Moving on After Breast Cancer Plus- for Breast Cancer Survivors

NCT ID: NCT03571984

Last Updated: 2023-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 354 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-10
• Study Completion Date: 2022-07-05

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.

Detailed Description

According to an estimate of World Health Organization (2000) cancer was responsible for 12% of all the deaths from all causes worldwide and rate of cancer is expected to increase 50% by the year 2020. In Pakistan every ninth women has a chance of developing breast cancer, which is highest rate in Asia. The estimated incidence rate of breast cancer in Pakistan is 50/100,000. Despite the high association of distress with breast cancer, data on prevalence of depression in women with breast cancer especially in low income countries is limited .

The proposed project consists of two phases: 1) Phase 1: Integration of the two existing interventions Moving On ABC and the Cognitive Behavior Therapy and the refinement of the integrated intervention. 2) Phase 2: Randomized Control Trial (RCT). Sample size of Phase II will be comprised of 50 patients. Patients will be divided into two groups. One group will receive Group moving on ABC Plus intervention and other group will receive routine care. The total sample size of the effectiveness trial 354.

Conditions

Breast Cancer Female; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Moving on ABC Plus

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

Group Type: EXPERIMENTAL

Moving on ABC Plus

Intervention Type: BEHAVIORAL

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

Routine Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Moving on ABC Plus

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pakistan Institute of Living and Learning

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nasim Chaudhry, MD

Role: PRINCIPAL_INVESTIGATOR

PILL

Locations

Civil Hospital

Karachi, , Pakistan

Countries

Pakistan

References

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 24605716 (View on PubMed)

Other Identifiers

BC001

Identifier Type: -

Identifier Source: org_study_id