NCT03571984

Brief Summary

Breast cancer (BC) ranks second among all the types of cancer and is equally common in developing as well as developed countries. Breast cancer is most common type of cancer worldwide and its diagnosis as well as early treatment is associated with distress. The aim of this study is to explore the feasibility of integrating a 'Moving on After Breast Cancer (ABC)' manual developed by service user (Dr A Saleem) with Cognitive Behavior Therapyfor Pakistani women who are breast cancer (BC) survivors attending primary care and oncology services in Pakistan B) refine the Moving on ABC plus so as to develop a culturally appropriate therapeutic programme to be tested in a future definitive randomized controlled trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
354

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 28, 2018

Completed
9 months until next milestone

Study Start

First participant enrolled

March 10, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2022

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

2.8 years

First QC Date

June 18, 2018

Last Update Submit

April 11, 2023

Conditions

Breast Cancer FemaleDepression

Keywords

Breast cancerdepressionMoving on ABC PlusPakistan

Outcome Measures

Primary Outcomes (1)

  • Patient Health Questionnaire-9 (PHQ-9)

    Patient Health Questionnaire-9 (PHQ-9) will be used to diagnose depression.Minimum score of PHQ-9 is 0 and maximum score is 27. This scale categorizes depression in 5 different categories: minimal depression (score range 1-4), Mild depression (5-9), Moderate depression (10-14), Moderately severe depression (15-19), and Sever depression (20-27).

    Changes from baseline to 4th and 6th month outcome

Secondary Outcomes (7)

  • Generalized Anxiety Disorder - 7

    Changes from baseline to 4th and 6th month outcome

  • EuroQol-5D (EQ-5D)

    Changes from baseline to 4th and 6th month outcome

  • Multidimensional Scale for Perceived Social Support (MSPSS)

    Changes from baseline to 4th and 6th month outcome

  • Intrusive Thoughts Scale

    Changes from baseline to 4th and 6th month outcome

  • Rosenberg Self Esteem Scale

    Changes from baseline to 4th and 6th month outcome

  • +2 more secondary outcomes

Study Arms (2)

Moving on ABC Plus

EXPERIMENTAL

Moving on ABC Plus is combination of two interventions. The culturally adapted CBT and Moving on ABC. CBT will be integrated with The Moving on After Breast Cancer (ABC), which has been developed by Dr Anneela Saleem who suffered from breast cancer. The integrated intervention will consist of 12 sessions (60-90 minutes). The first 8 sessions will be delivered weekly and the last four sessions will be delivered fortnightly

Behavioral: Moving on ABC Plus

Routine Care

NO INTERVENTION

This will consist of routine assessment and management as usually conducted by oncology clinics and general practice. GP's will be informed about the psychiatric diagnosis.

Interventions

Moving on ABC PlusBEHAVIORAL

The intervention has two components. CBT Moving on After Breast Cancer

Moving on ABC Plus

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female
  • Breast cancer (stage I to stage IV)
  • Has completed primary treatment for breast cancer
  • Score of 10 or above on PHQ - 9 or GAD - 7
  • Age 18 and above

You may not qualify if:

  • Already diagnosed with any psychiatric illness
  • Already taking psychiatric medicines
  • Severe cognitive impairment (not able to give consent to take part in intervention)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Civil Hospital

Karachi, 75500, Pakistan

Location

Related Publications (2)

  • American cancer society (2010). The global economic cost of cancer. The American Cancer Society, Inc

    BACKGROUND

  • Husain N, Chaudhry I, Raza-ur-Rehman, Ahmed GR. Self-esteem and obsessive compulsive disorder. J Pak Med Assoc. 2014 Jan;64(1):64-8.

    PMID: 24605716BACKGROUND

MeSH Terms

Conditions

DepressionBreast Neoplasms

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Nasim Chaudhry, MD

    PILL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2018

First Posted

June 28, 2018

Study Start

March 10, 2019

Primary Completion

December 30, 2021

Study Completion

July 5, 2022

Last Updated

April 12, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)