • Providing physical, emotional, or financial support to the patient
  • Willing to give informed consent

You may not qualify if:

  • Paid caregivers (professional or hired help)
  • Age under 15 years
  • Unwilling to provide consent or participate in the study
  • Incomplete or missing essential data required for analysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Ayub Teaching Hospital

Abbottabad, Pubjab, Pakistan

Location

Nishtar Medical University and Hospital

Multan, Punjab Province, Pakistan

Location

Jinnah Postgraduate Medical Center

Karachi, Sindh, Pakistan

Location

Benazir Bhutto Hospital

Rawalpindi, Pakistan

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

May 17, 2025

First Posted

May 28, 2025

Study Start

May 1, 2024

Primary Completion

April 30, 2025

Study Completion

May 10, 2025

Last Updated

May 28, 2025

Record last verified: 2025-05

Locations