Moving on After Breast Cancer Plus- for Breast Cancer Survivors

Depression Clinical Trial

— MovingonABC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03571984
• Other study ID #: BC001
• Status: Completed
• Phase: N/A
• Start date: March 10, 2019
• Est. completion date: July 5, 2022

Study information

• Verified date: April 2023
• Source: Pakistan Institute of Living and Learning
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 354
• Est. completion date: July 5, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms
• Depression

Intervention

Behavioral:
• Moving on ABC Plus
The intervention has two components. CBT Moving on After Breast Cancer

Locations

Country	Name	City	State
Pakistan	Civil Hospital	Karachi

Sponsors (1)

Lead Sponsor	Collaborator
Pakistan Institute of Living and Learning

Country where clinical trial is conducted

Pakistan, 

References & Publications (2)

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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