Clinical trial NCT03571984: Moving on After Breast Cancer Plus- for Breast Cancer Survivors
Official title: A Culturally Adapted Positive Health Programme - Moving on After Breast Cancer Plus- for Breast Cancer Survivors: A Feasibility Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Female
Depression
Keywords: Breast cancer
depression
Moving on ABC Plus
Pakistan
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
First posted: 2018-06-28
Enrollment: 354
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Changes from baseline to 4th and 6th month outcome
Secondary outcomes:
measure: Generalized Anxiety Disorder - 7
timeFrame: Changes from baseline to 4th and 6th month outcome
measure: EuroQol-5D (EQ-5D)
timeFrame: Changes from baseline to 4th and 6th month outcome
measure: Multidimensional Scale for Perceived Social Support (MSPSS)
timeFrame: Changes from baseline to 4th and 6th month outcome
measure: Intrusive Thoughts Scale
timeFrame: Changes from baseline to 4th and 6th month outcome
measure: Rosenberg Self Esteem Scale
timeFrame: Changes from baseline to 4th and 6th month outcome
measure: The Functional Assessment of Cancer Therapy - Breast (FACT-B)
timeFrame: Changes from baseline to 4th and 6th month outcome
measure: Client Satisfaction Questionnaire
timeFrame: This will be administered at 4-month follow up
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Civil Hospital
Study officials:
affiliation: PILL
name: Nasim Chaudhry, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: American cancer society (2010). The global economic cost of cancer. The American Cancer Society, Inc
citation: 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.