Moving on After Breast Cancer Plus- for Breast Cancer Survivors

Study Overview
=================
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.

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

Conditions
-----------------
Depression, Breast Cancer Female

Intervention / Treatment
-----------------
* Behavioral: Moving on ABC Plus


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moving on ABC Plus<br>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<br>* The intervention has two components. CBT Moving on After Breast Cancer<br>|
| No Intervention: Routine Care<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Generalized Anxiety Disorder - 7 | This is a short self-report measure to assess the presence and severity of generalized anxiety. | Changes from baseline to 4th and 6th month outcome | 
| EuroQol-5D (EQ-5D) | EuroQol-5D (EQ-5D), a 5-itme scale, will be used to assess the quality of life. Lower raw score indicates better quality of life | Changes from baseline to 4th and 6th month outcome | 
| Multidimensional Scale for Perceived Social Support (MSPSS) | Multidimensional Scale for Perceived Social Support (MSPSS) will be used to assess level of social support. Higher scores indicate higher level of support | Changes from baseline to 4th and 6th month outcome | 
| Intrusive Thoughts Scale | We will measure Breast Cancer distress with the 7 item subscale of the revised Impact of Event Scale which is reported to be sensitive to change in BC survivors who are receiving a CBT intervention | Changes from baseline to 4th and 6th month outcome | 
| Rosenberg Self Esteem Scale | This is a ten item Likert scale to measure self-esteem. Higher scores indicate better self esteem. | Changes from baseline to 4th and 6th month outcome | 
| The Functional Assessment of Cancer Therapy - Breast (FACT-B) | This is one of the most widely used scales to measure health-related quality of life in BC patients. Minimum total score on the scale is 0 and maximum score is 148. Higher score on the scale indicate poor quality of life | Changes from baseline to 4th and 6th month outcome | 
| Client Satisfaction Questionnaire | This is a well validated self-report measure of client/ patient satisfaction with health services. Minimum total score is 1 and maximum score is 32. Higher score indicate higher level of satisfaction with the services. | This will be administered at 4-month follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer, depression, Moving on ABC Plus, Pakistan