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NCT Number: NCT03571984

Moving on After Breast Cancer Plus- for Breast Cancer Survivors

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.

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Key information

Conditions

Breast Cancer Female Behavior Behavioral Symptoms Breast Diseases Breast Neoplasms Depression Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Civil Hospital

Karachi, 75500, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Moving on ABC Plus

Behavioral

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

Primary outcomes

  1. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Changes from baseline to 4th and 6th month outcome

    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).

Secondary outcomes

  1. Generalized Anxiety Disorder - 7

    Time frame: Changes from baseline to 4th and 6th month outcome

    This is a short self-report measure to assess the presence and severity of generalized anxiety.

  2. EuroQol-5D (EQ-5D)

    Time frame: Changes from baseline to 4th and 6th month outcome

    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

  3. Multidimensional Scale for Perceived Social Support (MSPSS)

    Time frame: Changes from baseline to 4th and 6th month outcome

    Multidimensional Scale for Perceived Social Support (MSPSS) will be used to assess level of social support. Higher scores indicate higher level of support

  4. Intrusive Thoughts Scale

    Time frame: Changes from baseline to 4th and 6th month outcome

    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

  5. Rosenberg Self Esteem Scale

    Time frame: Changes from baseline to 4th and 6th month outcome

    This is a ten item Likert scale to measure self-esteem. Higher scores indicate better self esteem.

  6. The Functional Assessment of Cancer Therapy - Breast (FACT-B)

    Time frame: Changes from baseline to 4th and 6th month outcome

    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

  7. Client Satisfaction Questionnaire

    Time frame: This will be administered at 4-month follow up

    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.

Sponsors and collaborators

Lead sponsor

Pakistan Institute of Living and Learning

Other

Registry information

Official study title

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

Acronym: MovingonABC

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jun 28, 2018
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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