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AzTrials

Breast Cancer FemaleMovingonABCNCT03571984

Moving on After Breast Cancer Plus- for Breast Cancer Survivors

A study testing Moving on ABC Plus in people with Breast Cancer Female and Depression, run by Pakistan Institute of Living and Learning at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer Female, Depression
What is being tested?
Moving on ABC Plus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
354 participants
Where
1 sitePakistan
Study dates
10 Mar 2019to 5 Jul 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Already diagnosed with any psychiatric illness
  • Already taking psychiatric medicines
  • Severe cognitive impairment (not able to give consent to take part in intervention)

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Civil Hospital

    Karachi, 75500

Other trials in Pakistan

About this study

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

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.

Read the 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.

Being tested
Moving on ABC Plus
Keywords
Breast cancer, depression, Moving on ABC Plus, Pakistan
Medical subject headings
Depression, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Moving on ABC PlusBehavioural

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

Study groups in NCT03571984
Study groupRoleWhat they receive
Moving on ABC PlusExperimentalMoving 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
Receives: Behavioral: Moving on ABC Plus
Routine CareNo interventionThis 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Changes from baseline to 4th and 6th month outcome

Secondary outcomes (7)

  1. Generalized Anxiety Disorder - 7

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

    Measured: Changes from baseline to 4th and 6th month outcome

  2. 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

    Measured: Changes from baseline to 4th and 6th month outcome

  3. 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

    Measured: Changes from baseline to 4th and 6th month outcome

  4. 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

    Measured: Changes from baseline to 4th and 6th month outcome

  5. Rosenberg Self Esteem Scale

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

    Measured: Changes from baseline to 4th and 6th month outcome

  6. 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

    Measured: Changes from baseline to 4th and 6th month outcome

  7. 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.

    Measured: This will be administered at 4-month follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2018
  2. Study start10 Mar 2019
  3. Primary completion30 Dec 2021
  4. Study completion5 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
354 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03571984
Sponsor's protocol ID
BC001
Acronym
MovingonABC
Status last verified
Apr 2023
First submitted
18 Jun 2018
Last updated
12 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24605716

Questions about this trial

What is this clinical trial studying?

A study testing Moving on ABC Plus in people with Breast Cancer Female and Depression, run by Pakistan Institute of Living and Learning at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Health Questionnaire-9 (PHQ-9) (time frame: Changes from baseline to 4th and 6th month outcome). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03571984, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.

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