NCT03571984

Moving on After Breast Cancer Plus- for Breast Cancer Survivors

A Culturally Adapted Positive Health Programme - Moving on After Breast Cancer Plus- for Breast Cancer Survivors: A Feasibility Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 354 (actual)
• Sponsor: Pakistan Institute of Living and Learning · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	Moving on ABC Plus	The intervention has two components. CBT Moving on After Breast Cancer

Timeline

• Start date: 2019-03-10
• Primary completion: 2021-12-30
• Completion: 2022-07-05
• First posted: 2018-06-28
• Last updated: 2023-04-12

Locations

1 site across 1 country: Pakistan